Published:
Arthrosurface HemiCAP(R) Focal Knee Resurfacing Implant Receives FDA Approval to Move into Final Investigational Stage
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(R) 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(R) 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(R) 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(R) 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.
Copyright © 2008, PRNewswire
Copyright © 2008, NewsBlaze,
Daily NewsTags: ,HEA,MTC,FDA,MA-Arthrosurface-FDA
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