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Product Update: Sureglide Cesarean Scalpel; Viveve Medical; NovaSure ADVANCED

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Product Update: Sureglide Cesarean Scalpel; Viveve Medical; NovaSure ADVANCED

SAFER CESAREAN SCALPEL

The Sureglide Cesarean Scalpel™ is designed to reduce the risk of fetal injury from nicks, cuts, or lacerations during hysterotomy and protect physicians, nurses, and other surgical staff from sharp injury. Sureglide manufacturer Ecomed Solutions points out that, as the number of cesarean deliveries increases so does the risk of fetal injury as often the face, cheek, and ear of the fetus are in line with the hysterotomy incision. Unlike typical scalpels, Sureglide’s design eliminates fetal exposure to the blade regardless of uterine wall thickness or number of passes, says Ecomed. The scalpel’s protected blade is designed to cut up and away from the fetus and eliminate exposure to the blade by surgical staff.

FOR MORE INFORMATION, VISIT: www.sureglide.info

 

RF ENERGY TO IMPROVE SEXUAL FUNCTION

Viveve Medical says its GENEVEVE treatment offers improvement in vaginal laxity and sexual function using cryogen-cooled monopolar radiofrequency (CMRF) to uniformly deliver volumetric heating (90 J/cm2) while cooling delicate surface tissue. CMRF stimulates the body’s natural collagen formation process by penetrating 3–5 mm deep into connective tissue. The Geneveve single-session treatment is performed in an outpatient setting in 30 minutes.

According to Viveve Medical, results of the recent Viveve I multicenter, blinded, randomized, sham controlled study showed no serious adverse effects plus improvement in arousal and/or orgasm self-reported by 9 of 10 women who noted vaginal laxity and sexual dysfunction following vaginal childbirth.

FOR MORE INFORMATION, VISIT: www.viveve.com

 

NEXT-GENERATION ENDOMETRIAL ABLATION

Hologic’s new NovaSure® ADVANCED global endometrial ablation system with a 6-mm sheath size requires less cervical dilation than the 8-mm NovaSure device. Hologic says the new device is designed to improve patient comfort and physician ease-of-use while maintaining clinical efficacy. NovaSure ADVANCED’s acorn-shaped cervical seal provides 13% more working length than the 8-mm NovaSure device. Smooth Access™ tips and blue handle simplify insertion. NovaSure endometrial ablation, a one-time procedure, can be performed in the office or operating room to reduce or stop abnormal uterine bleeding.

FOR MORE INFORMATION, VISIT: www.novasure.com

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SAFER CESAREAN SCALPEL

The Sureglide Cesarean Scalpel™ is designed to reduce the risk of fetal injury from nicks, cuts, or lacerations during hysterotomy and protect physicians, nurses, and other surgical staff from sharp injury. Sureglide manufacturer Ecomed Solutions points out that, as the number of cesarean deliveries increases so does the risk of fetal injury as often the face, cheek, and ear of the fetus are in line with the hysterotomy incision. Unlike typical scalpels, Sureglide’s design eliminates fetal exposure to the blade regardless of uterine wall thickness or number of passes, says Ecomed. The scalpel’s protected blade is designed to cut up and away from the fetus and eliminate exposure to the blade by surgical staff.

FOR MORE INFORMATION, VISIT: www.sureglide.info

 

RF ENERGY TO IMPROVE SEXUAL FUNCTION

Viveve Medical says its GENEVEVE treatment offers improvement in vaginal laxity and sexual function using cryogen-cooled monopolar radiofrequency (CMRF) to uniformly deliver volumetric heating (90 J/cm2) while cooling delicate surface tissue. CMRF stimulates the body’s natural collagen formation process by penetrating 3–5 mm deep into connective tissue. The Geneveve single-session treatment is performed in an outpatient setting in 30 minutes.

According to Viveve Medical, results of the recent Viveve I multicenter, blinded, randomized, sham controlled study showed no serious adverse effects plus improvement in arousal and/or orgasm self-reported by 9 of 10 women who noted vaginal laxity and sexual dysfunction following vaginal childbirth.

FOR MORE INFORMATION, VISIT: www.viveve.com

 

NEXT-GENERATION ENDOMETRIAL ABLATION

Hologic’s new NovaSure® ADVANCED global endometrial ablation system with a 6-mm sheath size requires less cervical dilation than the 8-mm NovaSure device. Hologic says the new device is designed to improve patient comfort and physician ease-of-use while maintaining clinical efficacy. NovaSure ADVANCED’s acorn-shaped cervical seal provides 13% more working length than the 8-mm NovaSure device. Smooth Access™ tips and blue handle simplify insertion. NovaSure endometrial ablation, a one-time procedure, can be performed in the office or operating room to reduce or stop abnormal uterine bleeding.

FOR MORE INFORMATION, VISIT: www.novasure.com

SAFER CESAREAN SCALPEL

The Sureglide Cesarean Scalpel™ is designed to reduce the risk of fetal injury from nicks, cuts, or lacerations during hysterotomy and protect physicians, nurses, and other surgical staff from sharp injury. Sureglide manufacturer Ecomed Solutions points out that, as the number of cesarean deliveries increases so does the risk of fetal injury as often the face, cheek, and ear of the fetus are in line with the hysterotomy incision. Unlike typical scalpels, Sureglide’s design eliminates fetal exposure to the blade regardless of uterine wall thickness or number of passes, says Ecomed. The scalpel’s protected blade is designed to cut up and away from the fetus and eliminate exposure to the blade by surgical staff.

FOR MORE INFORMATION, VISIT: www.sureglide.info

 

RF ENERGY TO IMPROVE SEXUAL FUNCTION

Viveve Medical says its GENEVEVE treatment offers improvement in vaginal laxity and sexual function using cryogen-cooled monopolar radiofrequency (CMRF) to uniformly deliver volumetric heating (90 J/cm2) while cooling delicate surface tissue. CMRF stimulates the body’s natural collagen formation process by penetrating 3–5 mm deep into connective tissue. The Geneveve single-session treatment is performed in an outpatient setting in 30 minutes.

According to Viveve Medical, results of the recent Viveve I multicenter, blinded, randomized, sham controlled study showed no serious adverse effects plus improvement in arousal and/or orgasm self-reported by 9 of 10 women who noted vaginal laxity and sexual dysfunction following vaginal childbirth.

FOR MORE INFORMATION, VISIT: www.viveve.com

 

NEXT-GENERATION ENDOMETRIAL ABLATION

Hologic’s new NovaSure® ADVANCED global endometrial ablation system with a 6-mm sheath size requires less cervical dilation than the 8-mm NovaSure device. Hologic says the new device is designed to improve patient comfort and physician ease-of-use while maintaining clinical efficacy. NovaSure ADVANCED’s acorn-shaped cervical seal provides 13% more working length than the 8-mm NovaSure device. Smooth Access™ tips and blue handle simplify insertion. NovaSure endometrial ablation, a one-time procedure, can be performed in the office or operating room to reduce or stop abnormal uterine bleeding.

FOR MORE INFORMATION, VISIT: www.novasure.com

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Product News: January 2017

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Enbrel

Amgen Inc announces that the US Food and Drug Administration has approved the supplemental Biologics License Application for the expanded use of Enbrel (etanercept) for the treatment of moderate to severe plaque psoriasis in pediatric patients (aged 4–17 years). Enbrel, a tumor necrosis factor blocker, was approved for the treatment of moderate to severe plaque psoriasis in adults in 2004. For more information, visit www.enbrel.com.

Eucrisa

Pfizer Inc announces US Food and Drug Administration approval of Eucrisa (crisaborole) ointment 2% for the treatment of mild to moderate atopic dermatitis in patients 2 years and older. Eucrisa is a nonsteroidal topical phosphodiesterase 4 inhibitor and is applied twice daily. This approval provides patients with atopic dermatitis another treatment alternative, as this community has not had a new prescription treatment for more than 10 years. For more information, visit www.pfizer.com.

Isdinceutics

Isdin based in Spain has launched the Isdinceutics line of physician-dispensed cosmeceuticals to the US market, which focuses on vitamins and hydrators rather than chemicals to rejuvenate the skin. Isdinceutics features a daily antioxidant routine with Flavo-C Ultraglican and Flavo-C Serum to reduce the appearance of microwrinkles and elevate the skin’s natural moisture production. Products to correct pigmentation problems as well as undereye circles and puffiness also are available. For more information, visit www.isdin.com/us.

 

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

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Enbrel

Amgen Inc announces that the US Food and Drug Administration has approved the supplemental Biologics License Application for the expanded use of Enbrel (etanercept) for the treatment of moderate to severe plaque psoriasis in pediatric patients (aged 4–17 years). Enbrel, a tumor necrosis factor blocker, was approved for the treatment of moderate to severe plaque psoriasis in adults in 2004. For more information, visit www.enbrel.com.

Eucrisa

Pfizer Inc announces US Food and Drug Administration approval of Eucrisa (crisaborole) ointment 2% for the treatment of mild to moderate atopic dermatitis in patients 2 years and older. Eucrisa is a nonsteroidal topical phosphodiesterase 4 inhibitor and is applied twice daily. This approval provides patients with atopic dermatitis another treatment alternative, as this community has not had a new prescription treatment for more than 10 years. For more information, visit www.pfizer.com.

Isdinceutics

Isdin based in Spain has launched the Isdinceutics line of physician-dispensed cosmeceuticals to the US market, which focuses on vitamins and hydrators rather than chemicals to rejuvenate the skin. Isdinceutics features a daily antioxidant routine with Flavo-C Ultraglican and Flavo-C Serum to reduce the appearance of microwrinkles and elevate the skin’s natural moisture production. Products to correct pigmentation problems as well as undereye circles and puffiness also are available. For more information, visit www.isdin.com/us.

 

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

Enbrel

Amgen Inc announces that the US Food and Drug Administration has approved the supplemental Biologics License Application for the expanded use of Enbrel (etanercept) for the treatment of moderate to severe plaque psoriasis in pediatric patients (aged 4–17 years). Enbrel, a tumor necrosis factor blocker, was approved for the treatment of moderate to severe plaque psoriasis in adults in 2004. For more information, visit www.enbrel.com.

Eucrisa

Pfizer Inc announces US Food and Drug Administration approval of Eucrisa (crisaborole) ointment 2% for the treatment of mild to moderate atopic dermatitis in patients 2 years and older. Eucrisa is a nonsteroidal topical phosphodiesterase 4 inhibitor and is applied twice daily. This approval provides patients with atopic dermatitis another treatment alternative, as this community has not had a new prescription treatment for more than 10 years. For more information, visit www.pfizer.com.

Isdinceutics

Isdin based in Spain has launched the Isdinceutics line of physician-dispensed cosmeceuticals to the US market, which focuses on vitamins and hydrators rather than chemicals to rejuvenate the skin. Isdinceutics features a daily antioxidant routine with Flavo-C Ultraglican and Flavo-C Serum to reduce the appearance of microwrinkles and elevate the skin’s natural moisture production. Products to correct pigmentation problems as well as undereye circles and puffiness also are available. For more information, visit www.isdin.com/us.

 

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

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Product Update: JUST…Love, pjur med

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MASSAGE AND MOISTURING OIL

JUST…Love, from Just Pure Essentials, is a massage and moisturizing oil product line made of plant-based oils infused with a variety of herbs.

Just Pure Essentials suggests that JUST…Love be used to moisturize the face and body and for facial cleansing and shaving. It has been recommended by women’s health professionals as a lubricant and moisturizer to relieve vaginal dryness, says the manufacturer.

Just Pure Essentials products are 100% vegan; chemical and preservative free; and without alcohols, additives, or phytoestrogens. The base of each product is coconut medium-chain triglyceride (MCT) oil pressed from nongenetically modified coconut oil by a steam distillation process. The oil is blended with other organic oils and botanical ingredients, including green tea see oil, French plum oil, argan, and marshmallow leaf. It does not contain dyes, perfumes, or artificial flavors. Just Pure Essentials says its formulas do not dry up and turn sticky.

FOR MORE INFORMATION, VISIT: www.justpureessentials.com

 

 

SEXUAL HEALTH AND WELLBEING

pjur med offers a line of sexual health and wellbeing products that are both water- and silicon-based. Products have natural and nature-identical ingredients to treat vaginal dryness, especially during menopause, after long-term drug ingestion, or when hormonal balance may be disturbed by stress or during pregnancy or lactation, resulting in insufficient natural moisture.

pjur med says that PREMIUM glide is specially formulated for dry or highly sensitive genital mucous membranes and is made of non–pore-blocking, high-quality silicones. SENSITIVE glide is specifically developed for those with very sensitive genital mucous membranes, according to the manufacturer. Both products are available in 3.4 fl oz bottles. pjur med suggests its products are suitable for every skin type and maintains that they are dermatologically tested and paraben-, glycerin-, and preservative-free. In addition, pjur med says its formulas have been kept as neutral as possible and the ingredients have been put together in a way that microbial growth cannot occur.

FOR MORE INFORMATION, VISIT: www.pjurmed.com

 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

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MASSAGE AND MOISTURING OIL

JUST…Love, from Just Pure Essentials, is a massage and moisturizing oil product line made of plant-based oils infused with a variety of herbs.

Just Pure Essentials suggests that JUST…Love be used to moisturize the face and body and for facial cleansing and shaving. It has been recommended by women’s health professionals as a lubricant and moisturizer to relieve vaginal dryness, says the manufacturer.

Just Pure Essentials products are 100% vegan; chemical and preservative free; and without alcohols, additives, or phytoestrogens. The base of each product is coconut medium-chain triglyceride (MCT) oil pressed from nongenetically modified coconut oil by a steam distillation process. The oil is blended with other organic oils and botanical ingredients, including green tea see oil, French plum oil, argan, and marshmallow leaf. It does not contain dyes, perfumes, or artificial flavors. Just Pure Essentials says its formulas do not dry up and turn sticky.

FOR MORE INFORMATION, VISIT: www.justpureessentials.com

 

 

SEXUAL HEALTH AND WELLBEING

pjur med offers a line of sexual health and wellbeing products that are both water- and silicon-based. Products have natural and nature-identical ingredients to treat vaginal dryness, especially during menopause, after long-term drug ingestion, or when hormonal balance may be disturbed by stress or during pregnancy or lactation, resulting in insufficient natural moisture.

pjur med says that PREMIUM glide is specially formulated for dry or highly sensitive genital mucous membranes and is made of non–pore-blocking, high-quality silicones. SENSITIVE glide is specifically developed for those with very sensitive genital mucous membranes, according to the manufacturer. Both products are available in 3.4 fl oz bottles. pjur med suggests its products are suitable for every skin type and maintains that they are dermatologically tested and paraben-, glycerin-, and preservative-free. In addition, pjur med says its formulas have been kept as neutral as possible and the ingredients have been put together in a way that microbial growth cannot occur.

FOR MORE INFORMATION, VISIT: www.pjurmed.com

 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

MASSAGE AND MOISTURING OIL

JUST…Love, from Just Pure Essentials, is a massage and moisturizing oil product line made of plant-based oils infused with a variety of herbs.

Just Pure Essentials suggests that JUST…Love be used to moisturize the face and body and for facial cleansing and shaving. It has been recommended by women’s health professionals as a lubricant and moisturizer to relieve vaginal dryness, says the manufacturer.

Just Pure Essentials products are 100% vegan; chemical and preservative free; and without alcohols, additives, or phytoestrogens. The base of each product is coconut medium-chain triglyceride (MCT) oil pressed from nongenetically modified coconut oil by a steam distillation process. The oil is blended with other organic oils and botanical ingredients, including green tea see oil, French plum oil, argan, and marshmallow leaf. It does not contain dyes, perfumes, or artificial flavors. Just Pure Essentials says its formulas do not dry up and turn sticky.

FOR MORE INFORMATION, VISIT: www.justpureessentials.com

 

 

SEXUAL HEALTH AND WELLBEING

pjur med offers a line of sexual health and wellbeing products that are both water- and silicon-based. Products have natural and nature-identical ingredients to treat vaginal dryness, especially during menopause, after long-term drug ingestion, or when hormonal balance may be disturbed by stress or during pregnancy or lactation, resulting in insufficient natural moisture.

pjur med says that PREMIUM glide is specially formulated for dry or highly sensitive genital mucous membranes and is made of non–pore-blocking, high-quality silicones. SENSITIVE glide is specifically developed for those with very sensitive genital mucous membranes, according to the manufacturer. Both products are available in 3.4 fl oz bottles. pjur med suggests its products are suitable for every skin type and maintains that they are dermatologically tested and paraben-, glycerin-, and preservative-free. In addition, pjur med says its formulas have been kept as neutral as possible and the ingredients have been put together in a way that microbial growth cannot occur.

FOR MORE INFORMATION, VISIT: www.pjurmed.com

 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

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Product Update: Kyleena; LapCap2

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NEW LNG IUS: GOOD FOR 5 YEARS

Kyleena™ (levonorgestrel-releasing intrauterine system; IUS) 19.5 mg, from Bayer, is a new hormonal contraceptive device used to prevent pregnancy for up to 5 years. The small, flexible plastic, T-shaped long-acting reversible contraceptive can be distinguished from other IUSs by the combination of the visibility of the silver ring on ultrasound and the blue color of the removal threads, says Bayer. Kyleena is placed by a health care provider during an office visit. Bayer indicates that metrorrhagia or menorrhagia may occur during the first 3 to 6 months of use, and menstrual periods may become infrequent or cease.

FOR MORE INFORMATION, VISIT:
https://hcp.kyleena-us.com/

 

 

EASIER LAPAROSCOPIC ACCESS

LapCap2 is a sterile, single-use device with a molded plastic dome, a suction-system port, and a septum for Veress needle insertion from Life Care Medical Devices that is designed to provide safe and rapid access for minimally invasive surgery. Life Care says single-operator access and abdominal stabilization are advantages of LapCap2.

To use LapCap2, says Life Care, center it over the umbilicus, attach a hose to the suction port, and apply negative pressure. The abdomen immediately rises for Veress needle insertion. Inert gas is then delivered to replace the negative pressure, and the procedure can continue.

FOR MORE INFORMATION, VISIT:
http://www.lcmd.com/products/lapcap2

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NEW LNG IUS: GOOD FOR 5 YEARS

Kyleena™ (levonorgestrel-releasing intrauterine system; IUS) 19.5 mg, from Bayer, is a new hormonal contraceptive device used to prevent pregnancy for up to 5 years. The small, flexible plastic, T-shaped long-acting reversible contraceptive can be distinguished from other IUSs by the combination of the visibility of the silver ring on ultrasound and the blue color of the removal threads, says Bayer. Kyleena is placed by a health care provider during an office visit. Bayer indicates that metrorrhagia or menorrhagia may occur during the first 3 to 6 months of use, and menstrual periods may become infrequent or cease.

FOR MORE INFORMATION, VISIT:
https://hcp.kyleena-us.com/

 

 

EASIER LAPAROSCOPIC ACCESS

LapCap2 is a sterile, single-use device with a molded plastic dome, a suction-system port, and a septum for Veress needle insertion from Life Care Medical Devices that is designed to provide safe and rapid access for minimally invasive surgery. Life Care says single-operator access and abdominal stabilization are advantages of LapCap2.

To use LapCap2, says Life Care, center it over the umbilicus, attach a hose to the suction port, and apply negative pressure. The abdomen immediately rises for Veress needle insertion. Inert gas is then delivered to replace the negative pressure, and the procedure can continue.

FOR MORE INFORMATION, VISIT:
http://www.lcmd.com/products/lapcap2

NEW LNG IUS: GOOD FOR 5 YEARS

Kyleena™ (levonorgestrel-releasing intrauterine system; IUS) 19.5 mg, from Bayer, is a new hormonal contraceptive device used to prevent pregnancy for up to 5 years. The small, flexible plastic, T-shaped long-acting reversible contraceptive can be distinguished from other IUSs by the combination of the visibility of the silver ring on ultrasound and the blue color of the removal threads, says Bayer. Kyleena is placed by a health care provider during an office visit. Bayer indicates that metrorrhagia or menorrhagia may occur during the first 3 to 6 months of use, and menstrual periods may become infrequent or cease.

FOR MORE INFORMATION, VISIT:
https://hcp.kyleena-us.com/

 

 

EASIER LAPAROSCOPIC ACCESS

LapCap2 is a sterile, single-use device with a molded plastic dome, a suction-system port, and a septum for Veress needle insertion from Life Care Medical Devices that is designed to provide safe and rapid access for minimally invasive surgery. Life Care says single-operator access and abdominal stabilization are advantages of LapCap2.

To use LapCap2, says Life Care, center it over the umbilicus, attach a hose to the suction port, and apply negative pressure. The abdomen immediately rises for Veress needle insertion. Inert gas is then delivered to replace the negative pressure, and the procedure can continue.

FOR MORE INFORMATION, VISIT:
http://www.lcmd.com/products/lapcap2

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Product News: October 2016

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Carmex Comfort Care

Carma Labs Inc introduces Carmex Comfort Care lip balm, a natural lip care product formulated with colloidal oatmeal and cold-pressed fruit oil to deliver soothing, long-lasting moisture and hydration. Colloidal oatmeal also possesses antioxidant and anti-inflammatory properties that benefit sensitive drug skin, especially on the lips. For more information, visit www.mycarmex.com.

Erelzi

Sandoz Inc, a Novartis Division, announces US Food and Drug Administration approval of Erelzi (etanercept-szzs) for all indications included in the reference product label: rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis. Erelzi is the second approved biosimilar from Sandoz. For more information, visit www.erelzi.com.

Loprox Cream

Medimetriks Pharmaceuticals, Inc, announces the launch of Loprox (ciclopirox) Cream 0.77% and the Loprox Cream Kit. Loprox Cream is a broad-spectrum therapy that treats 5 different skin infections from 6 different pathogens. It is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis due to Candia albicans; and tinea (pityriasis) versicolor due to Malassezia furfur. Loprox Cream works quickly, usually within the first week (2 weeks for tinea versicolor), providing patients needed relief of pruritus and other symptoms. The Loprox Cream Kit includes Loprox Cream and Rehyla Hair + Body Cleanser for patient convenience. The cleanser hydrates and conditions and is gentle for daily use on the scalp and body. For more information, visit www.medimetriks.com.


If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

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Cutis - 98(4)
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Carmex Comfort Care

Carma Labs Inc introduces Carmex Comfort Care lip balm, a natural lip care product formulated with colloidal oatmeal and cold-pressed fruit oil to deliver soothing, long-lasting moisture and hydration. Colloidal oatmeal also possesses antioxidant and anti-inflammatory properties that benefit sensitive drug skin, especially on the lips. For more information, visit www.mycarmex.com.

Erelzi

Sandoz Inc, a Novartis Division, announces US Food and Drug Administration approval of Erelzi (etanercept-szzs) for all indications included in the reference product label: rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis. Erelzi is the second approved biosimilar from Sandoz. For more information, visit www.erelzi.com.

Loprox Cream

Medimetriks Pharmaceuticals, Inc, announces the launch of Loprox (ciclopirox) Cream 0.77% and the Loprox Cream Kit. Loprox Cream is a broad-spectrum therapy that treats 5 different skin infections from 6 different pathogens. It is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis due to Candia albicans; and tinea (pityriasis) versicolor due to Malassezia furfur. Loprox Cream works quickly, usually within the first week (2 weeks for tinea versicolor), providing patients needed relief of pruritus and other symptoms. The Loprox Cream Kit includes Loprox Cream and Rehyla Hair + Body Cleanser for patient convenience. The cleanser hydrates and conditions and is gentle for daily use on the scalp and body. For more information, visit www.medimetriks.com.


If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

Carmex Comfort Care

Carma Labs Inc introduces Carmex Comfort Care lip balm, a natural lip care product formulated with colloidal oatmeal and cold-pressed fruit oil to deliver soothing, long-lasting moisture and hydration. Colloidal oatmeal also possesses antioxidant and anti-inflammatory properties that benefit sensitive drug skin, especially on the lips. For more information, visit www.mycarmex.com.

Erelzi

Sandoz Inc, a Novartis Division, announces US Food and Drug Administration approval of Erelzi (etanercept-szzs) for all indications included in the reference product label: rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis. Erelzi is the second approved biosimilar from Sandoz. For more information, visit www.erelzi.com.

Loprox Cream

Medimetriks Pharmaceuticals, Inc, announces the launch of Loprox (ciclopirox) Cream 0.77% and the Loprox Cream Kit. Loprox Cream is a broad-spectrum therapy that treats 5 different skin infections from 6 different pathogens. It is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis due to Candia albicans; and tinea (pityriasis) versicolor due to Malassezia furfur. Loprox Cream works quickly, usually within the first week (2 weeks for tinea versicolor), providing patients needed relief of pruritus and other symptoms. The Loprox Cream Kit includes Loprox Cream and Rehyla Hair + Body Cleanser for patient convenience. The cleanser hydrates and conditions and is gentle for daily use on the scalp and body. For more information, visit www.medimetriks.com.


If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

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Product Update: SureSound+ device; LILETTA single-handed inserter

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PRECISE PREABLATION MEASUREMENT

The SureSound® + device is new to the NovaSure® system. Hologic, Inc. says that the SureSound + device provides the precise uterine cavity length measurement to allow NovaSure to effectively deliver ablation to alleviate or end heavy menstrual bleeding without hormonal side effects. According to Hologic, their research indicates high patient satisfaction rates and low complication rates.

The SureSound + device is designed to allow a physician to measure cavity length with one click, unlike traditional sounding methods that require multiple calculations, says Hologic. Hologic indicates that the device is inserted through the cervical canal, the Malecot anchor is deployed on the internal os, and the inner probe’s polyethylene tip is extended to the fundus to gauge uterine cavity length. The single-use device also may reduce the risk of contamination, says Hologic.

The manufacturer indicates the NovaSure procedure is appropriate for treating premenopausal women with heavy periods due to benign causes who have finished childbearing.

FOR MORE INFORMATION, VISIT: http://www.novasure.com/hcp/suresound_plus

 

NEW LILETTA INSERTER

Allergan and Medicines360 announce the launch of a new LILETTA® (levonorgestrel-releasing intrauterine system) 52-mg intrauterine device (IUD) single-handed inserter following US Food and Drug Administration approval in January 2016.

The companies indicate that the LILETTA IUD is for use by women wishing to prevent pregnancy for up to 3 years regardless of parity or body mass index, with a cumulative 3-year efficacy rate of 99.45%. Approval of the new LILETTA single-handed inserter was based on the ACCESS IUS study that enrolled 1,751 US women and also led to LILETTA’s approval. Product marketing materials state that, during the ACCESS IUS study, the success rate for insertions with the new inserter was 99.2%. The original inserter requires a 2-handed technique.

According to Allergan and Medicines360, the new inserter includes: an ergonomic design allowing for single-handed insertion that can be used with either hand, a bendable tube to accommodate the anatomy of the patient during insertion, and the ability to reload the device if needed before insertion.

FOR MORE INFORMATION, VISIT: https://www.liletta.com

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PRECISE PREABLATION MEASUREMENT

The SureSound® + device is new to the NovaSure® system. Hologic, Inc. says that the SureSound + device provides the precise uterine cavity length measurement to allow NovaSure to effectively deliver ablation to alleviate or end heavy menstrual bleeding without hormonal side effects. According to Hologic, their research indicates high patient satisfaction rates and low complication rates.

The SureSound + device is designed to allow a physician to measure cavity length with one click, unlike traditional sounding methods that require multiple calculations, says Hologic. Hologic indicates that the device is inserted through the cervical canal, the Malecot anchor is deployed on the internal os, and the inner probe’s polyethylene tip is extended to the fundus to gauge uterine cavity length. The single-use device also may reduce the risk of contamination, says Hologic.

The manufacturer indicates the NovaSure procedure is appropriate for treating premenopausal women with heavy periods due to benign causes who have finished childbearing.

FOR MORE INFORMATION, VISIT: http://www.novasure.com/hcp/suresound_plus

 

NEW LILETTA INSERTER

Allergan and Medicines360 announce the launch of a new LILETTA® (levonorgestrel-releasing intrauterine system) 52-mg intrauterine device (IUD) single-handed inserter following US Food and Drug Administration approval in January 2016.

The companies indicate that the LILETTA IUD is for use by women wishing to prevent pregnancy for up to 3 years regardless of parity or body mass index, with a cumulative 3-year efficacy rate of 99.45%. Approval of the new LILETTA single-handed inserter was based on the ACCESS IUS study that enrolled 1,751 US women and also led to LILETTA’s approval. Product marketing materials state that, during the ACCESS IUS study, the success rate for insertions with the new inserter was 99.2%. The original inserter requires a 2-handed technique.

According to Allergan and Medicines360, the new inserter includes: an ergonomic design allowing for single-handed insertion that can be used with either hand, a bendable tube to accommodate the anatomy of the patient during insertion, and the ability to reload the device if needed before insertion.

FOR MORE INFORMATION, VISIT: https://www.liletta.com

PRECISE PREABLATION MEASUREMENT

The SureSound® + device is new to the NovaSure® system. Hologic, Inc. says that the SureSound + device provides the precise uterine cavity length measurement to allow NovaSure to effectively deliver ablation to alleviate or end heavy menstrual bleeding without hormonal side effects. According to Hologic, their research indicates high patient satisfaction rates and low complication rates.

The SureSound + device is designed to allow a physician to measure cavity length with one click, unlike traditional sounding methods that require multiple calculations, says Hologic. Hologic indicates that the device is inserted through the cervical canal, the Malecot anchor is deployed on the internal os, and the inner probe’s polyethylene tip is extended to the fundus to gauge uterine cavity length. The single-use device also may reduce the risk of contamination, says Hologic.

The manufacturer indicates the NovaSure procedure is appropriate for treating premenopausal women with heavy periods due to benign causes who have finished childbearing.

FOR MORE INFORMATION, VISIT: http://www.novasure.com/hcp/suresound_plus

 

NEW LILETTA INSERTER

Allergan and Medicines360 announce the launch of a new LILETTA® (levonorgestrel-releasing intrauterine system) 52-mg intrauterine device (IUD) single-handed inserter following US Food and Drug Administration approval in January 2016.

The companies indicate that the LILETTA IUD is for use by women wishing to prevent pregnancy for up to 3 years regardless of parity or body mass index, with a cumulative 3-year efficacy rate of 99.45%. Approval of the new LILETTA single-handed inserter was based on the ACCESS IUS study that enrolled 1,751 US women and also led to LILETTA’s approval. Product marketing materials state that, during the ACCESS IUS study, the success rate for insertions with the new inserter was 99.2%. The original inserter requires a 2-handed technique.

According to Allergan and Medicines360, the new inserter includes: an ergonomic design allowing for single-handed insertion that can be used with either hand, a bendable tube to accommodate the anatomy of the patient during insertion, and the ability to reload the device if needed before insertion.

FOR MORE INFORMATION, VISIT: https://www.liletta.com

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Collagen Meniscus Implant

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Ivy Sports Medicine (http://www.ivysportsmed.com/en)

Collagen Meniscus Implant

The number of patients undergoing arthroscopic partial meniscectomy has continued to increase. However, this is potentially not a benign procedure, as there are increased contact pressures on the articular cartilage even with the removal of only a segment of the meniscus.

The Collagen Meniscus Implant (CMI, Ivy Sports Medicine) is a resorbable and biocompatible Type I collagen matrix that was developed to restore the segmental loss of meniscal tissue in the knee. It consists of a porous cross-linked matrix scaffold that allows for the ingrowth of the body’s own cells. The CMI is the only meniscal implant composed of purely biological materials and is available in an off-the-shelf supply.

The CMI is available in the United States for use in the restoration of segmental loss of the medial meniscus. The CMI can be utilized in either an acute or chronic situation. In the acute case, it would be indicated when the medial meniscus is irreparable, and that segment must be removed. In the chronic case, the patient would have had a previous partial meniscectomy and/or failed meniscus repair and had developed either pain or signs of early articular cartilage wear in the compartment. The procedure can be done arthroscopically and as an outpatient. The CMI can be kept on the shelf to be available as needed; it has a 2-year shelf life. There are specialized instruments for measuring the length of implant needed and for delivery of the implant.

The CMI has been utilized clinically for 18 years with excellent clinical results. Patients treated with CMI have benefited in over 80% of cases. Studies have demonstrated improved knee function, activity levels, and pain values from the pre- to postoperative periods.1,2 In addition, functional improvements have been maintained for over 10 years. The reoperation rate has been demonstrated to be 10% to 20%, which is comparable to the reoperation rate after meniscal repair.

Surgical pearl: The surgical technique for insertion of the CMI is relatively uncomplicated (Figures A, B).

Figure.
The first step is the resection of all dysfunctional meniscus and then creating 90° walls to attach to posteriorly and anteriorly, and a firm peripheral rim to attach the CMI into.

The second step is to measure the length of your meniscus defect with the measuring rod.

Once measured, you want to oversize the implant 10% to 15% (ie, if you measure 30 mm, you will cut at least 34 mm). Use the measuring rod to measure the length of the CMI and mark your length. Use a new scalpel blade to cut the CMI.

 

 

Place the measured CMI into the delivery clamp and insert through a mini-arthrotomy into the meniscal defect. The fixation technique of the CMI is entirely up to the implanting surgeon. Most surgeons have used a combination of all-inside and inside-out meniscus repair techniques. It is recommended to start fixing the CMI first posteriorly. The posterior stitch is usually an all-inside horizontal mattress stitch. Coming 1 cm anteriorly, place a vertical mattress stitch. Continue this method sequentially while moving anteriorly. The anterior suture is the surgeon’s choice for device, but it should be a horizontal mattress like the most posterior stitch. It is important while tightening your suture tension to apply the concept of “approximated and not strangulated.” Once completed, close wounds in typical fashion.
References

1. Zaffagnini S, Marcheggiani Muccioli GM, Lopomo N, et al. Prospective long-term outcomes of the medial collagen meniscus implant versus partial medial meniscectomy: a minimum 10-year follow-up study. Am J Sports Med. 2011;39(5):977-985

2. Bulgheroni P, Murena L, Ratti C, Bulgheroni E, Ronga M, Cherubino P. Follow-up of collagen meniscus implant patients: clinical, radiological, and magnetic resonance imaging results at 5 years. Knee. 2010;17(3):224-229.

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Author’s Disclosure Statement: Dr. Gersoff reports that he is a consultant for Ivy Sports Medicine and Vericell.

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Author’s Disclosure Statement: Dr. Gersoff reports that he is a consultant for Ivy Sports Medicine and Vericell.

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Author’s Disclosure Statement: Dr. Gersoff reports that he is a consultant for Ivy Sports Medicine and Vericell.

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Ivy Sports Medicine (http://www.ivysportsmed.com/en)

Collagen Meniscus Implant

The number of patients undergoing arthroscopic partial meniscectomy has continued to increase. However, this is potentially not a benign procedure, as there are increased contact pressures on the articular cartilage even with the removal of only a segment of the meniscus.

The Collagen Meniscus Implant (CMI, Ivy Sports Medicine) is a resorbable and biocompatible Type I collagen matrix that was developed to restore the segmental loss of meniscal tissue in the knee. It consists of a porous cross-linked matrix scaffold that allows for the ingrowth of the body’s own cells. The CMI is the only meniscal implant composed of purely biological materials and is available in an off-the-shelf supply.

The CMI is available in the United States for use in the restoration of segmental loss of the medial meniscus. The CMI can be utilized in either an acute or chronic situation. In the acute case, it would be indicated when the medial meniscus is irreparable, and that segment must be removed. In the chronic case, the patient would have had a previous partial meniscectomy and/or failed meniscus repair and had developed either pain or signs of early articular cartilage wear in the compartment. The procedure can be done arthroscopically and as an outpatient. The CMI can be kept on the shelf to be available as needed; it has a 2-year shelf life. There are specialized instruments for measuring the length of implant needed and for delivery of the implant.

The CMI has been utilized clinically for 18 years with excellent clinical results. Patients treated with CMI have benefited in over 80% of cases. Studies have demonstrated improved knee function, activity levels, and pain values from the pre- to postoperative periods.1,2 In addition, functional improvements have been maintained for over 10 years. The reoperation rate has been demonstrated to be 10% to 20%, which is comparable to the reoperation rate after meniscal repair.

Surgical pearl: The surgical technique for insertion of the CMI is relatively uncomplicated (Figures A, B).

Figure.
The first step is the resection of all dysfunctional meniscus and then creating 90° walls to attach to posteriorly and anteriorly, and a firm peripheral rim to attach the CMI into.

The second step is to measure the length of your meniscus defect with the measuring rod.

Once measured, you want to oversize the implant 10% to 15% (ie, if you measure 30 mm, you will cut at least 34 mm). Use the measuring rod to measure the length of the CMI and mark your length. Use a new scalpel blade to cut the CMI.

 

 

Place the measured CMI into the delivery clamp and insert through a mini-arthrotomy into the meniscal defect. The fixation technique of the CMI is entirely up to the implanting surgeon. Most surgeons have used a combination of all-inside and inside-out meniscus repair techniques. It is recommended to start fixing the CMI first posteriorly. The posterior stitch is usually an all-inside horizontal mattress stitch. Coming 1 cm anteriorly, place a vertical mattress stitch. Continue this method sequentially while moving anteriorly. The anterior suture is the surgeon’s choice for device, but it should be a horizontal mattress like the most posterior stitch. It is important while tightening your suture tension to apply the concept of “approximated and not strangulated.” Once completed, close wounds in typical fashion.

Ivy Sports Medicine (http://www.ivysportsmed.com/en)

Collagen Meniscus Implant

The number of patients undergoing arthroscopic partial meniscectomy has continued to increase. However, this is potentially not a benign procedure, as there are increased contact pressures on the articular cartilage even with the removal of only a segment of the meniscus.

The Collagen Meniscus Implant (CMI, Ivy Sports Medicine) is a resorbable and biocompatible Type I collagen matrix that was developed to restore the segmental loss of meniscal tissue in the knee. It consists of a porous cross-linked matrix scaffold that allows for the ingrowth of the body’s own cells. The CMI is the only meniscal implant composed of purely biological materials and is available in an off-the-shelf supply.

The CMI is available in the United States for use in the restoration of segmental loss of the medial meniscus. The CMI can be utilized in either an acute or chronic situation. In the acute case, it would be indicated when the medial meniscus is irreparable, and that segment must be removed. In the chronic case, the patient would have had a previous partial meniscectomy and/or failed meniscus repair and had developed either pain or signs of early articular cartilage wear in the compartment. The procedure can be done arthroscopically and as an outpatient. The CMI can be kept on the shelf to be available as needed; it has a 2-year shelf life. There are specialized instruments for measuring the length of implant needed and for delivery of the implant.

The CMI has been utilized clinically for 18 years with excellent clinical results. Patients treated with CMI have benefited in over 80% of cases. Studies have demonstrated improved knee function, activity levels, and pain values from the pre- to postoperative periods.1,2 In addition, functional improvements have been maintained for over 10 years. The reoperation rate has been demonstrated to be 10% to 20%, which is comparable to the reoperation rate after meniscal repair.

Surgical pearl: The surgical technique for insertion of the CMI is relatively uncomplicated (Figures A, B).

Figure.
The first step is the resection of all dysfunctional meniscus and then creating 90° walls to attach to posteriorly and anteriorly, and a firm peripheral rim to attach the CMI into.

The second step is to measure the length of your meniscus defect with the measuring rod.

Once measured, you want to oversize the implant 10% to 15% (ie, if you measure 30 mm, you will cut at least 34 mm). Use the measuring rod to measure the length of the CMI and mark your length. Use a new scalpel blade to cut the CMI.

 

 

Place the measured CMI into the delivery clamp and insert through a mini-arthrotomy into the meniscal defect. The fixation technique of the CMI is entirely up to the implanting surgeon. Most surgeons have used a combination of all-inside and inside-out meniscus repair techniques. It is recommended to start fixing the CMI first posteriorly. The posterior stitch is usually an all-inside horizontal mattress stitch. Coming 1 cm anteriorly, place a vertical mattress stitch. Continue this method sequentially while moving anteriorly. The anterior suture is the surgeon’s choice for device, but it should be a horizontal mattress like the most posterior stitch. It is important while tightening your suture tension to apply the concept of “approximated and not strangulated.” Once completed, close wounds in typical fashion.
References

1. Zaffagnini S, Marcheggiani Muccioli GM, Lopomo N, et al. Prospective long-term outcomes of the medial collagen meniscus implant versus partial medial meniscectomy: a minimum 10-year follow-up study. Am J Sports Med. 2011;39(5):977-985

2. Bulgheroni P, Murena L, Ratti C, Bulgheroni E, Ronga M, Cherubino P. Follow-up of collagen meniscus implant patients: clinical, radiological, and magnetic resonance imaging results at 5 years. Knee. 2010;17(3):224-229.

References

1. Zaffagnini S, Marcheggiani Muccioli GM, Lopomo N, et al. Prospective long-term outcomes of the medial collagen meniscus implant versus partial medial meniscectomy: a minimum 10-year follow-up study. Am J Sports Med. 2011;39(5):977-985

2. Bulgheroni P, Murena L, Ratti C, Bulgheroni E, Ronga M, Cherubino P. Follow-up of collagen meniscus implant patients: clinical, radiological, and magnetic resonance imaging results at 5 years. Knee. 2010;17(3):224-229.

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