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TMCNet:  On-X Life Technologies to launch its On-X® Plus 1.5™ Aortic Heart Valve at Annual Meeting of the Society for Cardiothoracic Surgery (SCS) in Great Britain & Ireland

[March 05, 2014]

On-X Life Technologies to launch its On-X® Plus 1.5™ Aortic Heart Valve at Annual Meeting of the Society for Cardiothoracic Surgery (SCS) in Great Britain & Ireland

AUSTIN, Texas --(Business Wire)--

Privately held On-X® Life Technologies Inc. (On-X LTI) announced today that it will launch its European marketing campaign for the On-X Plus 1.5 Aortic Heart Valve in concert with its Great Britain distributor Vascutek Corp. at the Annual Meeting & Cardiothoracic Forum of the Society for Cardiothoracic Surgery in Great Britain & Ireland, March 10-12, Edinburgh, Scotland.

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 anticoagulants (warfarin). The On-X® Plus 1.5™ Aortic Heart Valve is the only heart valve that allows patients to be managed at INR (International Normalized Ratio) levels as low as 1.5-2.0. An INR blood test measures the time it takes for patients' blood to clot.

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"Europe has been waiting for just such guidance from a leading mechanical valve producer, and we are very happy to see On-X take this lead with the new labeling on its product," said John McKenna, Vice President of Cardiothoracic Business Development for Vascutek Ltd., a subsidiary of Terumo Corporation. "Cardiac surgeons in the UK immediately presented us with an order on hearing of or catching sight of the new labeling. We are very excited by the prospects for patients, surgeons and hospitals."

"We are extremely pleased with the market's eagerness to embrace our state-of-the-art On-X Plus 1.5 valve," added Clyde Baker, resident and CEO of On-X LTI. "In Europe the On-X aortic valve is unique among all other mechanical valves and also offers a new option to patients in their 50s and 60s who are considering a tissue valve. These patients are expected to live an additional 20 years. Tissue valve failure is documented to occur between eight to 16 years post-implant. Replacement valve surgery will be necessary for these patients when they are in their 70's and 80's. Now that it has been shown to be safe to use the On-X mechanical valve with low levels of warfarin, these patients and their surgeons have a new valve option available, and the early response of clinicians has been very encouraging."


The European expanded labeling claim was supported by interim data from a recently completed arm of an FDA IDE clinical trial-Prospective Randomized On-X Anticoagulation Clinical Trial ("PROACT")-presented by principal investigator John D. Puskas, M.D., Cardiothoracic Surgery, Emory University, Atlanta, at the annual scientific meeting of the American Association for Thoracic Surgery (AATS) in 2013. These data demonstrated the safety of maintaining On-X® aortic heart valve patients on a reduced anticoagulation therapy regimen while decreasing bleeding complications by 60 percent.

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.

1 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 the 1998 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


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