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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Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
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