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. |