FRANKLIN, Mass., Sept. 5 /PRNewswire/ -- Arthrosurface, Inc. (http://www.arthrosurface.com), the developer of less-invasive joint resurfacing systems, announced that it has received approval from the U.S. FDA to begin its pivotal investigation for its line of focal knee resurfacing implants. The FDA 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 U.S. FDA IDE investigation. "We are very pleased with our 2 year results in the feasibility study. Our data has demonstrated remarkable improvement in pain and function in a challenging middle-aged patient population," said Matthias R. Schurhoff, MD, Vice President of Clinical Operations and Scientific Affairs.
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. HemiCAP® resurfacing is intended to bridge the gap between biologic procedures and conventional joint replacement. Arthrosurface's minimally invasive resurfacing system allows for preservation of healthy tissue and joint structures by limiting treatment to localized defects using a shallow inlay implant that is matched to the patient's own unique joint surface anatomy. "Maintaining the overall joint integrity and avoiding early tissue loss through arthroplasty bone cuts may provide a significant benefit for patients in the long-term management of joint degeneration," commented Steven Ek, COO.
With this Phase III study approval, the company is moving one step closer to bringing this new treatment option to U.S. patients.
The HemiCAP® knee implant, which has been in clinical use outside the U.S. for over 4 years, is the smallest or perhaps earliest surgical intervention within the company's comprehensive knee resurfacing catalogue of products. Together with the company's currently globally-marketed UniCAP(TM) unicondylar knee resurfacing and patello-femoral resurfacing implants, the company offers a unique family of resurfacing interventions designed to treat a variety of knee disorders.
Based on the same platform technology, the company also globally markets products in other major joints and extremities.
Source: Arthrosurface, Inc.