[April 27, 2015]

Cardiothoracic Clinicians to Examine Benefits of Reducing On-X Aortic Valve Patients' Warfarin Regimen at AATS

Cardiothoracic surgeons and cardiologists attending the 95^th annual meeting of the American Association of Thoracic Surgeons will hear a panel of clinical experts discussing the FDA's recent decision allowing patients with aortic heart valves from On-X® Life Technologies Inc. (ONXLTI) to reduce their warfarin anticoagulation regimen and be managed, starting three months after their surgery, at an INR (International Normalized Ratio) level of 1.5 to 2.0, which is closer to an unmedicated INR.

The event, scheduled for 5-7 pm tonight at the Sheraton Hotel in Seattle, will be hosted by John Puskas, M.D., Chairman, Department of Cardiothoracic Surgery at Mount Sinai Beth Israel New York. Dr. Puskas was the Principal Investigator for the PROACT (Prospective Randomized On-X Anticoagulation Clinical Trial) study, which affirmed that high-risk trial patients with On-X Aortic Heart Valves who reduced their regular blood-thinning medication dosage to maintain a lower INR of 1.5 to 2.0 and took a low-dose aspirin experienced a 65% overall reduction in bleeding events with no increase in stroke rate.^1,2

The event will feature other PROACT investigators, as well as panelists Ralph Damiano, Jr., MD, Professor and Chief, Division Cardiac Surgery, Barnes Jewish Hospital South, St. Louis and Mohan Sathyamoorthy, MD, FACC, Chief, Cardiovascular Division from Baylor All Saints Medical Center, Dallas.

"The FDA cleaance gives younger aortic heart valve replacement patients - particularly those 65 years and under - a more permanent solution for their aortic valve disease. The On-X valve not only presents patients with potentially reduced risk of bleeding complications, but its proven clinical durability is intended to eliminate the trauma associated with future cardiac reoperations needed to replace failing animal tissue valves," said Clyde Baker, On-X Life Technologies CEO.

On-X Features Chord-X Mitral Valve Repair System

During AATS, On-X also is highlighting its innovative On-X Chord-X® Mitral Valve Chordal Repair System, at booth #730. This new system, which is produced with On-X LTI's proprietary ePTFE suture material, features pre-measured chordal loops and an adjustable suture system intended to simplify artificial chord replacement during mitral valve repair. Published clinical data suggest that repair of the mitral valve annulus in combination with chordal repair is ideal for many patients.

About On-X LTI

Headquartered in Austin, Texas, the privately held 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. To learn more, visit www.onxlti.com.

On-X and Chord-X are registered trademarks of On-X Life Technologies, Inc.

¹ Puskas et al., Jnl Thoracic and Cardiovascular Surgery, Vol. 147 No. 4, April 2014, http://www.jtcvsonline.org/article/S0022-5223(14)00010-5/pdf

² Yanagawa B, Levitsky S, Puskas JD, et al. Reduced anticoagulation as safe in high risk patients with the On-X mechanical aortic valve. Current Opinion in Cardiology 2015; 30:140-5

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