Product Review

 

NEW SACRAL NEUROMODULATION DEVICE

Axonics Modulation Technologies, Inc. announced the first implantation of its recently US Food and Drug Administration (FDA)-cleared, implantable, rechargeable sacral neuromodulation device. The implantation was the first to occur outside of a clinical study setting. The device is designed to reduce urinary and bowel dysfunction symptoms and reestablish pelvic floor function by restoring communication between the bladder and bowel to the brain. The Axonics r-SNM System is the first sacral neuromodulation device to be sold in the world. It is a miniaturized neurostimulator approximately the size of a USB stick and is qualified to operate for at least 15 years. The device can be safely left in place during full-body magnetic resonance imaging, says Axonics.

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

CERVICAL SEAL FOR HYSTEROSCOPIC DEVICES

Hologic has expanded its hysteroscopy portfolio with the launch of its Omni™ Lok cervical seal. The seal is designed to help maintain uterine distention and improve procedural efficiency in the operating room (OR) by minimizing fluid leakage during hysteroscopic procedures. Hologic says that Omni Lok is compatible with the MyoSure® and Omni™ hysteroscopes and reduces fluid leakage by an average of 94%. The Omni Lok cervical seal is commercially available in the United States and Canada. The device should not be used in a patient with a contraindication to hysteroscopy, says Hologic.

For more information, visit: https://gynsurgicalsolutions.com/product/omni-lok/

UNIVERSAL CYSTOSCOPY SIMPLIFIED

Emmy Medical announces the CystoSure® XL, an all-in-one silicone urinary catheter with an additional port for the introduction of a conventional hysteroscope to conduct simple cystoscopy. An addition to the CystoSure Silicone Cystoscopy Catheters, the new CystoSure XL provides a solution for the surgeon to view the bladder in every patient every time without the need to open and introduce a complete cystoscopy tray and instrumentation, says Emmy. According to the manufacturer, the CystoSure System combines the familiarity of a urinary catheter with the functionality of a cystoscope into a singular product providing easy viewing access of the bladder at any time in an OR or office procedure.

FOR MORE INFORMATION, VISIT: https://cystosure.com/

 

NEXT FRONTIER IN VACCINE IMMUNIZATION

Pfizer announces that it is embarking on the next frontier in vaccine immunization by conducting several studies of infant protection through maternal vaccination. While no vaccine currently is licensed for use in pregnant women to protect her infant, multiple studies have demonstrated that this can be done, says Pfizer. The company is currently investigating, in phase 1 and 2 studies, vaccines for Group B Streptococcus (GBS) and respiratory syncytial virus (RSV).

Globally, there are 410,000 cases of GBS every year. GBS is most common in newborns; women who are carriers of the GBS bacteria may pass it on to their newborns during labor and birth. An estimated 10% to 30% of pregnant women carry the GBS bacteria. The disease can manifest as sepsis, pneumonia, and meningitis, with potentially fatal outcomes for some. A maternal vaccine may prevent 231,000 infant and maternal GBS cases, says Pfizer.

According to Pfizer, RSV causes more hospitalizations each year than influenza among young children, with an estimated 33 million cases globally each year in children less than age 5 years.

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

 

NEW SACRAL NEUROMODULATION DEVICE

Axonics Modulation Technologies, Inc. announced the first implantation of its recently US Food and Drug Administration (FDA)-cleared, implantable, rechargeable sacral neuromodulation device. The implantation was the first to occur outside of a clinical study setting. The device is designed to reduce urinary and bowel dysfunction symptoms and reestablish pelvic floor function by restoring communication between the bladder and bowel to the brain. The Axonics r-SNM System is the first sacral neuromodulation device to be sold in the world. It is a miniaturized neurostimulator approximately the size of a USB stick and is qualified to operate for at least 15 years. The device can be safely left in place during full-body magnetic resonance imaging, says Axonics.

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

CERVICAL SEAL FOR HYSTEROSCOPIC DEVICES

Hologic has expanded its hysteroscopy portfolio with the launch of its Omni™ Lok cervical seal. The seal is designed to help maintain uterine distention and improve procedural efficiency in the operating room (OR) by minimizing fluid leakage during hysteroscopic procedures. Hologic says that Omni Lok is compatible with the MyoSure® and Omni™ hysteroscopes and reduces fluid leakage by an average of 94%. The Omni Lok cervical seal is commercially available in the United States and Canada. The device should not be used in a patient with a contraindication to hysteroscopy, says Hologic.

For more information, visit: https://gynsurgicalsolutions.com/product/omni-lok/

UNIVERSAL CYSTOSCOPY SIMPLIFIED

Emmy Medical announces the CystoSure® XL, an all-in-one silicone urinary catheter with an additional port for the introduction of a conventional hysteroscope to conduct simple cystoscopy. An addition to the CystoSure Silicone Cystoscopy Catheters, the new CystoSure XL provides a solution for the surgeon to view the bladder in every patient every time without the need to open and introduce a complete cystoscopy tray and instrumentation, says Emmy. According to the manufacturer, the CystoSure System combines the familiarity of a urinary catheter with the functionality of a cystoscope into a singular product providing easy viewing access of the bladder at any time in an OR or office procedure.

FOR MORE INFORMATION, VISIT: https://cystosure.com/

 

NEXT FRONTIER IN VACCINE IMMUNIZATION

Pfizer announces that it is embarking on the next frontier in vaccine immunization by conducting several studies of infant protection through maternal vaccination. While no vaccine currently is licensed for use in pregnant women to protect her infant, multiple studies have demonstrated that this can be done, says Pfizer. The company is currently investigating, in phase 1 and 2 studies, vaccines for Group B Streptococcus (GBS) and respiratory syncytial virus (RSV).

Globally, there are 410,000 cases of GBS every year. GBS is most common in newborns; women who are carriers of the GBS bacteria may pass it on to their newborns during labor and birth. An estimated 10% to 30% of pregnant women carry the GBS bacteria. The disease can manifest as sepsis, pneumonia, and meningitis, with potentially fatal outcomes for some. A maternal vaccine may prevent 231,000 infant and maternal GBS cases, says Pfizer.

According to Pfizer, RSV causes more hospitalizations each year than influenza among young children, with an estimated 33 million cases globally each year in children less than age 5 years.

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

 

NEW SACRAL NEUROMODULATION DEVICE

Axonics Modulation Technologies, Inc. announced the first implantation of its recently US Food and Drug Administration (FDA)-cleared, implantable, rechargeable sacral neuromodulation device. The implantation was the first to occur outside of a clinical study setting. The device is designed to reduce urinary and bowel dysfunction symptoms and reestablish pelvic floor function by restoring communication between the bladder and bowel to the brain. The Axonics r-SNM System is the first sacral neuromodulation device to be sold in the world. It is a miniaturized neurostimulator approximately the size of a USB stick and is qualified to operate for at least 15 years. The device can be safely left in place during full-body magnetic resonance imaging, says Axonics.

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

CERVICAL SEAL FOR HYSTEROSCOPIC DEVICES

Hologic has expanded its hysteroscopy portfolio with the launch of its Omni™ Lok cervical seal. The seal is designed to help maintain uterine distention and improve procedural efficiency in the operating room (OR) by minimizing fluid leakage during hysteroscopic procedures. Hologic says that Omni Lok is compatible with the MyoSure® and Omni™ hysteroscopes and reduces fluid leakage by an average of 94%. The Omni Lok cervical seal is commercially available in the United States and Canada. The device should not be used in a patient with a contraindication to hysteroscopy, says Hologic.

For more information, visit: https://gynsurgicalsolutions.com/product/omni-lok/

UNIVERSAL CYSTOSCOPY SIMPLIFIED

Emmy Medical announces the CystoSure® XL, an all-in-one silicone urinary catheter with an additional port for the introduction of a conventional hysteroscope to conduct simple cystoscopy. An addition to the CystoSure Silicone Cystoscopy Catheters, the new CystoSure XL provides a solution for the surgeon to view the bladder in every patient every time without the need to open and introduce a complete cystoscopy tray and instrumentation, says Emmy. According to the manufacturer, the CystoSure System combines the familiarity of a urinary catheter with the functionality of a cystoscope into a singular product providing easy viewing access of the bladder at any time in an OR or office procedure.

FOR MORE INFORMATION, VISIT: https://cystosure.com/

 

NEXT FRONTIER IN VACCINE IMMUNIZATION

Pfizer announces that it is embarking on the next frontier in vaccine immunization by conducting several studies of infant protection through maternal vaccination. While no vaccine currently is licensed for use in pregnant women to protect her infant, multiple studies have demonstrated that this can be done, says Pfizer. The company is currently investigating, in phase 1 and 2 studies, vaccines for Group B Streptococcus (GBS) and respiratory syncytial virus (RSV).

Globally, there are 410,000 cases of GBS every year. GBS is most common in newborns; women who are carriers of the GBS bacteria may pass it on to their newborns during labor and birth. An estimated 10% to 30% of pregnant women carry the GBS bacteria. The disease can manifest as sepsis, pneumonia, and meningitis, with potentially fatal outcomes for some. A maternal vaccine may prevent 231,000 infant and maternal GBS cases, says Pfizer.

According to Pfizer, RSV causes more hospitalizations each year than influenza among young children, with an estimated 33 million cases globally each year in children less than age 5 years.

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

FDA REMOVES ALCOHOL BAN WITH ADDYI

Sprout Pharmaceuticals announced that the US Food and Drug Administration (FDA) has removed their contraindication on alcohol use with Addyi® (flibanserin). Addyi was approved in 2015 and is an oral nonhormonal pill for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Patients are advised to discontinue drinking alcohol at least 2 hours before taking Addyi at bedtime or skip the Addyi dose that evening.

The FDA also removed the requirement, under its Risk Evaluation and Mitigation Strategy (REMS) program, for health care practitioners or pharmacies to be certified to prescribe or dispense Addyi. Sprout says that to make all labeling elements consistent with the FDA’s findings the boxed warning will change and the medication guide will be updated and included under the REMS. 

The most commonly reported adverse events among patients taking Addyi are dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth. Addyi is contraindicated in patients taking moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors and in those with hepatic impairment.

FOR MORE INFORMATION AND THE FULL PRESCRIBING INFORMATION AND MEDICATION GUIDE, VISIT: www.addyi.com

FEZOLINETANT FOR VMS

Astellas Pharma Inc. announced that it has initiated phase 3 trials for oral, nonhormonal fezolinetant to treat moderate-to-severe vasomotor symptoms (VMS) in postmenopausal women. Fezolinetant is a selective neurokinin-3 receptor antagonist, with dosages of 30 and 45 mg once daily being evaluated for efficacy and safety of reducing VMS frequency and severity. The trials each will enroll about 450 women with moderate-to-severe VMS at approximately 200 sites within the United States, Canada, and Europe. They will be double-blinded and placebo-controlled for the first 12 weeks, followed by noncontrolled 40-week extension periods. An additional 52-week trial will investigate long-term safety.

FOR MORE INFORMATION, VISIT: http://www.clinicaltrials.gov, TRIAL IDENTIFIERS NCT04003155, NCT04003142, AND NCT04003389

SOLUTIONS FOR OUTCOME TRACKING

DrChrono and OutcomeMD announce a partnership to track and analyze patient outcome data and confounding factors. DrChrono is an electronic health record (EHR) system, and OutcomeMD is a software solution that uses literature-validated patient-reported outcome instruments to score and track a patient’s symptom severity and inform treatment decisions for users.

Via a HIPAA compliant process, patients answer a list of questions that are accessed through a web link on their mobile or desktop devices. OutcomeMD summarizes the symptoms into a score that displays to both the physician and patient. Patients’ answers and scores are pushed to the clinician’s DrChrono EHR medical note. As care progresses in the OutcomeMD platform, patients remotely track how their symptoms change, and notifications alert clinicians of patients who may need attention. The integration with DrChrono also allows patient data on confounding factors to be automatically pushed from the patient’s device into the clinician’s medical note. The partnership will enable physicians to visualize patients’ status, and all the factors involved in their care, on one screen, says DrChrono and OutcomeMD, strengthening documentation and saving time for both patients and clinicians. An integration demo video is available at https://youtu.be/jnh7YPII080.

FOR MORE INFORMATION, VISIT: www.outcomemd.com

Continue to: NEW MATERNITY GOWN...

 

 

NEW MATERNITY GOWN

ImageFIRST launched a new maternity gown for expecting mothers. The Comfort Care^® Maternity Gown is a lightweight, premium polyester/nylon fabric that front snaps to allow for skin-to-skin access and optional breastfeeding. The gown also includes shoulder snaps and a full cut for extra coverage and to accommodate a variety of body types, says ImageFIRST.

ImageFIRST is a national linen rental provider. It developed the Comfort Care^® Maternity Gown with input from labor and delivery departments to best meet the needs of expecting mothers. It also says that a portion of the proceeds from each gown rental will be donated to the National Pediatric Cancer Foundation. 

FOR MORE INFORMATION, VISIT: www.imagefirst.com

FDA REMOVES ALCOHOL BAN WITH ADDYI

Sprout Pharmaceuticals announced that the US Food and Drug Administration (FDA) has removed their contraindication on alcohol use with Addyi® (flibanserin). Addyi was approved in 2015 and is an oral nonhormonal pill for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Patients are advised to discontinue drinking alcohol at least 2 hours before taking Addyi at bedtime or skip the Addyi dose that evening.

The FDA also removed the requirement, under its Risk Evaluation and Mitigation Strategy (REMS) program, for health care practitioners or pharmacies to be certified to prescribe or dispense Addyi. Sprout says that to make all labeling elements consistent with the FDA’s findings the boxed warning will change and the medication guide will be updated and included under the REMS. 

The most commonly reported adverse events among patients taking Addyi are dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth. Addyi is contraindicated in patients taking moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors and in those with hepatic impairment.

FOR MORE INFORMATION AND THE FULL PRESCRIBING INFORMATION AND MEDICATION GUIDE, VISIT: www.addyi.com

FEZOLINETANT FOR VMS

Astellas Pharma Inc. announced that it has initiated phase 3 trials for oral, nonhormonal fezolinetant to treat moderate-to-severe vasomotor symptoms (VMS) in postmenopausal women. Fezolinetant is a selective neurokinin-3 receptor antagonist, with dosages of 30 and 45 mg once daily being evaluated for efficacy and safety of reducing VMS frequency and severity. The trials each will enroll about 450 women with moderate-to-severe VMS at approximately 200 sites within the United States, Canada, and Europe. They will be double-blinded and placebo-controlled for the first 12 weeks, followed by noncontrolled 40-week extension periods. An additional 52-week trial will investigate long-term safety.

FOR MORE INFORMATION, VISIT: http://www.clinicaltrials.gov, TRIAL IDENTIFIERS NCT04003155, NCT04003142, AND NCT04003389

SOLUTIONS FOR OUTCOME TRACKING

DrChrono and OutcomeMD announce a partnership to track and analyze patient outcome data and confounding factors. DrChrono is an electronic health record (EHR) system, and OutcomeMD is a software solution that uses literature-validated patient-reported outcome instruments to score and track a patient’s symptom severity and inform treatment decisions for users.

Via a HIPAA compliant process, patients answer a list of questions that are accessed through a web link on their mobile or desktop devices. OutcomeMD summarizes the symptoms into a score that displays to both the physician and patient. Patients’ answers and scores are pushed to the clinician’s DrChrono EHR medical note. As care progresses in the OutcomeMD platform, patients remotely track how their symptoms change, and notifications alert clinicians of patients who may need attention. The integration with DrChrono also allows patient data on confounding factors to be automatically pushed from the patient’s device into the clinician’s medical note. The partnership will enable physicians to visualize patients’ status, and all the factors involved in their care, on one screen, says DrChrono and OutcomeMD, strengthening documentation and saving time for both patients and clinicians. An integration demo video is available at https://youtu.be/jnh7YPII080.

FOR MORE INFORMATION, VISIT: www.outcomemd.com

Continue to: NEW MATERNITY GOWN...

 

 

NEW MATERNITY GOWN

ImageFIRST launched a new maternity gown for expecting mothers. The Comfort Care^® Maternity Gown is a lightweight, premium polyester/nylon fabric that front snaps to allow for skin-to-skin access and optional breastfeeding. The gown also includes shoulder snaps and a full cut for extra coverage and to accommodate a variety of body types, says ImageFIRST.

ImageFIRST is a national linen rental provider. It developed the Comfort Care^® Maternity Gown with input from labor and delivery departments to best meet the needs of expecting mothers. It also says that a portion of the proceeds from each gown rental will be donated to the National Pediatric Cancer Foundation. 

FOR MORE INFORMATION, VISIT: www.imagefirst.com

FDA REMOVES ALCOHOL BAN WITH ADDYI

Sprout Pharmaceuticals announced that the US Food and Drug Administration (FDA) has removed their contraindication on alcohol use with Addyi® (flibanserin). Addyi was approved in 2015 and is an oral nonhormonal pill for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Patients are advised to discontinue drinking alcohol at least 2 hours before taking Addyi at bedtime or skip the Addyi dose that evening.

The FDA also removed the requirement, under its Risk Evaluation and Mitigation Strategy (REMS) program, for health care practitioners or pharmacies to be certified to prescribe or dispense Addyi. Sprout says that to make all labeling elements consistent with the FDA’s findings the boxed warning will change and the medication guide will be updated and included under the REMS. 

The most commonly reported adverse events among patients taking Addyi are dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth. Addyi is contraindicated in patients taking moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors and in those with hepatic impairment.

FOR MORE INFORMATION AND THE FULL PRESCRIBING INFORMATION AND MEDICATION GUIDE, VISIT: www.addyi.com

FEZOLINETANT FOR VMS

Astellas Pharma Inc. announced that it has initiated phase 3 trials for oral, nonhormonal fezolinetant to treat moderate-to-severe vasomotor symptoms (VMS) in postmenopausal women. Fezolinetant is a selective neurokinin-3 receptor antagonist, with dosages of 30 and 45 mg once daily being evaluated for efficacy and safety of reducing VMS frequency and severity. The trials each will enroll about 450 women with moderate-to-severe VMS at approximately 200 sites within the United States, Canada, and Europe. They will be double-blinded and placebo-controlled for the first 12 weeks, followed by noncontrolled 40-week extension periods. An additional 52-week trial will investigate long-term safety.

FOR MORE INFORMATION, VISIT: http://www.clinicaltrials.gov, TRIAL IDENTIFIERS NCT04003155, NCT04003142, AND NCT04003389

SOLUTIONS FOR OUTCOME TRACKING

DrChrono and OutcomeMD announce a partnership to track and analyze patient outcome data and confounding factors. DrChrono is an electronic health record (EHR) system, and OutcomeMD is a software solution that uses literature-validated patient-reported outcome instruments to score and track a patient’s symptom severity and inform treatment decisions for users.

Via a HIPAA compliant process, patients answer a list of questions that are accessed through a web link on their mobile or desktop devices. OutcomeMD summarizes the symptoms into a score that displays to both the physician and patient. Patients’ answers and scores are pushed to the clinician’s DrChrono EHR medical note. As care progresses in the OutcomeMD platform, patients remotely track how their symptoms change, and notifications alert clinicians of patients who may need attention. The integration with DrChrono also allows patient data on confounding factors to be automatically pushed from the patient’s device into the clinician’s medical note. The partnership will enable physicians to visualize patients’ status, and all the factors involved in their care, on one screen, says DrChrono and OutcomeMD, strengthening documentation and saving time for both patients and clinicians. An integration demo video is available at https://youtu.be/jnh7YPII080.

FOR MORE INFORMATION, VISIT: www.outcomemd.com

Continue to: NEW MATERNITY GOWN...

 

 

NEW MATERNITY GOWN

ImageFIRST launched a new maternity gown for expecting mothers. The Comfort Care^® Maternity Gown is a lightweight, premium polyester/nylon fabric that front snaps to allow for skin-to-skin access and optional breastfeeding. The gown also includes shoulder snaps and a full cut for extra coverage and to accommodate a variety of body types, says ImageFIRST.

ImageFIRST is a national linen rental provider. It developed the Comfort Care^® Maternity Gown with input from labor and delivery departments to best meet the needs of expecting mothers. It also says that a portion of the proceeds from each gown rental will be donated to the National Pediatric Cancer Foundation. 

FOR MORE INFORMATION, VISIT: www.imagefirst.com

 

MENSTRUAL PAIN RELIEF THROUGH MICRO-PULSES

Livia, by iPulse Medical Ltd, is a US Food and Drug Administration (FDA) approved, drug-free option to treat menstrual pain through the transmission of electrical pulses. Electrodes are placed on the body at the source of menstrual pain and send a frequency to the nerves to reduce pain. Livia was designed based on the principles of the “gate control” theory of pain, says iPulse Medical. When the nerves are stimulated by the device’s electrodes, the nerve gate is closed, preventing pain signals from being received or felt in the brain.

 

The device can be worn in public or at home and allows the user to adjust the frequency of the electrical signal to correspond with her pain intensity. According to iPulse Medical, there are no adverse effects and the user will not build up a tolerance; however, the device should not be worn if the user has a pacemaker or is undergoing fertility treatment.

 

 

 

 

 

 

FOR MORE INFORMATION, VISIT: https://mylivia.com/

EXPAREL FOR CESAREAN DELIVERY

Pacira BioSciences an-nounced completion of their Phase 4 study of Exparel (bupivacaine lipsome injectable suspension), a local analgesic given to patients undergoing planned cesarean delivery (CD), aimed at reducing postsurgical pain and total opioid consumption through the first 72 hours postsurgery. Exparel is administered through transversus abdominis plane field block.

 

Pacira’s multicenter, randomized, double-blind study of 186 patients showed that those receiving Exparel plus bupivacaine HCl had a 52% reduction in total opioid consumption and significantly lower pain scores through the first 72 hours after CD, compared with those receiving only bupivacaine HCl. The most common adverse effects are itching and nausea. Exparel should not be used for patients under the age of 18 and should be used cautiously in patients with hepatic disease.

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

M GENITALIUM ASSAY DETECTS THE STI

Hologic’s Aptima^® Mycoplasma genitalium assay is the first FDA-cleared diagnostic test for this sexually transmitted infection (STI), which has been identified by the Centers for Disease Control and Prevention as an emerging public health threat. The assay is an in vitro nucleic acid amplification test that can be used to verify swab or urine samples from women and men. In published studies, the ribosomal RNA-based assay displayed greater sensitivity than lab-developed or CE-marked DNA-based tests. Early detection is important, Hologic asserts, because M genitalium is increasing in prevalence among higher-risk populations; however, it is not well known and often misdiagnosed, leading to incorrect treatment as well as risk for transmission and recurrence.

Hologic cites several studies that have shown M genitalium can be asymptomatic; however, it also can be associated with nongonococcal urethritis in men and cervicitis in women, as well as increased risk for pelvic inflammatory disease, preterm birth, spontaneous abortion, and infertility. A high percentage of infected people have an antibiotic-resistant strain, demonstrating a need for early detection and screening.

 

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

NEW ART OPTION

INVOcell™ is an intravaginal culture system offering women and their partners another option for proven, effective assisted reproductive technology (ART), says Ferring Pharmaceuticals. The INVOcell Culture Device uses a woman’s own body as a natural incubator during fertilization and early embryo development. It differs from in vitro fertilization, as the incubation happens intravaginally and not in a lab. During the process, the patient undergoes a mild ovarian stimulation and monitoring cycle. After the eggs and sperm are collected, they are placed into the device and then immediately placed into the vaginal cavity to incubate and allow early embryo development to take place. After the incubation period, the INVOcell device is removed and the embryos are transferred or frozen, according to Ferring. For Important Safety Information, see INVOcell’s instructions for use.

 

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

 

MENSTRUAL PAIN RELIEF THROUGH MICRO-PULSES

Livia, by iPulse Medical Ltd, is a US Food and Drug Administration (FDA) approved, drug-free option to treat menstrual pain through the transmission of electrical pulses. Electrodes are placed on the body at the source of menstrual pain and send a frequency to the nerves to reduce pain. Livia was designed based on the principles of the “gate control” theory of pain, says iPulse Medical. When the nerves are stimulated by the device’s electrodes, the nerve gate is closed, preventing pain signals from being received or felt in the brain.

 

The device can be worn in public or at home and allows the user to adjust the frequency of the electrical signal to correspond with her pain intensity. According to iPulse Medical, there are no adverse effects and the user will not build up a tolerance; however, the device should not be worn if the user has a pacemaker or is undergoing fertility treatment.

 

 

 

 

 

 

FOR MORE INFORMATION, VISIT: https://mylivia.com/

EXPAREL FOR CESAREAN DELIVERY

Pacira BioSciences an-nounced completion of their Phase 4 study of Exparel (bupivacaine lipsome injectable suspension), a local analgesic given to patients undergoing planned cesarean delivery (CD), aimed at reducing postsurgical pain and total opioid consumption through the first 72 hours postsurgery. Exparel is administered through transversus abdominis plane field block.

 

Pacira’s multicenter, randomized, double-blind study of 186 patients showed that those receiving Exparel plus bupivacaine HCl had a 52% reduction in total opioid consumption and significantly lower pain scores through the first 72 hours after CD, compared with those receiving only bupivacaine HCl. The most common adverse effects are itching and nausea. Exparel should not be used for patients under the age of 18 and should be used cautiously in patients with hepatic disease.

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

M GENITALIUM ASSAY DETECTS THE STI

Hologic’s Aptima^® Mycoplasma genitalium assay is the first FDA-cleared diagnostic test for this sexually transmitted infection (STI), which has been identified by the Centers for Disease Control and Prevention as an emerging public health threat. The assay is an in vitro nucleic acid amplification test that can be used to verify swab or urine samples from women and men. In published studies, the ribosomal RNA-based assay displayed greater sensitivity than lab-developed or CE-marked DNA-based tests. Early detection is important, Hologic asserts, because M genitalium is increasing in prevalence among higher-risk populations; however, it is not well known and often misdiagnosed, leading to incorrect treatment as well as risk for transmission and recurrence.

Hologic cites several studies that have shown M genitalium can be asymptomatic; however, it also can be associated with nongonococcal urethritis in men and cervicitis in women, as well as increased risk for pelvic inflammatory disease, preterm birth, spontaneous abortion, and infertility. A high percentage of infected people have an antibiotic-resistant strain, demonstrating a need for early detection and screening.

 

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

NEW ART OPTION

INVOcell™ is an intravaginal culture system offering women and their partners another option for proven, effective assisted reproductive technology (ART), says Ferring Pharmaceuticals. The INVOcell Culture Device uses a woman’s own body as a natural incubator during fertilization and early embryo development. It differs from in vitro fertilization, as the incubation happens intravaginally and not in a lab. During the process, the patient undergoes a mild ovarian stimulation and monitoring cycle. After the eggs and sperm are collected, they are placed into the device and then immediately placed into the vaginal cavity to incubate and allow early embryo development to take place. After the incubation period, the INVOcell device is removed and the embryos are transferred or frozen, according to Ferring. For Important Safety Information, see INVOcell’s instructions for use.

 

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

 

MENSTRUAL PAIN RELIEF THROUGH MICRO-PULSES

Livia, by iPulse Medical Ltd, is a US Food and Drug Administration (FDA) approved, drug-free option to treat menstrual pain through the transmission of electrical pulses. Electrodes are placed on the body at the source of menstrual pain and send a frequency to the nerves to reduce pain. Livia was designed based on the principles of the “gate control” theory of pain, says iPulse Medical. When the nerves are stimulated by the device’s electrodes, the nerve gate is closed, preventing pain signals from being received or felt in the brain.

 

The device can be worn in public or at home and allows the user to adjust the frequency of the electrical signal to correspond with her pain intensity. According to iPulse Medical, there are no adverse effects and the user will not build up a tolerance; however, the device should not be worn if the user has a pacemaker or is undergoing fertility treatment.

 

 

 

 

 

 

FOR MORE INFORMATION, VISIT: https://mylivia.com/

EXPAREL FOR CESAREAN DELIVERY

Pacira BioSciences an-nounced completion of their Phase 4 study of Exparel (bupivacaine lipsome injectable suspension), a local analgesic given to patients undergoing planned cesarean delivery (CD), aimed at reducing postsurgical pain and total opioid consumption through the first 72 hours postsurgery. Exparel is administered through transversus abdominis plane field block.

 

Pacira’s multicenter, randomized, double-blind study of 186 patients showed that those receiving Exparel plus bupivacaine HCl had a 52% reduction in total opioid consumption and significantly lower pain scores through the first 72 hours after CD, compared with those receiving only bupivacaine HCl. The most common adverse effects are itching and nausea. Exparel should not be used for patients under the age of 18 and should be used cautiously in patients with hepatic disease.

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

M GENITALIUM ASSAY DETECTS THE STI

Hologic’s Aptima^® Mycoplasma genitalium assay is the first FDA-cleared diagnostic test for this sexually transmitted infection (STI), which has been identified by the Centers for Disease Control and Prevention as an emerging public health threat. The assay is an in vitro nucleic acid amplification test that can be used to verify swab or urine samples from women and men. In published studies, the ribosomal RNA-based assay displayed greater sensitivity than lab-developed or CE-marked DNA-based tests. Early detection is important, Hologic asserts, because M genitalium is increasing in prevalence among higher-risk populations; however, it is not well known and often misdiagnosed, leading to incorrect treatment as well as risk for transmission and recurrence.

Hologic cites several studies that have shown M genitalium can be asymptomatic; however, it also can be associated with nongonococcal urethritis in men and cervicitis in women, as well as increased risk for pelvic inflammatory disease, preterm birth, spontaneous abortion, and infertility. A high percentage of infected people have an antibiotic-resistant strain, demonstrating a need for early detection and screening.

 

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

NEW ART OPTION

INVOcell™ is an intravaginal culture system offering women and their partners another option for proven, effective assisted reproductive technology (ART), says Ferring Pharmaceuticals. The INVOcell Culture Device uses a woman’s own body as a natural incubator during fertilization and early embryo development. It differs from in vitro fertilization, as the incubation happens intravaginally and not in a lab. During the process, the patient undergoes a mild ovarian stimulation and monitoring cycle. After the eggs and sperm are collected, they are placed into the device and then immediately placed into the vaginal cavity to incubate and allow early embryo development to take place. After the incubation period, the INVOcell device is removed and the embryos are transferred or frozen, according to Ferring. For Important Safety Information, see INVOcell’s instructions for use.

 

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

 

OSPHENA HAS NEW INDICATION

Duchesnay Inc. has added moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy (VVA), due to menopause, to the indication of Osphena^TM (ospemifene). The US Food and Drug Administration (FDA) approved Duchesnay’s supplemental New Drug Application in early 2019. Prior to this approval, Osphena was indicated only for the treatment of moderate to severe dyspareunia (painful intercourse), also a symptom of VVA, due to menopause. Osphena is nonhormonal and helps to improve vaginal tissues by increasing superficial cells, decreasing parabasal cells, and reducing vaginal pH, according to Duchesnay. The prescribing information for Osphena includes a boxed warning regarding endometrial cancer and cardiovascular disorders. Duchesnay encourages the reporting of negative adverse effects of prescription drugs to the FDA (www.fda.gov/medwatch).

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

NEW 3-IN-1 HYSTEROSCOPE

Hologic has a new 3-in-1 hysteroscope (Omni^TM), which became available for use in the United States in late 2018 after 510(k) clearance by the FDA. The device features a flexible, modular design offering powerful visualization with 3 sheath options to see and treat pathology, says Hologic. No longer will a physician be required to use a diagnostic scope to look in the uterine cavity for fibroids or polyps, and then switch to an operative scope to biopsy or treat the pathology. Omni’s sheaths also are designed with smaller diameters (3.7 mm diagnostic sheath; 5 mm operative sheath; 6 mm operative sheath) to reduce required dilation, promoting patient comfort. In addition, the device features a long (200 mm) working length to facilitate access and treatment in obese patients, according to the manufacturer. Consult the device’s instructions for use benefit and risk information.

FOR MORE INFORMATION, VISIT: https://gynsurgicalsolutions.com/product/omni-hysteroscope/.

SURGICAL RF TECHNOLOGY

FDA-cleared TempSure™ Surgical RF Technology is now available in North America, Hologic’s Cynosure division announced. The TempSure radiofrequency platform provides clinicians with the ability to perform both surgical and nonsurgical aesthetic procedures across a variety of specialties, on a single device, says Hologic. Cynosure also has returned TempSure™ Vitalia hand pieces and probes to the market and will continue to market its MonaLisa Touch^TM CO2 laser following the FDA’s inquiry on products used in energy-based women’s health procedures. Cynosure says that it has worked closely with the FDA and reviewed and updated all of its marketing and promotional materials to ensure that they are consistent with the FDA’s labeling expectations.

FOR MORE INFORMATION, VISIT: https://www.cynosure.com/tempsure-platform. 

PROFESSIONAL FOOT SUPPORTS

comenityMED™ announces the release of Resilient™ Professional Foot Supports. The foot supports are the first all-silicone medical exam table stirrup cover that provides patients with support during office-based exams and procedures. Attaching securely to exam table stirrups by means of stretch attachment, the platform ergonomically cradles the foot, increasing patient comfort and satisfaction and offering a professional appearance and slip resistance, says comenityMED. The supports are designed to undergo a high level of disinfection by means of chemical or heat sterilization between patients and conveniently fold back into the bed, according to the manufacturer. 

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

 

OSPHENA HAS NEW INDICATION

Duchesnay Inc. has added moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy (VVA), due to menopause, to the indication of Osphena^TM (ospemifene). The US Food and Drug Administration (FDA) approved Duchesnay’s supplemental New Drug Application in early 2019. Prior to this approval, Osphena was indicated only for the treatment of moderate to severe dyspareunia (painful intercourse), also a symptom of VVA, due to menopause. Osphena is nonhormonal and helps to improve vaginal tissues by increasing superficial cells, decreasing parabasal cells, and reducing vaginal pH, according to Duchesnay. The prescribing information for Osphena includes a boxed warning regarding endometrial cancer and cardiovascular disorders. Duchesnay encourages the reporting of negative adverse effects of prescription drugs to the FDA (www.fda.gov/medwatch).

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

NEW 3-IN-1 HYSTEROSCOPE

Hologic has a new 3-in-1 hysteroscope (Omni^TM), which became available for use in the United States in late 2018 after 510(k) clearance by the FDA. The device features a flexible, modular design offering powerful visualization with 3 sheath options to see and treat pathology, says Hologic. No longer will a physician be required to use a diagnostic scope to look in the uterine cavity for fibroids or polyps, and then switch to an operative scope to biopsy or treat the pathology. Omni’s sheaths also are designed with smaller diameters (3.7 mm diagnostic sheath; 5 mm operative sheath; 6 mm operative sheath) to reduce required dilation, promoting patient comfort. In addition, the device features a long (200 mm) working length to facilitate access and treatment in obese patients, according to the manufacturer. Consult the device’s instructions for use benefit and risk information.

FOR MORE INFORMATION, VISIT: https://gynsurgicalsolutions.com/product/omni-hysteroscope/.

SURGICAL RF TECHNOLOGY

FDA-cleared TempSure™ Surgical RF Technology is now available in North America, Hologic’s Cynosure division announced. The TempSure radiofrequency platform provides clinicians with the ability to perform both surgical and nonsurgical aesthetic procedures across a variety of specialties, on a single device, says Hologic. Cynosure also has returned TempSure™ Vitalia hand pieces and probes to the market and will continue to market its MonaLisa Touch^TM CO2 laser following the FDA’s inquiry on products used in energy-based women’s health procedures. Cynosure says that it has worked closely with the FDA and reviewed and updated all of its marketing and promotional materials to ensure that they are consistent with the FDA’s labeling expectations.

FOR MORE INFORMATION, VISIT: https://www.cynosure.com/tempsure-platform. 

PROFESSIONAL FOOT SUPPORTS

comenityMED™ announces the release of Resilient™ Professional Foot Supports. The foot supports are the first all-silicone medical exam table stirrup cover that provides patients with support during office-based exams and procedures. Attaching securely to exam table stirrups by means of stretch attachment, the platform ergonomically cradles the foot, increasing patient comfort and satisfaction and offering a professional appearance and slip resistance, says comenityMED. The supports are designed to undergo a high level of disinfection by means of chemical or heat sterilization between patients and conveniently fold back into the bed, according to the manufacturer. 

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

 

OSPHENA HAS NEW INDICATION

Duchesnay Inc. has added moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy (VVA), due to menopause, to the indication of Osphena^TM (ospemifene). The US Food and Drug Administration (FDA) approved Duchesnay’s supplemental New Drug Application in early 2019. Prior to this approval, Osphena was indicated only for the treatment of moderate to severe dyspareunia (painful intercourse), also a symptom of VVA, due to menopause. Osphena is nonhormonal and helps to improve vaginal tissues by increasing superficial cells, decreasing parabasal cells, and reducing vaginal pH, according to Duchesnay. The prescribing information for Osphena includes a boxed warning regarding endometrial cancer and cardiovascular disorders. Duchesnay encourages the reporting of negative adverse effects of prescription drugs to the FDA (www.fda.gov/medwatch).

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

NEW 3-IN-1 HYSTEROSCOPE

Hologic has a new 3-in-1 hysteroscope (Omni^TM), which became available for use in the United States in late 2018 after 510(k) clearance by the FDA. The device features a flexible, modular design offering powerful visualization with 3 sheath options to see and treat pathology, says Hologic. No longer will a physician be required to use a diagnostic scope to look in the uterine cavity for fibroids or polyps, and then switch to an operative scope to biopsy or treat the pathology. Omni’s sheaths also are designed with smaller diameters (3.7 mm diagnostic sheath; 5 mm operative sheath; 6 mm operative sheath) to reduce required dilation, promoting patient comfort. In addition, the device features a long (200 mm) working length to facilitate access and treatment in obese patients, according to the manufacturer. Consult the device’s instructions for use benefit and risk information.

FOR MORE INFORMATION, VISIT: https://gynsurgicalsolutions.com/product/omni-hysteroscope/.

SURGICAL RF TECHNOLOGY

FDA-cleared TempSure™ Surgical RF Technology is now available in North America, Hologic’s Cynosure division announced. The TempSure radiofrequency platform provides clinicians with the ability to perform both surgical and nonsurgical aesthetic procedures across a variety of specialties, on a single device, says Hologic. Cynosure also has returned TempSure™ Vitalia hand pieces and probes to the market and will continue to market its MonaLisa Touch^TM CO2 laser following the FDA’s inquiry on products used in energy-based women’s health procedures. Cynosure says that it has worked closely with the FDA and reviewed and updated all of its marketing and promotional materials to ensure that they are consistent with the FDA’s labeling expectations.

FOR MORE INFORMATION, VISIT: https://www.cynosure.com/tempsure-platform. 

PROFESSIONAL FOOT SUPPORTS

comenityMED™ announces the release of Resilient™ Professional Foot Supports. The foot supports are the first all-silicone medical exam table stirrup cover that provides patients with support during office-based exams and procedures. Attaching securely to exam table stirrups by means of stretch attachment, the platform ergonomically cradles the foot, increasing patient comfort and satisfaction and offering a professional appearance and slip resistance, says comenityMED. The supports are designed to undergo a high level of disinfection by means of chemical or heat sterilization between patients and conveniently fold back into the bed, according to the manufacturer. 

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