News | August 08, 2011

Edwards Lifesciences Launches Physio Tricuspid Heart Valve Repair Ring

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:

Related Content

Bilateral Artery Use Does Not Improve 10-Year CABG Outcomes
News | Cardiovascular Surgery | September 06, 2018
While it is firmly established that the use of one internal thoracic artery can improve life expectancy in coronary...
Mandatory Public Coronary Artery Bypass Grafting Reporting Associated With Better Patient Outcomes
News | Cardiovascular Surgery | April 30, 2018
Mandatory public reporting of coronary artery bypass grafting (CABG) results in Massachusetts was associated with...
Gecko Biomedical Receives CE Mark Approval for Setalum Sealant
News | Cardiovascular Surgery | September 19, 2017
Gecko Biomedical announced it has received CE Mark approval for its Setalum Sealant, allowing the company to market its...
ClearFlow Inc. Announces Positive U.S. Clinical Trial Results
News | Cardiovascular Surgery | September 08, 2017
September 8, 2017 — ClearFlow Inc.
Videos | Cardiovascular Surgery | July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Intensive Glycemic Control Program Produces Significant Per-Patient Cost Savings for CABG Surgery
News | Cardiovascular Surgery | May 25, 2017
A new study from Emory University observed a near-20 percent reduction in perioperative complications, a 1.2-day...
Risk of Heart Transplant Rejection Reduced by Desensitizing Patient Antibodies
News | Cardiovascular Surgery | May 23, 2017
The risk of heart transplant rejection can be reduced by desensitizing patient antibodies, according to research...
Scientists Show How Cells React to Injury From Open-Heart Surgery
News | Cardiovascular Surgery | May 04, 2017
Cedars-Sinai Heart Institute investigators have learned how cardiac muscle cells react to a certain type of injury that...
ERACS Session Highlights Need for Standardized Best Practices in Cardiac Surgery
News | Cardiovascular Surgery | May 02, 2017
The recently formed group Enhanced Recovery After Cardiac Surgery (ERACS) hosted an organizing session in Boston on...
ClearFlow Receives Frost & Sullivan New Product Innovation Award for PleuraFlow Technology
News | Cardiovascular Surgery | May 01, 2017
ClearFlow Inc. has received the prestigious 2017 Global Frost & Sullivan Award for New Product Innovation. The...
Overlay Init