`A#X/hC > ]IUVil E6uVmwpYzGYUijK/,?j/^*,.Yg[]O#\uoYy_m*[k+l-:_$LPH[xE9!]1}*! According to Active Implants, more than 2 million partial meniscectomys are performed worldwide annually in an attempt to alleviate pain. Time allotted for each presentation may be limited. FDA Grants Breakthrough Designation to 'Artificial Meniscus Q#(Gd!c!QGzHCN0$ 0M@-`Xj7[ Bn@UrM9>9hr$V_ -PYD Study design: Cohort study; Level of evidence, 2. And, in case the implant doesnt fit the patient, which very rarely happens, it can be taken out and the knee is back to the same situation as before the implantation.. endstream endobj 792 0 obj <>stream Active Implants LLC Secures First Tranche of a $40 Million Equity Financing. The SUN and VENUS U.S. clinical trials completed enrollment in June 2018, and Active Implants is expecting to file for regulatory approval in the U.S. in the next two years. 3 ). First FDA Approved Artificial Meniscus - Medical Automation Surgeons at two medical centers in Israel have completed successful implantations of the NUsurface Meniscus Implant, manufactured by Active Implants LLC. Our website services, content, and products are for informational purposes only. Progressively, the implant will form a customized fit to the patients knee contour. You can find additional information at the links below: PMA Approvals: Monthly listings of all new or high-risk medical devices that were approved via the premarket approval (PMA) pathway.These . You can find additional information at the links below: Sign up to receive email updates on Recent Device Approvals. 6060 Primacy Parkway Suite 460 Memphis, TN 38119901.762.0352Privacy Policy EU Website: www.activeimplants.eu, Knee Replacement Options and Meniscus Pain Relief, American Academy of Orthopedic Surgeons Annua, Society for Arthroscopy and Joint Surgery / G, 6060 Primacy Parkway Suite 460 Memphis, TN 38119, The Ohio State University Wexner Medical Center, https://clinicaltrials.gov/show/NCT02108496. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. The site is secure. The FDA Breakthrough Devices Program was implemented to expedite the development and review process for medical devices that are novel or offer new technology for patients with life-threatening or irreversibly debilitating conditions. No need to drill into or cut the bone. Continued pain after repairing meniscus tears is a very common orthopedic problem, and until now, we have not had effective treatment options., Ted Davis, president and CEO of Active Implants, said, Filling the gap in treatment options between minimally invasive meniscus repair and total knee replacement is a large unmet need in the orthopedic market.
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