August 8, 2011 – Edwards Lifesciences announced the global launch of the Carpentier-Edwards Physio Tricuspid Annuloplasty Ring for the treatment of tricuspid valve insufficiency. The company received both 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE mark for European sales of the device.
“Tricuspid valve insufficiency is a progressive disease that often leads to severe tricuspid regurgitation. When left untreated, it can affect patient outcomes and survival,” said Kevin Accola, M.D., thoracic and cardiovascular surgery, Florida Hospital Cardiovascular Institute. “This new treatment offers important therapeutic advancements, designed to allow surgeons to restore proper valve function with a ring that preserves natural movement and conforms to the shape of the valve annulus.” Accola provides paid consulting services to Edwards for training and education.
The ring features a three-dimensional waveform shape that allows it to conform to the natural shape of a patient's tricuspid valve opening, or annulus. It is also designed with “selective flexibility” to allow the native valve to maintain its natural movement. The ring also incorporates a number of ease-of-implant features, including a distinct sewing ledge that facilitates intuitive suture placement and alignment.
Severe tricuspid regurgitation is caused by the inability of the tricuspid valve leaflets to close properly, allowing the backward flow of blood. Surgical repair with an annuloplasty repair ring is typically recommended for patients with significant dilation of the annulus. It is estimated that more than 100,000 patients suffer from tricuspid insufficiency annually in the United States.
For more information: www.edwards.com