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The Endlock Tumor Prosthesis With Short-Length Fixation: A Clinical Study
Computer Navigation in Joint Arthroplasty—Is This for Real?
Computer-Aided Surgery in Orthopedics: From Strength to Strength
New Products/Product News
Aesculap Implant Systems, LLC, has announced the launch of the S4 Element Pedicle Screw System.
The S4 Element Pedicle Screw System was made available to a select group of surgeons in May 2009 as part of the company’s Market Preference Evaluation, and a full launch of the system is planned for the second quarter of 2010, at which time the system will be released to surgeons throughout the United States.
Aesculap notes that some of S4 Element’s unique features include an industry-leading ultra-low-profile screw head for minimal impingement of anatomical structures and innovative placement instruments, like the speed-multiplier handle, which facilitates tapping and screw placement at a 3.5 times faster rate without altering bone–screw thread properties.
The S4 Element System will be sold through the Aesculap Implant Systems direct and indirect sales network.
For more information, contact
|
Soft-Tissue Repair
KFx Medical Corporation announced it has received 510k clearance from the US Food and Drug Administration (FDA) for products used in a wide variety of arthroscopic tenodesis knee procedures, such as anterior cruciate ligament, posterior cruciate ligament, and medial patellofemoral ligament reconstruction.
KFx Medical has also received 510k clearance from the FDA for its AppianFx™ product line for soft-tissue repair and reconstruction in the knee.
The AppianFx line of implants from KFx reattach tissue to bone in shoulder, knee, foot, and ankle procedures, which, combined, exceed well over 1 million annual surgical procedures. Product offerings include those that directly place and secure tissue into bone both with and without the use of sutures.
For more information, contact
KFx Medical Corporation
|
Hindfoot Deformities and Arthritis Treatment
Wright Medical Group, Inc., has announced the full commercial launch of the VALOR® Hindfoot Fusion Nail. The system was designed in conjunction with world-renowned foot and ankle surgeons to facilitate ankle fusion in the treatment of skeletal deformity, late-stage arthritis, or complications resulting from diabetes (neuro-osteoarthropathy). Since its initial premarket availability announced in November 2009, the system has been limited to use in a few centers in the United States, gathering early clinical results.
With an array of sizes and anatomical screw positions, the VALOR® Nail is designed to provide optimal fixation for each patient’s unique anatomy and condition. Each fusion nail also incorporates an internal compression device that allows the surgeon to control the compression between bone surfaces, thereby optimizing the conditions for fusion to occur.
Wright estimates that over 30,000 hindfoot fusion procedures are performed annually in the United States, and over 50% are estimated to be treated with a fusion nail. With the expanding diabetic population, the number of patients requiring a nail option for salvage will continue to expand.
The new VALOR® Hindfoot Fusion system will be made available immediately through Wright’s specialized Foot and Ankle sales force.
For more information, contact
Wright Medical Technology
|
Monoblock Ceramic Technology
Amedica Corporation, a spinal and orthopedic implant and instrument manufacturer focused on unique silicon nitride (SiN) ceramic technologies, announced that it has been granted a US patent covering its novel hip implant featuring a monoblock ceramic acetabular cup for use in articulating joints for total joint replacement. Currently under development, Amedica’s cup covered under this and other pending patents will be used as an ultra–low–wear–bearing component for motion-preserving implants.
The technology allows Amedica to combine high-strength silicon nitride ceramic with an ultra–low–wear surface–bearing technology, along with a bone-contacting Bioactive™ surface designed for secure, long-term fixation. Amedica notes that this provides surgeons with wider design choices and flexibility to improve anatomic fit and function compared with currently available alternate bearing options.
In addition to spinal implants, Amedica’s SiN materials have disruptive characteristics for hip and knee implant applications as well. The material is fracture-resistant; its articulating surfaces do not produce the wear debris that is linked to osteolysis-related reoperations. Additionally, the company notes that the Bioactive implants feature a hydrophilic surface and a conductive cancellous structure to enhance bone in-growth and attachment.
For more information, contact
Amedica
|
Postmenopausal Osteoporosis Treatment
Amgen, Inc., announced that the US FDA has approved Prolia™ (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture or multiple risk factors for fracture, or of patients who have failed or are intolerant to other available osteoporosis therapy. Prolia, the first and only FDA-approved RANK Ligand inhibitor, is a 60-mg subcutaneous injection administered by a health care professional every 6 months.
Prolia’s approval is based on a pivotal 3-year Phase 3 study involving 7,808 postmenopausal women with osteoporosis. Treatment with Prolia resulted in greater bone density, stronger bones, and reduced risk for vertebral, hip, and nonvertebral fractures measured at 3 years.1
The pivotal 3-year Phase 3 Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) study in 7,808 women with postmenopausal osteoporosis demonstrated that treatment with Prolia, administered as a 60-mg subcutaneous injection every 6 months, compared with placebo at 3 years resulted in: a 68% reduction in vertebral fractures (4.8% absolute risk reduction), a 40% reduction in hip fractures (0.3% absolute risk reduction), a 20% reduction in nonvertebral fractures (1.5% absolute risk reduction), and significant bone density increases at all key sites measured (8.8% at the lumbar spine, 6.4% at the total hip, and 5.2% at the femoral neck).2 The incidence of new spine fractures was 2.3% with Prolia vs. 7.2% with placebo. The incidence of hip fractures was 0.7% with Prolia vs. 1.2% with placebo. The incidence of non-spine fractures was 6.5% with Prolia vs. 8% with placebo.
ProliaPlus™ is a multifaceted product support program designed to provide comprehensive assistance to health care providers, patients, and their caregivers to help facilitate access to Prolia for appropriate patients. ProliaPlus provides information and assistance on issues related to product insurance coverage to physician offices. Additionally, upon request, ProliaPlus will remind patients and providers about when the patient’s next dose is due, thus helping to support patient adherence to therapy. ProliaPlus will also have information on the availability of potential financial assistance programs.
To review the Prolia prescribing information and REMS materials, visit www.amgen.com.
For more information, contact
References
Amgen Inc.
|
Disposable Biter
OrthoDynamix has introduced the ArthroSteer Biter. It is the first disposable biter used for meniscal shoulder and knee repair. A sharp jaw for every procedure affords excellent tissue interaction. Moreover, the Biter is steerable, allowing access to and around joint capsule structures. Besides the jaw’s ability to bend 180°, the jaw orientation to the tissue plane is made possible by the 360° jaw rotation, which is independent of the bend. OrthoDynamix notes that the ArthroSteer Biter can eliminate dozens of reusable biter instruments configured with varying preset bent shafts.
OrthoDynamix is a Gyrx LLC portfolio company.
To learn more, contact
OrthoDynamix
|
Aesculap Implant Systems, LLC, has announced the launch of the S4 Element Pedicle Screw System.
The S4 Element Pedicle Screw System was made available to a select group of surgeons in May 2009 as part of the company’s Market Preference Evaluation, and a full launch of the system is planned for the second quarter of 2010, at which time the system will be released to surgeons throughout the United States.
Aesculap notes that some of S4 Element’s unique features include an industry-leading ultra-low-profile screw head for minimal impingement of anatomical structures and innovative placement instruments, like the speed-multiplier handle, which facilitates tapping and screw placement at a 3.5 times faster rate without altering bone–screw thread properties.
The S4 Element System will be sold through the Aesculap Implant Systems direct and indirect sales network.
For more information, contact
|
Soft-Tissue Repair
KFx Medical Corporation announced it has received 510k clearance from the US Food and Drug Administration (FDA) for products used in a wide variety of arthroscopic tenodesis knee procedures, such as anterior cruciate ligament, posterior cruciate ligament, and medial patellofemoral ligament reconstruction.
KFx Medical has also received 510k clearance from the FDA for its AppianFx™ product line for soft-tissue repair and reconstruction in the knee.
The AppianFx line of implants from KFx reattach tissue to bone in shoulder, knee, foot, and ankle procedures, which, combined, exceed well over 1 million annual surgical procedures. Product offerings include those that directly place and secure tissue into bone both with and without the use of sutures.
For more information, contact
KFx Medical Corporation
|
Hindfoot Deformities and Arthritis Treatment
Wright Medical Group, Inc., has announced the full commercial launch of the VALOR® Hindfoot Fusion Nail. The system was designed in conjunction with world-renowned foot and ankle surgeons to facilitate ankle fusion in the treatment of skeletal deformity, late-stage arthritis, or complications resulting from diabetes (neuro-osteoarthropathy). Since its initial premarket availability announced in November 2009, the system has been limited to use in a few centers in the United States, gathering early clinical results.
With an array of sizes and anatomical screw positions, the VALOR® Nail is designed to provide optimal fixation for each patient’s unique anatomy and condition. Each fusion nail also incorporates an internal compression device that allows the surgeon to control the compression between bone surfaces, thereby optimizing the conditions for fusion to occur.
Wright estimates that over 30,000 hindfoot fusion procedures are performed annually in the United States, and over 50% are estimated to be treated with a fusion nail. With the expanding diabetic population, the number of patients requiring a nail option for salvage will continue to expand.
The new VALOR® Hindfoot Fusion system will be made available immediately through Wright’s specialized Foot and Ankle sales force.
For more information, contact
Wright Medical Technology
|
Monoblock Ceramic Technology
Amedica Corporation, a spinal and orthopedic implant and instrument manufacturer focused on unique silicon nitride (SiN) ceramic technologies, announced that it has been granted a US patent covering its novel hip implant featuring a monoblock ceramic acetabular cup for use in articulating joints for total joint replacement. Currently under development, Amedica’s cup covered under this and other pending patents will be used as an ultra–low–wear–bearing component for motion-preserving implants.
The technology allows Amedica to combine high-strength silicon nitride ceramic with an ultra–low–wear surface–bearing technology, along with a bone-contacting Bioactive™ surface designed for secure, long-term fixation. Amedica notes that this provides surgeons with wider design choices and flexibility to improve anatomic fit and function compared with currently available alternate bearing options.
In addition to spinal implants, Amedica’s SiN materials have disruptive characteristics for hip and knee implant applications as well. The material is fracture-resistant; its articulating surfaces do not produce the wear debris that is linked to osteolysis-related reoperations. Additionally, the company notes that the Bioactive implants feature a hydrophilic surface and a conductive cancellous structure to enhance bone in-growth and attachment.
For more information, contact
Amedica
|
Postmenopausal Osteoporosis Treatment
Amgen, Inc., announced that the US FDA has approved Prolia™ (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture or multiple risk factors for fracture, or of patients who have failed or are intolerant to other available osteoporosis therapy. Prolia, the first and only FDA-approved RANK Ligand inhibitor, is a 60-mg subcutaneous injection administered by a health care professional every 6 months.
Prolia’s approval is based on a pivotal 3-year Phase 3 study involving 7,808 postmenopausal women with osteoporosis. Treatment with Prolia resulted in greater bone density, stronger bones, and reduced risk for vertebral, hip, and nonvertebral fractures measured at 3 years.1
The pivotal 3-year Phase 3 Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) study in 7,808 women with postmenopausal osteoporosis demonstrated that treatment with Prolia, administered as a 60-mg subcutaneous injection every 6 months, compared with placebo at 3 years resulted in: a 68% reduction in vertebral fractures (4.8% absolute risk reduction), a 40% reduction in hip fractures (0.3% absolute risk reduction), a 20% reduction in nonvertebral fractures (1.5% absolute risk reduction), and significant bone density increases at all key sites measured (8.8% at the lumbar spine, 6.4% at the total hip, and 5.2% at the femoral neck).2 The incidence of new spine fractures was 2.3% with Prolia vs. 7.2% with placebo. The incidence of hip fractures was 0.7% with Prolia vs. 1.2% with placebo. The incidence of non-spine fractures was 6.5% with Prolia vs. 8% with placebo.
ProliaPlus™ is a multifaceted product support program designed to provide comprehensive assistance to health care providers, patients, and their caregivers to help facilitate access to Prolia for appropriate patients. ProliaPlus provides information and assistance on issues related to product insurance coverage to physician offices. Additionally, upon request, ProliaPlus will remind patients and providers about when the patient’s next dose is due, thus helping to support patient adherence to therapy. ProliaPlus will also have information on the availability of potential financial assistance programs.
To review the Prolia prescribing information and REMS materials, visit www.amgen.com.
For more information, contact
References
Amgen Inc.
|
Disposable Biter
OrthoDynamix has introduced the ArthroSteer Biter. It is the first disposable biter used for meniscal shoulder and knee repair. A sharp jaw for every procedure affords excellent tissue interaction. Moreover, the Biter is steerable, allowing access to and around joint capsule structures. Besides the jaw’s ability to bend 180°, the jaw orientation to the tissue plane is made possible by the 360° jaw rotation, which is independent of the bend. OrthoDynamix notes that the ArthroSteer Biter can eliminate dozens of reusable biter instruments configured with varying preset bent shafts.
OrthoDynamix is a Gyrx LLC portfolio company.
To learn more, contact
OrthoDynamix
|
Aesculap Implant Systems, LLC, has announced the launch of the S4 Element Pedicle Screw System.
The S4 Element Pedicle Screw System was made available to a select group of surgeons in May 2009 as part of the company’s Market Preference Evaluation, and a full launch of the system is planned for the second quarter of 2010, at which time the system will be released to surgeons throughout the United States.
Aesculap notes that some of S4 Element’s unique features include an industry-leading ultra-low-profile screw head for minimal impingement of anatomical structures and innovative placement instruments, like the speed-multiplier handle, which facilitates tapping and screw placement at a 3.5 times faster rate without altering bone–screw thread properties.
The S4 Element System will be sold through the Aesculap Implant Systems direct and indirect sales network.
For more information, contact
|
Soft-Tissue Repair
KFx Medical Corporation announced it has received 510k clearance from the US Food and Drug Administration (FDA) for products used in a wide variety of arthroscopic tenodesis knee procedures, such as anterior cruciate ligament, posterior cruciate ligament, and medial patellofemoral ligament reconstruction.
KFx Medical has also received 510k clearance from the FDA for its AppianFx™ product line for soft-tissue repair and reconstruction in the knee.
The AppianFx line of implants from KFx reattach tissue to bone in shoulder, knee, foot, and ankle procedures, which, combined, exceed well over 1 million annual surgical procedures. Product offerings include those that directly place and secure tissue into bone both with and without the use of sutures.
For more information, contact
KFx Medical Corporation
|
Hindfoot Deformities and Arthritis Treatment
Wright Medical Group, Inc., has announced the full commercial launch of the VALOR® Hindfoot Fusion Nail. The system was designed in conjunction with world-renowned foot and ankle surgeons to facilitate ankle fusion in the treatment of skeletal deformity, late-stage arthritis, or complications resulting from diabetes (neuro-osteoarthropathy). Since its initial premarket availability announced in November 2009, the system has been limited to use in a few centers in the United States, gathering early clinical results.
With an array of sizes and anatomical screw positions, the VALOR® Nail is designed to provide optimal fixation for each patient’s unique anatomy and condition. Each fusion nail also incorporates an internal compression device that allows the surgeon to control the compression between bone surfaces, thereby optimizing the conditions for fusion to occur.
Wright estimates that over 30,000 hindfoot fusion procedures are performed annually in the United States, and over 50% are estimated to be treated with a fusion nail. With the expanding diabetic population, the number of patients requiring a nail option for salvage will continue to expand.
The new VALOR® Hindfoot Fusion system will be made available immediately through Wright’s specialized Foot and Ankle sales force.
For more information, contact
Wright Medical Technology
|
Monoblock Ceramic Technology
Amedica Corporation, a spinal and orthopedic implant and instrument manufacturer focused on unique silicon nitride (SiN) ceramic technologies, announced that it has been granted a US patent covering its novel hip implant featuring a monoblock ceramic acetabular cup for use in articulating joints for total joint replacement. Currently under development, Amedica’s cup covered under this and other pending patents will be used as an ultra–low–wear–bearing component for motion-preserving implants.
The technology allows Amedica to combine high-strength silicon nitride ceramic with an ultra–low–wear surface–bearing technology, along with a bone-contacting Bioactive™ surface designed for secure, long-term fixation. Amedica notes that this provides surgeons with wider design choices and flexibility to improve anatomic fit and function compared with currently available alternate bearing options.
In addition to spinal implants, Amedica’s SiN materials have disruptive characteristics for hip and knee implant applications as well. The material is fracture-resistant; its articulating surfaces do not produce the wear debris that is linked to osteolysis-related reoperations. Additionally, the company notes that the Bioactive implants feature a hydrophilic surface and a conductive cancellous structure to enhance bone in-growth and attachment.
For more information, contact
Amedica
|
Postmenopausal Osteoporosis Treatment
Amgen, Inc., announced that the US FDA has approved Prolia™ (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture or multiple risk factors for fracture, or of patients who have failed or are intolerant to other available osteoporosis therapy. Prolia, the first and only FDA-approved RANK Ligand inhibitor, is a 60-mg subcutaneous injection administered by a health care professional every 6 months.
Prolia’s approval is based on a pivotal 3-year Phase 3 study involving 7,808 postmenopausal women with osteoporosis. Treatment with Prolia resulted in greater bone density, stronger bones, and reduced risk for vertebral, hip, and nonvertebral fractures measured at 3 years.1
The pivotal 3-year Phase 3 Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) study in 7,808 women with postmenopausal osteoporosis demonstrated that treatment with Prolia, administered as a 60-mg subcutaneous injection every 6 months, compared with placebo at 3 years resulted in: a 68% reduction in vertebral fractures (4.8% absolute risk reduction), a 40% reduction in hip fractures (0.3% absolute risk reduction), a 20% reduction in nonvertebral fractures (1.5% absolute risk reduction), and significant bone density increases at all key sites measured (8.8% at the lumbar spine, 6.4% at the total hip, and 5.2% at the femoral neck).2 The incidence of new spine fractures was 2.3% with Prolia vs. 7.2% with placebo. The incidence of hip fractures was 0.7% with Prolia vs. 1.2% with placebo. The incidence of non-spine fractures was 6.5% with Prolia vs. 8% with placebo.
ProliaPlus™ is a multifaceted product support program designed to provide comprehensive assistance to health care providers, patients, and their caregivers to help facilitate access to Prolia for appropriate patients. ProliaPlus provides information and assistance on issues related to product insurance coverage to physician offices. Additionally, upon request, ProliaPlus will remind patients and providers about when the patient’s next dose is due, thus helping to support patient adherence to therapy. ProliaPlus will also have information on the availability of potential financial assistance programs.
To review the Prolia prescribing information and REMS materials, visit www.amgen.com.
For more information, contact
References
Amgen Inc.
|
Disposable Biter
OrthoDynamix has introduced the ArthroSteer Biter. It is the first disposable biter used for meniscal shoulder and knee repair. A sharp jaw for every procedure affords excellent tissue interaction. Moreover, the Biter is steerable, allowing access to and around joint capsule structures. Besides the jaw’s ability to bend 180°, the jaw orientation to the tissue plane is made possible by the 360° jaw rotation, which is independent of the bend. OrthoDynamix notes that the ArthroSteer Biter can eliminate dozens of reusable biter instruments configured with varying preset bent shafts.
OrthoDynamix is a Gyrx LLC portfolio company.
To learn more, contact
OrthoDynamix
|
Arthroscopic Management of a Chronic Primary Anterior Shoulder Dislocation
Incidence of Early Development of Radiolucent Lines in Keeled Polyethylene Glenoid Components After Total Shoulder Arthroplasty
Resurfacing of Isolated Articular Cartilage Defects in the Glenohumeral Joint With Microfracture: A Surgical Technique & Case Report
Exostosis-Like Intra-articular Periosteal Osteoblastoma: A Rare Case
New Products/Product News
OA, RA, and Ankylosing Spondylitis Treatment Option
| AstraZeneca and POZEN, Inc., announced that the US Food and Drug Administration (FDA) has approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO, co-developed by POZEN, Inc., and AstraZeneca, is a fixed-dose combination of delayed-release enteric-coated naproxen, a pain-relieving nonsteroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole, a proton pump inhibitor (PPI). The FDA approval was supported by data from a clinical development program, including results from the pivotal PN400-301 and PN400-302 studies, which showed patients taking VIMOVO experienced significantly fewer endoscopic gastric ulcers compared with patients receiving enteric-coated naproxen. While many patients with osteoarthritis treat their symptoms with NSAIDs, 50% of chronic NSAID users are at risk of developing gastrointestinal ulcers. In the PN400-301 and -302 studies, the primary end point was the cumulative incidence of gastric ulcers through 6 months. In each of the trials, patients received either VIMOVO or enteric-coated naproxen 500 mg, twice daily, over a 6-month treatment period. Endoscopies were performed at baseline and at 1, 3, and 6 months. Data from study PN400-301 showed a 4.1% incidence of gastric ulcers in patients taking VIMOVO compared with 23.1% among patients taking enteric-coated naproxen (P<0.001). Study PN400-302 showed a 7.1% incidence of gastric ulcers among patients taking VIMOVO compared with 24.3% with enteric-coated naproxen (P<0.001). The most commonly observed adverse events in the clinical trials (experienced by >5% of patients in the VIMOVO group) were erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, and nausea. For more information, contact
|
Soft-Tissue Coagulation Device
| Bovie Medical Corporation has announced that they have received clearance from the US Food and Drug Administration (FDA) to market its proprietary BOSS™ bipolar sintered steel coagulation device. The BOSS™ is the latest device based on Bovie’s saline enhanced sintered steel technology. For more information, contact Bovie Medical |
Demineralized Bone Matrix
| Aesculap Implant Systems, LLC, has announced the launch of the new ProSpace DBM-D, a demineralized bone matrix available in two forms—a “flowable” paste or “moldable” putty. The moldable putty contains cortical-cancellous chips that create a 3-D scaffold for optimized osteoconduction. ProSpace DBM-D pastes and putties serve as bone void filler in many surgical applications. Unique features associated with this product allow for room temperature storage and re-hydration with a choice of fluids, including a patient’s own blood, sterile water, or saline. ProSpace DBM-D is manufactured for Aesculap by RTI Biologics, Inc. For more information, contact Aesculap |
Orthopedic Trauma Launch
| Salient Surgical Technologies, Inc., announced the availability of its line of AQUAMANTYS® bipolar sealers for use in orthopedic trauma procedures. Already in wide use for spinal fusion and orthopedic reconstruction of the hip and knee, the AQUAMANTYS System can help surgeons achieve hemostasis quickly while avoiding damage to delicate structures. Typical applications include lower-limb amputation, pelvic osteotomy, and large débridement procedures; sacral, hip, periprosthetic and femoral fractures; and long-bone nonunion procedures. The AQUAMANTYS System employs TRANSCOLLATION™ technology, Salient’s proprietary combination of radiofrequency energy and saline that seals specific types of collagen-based tissues while maintaining temperatures at or below 100°C. TRANSCOLLATION technology allows surgeons to rapidly treat tissue at the surgical site by transforming specific types of collagen-based structures to improve patient outcomes. To learn more, contact Salient |
30-Year Knee
| Smith & Nephew Orthopaedics Division has announced the results of unprecedented testing on its VERILAST technology for knee replacement implants. After simulating 30 years of physical activity on the company’s LEGION◊ knee replacement, VERILAST technology produced an 81% reduction* in wear, the leading cause of knee replacement failure. The FDA has reviewed the results and Smith & Nephew received 510k clearance for claims related to VERILAST technology’s ability to “provide wear performance sufficient for 30 years of actual use under typical conditions.” The consensus of scientific literature is that knee implants are expected to last 10 to 15 years. VERILAST technology is the combination of 2 advanced bearing surface technologies: Smith & Nephew’s patented metal alloy OXINIUM oxidized zirconium, used on the femoral side of the joint, and highly cross-linked polyethylene (plastic), implanted on the tibial side. OXINIUM◊ material has been in use in knee replacements for more than a decade, but was only recently coupled with highly cross-linked polyethylene components. OXINIUM is a metal alloy that undergoes a heating process, transforming its surface into a hard, smooth ceramic that is 4,900 times more resistant to scratching than traditional materials. Smith & Nephew notes that OXINIUM is 20% lighter than cobalt chromium, the metal used in conventional knee replacements, and because it doesn’t contain detectable amounts of nickel like cobalt chromium does, it is considered hypoallergenic and safe for patients with metal allergies. Smith & Nephew’s primary knee replacement systems, the LEGION◊ and GENESIS◊ II knee implants, are currently available with VERILAST technology. For more information, contact *As compared with wear simulator data seen for a traditional bearing couple for an estimated 5 years. Smith & Nephew, Inc. |
CMC Implant
| Ascension Orthopedics, Inc., has announced the launch of the Ascension® NuGripTM CMC Implant. The NuGrip is designed to relieve pain and restore range of motion in the first carpometacarpal (CMC) joint. The Ascension NuGrip is a joint replacement for the base of the thumb made of PyroCarbon, a material known for its superior wear and biocompatibility characteristics. The company notes that the implant is a bone-preserving, reliable alternative to soft-tissue reconstruction, which is the standard treatment for this indication. The Ascension NuGrip CMC implant is a single component that minimizes bone resections and preserves the trapezium. The stem is anatomically designed for a press fit within the intramedullary canal without cement. The specifically designed stem and collar enhance stability and maintain the anatomy’s joint space. The spherical head has an extended circumference which provides maximum opportunity for range of motion within the trapezium. The device offers 8 sizing options to fit patient anatomy. To learn more, contact Ascension Orthopedics |
OA, RA, and Ankylosing Spondylitis Treatment Option
| AstraZeneca and POZEN, Inc., announced that the US Food and Drug Administration (FDA) has approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO, co-developed by POZEN, Inc., and AstraZeneca, is a fixed-dose combination of delayed-release enteric-coated naproxen, a pain-relieving nonsteroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole, a proton pump inhibitor (PPI). The FDA approval was supported by data from a clinical development program, including results from the pivotal PN400-301 and PN400-302 studies, which showed patients taking VIMOVO experienced significantly fewer endoscopic gastric ulcers compared with patients receiving enteric-coated naproxen. While many patients with osteoarthritis treat their symptoms with NSAIDs, 50% of chronic NSAID users are at risk of developing gastrointestinal ulcers. In the PN400-301 and -302 studies, the primary end point was the cumulative incidence of gastric ulcers through 6 months. In each of the trials, patients received either VIMOVO or enteric-coated naproxen 500 mg, twice daily, over a 6-month treatment period. Endoscopies were performed at baseline and at 1, 3, and 6 months. Data from study PN400-301 showed a 4.1% incidence of gastric ulcers in patients taking VIMOVO compared with 23.1% among patients taking enteric-coated naproxen (P<0.001). Study PN400-302 showed a 7.1% incidence of gastric ulcers among patients taking VIMOVO compared with 24.3% with enteric-coated naproxen (P<0.001). The most commonly observed adverse events in the clinical trials (experienced by >5% of patients in the VIMOVO group) were erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, and nausea. For more information, contact
|
Soft-Tissue Coagulation Device
| Bovie Medical Corporation has announced that they have received clearance from the US Food and Drug Administration (FDA) to market its proprietary BOSS™ bipolar sintered steel coagulation device. The BOSS™ is the latest device based on Bovie’s saline enhanced sintered steel technology. For more information, contact Bovie Medical |
Demineralized Bone Matrix
| Aesculap Implant Systems, LLC, has announced the launch of the new ProSpace DBM-D, a demineralized bone matrix available in two forms—a “flowable” paste or “moldable” putty. The moldable putty contains cortical-cancellous chips that create a 3-D scaffold for optimized osteoconduction. ProSpace DBM-D pastes and putties serve as bone void filler in many surgical applications. Unique features associated with this product allow for room temperature storage and re-hydration with a choice of fluids, including a patient’s own blood, sterile water, or saline. ProSpace DBM-D is manufactured for Aesculap by RTI Biologics, Inc. For more information, contact Aesculap |
Orthopedic Trauma Launch
| Salient Surgical Technologies, Inc., announced the availability of its line of AQUAMANTYS® bipolar sealers for use in orthopedic trauma procedures. Already in wide use for spinal fusion and orthopedic reconstruction of the hip and knee, the AQUAMANTYS System can help surgeons achieve hemostasis quickly while avoiding damage to delicate structures. Typical applications include lower-limb amputation, pelvic osteotomy, and large débridement procedures; sacral, hip, periprosthetic and femoral fractures; and long-bone nonunion procedures. The AQUAMANTYS System employs TRANSCOLLATION™ technology, Salient’s proprietary combination of radiofrequency energy and saline that seals specific types of collagen-based tissues while maintaining temperatures at or below 100°C. TRANSCOLLATION technology allows surgeons to rapidly treat tissue at the surgical site by transforming specific types of collagen-based structures to improve patient outcomes. To learn more, contact Salient |
30-Year Knee
| Smith & Nephew Orthopaedics Division has announced the results of unprecedented testing on its VERILAST technology for knee replacement implants. After simulating 30 years of physical activity on the company’s LEGION◊ knee replacement, VERILAST technology produced an 81% reduction* in wear, the leading cause of knee replacement failure. The FDA has reviewed the results and Smith & Nephew received 510k clearance for claims related to VERILAST technology’s ability to “provide wear performance sufficient for 30 years of actual use under typical conditions.” The consensus of scientific literature is that knee implants are expected to last 10 to 15 years. VERILAST technology is the combination of 2 advanced bearing surface technologies: Smith & Nephew’s patented metal alloy OXINIUM oxidized zirconium, used on the femoral side of the joint, and highly cross-linked polyethylene (plastic), implanted on the tibial side. OXINIUM◊ material has been in use in knee replacements for more than a decade, but was only recently coupled with highly cross-linked polyethylene components. OXINIUM is a metal alloy that undergoes a heating process, transforming its surface into a hard, smooth ceramic that is 4,900 times more resistant to scratching than traditional materials. Smith & Nephew notes that OXINIUM is 20% lighter than cobalt chromium, the metal used in conventional knee replacements, and because it doesn’t contain detectable amounts of nickel like cobalt chromium does, it is considered hypoallergenic and safe for patients with metal allergies. Smith & Nephew’s primary knee replacement systems, the LEGION◊ and GENESIS◊ II knee implants, are currently available with VERILAST technology. For more information, contact *As compared with wear simulator data seen for a traditional bearing couple for an estimated 5 years. Smith & Nephew, Inc. |
CMC Implant
| Ascension Orthopedics, Inc., has announced the launch of the Ascension® NuGripTM CMC Implant. The NuGrip is designed to relieve pain and restore range of motion in the first carpometacarpal (CMC) joint. The Ascension NuGrip is a joint replacement for the base of the thumb made of PyroCarbon, a material known for its superior wear and biocompatibility characteristics. The company notes that the implant is a bone-preserving, reliable alternative to soft-tissue reconstruction, which is the standard treatment for this indication. The Ascension NuGrip CMC implant is a single component that minimizes bone resections and preserves the trapezium. The stem is anatomically designed for a press fit within the intramedullary canal without cement. The specifically designed stem and collar enhance stability and maintain the anatomy’s joint space. The spherical head has an extended circumference which provides maximum opportunity for range of motion within the trapezium. The device offers 8 sizing options to fit patient anatomy. To learn more, contact Ascension Orthopedics |
OA, RA, and Ankylosing Spondylitis Treatment Option
| AstraZeneca and POZEN, Inc., announced that the US Food and Drug Administration (FDA) has approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO, co-developed by POZEN, Inc., and AstraZeneca, is a fixed-dose combination of delayed-release enteric-coated naproxen, a pain-relieving nonsteroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole, a proton pump inhibitor (PPI). The FDA approval was supported by data from a clinical development program, including results from the pivotal PN400-301 and PN400-302 studies, which showed patients taking VIMOVO experienced significantly fewer endoscopic gastric ulcers compared with patients receiving enteric-coated naproxen. While many patients with osteoarthritis treat their symptoms with NSAIDs, 50% of chronic NSAID users are at risk of developing gastrointestinal ulcers. In the PN400-301 and -302 studies, the primary end point was the cumulative incidence of gastric ulcers through 6 months. In each of the trials, patients received either VIMOVO or enteric-coated naproxen 500 mg, twice daily, over a 6-month treatment period. Endoscopies were performed at baseline and at 1, 3, and 6 months. Data from study PN400-301 showed a 4.1% incidence of gastric ulcers in patients taking VIMOVO compared with 23.1% among patients taking enteric-coated naproxen (P<0.001). Study PN400-302 showed a 7.1% incidence of gastric ulcers among patients taking VIMOVO compared with 24.3% with enteric-coated naproxen (P<0.001). The most commonly observed adverse events in the clinical trials (experienced by >5% of patients in the VIMOVO group) were erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, and nausea. For more information, contact
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Soft-Tissue Coagulation Device
| Bovie Medical Corporation has announced that they have received clearance from the US Food and Drug Administration (FDA) to market its proprietary BOSS™ bipolar sintered steel coagulation device. The BOSS™ is the latest device based on Bovie’s saline enhanced sintered steel technology. For more information, contact Bovie Medical |
Demineralized Bone Matrix
| Aesculap Implant Systems, LLC, has announced the launch of the new ProSpace DBM-D, a demineralized bone matrix available in two forms—a “flowable” paste or “moldable” putty. The moldable putty contains cortical-cancellous chips that create a 3-D scaffold for optimized osteoconduction. ProSpace DBM-D pastes and putties serve as bone void filler in many surgical applications. Unique features associated with this product allow for room temperature storage and re-hydration with a choice of fluids, including a patient’s own blood, sterile water, or saline. ProSpace DBM-D is manufactured for Aesculap by RTI Biologics, Inc. For more information, contact Aesculap |
Orthopedic Trauma Launch
| Salient Surgical Technologies, Inc., announced the availability of its line of AQUAMANTYS® bipolar sealers for use in orthopedic trauma procedures. Already in wide use for spinal fusion and orthopedic reconstruction of the hip and knee, the AQUAMANTYS System can help surgeons achieve hemostasis quickly while avoiding damage to delicate structures. Typical applications include lower-limb amputation, pelvic osteotomy, and large débridement procedures; sacral, hip, periprosthetic and femoral fractures; and long-bone nonunion procedures. The AQUAMANTYS System employs TRANSCOLLATION™ technology, Salient’s proprietary combination of radiofrequency energy and saline that seals specific types of collagen-based tissues while maintaining temperatures at or below 100°C. TRANSCOLLATION technology allows surgeons to rapidly treat tissue at the surgical site by transforming specific types of collagen-based structures to improve patient outcomes. To learn more, contact Salient |
30-Year Knee
| Smith & Nephew Orthopaedics Division has announced the results of unprecedented testing on its VERILAST technology for knee replacement implants. After simulating 30 years of physical activity on the company’s LEGION◊ knee replacement, VERILAST technology produced an 81% reduction* in wear, the leading cause of knee replacement failure. The FDA has reviewed the results and Smith & Nephew received 510k clearance for claims related to VERILAST technology’s ability to “provide wear performance sufficient for 30 years of actual use under typical conditions.” The consensus of scientific literature is that knee implants are expected to last 10 to 15 years. VERILAST technology is the combination of 2 advanced bearing surface technologies: Smith & Nephew’s patented metal alloy OXINIUM oxidized zirconium, used on the femoral side of the joint, and highly cross-linked polyethylene (plastic), implanted on the tibial side. OXINIUM◊ material has been in use in knee replacements for more than a decade, but was only recently coupled with highly cross-linked polyethylene components. OXINIUM is a metal alloy that undergoes a heating process, transforming its surface into a hard, smooth ceramic that is 4,900 times more resistant to scratching than traditional materials. Smith & Nephew notes that OXINIUM is 20% lighter than cobalt chromium, the metal used in conventional knee replacements, and because it doesn’t contain detectable amounts of nickel like cobalt chromium does, it is considered hypoallergenic and safe for patients with metal allergies. Smith & Nephew’s primary knee replacement systems, the LEGION◊ and GENESIS◊ II knee implants, are currently available with VERILAST technology. For more information, contact *As compared with wear simulator data seen for a traditional bearing couple for an estimated 5 years. Smith & Nephew, Inc. |
CMC Implant
| Ascension Orthopedics, Inc., has announced the launch of the Ascension® NuGripTM CMC Implant. The NuGrip is designed to relieve pain and restore range of motion in the first carpometacarpal (CMC) joint. The Ascension NuGrip is a joint replacement for the base of the thumb made of PyroCarbon, a material known for its superior wear and biocompatibility characteristics. The company notes that the implant is a bone-preserving, reliable alternative to soft-tissue reconstruction, which is the standard treatment for this indication. The Ascension NuGrip CMC implant is a single component that minimizes bone resections and preserves the trapezium. The stem is anatomically designed for a press fit within the intramedullary canal without cement. The specifically designed stem and collar enhance stability and maintain the anatomy’s joint space. The spherical head has an extended circumference which provides maximum opportunity for range of motion within the trapezium. The device offers 8 sizing options to fit patient anatomy. To learn more, contact Ascension Orthopedics |