On-X LTI Enters License and Development Agreement

On-X Life Technologies Enters License and Development Agreement with Cleveland Clinic

Surgical System to Repair Mitral Valve Chordae System is intended to improve mitral valve repair and simplify procedure for cardiac surgeons

AUSTIN, TX — December 8, 2009On-X® Life Technologies, Inc. (On-X LTI), manufacturers of the On-X® Prosthetic Heart Valve announced today that it has entered into an exclusive worldwide license with the Cleveland Clinic for a system of products intended to improve and simplify the replacement of damaged or severed mitral valve chordae. The system is the creation of co-inventors A. Marc Gillinov, M.D., a staff cardiac surgeon at Cleveland Clinic, and Michael K. Banbury, M. D., of Christiana Care’s Center for Heart and Vascular Health, and will be co-developed with the On-X LTI New Product Development team.

Surgical repair of the mitral valve includes the insertion of a cloth-covered ring around the valve to bring the leaflets into contact with each other (annuloplasty), removal of redundant/loose segments of the leaflets and re-suspension of the leaflets with artificial cords (chordal replacement). Replacement of diseased mitral valve chordae with expanded polytetrafluoroethylene (ePTFE) sutures is an established technique with good long-term results. Various techniques have been described to assist the surgeon to establish the correct replacement chordal length.

“For the past three decades, there has been great focus on the roles of leaflet resection and annuloplasty for mitral valve repair in patients with mitral valve prolapse. More recently, surgeons have recognized the value of using artificial chordae to correct prolapse,” said Dr. Gillinov. “With current techniques, chordal replacement is technically challenging. The hope is to assist cardiac surgeons by providing a simple method for chordal replacement.”

“The surgical approach to mitral valve repair appears to be a method by which a long-term satisfactory outcome can be achieved,” said Dr. Banbury. “It is our expectation that the surgical tools we will develop with On-X LTI will further enable the surgical approach and enhance the consistency of surgical outcomes, providing patients with the best opportunity for a solution to their mitral incompetence.”

Approximately 50,000 mitral valve repair procedures are performed annually in the United States. Mitral valve repair is one of the fastest growing procedures in cardiac surgery due to the excellent long-term outcome. In a minority of cases the mitral valve may not be surgically repaired and must be replaced with a prosthetic valve.

“Cleveland Clinic, and Drs. Gillinov and Banbury are recognized leaders in the delivery of excellent heart surgery results,” said Clyde Baker, On-X LTI president and CEO. “The opportunity for On-X LTI to work with them and to develop this important new surgical system not only enhances the future product offerings of On-X Life Technologies, but also provides us with new insight into the future of heart valve treatment. We are extremely pleased to enter into this relationship and expect that surgeons and patients will receive meaningful value from the delivery of these innovative products.”

About On-X Life Technologies, Inc.
On-X LTI develops heart valve replacements that significantly improve the quality of life for patients. The On-X valve design was awarded a 2002 Medical Device Excellence Award in the Implant and Tissue-Replacement Products category. The company also provides OEM services utilizing its patented On-X carbon to manufacturers of other medical products, including orthopedic joint and spine implant devices. On-X LTI was founded in 1994 by a team of heart valve material and design scientists and engineers led by pioneer Jack Bokros, PhD. Capitalizing on more than 30 years of heart valve design experience the team developed and continues to manufacture the On-X Prosthetic Heart Valve. The valve is approved for use within the US and throughout the world. On-X LTI is headquartered in Austin, Texas. More information is located at www.onxlti.com.

Media Contacts:
Clyde Baker
President & CEO On-X Life Technologies, Inc.
512-339-8000 ext. 269

On-X® Prosthetic Heart Valve and On-X® carbon are trademarks of On-X LTI, registered in the US Patent and Trademark Office and corresponding foreign filings. All other trademarks mentioned herein belong to their respective companies.

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