On-X Life Launches Blood Cell Friendly Valves At EACTS And Seeks FDA Reduced Anti-coagulation Claim

In short

It’s EACTS week, so expect a few new product announcements. Here’s one, as Texan outfit On-X® Life Technologies, Inc. has launched two new heart valve products, the On-X® Aortic Prosthetic Valve with Anatomic Sewing Ring and an ePTFE suture Chord-X® for repair and replacement of mitral valve chordae.

Background

The On-X 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® enabled On-X LTI to make significant valve design changes that resulted in a prosthesis that acts more like a natural valve in its treatment of blood. It is well 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.

Long-term studies, such as the Prospective Randomized On-X Valve Reduced Anticoagulation Clinical Trial (PROACT) have documented fewer morbid events in recipients of On-X valves and compelling results indicating that patients may require less anticoagulation. To this end the company has submitted applications for review and FDA/CE approval with new Instructions for Use that recommend use of the On-X Aortic Valve at reduced levels of anticoagulation.
With the addition of the anatomic sewing ring, the valve is now easier to implant in small patients very common in southern Europe, Latin American and Asia.

Physician/developer comments

“The On- X Aortic Valve with Anatomic Sewing Ring combines two very important advances in mechanical valve technology,” said Xavier Ruyra-Baliarda, M.D., FECTS, of Barcelona, and a main inventor for the anatomic sewing cuff. “Unlike previous mechanical valve sewing rings, the anatomic sewing ring matches the anatomy of the aortic annulus, thereby precluding the need for flattening of the annulus and potential related complications.”

Company comments

“It is an exciting time at On-X Life Technologies,” said Clyde Baker, On-X LTI’s president. “Last week we announced the submission to the FDA/CE authorities of an application to modify the Instructions for Use (IFU) for the On-X valve to lower anticoagulation levels than the previously recommended by profession society guidelines. This week, we are launching an important new feature—the anatomic sewing cuff model—as well as entering the mitral valve repair market. We look forward to a very positive EACTS meeting.”

Source: On-X Life Technologies, Inc.