April 21, 2010 — A landmark clinical trial has begun in Europe to explore the safety and efficacy of a paclitaxel-eluting stent for the treatment of renal artery disease.
Cook Medical, a license holder of Angiotech Pharmaceuticals Inc.’s stent technology, has enrolled the first patient in the Formula clinical trial. The multicenter, randomized trial plans to enroll 120 patients at sites across Europe. The trial utilizes Cook's Formula renal stent, which is designed with a very low profile that may help it cross tightly blocked vessels for placement into diseased renal arteries.
"Following Cook Medical's success with the Zilver PTX, we chose to be involved in the clinical trial for the Formula PTX balloon expandable renal stent," said Dierk Scheinert, professor and angiology and cardiology specialist at participating hospital, Park-Krankenhaus Leipzig-South. "Given the early success of the US REFORM clinical trial evaluating the Formula balloon expandable stent, we remain very excited about the potential of a drug-eluting renal stent."
"Providing physicians with a greater range of devices will ultimately help patients receive the best possible treatment options," Scheinert added.
Renal artery disease is a narrowing of the arteries that supply blood to the kidneys, increasing the risk of a stroke due to high blood pressure, and possible renal insufficiency and kidney failure.
For more information: www.angiotech.com, www.cookmedical.com