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Guidant Prizm 2, HE AICD Launches Will Benefit From Sales Force Expansion

This article was originally published in The Gray Sheet

Executive Summary

Guidant's planned expansion of its Cardiac Rhythm Management sales force will support the U.S. launch of the Ventak Prizm 2 and Prizm HE dual-chamber automatic implantable cardioverter defibrillators, approved on Aug. 8 and on Aug. 9, respectively.

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Guidant's Ventak Prizm 2

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

Guidant's Ventak Prizm 2

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

Guidant Tetra Stent Approval Opens Opportunity To Recoup Lost Market Share

Guidant is looking to its Multi-Link Tetra fourth-generation coronary stent platform to recoup a recent loss in U.S. stent market share, following a drop-off in demand for its Tri-Star stent.

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