On-X Life Technologies to present its newest advance in heart valve technology at “94th Annual Scientific Meeting” of the American Association for Thoracic Surgery (AATS) in Toronto
AUSTIN, TX — April 24, 2014 — Privately held On-X® Life Technologies, Inc. (On-X LTI) announced today that it will present the results of the PROACT1 clinical trial of the CE-marked On-X® Plus 1.5™ Aortic Heart Valve during the upcoming scientific meeting of the American Association for Thoracic Surgery (AATS) in Toronto, April 27-30.
The company will display its products at Booth No. 429. One of the highlights of this scientific meeting will be a company-sponsored symposium on Sunday evening, April 27, featuring: (1) John Puskas, MD, The Mt. Sinai Hospital, New York “Reduced Anticoagulation after Mechanical Aortic Valve Replacement: Interim Results from the PROACT Randomized FDA IDE Trial.” (2) Shuichiro Takanashi, MD, Sakakibara Heart Institute, Tokyo “The On-X Valve Experience for Small Annulus Patients and Lower INR Levels.”
In January 2014, On-X LTI announced 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.
“Our On-X® Plus 1.5™ Aortic Heart Valve is creating a lot of excitement with heart surgeons throughout Europe and Asia since we began shipping the valve in March: not only among our current customers but also new surgeons who want the best mechanical valve for their patients. The On-X valve is the only mechanical valve in the world with a clinically established 60% reduction in bleeding with no increase in thromboembolic events at the lower warfarin dosage as demonstrated in the PROACT clinical trial, an FDA-approved multicenter study with over 1,400 patient years and over 53,000 INR data points,” said Clyde Baker, President and CEO of On-X LTI. “We are looking forward to continuing to educate physicians at this important upcoming AATS scientific meeting.”
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.
About On-X Life Technologies, Inc.
On-X Life Technologies (On-X LTI) offers a range of cardiac products that are designed to dramatically improve the quality of life of patients including mechanical heart valves for aortic and mitral valve replacements, the CHORD-X™ ePTFE Suture for chordal replacement and repair and the CarbonAid® & CarbonMini™ to prevent air embolism during open-heart surgery. Headquartered in Austin, Texas, On-X LTI is a privately held company. More information is located at www.onxlti.com.
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Media Contact: Ronald Trahan, APR, Ronald Trahan Associates Inc., +1-508-359-4005, x108
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.2 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.
- Puskas 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
- ACC/ AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the1998 Guidelines for the Management of Patients With Valvular Heart Disease): Developed in Collaboration With the Society of Cardiovascular Anesthesiologists Endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons Circulation 2006;114;84-231. DOI: 10.1161/CIRCULATIONAHA.106.176857