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news.Arthrosurface, a developer of less-invasive joint resurfacing systems, has received approval from the FDA to begin its pivotal investigation for its line of focal knee resurfacing implants.
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The FDA has stated that there are no outstanding safety concerns with the device and granted Phase III initiation. Arthrosurface has been evaluating the safety and efficacy of its HemiCAP implants for focal femoral condyle defects under an ongoing FDA investigational device exemption investigation.
With the HemiCAP knee implant, the company is targeting a subgroup of knee patients, typically between the ages of 40 and 60 years, who have focal condylar defects and are likely to undergo knee replacement surgery in the future.
With this Phase III study approval, the company is moving one step closer to bringing this new treatment option to US patients.
Matthias Schurhoff, vice president of clinical operations and scientific affairs at Arthrosurface, said: “We are very pleased with our two year results in the feasibility study. Our data has demonstrated remarkable improvement in pain and function in a challenging middle-aged patient population.”