Navigation Links
Arthrosurface HemiCAP(R) Focal Knee Resurfacing Implant Receives FDA Approval to Move into Final Investigational Stage
Date:9/5/2008

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 PR Newswire.
All rights reserved

Related medicine news :

1. Cellvizio(R) Confocal Microscopy Improves ERCP Bile Duct Cancer Detection, According to New Study Presented at DDW
2. VivaScope(R) Confocal Imager May Eliminate Need for Routine Skin Biopsies for Dermatology Patients
3. JUVA Skin & Laser Center Introduces Affirm CO2 to New York City Laser Resurfacing Clients
4. Laser Resurfacing Produces Long-Term Results
5. DOT Therapy: Newest Breakthrough Technology in Laser Skin Resurfacing
6. DeepFX(TM) and ActiveFX(TM) Fractional Resurfacing Featured at Annual Meeting of The American Society Of Aesthetic Plastic Surgery
7. The DOT CO2 Fractional: The Next Step in Laser Skin Resurfacing
8. Keep Father Time From Marching On: New Laser Treatments Offer Gentle and Effective Skin Resurfacing in a Flash
9. Ascension Orthopedics Launches the TITAN(TM) Humeral Resurfacing Device World Wide
10. Frost & Sullivan Honors ConforMIS for Its Contribution to Personalized Care Through its Customized Implant Development Technologies
11. New implant device remotely monitors heart failure patients at Northwestern Memorial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2017)... ... May 24, 2017 , ... Dr. Alan I. Benvenisty, MD is dual ... City. He is known for his distinguished expertise and experience in the diagnosis and ... sub-specialty training in treating renovascular disease and aortic aneurysm . He is known ...
(Date:5/24/2017)... ... May 24, 2017 , ... NucleusHealth ... interpretation, has received U.S. Food and Drug Administration (FDA) 510(k) clearance ... and secure cloud platform for medical image management. At the core is patented ...
(Date:5/24/2017)... ... 2017 , ... Dr. Manju R. Kejriwal, a leading Ohio dentist, is now ... a referral. Dr. Kejriwal understands the emotional and financial toll traditional orthodontics can take ... Patients no longer need to feel the esthetic effects of wires and brackets when ...
(Date:5/24/2017)... ... May 24, 2017 , ... ... Policy Solutions is vehemently opposed to Donald Trump’s budget, “A New Foundation for ... that inspires fear, demonizes the poor, marginalizes underserved populations, undermines productivity, and destroys ...
(Date:5/24/2017)... ... May 24, 2017 , ... ... Course II of the HP3 (High-Performance Periodontal Practice) continuing education (CE) series. As ... latest advancements in his field by attending numerous CE courses each year. His ...
Breaking Medicine News(10 mins):
(Date:5/9/2017)... , May 9, 2017  Semler Scientific, Inc. ... technology solutions to improve the clinical effectiveness and ... for the first quarter ended March 31, 2017. ... enable our customers to identify when preventive care ... before events like heart attacks or strokes occur," ...
(Date:5/6/2017)... --  Provista , a proven leader in the supply chain ... Jim Cunniff as the company,s new president and ... to Provista, including most recently serving as the president and ... . He assumed his new role with Provista on May ... Provista," says Jody Hatcher , president, Sourcing and Collaboration ...
(Date:5/4/2017)... MONTREAL , May 4, 2017  Fortuna Fix Inc. (" ... aiming to be the first to eliminate the need for ... autologous cells to treat neurodegenerative diseases. Fortuna ... ("SAB") with Professor Michael Fehlings , MD, PhD; Father ... Hack , MD, MPH; and Professor James Giordano , ...
Breaking Medicine Technology: