On-X® Life Technologies Inc. has announced that it will officially launch its On-X Plus 1.5 Aortic Heart Valve at the Annual Meeting & Cardiothoracic Forum of the Society for Cardiothoracic Surgery in Great Britain & Ireland, March 10-12, Edinburgh, Scotland.
Background
In January, On-X LTI received CE Mark approval for an expanded labeling claim, as we reported here. This 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.
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.
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.
Physician comments
“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.”
Company comments
“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, President 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.”
Source: On-X® Life Technologies, Inc., Business Wire
published: March 6, 2014 in: Cardio, Clinical Studies/Trials, Congresses and Meetings, Launches / Withdrawals