The US Food and Drug Administration (FDA) has approved On-X Life Technologies’ new On-X aortic prosthetic valve with anatomic sewing ring.
Made of On-X Carbon, a pure form of isotropic pyrolytic carbon, the On-X aortic prosthetic valve features an advanced design that causes less blood cell damage.
The company is also carrying out an ongoing prospective, randomised study, On-X valve reduced anticoagulation clinical trial (PROACT), which is attempting to demonstrate that patients may require less anticoagulation with the On-X valve.
In addition, long-term studies of the On-X heart valve have demonstrated fewer morbid events.
The company said the valve’s sewing ring matches the shape of the native aortic annulus, helping to prevent flattening and distortion, and making it easier for clinicians to implant it in small patients in southern Europe, Latin American and Asia.
Franciscan chief St Francis Health Heart Centre cardiovascular and thoracic surgery Dr Marc Gerdisch said the On-X heart valve with anatomic sewing ring also preserves normal cardiac architecture and reduces tissue tension.
"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," Gerdisch said.
On-X Life Technologies president Clyde Baker said; "Last October, we announced the submission to the FDA of an application to allow modification of the Instructions for Use (IFU) for the On-X heart valve to lower anticoagulation levels than those previously recommended by professional society guidelines."