Guidant's Ventak Prizm 2
This article was originally published in The Gray Sheet
Executive Summary
Dual-chamber ICD launches worldwide, firm announces Nov. 8. Automatic device is approximately 20% smaller than nearest competitor, Guidant notes. FDA approved the device via PMA supplement on Aug. 8 (1"The Gray Sheet" Aug. 14, 2000, p. 9). Separately, the firm's Multi-Link Pixel coronary stent receives a CE mark Nov. 7. Lesion-specific device is designed to treat first-time blockages in native coronary arteries and saphenous vein bypass grafts with diameters less than 3.0 mm. Guidant plans to apply for FDA approval of the system in the second half of 2001 following completion of 150-patient U.S. clinical trial. Also in the stent area, the company reports the launch of the 30-patient SSYLVIA trial for treatment of cerebral atherosclerosis