On-X Life Technologies reports CE mark approval to sell its mechanical aortic heart valve with an expanded labeling claim: a reduction in the required use of blood thinners
“This approval allows European clinicians to maintain patients on a lower dose of anticoagulant, which has been shown in a multicenter clinical trial (PROACT: Prospective On-X Anticoagulation Clinical Trial) to decrease bleeding by more than 50%.” – Clyde Baker, CEO
AUSTIN, TX — Jan. 13, 2014 — On-X® Life Technologies, Inc. announced today that its previously CE (Conformité Européenne)-marked On-X® Prosthetic Heart Valve has 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 newly branded On-X® Plus 1.5™ Aortic Heart Valve is now the only heart valve that allows patients to be managed at INR (International Normalized Ratio) levels as low as 1.5, a near-normal level. An INR blood test measures the time it takes for patients’ blood to clot.
The 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). These data demonstrated the safety of maintaining On-X® Prosthetic Heart Valve patients on a reduced anticoagulation therapy regimen while decreasing bleeding complications by more than 50 percent.
“On-X is the first prosthetic heart valve designed to combine the durability of a mechanical valve with the reduced complication rates of tissue valves,” said Jack Bokros, Ph.D., On-X LTI’s founder.
“This is a significant medical advance for aortic heart valve patients in Europe,” said Clyde Baker, President and CEO, On-X Life Technologies. “In the past, the primary concern related to mechanical heart valves had been the requirement for complementary anticoagulation therapy despite its well-documented risk of bleeding. Now, On-X Plus 1.5 Aortic Valve recipients in Europe will be able to take a lower level of anticoagulant that will reduce the potential incidence of bleeding complications caused by taking the higher dosages normally prescribed after receiving a mechanical heart valve. We will commence marketing efforts with our new labeling claim immediately.”
“It changes our perspective on how patients can be managed if they have an On-X mechanical valve with respect to their wafarin or Coumadin dose,” said Marc Gerdisch, M.D., cardiac surgeon, PROACT investigator. “We have always known that most people age 65 or younger should be treated with a mechanical valve. Now we recognize that the On-X valve provides the additional advantage of being able to maintain the blood thinner at a lower dose, and in fact improve safety, because the incidence of bleeding events is less.”
“I think this is a potential game-changing, paradigm-shifting opportunity in clinical cardiac medicine and in valve disease in general,” said Mohan Sathyamoorthy, M.D., cardiologist. “I think the really exciting aspect is the potential to reduce anticoagulation burden.”
“On-X is proud of its investment into this research and clinical effort. The On-X Plus 1.5 valve is designed to be the next step in the evolution of valve technology,” added Clyde Baker, CEO. “The approval of an expanded labeling claim in Europe sets the On-X aortic valve apart from all other mechanical valves and also offers a new option to patients in their 50’s and 60’s 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. One that will likely last the rest of their life.”
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 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.
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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.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.
- 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.