On-X LTI Receives FDA Approval

On-X Heart Valve with Anatomic Shaped Sewing Ring

The On-X Aortic Heart Valve with an anatomic shaped sewing ring matches the shape of the native aortic annulus and helps prevent flattening and distortion

AUSTIN, TX – February 26, 2013On-X® Life Technologies, Inc. (On-X LTI) announced today that it has received approval from the US Food & Drug Administration (FDA) to market the new On-X® Aortic Prosthetic Valve with Anatomic Sewing Ring. The sewing ring matches the shape of native aortic annulus and helps prevent flattening and distortion, making the On-X heart valve easier to implant in small patients who are very common in southern Europe, Latin American and Asia.

On-X heart valves are made of pure On-X Carbon® and have an advanced design that causes less blood cell damage than traditional mechanical valves. Long-term studies have documented fewer morbid events in recipients of On-X valves and the ongoing Prospective Randomized On-X Valve Reduced Anticoagulation Clinical Trial (PROACT) has the potential to prove that patients may require less anticoagulation with the On-X valve.

“The On- X Aortic Valve with Anatomic Sewing Ring combines two very important advances in mechanical heart 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. This prevents flattening of the annulus and potential related complications.”

Marc W. Gerdisch, M.D., Chief of Cardiovascular and Thoracic Surgery at Franciscan St. Francis Health Heart Center, Indianapolis, Indiana, collaborated on the design of the new cuff and was the first surgeon in the United States to implant the device. He added, “The On-X heart valve with anatomic sewing ring seats beautifully into the annulus. By not changing the annulus shape, normal cardiac architecture is preserved and tension on the tissue is reduced. The implantation of the most advanced mechanical heart valve is made easier while the On-X anatomic sewing ring design also becomes the first to address the important concern of distorting the annulus and adjacent structures.”

“It is an exciting time at On-X Life Technologies,” said Clyde Baker, On-X LTI’s president. “Last October, we announced the submission to the FDA of an application to allow modification of the Instructions for Use (IFU) for the On-X heart valve to lower anticoagulation levels than those previously recommended by professional society guidelines. This week, we are launching an important new feature for the On-X heart valve: the anatomic sewing ring model.”

The On-X heart 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 heart 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® heart 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® and On-X Carbon® are registered trademarks 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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