The Gray Sheet
March 15, 2010
Stryker knee IDE study fails: Firm will not pursue FDA approval and commercialization of a mobile bearing knee after results of a pivotal study showed no difference in clinical outcomes between the device andraditional fixed bearing knees, Stryker reports March 8 at the American Academy of Orthopaedic Surgeons annual meeting in New Orleans. The company will instead continue to focus on marketing its Triathalon knee system with X3 advanced bearing technology, which has a lower risk of revision than mobile kneetems, Stryker says. According to Millennium Research Group’s “U.S. Markets for Large-Joint Reconstructive Implants 2009” report, mobile bearing knees account for about 15% of the total domestic knee arthroplasty market, while fixed bearing knees account for roughly 85%. Johnson & Johnson/DePuy was first to market with its LCS Complete RPM Flexion Knee in 2004, and FDA approved Zimmer’s NexGen LPS-Flex mobile bearing knee system in 2007 (“The Gray Sheet” Dec. 17, 2007).
Stryker hips: ADM X3 mobile bearing acetabular system for hip replacement surgery is now available in the U.S., after FDA granted 510(k) clearance in December 2009. The device helps prevent dislocation without the risk of metal ion release associated with metal-on-metal systems, according to Stryker. The firm’s X3 technology also helps increase the implant’s longevity, the firm says, adding that lab testing has shown a 97% reduction in volumetric wear compared to conventional polyethylene. The X3 line helped drive global hip sales up 10% on a reported basis, or 4% at constant currency in the fourth quarter, Stryker reported in its most recent earnings call (“The Gray Sheet” Feb. 1, 2010).
Smith & Nephew: Versatile VLP FOOT variable-angle locked plating system launches at the AAOS annual meeting. The system’s “broad range of screw types and plate designs … solves one of the key issues facing orthopedic surgeons – matching the internal bone fixation technology to the patient’s sometimes difficult bone type.” The firm also introduced its FAST-FIX 360 meniscal repair system, a next generation system that includes 360-degree actuation, allowing surgeons to deploy implants in any hand position, either vertically or horizontally on either side of the meniscus, according to Smith & Nephew. FAST-FIX originally launched in 2001.
Integra Lifesciences: Firm introduces its OsteoSparx and OsteoSurge demineralized bone matrix (DBM) and OsteoStrux osteoconductive scaffold products for use with its spine implants during the AAOS annual meeting. OsteoSparx incorporates a standard DBM and firm’s poloxamer Reverse Phase Medium; OsteoSurge is composed of “an optimized blend” of particulate DBM, Integra’s proprietary Accell bone matrix and poloxamer Reverse Phase Medium; and OsteoStrux is a collagen ceramic matrix. Accell, an open-structured and more dispersed form of DBM, allows greater access to bone proteins, creating a favorable environment for bone formation without the need for partial breakdown of the implanted material, the company explains. The products will address a U.S. market for bone graft substitutes in orthopedic spine procedures estimated at $1.5 billion.
J&J/DePuy shoulder systems: Company is adding a new high-mobility cup to its Delta XTEND reverse shoulder system. Introduced during AAOS, the high mobility humeral cup with Premieron X-linked polyethylene reduces wear debris by 85% compared to cups with conventionally manufactured and sterilized polyethylene, according to DePuy. It also has a shallower depth than other cups, which may further reduce the risk of scapular neck erosion, the firm adds. Delta XTEND launched in 2004 as the first reverse shoulder replacement system. DePuy also showcased the Global CAP CTA, its first resurfacing prosthesis for cuff tear arthroplasty, and two new additions to its anatomic locked plating systems for the elbow and proximal tibia during the meeting.
Ascension Orthopedics: PyroTITAN humeral resurfacing arthroplasty system is the latest addition to the Austin, Texas, company’s line of PyroCarbon-based orthopedic devices. PyroTITAN comes in 12 sizes and addresses glenohumeral joint disease by replacing the damaged humeral head bearing surface and restoring patient’s anatomy while preserving bone, Ascension says. The device is launching internationally. Bacterin’s OsteoSelect: AAOS marks the commercial launch of the Montana biologics company’s first allograft device, OsteoSelect DBM Putty, for use in orthopedic bone grafting. The product, a moldable allograft made of demineralized bone matrix allograft suspended in a polymer carrier material, is designed to withstand irrigation while exhibiting osteoinductive properties for bone regeneration, Bacterin explains. The company’s other marketed medical devices are used to help drain wounds.
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