AUSTIN, Texas -- (BUSINESS WIRE) -- Privately held On-X® Life Technologies Inc. (On-X LTI), whose mechanical heart valves have been implanted in more than 150,000 patients in over 90 countries, announced today that it has begun shipping its On-X Plus 1.5 Aortic Heart Valve to European hospitals. The early demand for the mechanical valve, particularly in Germany, Spain, Sweden, Finland and Greece, is a direct result of On-X LTI receiving European regulatory approval for an expanded labeling claim earlier this year. The new CE Mark permits the company to market its breakthrough valve in Europe with a reduced requirement for the use of the blood-thinning drug 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.
“I am not surprised by European clinicians’ swift adoption of the On-X Plus 1.5 Aortic Heart Valve,” said Marc Gerdisch, M.D., cardiac surgeon and PROACT1 investigator. “Now the On-X valve not only provides superior hemodynamics but also improves safety by significantly reducing the incidence of bleeding events.”
“We are extremely pleased with European heart surgeons’ eagerness to adopt our state-of-the-art On-X Plus 1.5 valve,” added Clyde Baker, President and CEO of On-X Life Technologies. “In Europe, the On-X aortic valve is unique among all other mechanical valves. We recently convened our European distribution network for intense training, and they now are meeting with their surgeon-customers to introduce this breakthrough mechanical heart valve across Europe.”
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.
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.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.
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
2 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