On-X Life Technologies has gained US marketing rights to its new On-X aortic prosthetic valve with anatomic sewing ring, following the regulatory approval from the US Food and Drug Administration (FDA).
The prosthetic valve, which is made of pure On-X Carbon, features an advanced design that causes less blood cell damage.
The company said valves' sewing ring matches the shape of native aortic annulus that helps in preventing flattening and distortion, making it easier to clinicians to implant in small patients in southern Europe, Latin American and Asia.
In addition, On-X heart valve with anatomic sewing ring preserves normal cardiac architecture and reduces tissue tension.
The long-term studies of On-X heart valve have demonstrated fewer morbid events, according to the company.
Franciscan chief St. Francis Health Heart Centre cardiovascular and thoracic surgery Marc Gerdisch said, "The implantation of the most advanced mechanical heart valve is made easier while the On-X anatomic sewing ring design also becomes the first to address the important concern of distorting the annulus and adjacent structures."
The company said it is also conducting an ongoing prospective, randomized On-X Valve Reduced Anticoagulation Clinical trial (PROACT), which has the potential to prove that patients may require less anticoagulation with the On-X valve.
