FDA Receives Application for New Renal Stent


September 27, 2010

September 27, 2010 – A premarket approval (PMA) application has been submitted for the Formula balloon-expandable stent to help treat patients suffering from renal artery stenosis. Cook Medical’s submission to the U.S. Food and Drug Administration (FDA) included data from the REFORM trial.

Renal artery stenosis is a narrowing of the arteries that supply blood to the kidneys. The new stent has a low-profile design and does not shorten upon expansion.

“Renal artery disease decreases the ability of the kidneys to filter and remove waste and fluids from the body, leading to possible renal insufficiency and kidney failure,” said Robert Bersin, M.D., the trial's principal investigator and medical director of endovascular services at Seattle Cardiology and Swedish Medical Center. “Balloon angioplasty has historically been the preferred approach to treating this condition, but can require re-intervention of the narrowed blood vessel. Stenting typically increases patency compared to balloon angioplasty.”

For more information: www.cookmedical.com