AUSTIN, Texas, April 2, 2014—Privately held On-X® Life Technologies Inc. (On-X LTI) announced today that it will introduce the On-X® Plus 1.5™ Aortic Heart Valve and present the results of the PROACT1 clinical trial at a company-sponsored luncheon symposium during the upcoming annual scientific meeting of Asian Society for Cardiovascular and Thoracic Surgery (ASCVTS) in Istanbul as part of its international marketing campaign.On-X has been successfully selling mechanical valves in International markets since July 1998.
In January, On-X LTI received European regulatory approval for an expanded labeling claim, which now permits the company to market its breakthrough mechanical heart valve in Europe with a reduced requirement for the use of blood-thinning drugs such as warfarin. The On-X® Plus 1.5™ Aortic Heart Valve is the only approved mechanical heart valve that allows patients to be managed at an INR (International Normalized Ratio) range between 1.5—2.0. An INR blood test measures the time it takes for patients’ blood to clot.
“We fully expect that our On-X Plus 1.5 Aortic Heart Valve will be rapidly and broadly embraced by heart surgeons throughout Europe and Asia, not only by our current customers but also by new surgeons who want the best mechanical valve for their patients. The On-X valve is the only mechanical valve with a clinically established 60% reduction in bleeding with no increase in thromboembolic events at the lower warfarin dosage in the PROACT clinical trial, an FDA-approved multicenter study with over 1,400 patient years and over 50,000 INR data points,” said Clyde Baker, President and CEO of On-X LTI.
“We have a long history of commitment to physicians and their patients who want the very best, safest mechanical valve available,” added Mr. Baker. “Because it has been shown to be safe to use the On-X mechanical valve with low levels of warfarin, patients and their surgeons now have a new valve alternative, and the initial response from clinicians has been overwhelmingly positive.”
1Puskas J, Gerdisch M, Nichols D, et al. Reduced anticoagulation after mechanical aortic valve replacement: Interim results from the Prospective Randomized On-X Valve Anticoagulation Clinical Trial randomized Food and Drug Administration investigational device exemption trial. J Thorac Cardiovasc Surg 2014;147(4):1202-11
About the On-X® Prosthetic Heart Valve
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 has enabled On-X LTI to make significant valve design changes that have resulted in a prosthesis that acts more like a natural valve in its treatment of blood. Clinical studies have 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, which is the basis of the expanded labeling claim recently granted to On-X LTI in the European Union.
About On-X® Life Technologies (On-X LTI)
On-X Life Technologies (On-X LTI) develops mechanical heart valve replacements that are designed to dramatically improve the quality of life of patients. Headquartered in Austin, Texas, On-X LTI is a privately held company. More information is located at www.onxlti.com.
On-X is a registered trademark of On-X Life Technologies Inc. All other trademarks mentioned herein belong to their respective companies.
The approval of a lower INR recommendation through the EU regulatory process applies only within that jurisdiction and others that accept EU review. This therapy is not approved in the US or other countries that have reviews independent of the EU. In these countries On-X Life Technologies, Inc., continues to recommend standard anticoagulation therapy as presently prescribed by various professional societies for the On-X valve.1 On-X aortic and mitral valves are FDA approved.
CAUTION: Federal law restricts this device to sale by or on the order of a physician. Refer to the Instructions for Use that accompany each valve for indications, contraindications, warnings, precautions and possible complications. CAUTION: Investigational use of this device in the Prospective Randomized On-X Valve Anticoagulation Trial (PROACT) is limited by federal law to investigational sites. For further information, visit www.onxlti.com.
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