Medical Devices Today

OrbusNeich Says "Bio-Engineered" Stent May Be Solution To Thrombosis Risk

From the May 28, 2007, issue of "The Gray Sheet"

OrbusNeich hopes to lead a new wave of stent technology with its Genous Bio-engineered R-Stent, which the firm says is safer than existing drug-eluting stents because it has a natural antibody coating instead of a drug-eluting polymer.

David Camp, OrbusNeich's VP-strategic marketing and business development, spoke to "The Gray Sheet" about the device's potential May 23 from Barcelona, host of the EuroPCR conference May 22-25.

Genous was CE marked in August 2005 and is being evaluated in a number of studies in Europe. The Hong Kong firm met with FDA in March to discuss a pivotal trial to support U.S. approval of the device.

Edwards Set To Launch "Two-Trials-In-One" For Sapien Percutaneous Valve

From the March 26, 2007, issue of "The Gray Sheet"

Edwards Lifesciences will soon begin a 600-patient U.S. pivotal clinical trial for its Sapien transcatheter aortic replacement heart valve at Columbia University Medical Center and the Cleveland Clinic, the company says.

Announced March 20, FDA clearance allows the company to enroll the first 40 patients at up to eight centers in the PARTNER trial (Placement of AoRTic traNscathetER valves). Edwards plans to expand the trial to 15 additional sites, pending FDA clearance.