On-X Life Technologies Permitted to Sell Heart Valve With Expanded Labeling Claim

On-X Life Technologies has received European regulatory approval to market its On-X Plus 1.5 Aortic Heart Valve with a lower dose of blood-thinning drugs such as warfarin. The expanded labeling claim makes the company’s valve the only such product that allows patients to manage their INR (International Normalized Ratio) levels as low as 1.5 (near normal). An INR blood test measures the time it takes for the 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). 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.”

Marc Gerdisch, M.D., a cardiac surgeon and PROACT investigator, said the valve changes clinicians’ perspective on patient management of their warfarin or Coumadin doses. He noted the incidence of bleeding events is less with the On-X mechanical valve.

“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 Baker. “The approval of an expanded labeling claim in Europe 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 70s and 80s. 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 comprised of 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, On-X claims. 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 is a privately held developer of mechanical heart valve replacements. The company is headquartered in Austin, Texas.