Navigation Links
Collagen Matrix, Inc. Receives FDA 510(k) Clearance for TenoMend(TM) Collagen Tendon Wrap for the Management and Protection of Tendon Injuries
Date:5/27/2008

FRANKLIN LAKES, N.J., May 27 /PRNewswire/ -- Collagen Matrix, Inc. announced today that it has received the United States Food and Drug Administration's 510(k) clearance of its TenoMend(TM) Collagen Tendon Wrap indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

TenoMend(TM) Collagen Tendon Wrap is a resorbable type 1 collagen matrix that provides a non-constricting encasement for injured tendons. TenoMend(TM) Collagen Tendon Wrap is designed to be an interface between the tendon and tendon sheath or the surrounding tissue. When hydrated, TenoMend(TM) Collagen Tendon Wrap is a conformable, nonfriable, self-curling collagen sheet designed for easy placement under, around or over the injured tendon. The patented self-curling wrap design offers the ability to implant with minimal suturing. The device provides a protected environment and gliding surface of the sheath for tendon healing.

In trauma cases, fractures and injuries of bones in the extremities typically result in injury of the associated soft tissue such as tendon and peripheral nerves. Tendon scarring can often occur as a result of tendon repair. When tendon scarring occurs, other structures such as joints may lose normal range of motion.

Collagen Matrix's portfolio of orthopaedic products now includes solutions for bone, tendon, and peripheral nerve repair. With Collagen Matrix's OssiGuide(TM) Cancellous Granules, OssiMend(TM) and OssiMend(TM) Putty Mineral-Collagen Composites, OssiPatch(TM) Bone Healing Protective Sheet, NeuroMatrix(TM) Collagen Nerve Conduit, Neuroflex(TM) Flexible Collagen Nerve Conduit, NeuroMend(TM) Collagen Nerve Wrap and TenoMend(TM) Collagen Tendon Wrap, the surgeon is equipped with the products needed to repair a complex injury.

The results of an animal flexor tendon repair study using TenoMend(TM) Collagen Tendon Wrap demonstrated the ease of implantation with the tendon's return to full range of motion comparable to normal unsevered tendons. The controls in which severed tendons were repaired but not wrapped, demonstrated statistically significant reduction in range of motion. TenoMend(TM) Collagen Tendon Wrap was successful in providing a protective environment for tendon repair.

"We are committed to providing the surgical community with a full line of products to address complicated orthopaedic injuries involving hard and soft tissues. TenoMend(TM) Collagen Tendon Wrap is the first in a series of tendon repair products under development," said Shu-Tung Li, Ph.D., Founder and CEO of Collagen Matrix. "We are currently exploring potential product marketing and distribution opportunities for worldwide distribution of TenoMend(TM) Collagen Tendon Wrap, which is available immediately," he added.

Collagen Matrix, Inc. is a leader in the design and engineering of collagen- and mineral-based extracellular matrices for tissue and organ repair and regeneration. Since its inception in 1997, the Company has received many government grants for the development of collagen-based matrix products in the areas of neurological, vascular, urological, and orthopaedic tissue regeneration applications. The Company currently manufactures collagen- and mineral-based finished medical devices in the areas of neurosurgery, oral surgery, orthopedic-spine surgery, and wound care. More information about the Company can be found at http://www.collagenmatrix.com.

CONTACT:

Peggy Hansen, RAC

Sr. Director, Clinical, Regulatory,

and Quality Assurance

Tel: 201-405-1477

Fax: 201-405-1355


'/>"/>
SOURCE Collagen Matrix, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Galderma Completes Acquisition of CollaGenex
2. Investor Alert from Cauley Bowman Carney & Williams, PLLC: Update on Proposed Acquisition of CollaGenex Pharmaceuticals, Inc. - CGPI
3. Collagen Matrix, Inc. Launches OssiMend(TM) Bone Graft Matrix for Orthopedic and Spine Applications
4. TEI Biosciences Launches SurgiMend(TM) Collagen Matrix for Soft Tissue Reconstruction
5. Jarrow Formulas Launches New Products Featuring BioCell Collagen II(R)
6. Organogenesis, Inc. Announces Acquisition of NanoMatrix, Inc.
7. BMP Sunstone Receives Import Drug License (IDL) from SFDA
8. Nikon Instruments Receives Record Number of Entries for Nikon Small World
9. BioMS Medicals relapsing-remitting multiple sclerosis trial receives positive review from Data Safety Monitoring Board
10. febit Receives U.S. Patent for Microfluidic Extraction Method
11. Prime Therapeutics Receives VIPPS Accreditation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... ... medical technologies, services and solutions to the healthcare market. The company's primary focus ... distribution, manufacturing, sales and marketing strategies that are necessary to help companies efficiently ...
(Date:6/27/2016)... 27, 2016  Liquid Biotech USA ... of a Sponsored Research Agreement with The University ... (CTCs) from cancer patients.  The funding will be ... correlate with clinical outcomes in cancer patients undergoing ... then be employed to support the design of ...
(Date:6/24/2016)... discussions on a range of subjects including policies, debt and ... Poloz. Speaking at a lecture to the Canadian ... to the country,s inflation target, which is set by both ... "In certain areas there needs to be ... why not sit down and address strategy together?" ...
(Date:6/24/2016)... ... June 24, 2016 , ... While the majority of commercial spectrophotometers and fluorometers ... the 6000i models are higher end machines that use the more unconventional z-dimension of ... beam from the bottom of the cuvette holder. , FireflySci has developed several ...
Breaking Biology Technology:
(Date:6/7/2016)... June 7, 2016  Syngrafii Inc. and San ... relationship that includes integrating Syngrafii,s patented LongPen™ eSignature ... This collaboration will result in greater convenience for ... union, while maintaining existing document workflow and compliance ... ...
(Date:6/2/2016)... The Department of Transport Management (DOTM) ... million US Dollar project, for the , Supply ... Enrolment, and IT Infrastructure , to ... implementation of Identity Management Solutions. Numerous renowned international vendors participated ... was selected for the most compliant and innovative ...
(Date:6/2/2016)... Perimeter Surveillance & Detection Systems, Biometrics & ... & Other Service  The latest report from ... of the global Border Security market . Visiongain ... billion in 2016. Now: In November 2015 ... and hardware technologies for advanced video surveillance. ...
Breaking Biology News(10 mins):