In short
Regenerative medicine company Kensey Nash Corporation, has been trumpeting its Meso BioMatrix™ surgical mesh including news of the first clinical implant of the product.
Background
Meso BioMatrix™ surgical mesh is manufactured using Kensey Nash’s proprietary Optrix™ process, which gently disinfects tissues, inactivates viruses and removes cells while preserving extracellular matrix (ECM) components. According to the company the result is a unique tissue, derived from porcine peritoneum, with a thinner profile, and desirable handling characteristics. Kensy Nash claims that pre-clinical studies have shown more rapid cellular infiltration when compared to dermis based xenograft materials.
Meso BioMatrix™ products are indicated for use in the United States for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair and reinforcement in plastic and reconstructive surgery. The first procedure using the product was performed by Dennis Hammond, M.D. of Partners in Plastic Surgery in Grand Rapids, Michigan.
Clinician comments
“The Meso BioMatrix™ product offers several advantages for use in plastic and reconstructive surgery including strength with just the right amount of pliability, and easy re-draping around corners and complex contours. It will serve as an excellent adjunct in plastic and reconstructive surgery,” commented Dr. Hammond.
Wound Matrix
Kensey Nash has received 510k clearance for its Meso BioMatrix™ Wound Matrix. This clearance allows for the use of the Meso BioMatrix™ device in the management of topical wounds. Next steps for the technology include CE Mark submissions for both wound and breast surgery applications, and the initiation of an Investigational Device Exemption (IDE) feasibility clinical study for the use of Meso BioMatrix™ for soft tissue reinforcement in two-stage post-mastectomy breast reconstruction surgery.
The Company has received conditional approval on the IDE protocol from the FDA and has begun clinical site qualifications.
Company comments
“The Meso BioMatrix™ products and the previously launched porcine dermis products demonstrate the versatility of the OPTRIX™ processing technology to provide a full spectrum of ECM products with a diverse range of properties for multiple surgical applications. Surgeons have responded favorably to now having an option of biologic materials to meet an array of surgical needs. We anticipate that these efforts will allow Kensey Nash to explore various partnership opportunities in these growing biologic markets,” commented Doug Evans, Chief Operating Officer.
Kensey Nash will be exhibiting the Meso BioMatrix™ product May 5th-7th at the American Society of Aesthetic Plastic Surgery Meeting in Vancouver, BC.
Source: Kensey Nash Corporation, PR Newswire
published: April 25, 2012 in: Launches / Withdrawals, Plastic/Reconstructive, Technology