On-X LTI Launches Innovative Heart Valve Products

European Meeting in Barcelona

The On-X aortic valve with an anatomic shaped sewing ring and ePTFE suture for repair of mitral valve chordae presented at EACTS

AUSTIN, TX – October 29, 2012On-X® Life Technologies, Inc. (On-X LTI) announced today that it is launching two new heart valve products, the On-X® Aortic Prosthetic Valve with Anatomic Sewing Ring and an ePTFE suture Chord-X® for repair and replacement of mitral valve chordae tendeneae “chords,” at the European Association for Cardio-Thoracic Surgery (EACTS) meeting in Barcelona, Spain, on October 28-31, 2012.

On-X heart valves are made of pure On-X Pyrolytic Carbon and have an advanced design that causes less blood cell damage than traditional mechanical valves. Long-term studies, such as the Prospective Randomized On-X Valve Reduced Anticoagulation Clinical Trial (PROACT) have documented fewer morbid events in recipients of On-X valves and compelling results indicating that patients may require less anticoagulation. With the addition of the anatomic sewing ring, the valve is now easier to implant in small patients very common in southern Europe, Latin American and Asia.

“The On- X Aortic Valve with Anatomic Sewing Ring combines two very important advances in mechanical valve technology,” said Xavier Ruyra-Baliarda, M.D., FECTS, of Barcelona, and a main inventor for the anatomic sewing cuff. “Unlike previous mechanical valve sewing rings, the anatomic sewing ring matches the anatomy of the aortic annulus, thereby precluding the need for flattening of the annulus and potential related complications.”

In addition to the launch of the new products, On-X LTI hosted a reception for EACTS attendees on Sunday, October 28. During the reception, Dr. Ruyra-Baliarda presented the On-X valves advanced design features and Thierry Mesana, M.D., Ph.D., of Ottawa, Canada, provided a PROACT update.

“It is an exciting time at On-X Life Technologies,” said Clyde Baker, On-X LTI’s president. “Last week we announced the submission to the FDA/CE authorities of an application to modify the Instructions for Use (IFU) for the On-X valve to lower anticoagulation levels than the previously recommended by profession society guidelines. This week, we are launching an important new feature—the anatomic sewing cuff model—as well as entering the mitral valve repair market. We look forward to a very positive EACTS meeting.”

The On-X valve is the result of a breakthrough in medical grade carbon technology—On-X® pure pyrolytic carbon. In addition to providing a more thromboresistant surface, the comparatively high strength of pure On-X Carbon® enabled On-X LTI to make significant valve design changes that resulted in a prosthesis that acts more like a natural valve in its treatment of blood. It is well documented that the On-X valve does not produce the turbulence and blood damage commonly produced by other mechanical heart valve prostheses and, therefore, significantly reduces the potential for life-threatening blood clots.

About On-X LTI
On-X® Life Technologies, Inc. (On-X LTI) develops heart valve replacements that significantly improve the quality of life of patients. Jack Bokros, Ph.D., and his associates founded On-X LTI in 1994 to further advance prosthetic heart valve technology by capitalizing on their new form of pyrolytic carbon. The company has FDA, CE and Japanese approval for sale of the On-X® valve. On-X LTI also provides contract-manufacturing services utilizing its patented pyrolytic carbon to manufacturers of other medical products, including orthopedic joint and spine prostheses. Headquartered in Austin, Texas, On-X LTI is a privately held company. More information is located at www.onxlti.com.

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On-X is a registered trademark of On-X Life Technologies, Inc. All other trademarks mentioned herein belong to their respective companies.

Media Contact: Clyde Baker, On-X Life Technologies, Inc., 512-339-8000 ext. 269, cbaker@onxlti.com

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