AAOS Annual Meeting In Brief
Stryker knee IDE study: 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 and traditional 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 knee systems, 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 (1"The Gray Sheet" Dec. 17, 2007)
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A framework to end the Iran war is in place but fractured supply chains can’t recover overnight. Data from India suggests solvent prices have generally cooled from April peaks, but API costs stay elevated or even climbed in June for some products.
REUSE OF DISPOSABLE CARDIAC CATHETERS TARGETED BY FDA in an effort to address safety concerns about reuse of single-use products. The cardiac catheter product area "seems to jump up as one that is an area for us to focus on," Larry Spears, director of the Office of Compliance's Division of Enforcement III in FDA's Center for Devices and Radiological Health, said June 24 at a Food Drug and Law Institute conference held in Washington, D.C.
St Jude Medical and Spire are to develop anti-bacterial heart valve sewing cuffs using Spire's Spi-Argent silver coating process. The agreement covers a variety of valve designs as well as ancillary components. The treatment is aimed at reducing the incidence of endocarditis, a rare but dangerous complication of valve transplant which has a mortality rate as high as 60%.
Nissho saw sales rise only 1% to ¥17 billion ($930 million) in the year to March 1997. The Japanese company's net income was Yen3 billion, compared with Yen1.7 billion for the previous year, reports Reuters. Nissho produces disposable medical equipment.
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Class III devices and panel-track supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.
AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.