On-X Life Technologies 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 brandedis 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— P rospective R andomized O n-X A nticoagulation C linical T rial (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.” 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.