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:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a leading Health and Nutrition ... the Purzorb™process to full spectrum CBD oil will revolutionize the rapidly growing CBD market ... can be easily incorporated into liquid products, while reducing costs to end users. , ...
(Date:10/13/2017)... , ... October 13, 2017 , ... The Visiting Nurse ... Market. Featuring a collection of specialty vendors and unique items from across the nation, ... quality-focused health and wellness services offered by the VNA. The boutique will be ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... DevOps and Agile Software Development, has been awarded a contract by the Center ... Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies in ...
(Date:10/12/2017)... ... ... Planet Fitness, one of the largest and fastest growing franchisors and operators ... location in Covington, LA at 401 N. U.S. Highway 190, in January of 2018. ... in the Holiday Square shopping center. Its location allows it to serve both Covington ...
(Date:10/12/2017)... ... October 12, 2017 , ... Information about the technology: ... develop to enable prevention of a major side effect of chemotherapy in children. ... pediatric patients. For cisplatin, hearing loss is FDA listed on-label as a dose ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... , Oct. 12, 2017 AVACEN Medical , ... company with their  2017 New Product Innovation Award for ... extensive primary and secondary medical device market research by Frost ... its first-to-market OTC, drug-free pain relief product, the AVACEN 100, ... to treating fibromyalgia widespread pain. ...
(Date:10/11/2017)...  Caris Life Sciences ® , a leading innovator ... precision medicine, today announced that St. Jude Medical Center,s ... (POA) as its 17 th member. Through participation ... Cancer Institute will help develop standards of care and ... making cancer treatment more precise and effective. ...
(Date:10/10/2017)... EXTON, Pa. , Oct. 10, 2017   ... leader in innovative solutions for injectable drug administration, today ... of West,s ID Adapter for improving the intradermal administration ... the Fourth Skin Vaccination Summit in May 2017 by ... Team Lead, Polio Department, World Health Organization (WHO), and ...
Breaking Medicine Technology: