FDA Approves First Cobalt-Chromium StentFDA Approves First Cobalt-Chromium Stent

Originally Published MDDI August 2003

NEWSTRENDS

Maureen Kingsley

Guidant Corp. (Indianapolis) has received FDA approval to market its unprecedented cobalt-chromium stent for cardiovascular applications. According to the company, the use of the cobalt-chromium alloy makes for a thinner strut design and lower profile. These features enable physicians to access more-difficult coronary blockages. 

Guidant plans to use the new technology in such treatments as drug-eluting stents and vulnerable-plaque therapies. The specific product receiving approval—the Multi-Link Vision—will be offered in diameters of 3.0–4.0 mm, and lengths of 8.0–28.0 mm. 

In clinical trials, the device achieved a six-month, clinically driven target-lesion revascularization (TLR) rate of 1.9%. TLR is defined as a repeat procedure at the original site during the follow-up period.  The company also plans to introduce its Multi-Link Mini-Vision product, a small-vessel cobalt-chromium stent, in Europe later this year. 

Guidant also announced recently that it has received market approval for its Vitality DS implantable cardioverter defibrillator (ICD) system. The company reports that this dual-chamber ICD is the smallest in the world. 

The Vitality DS is designed to treat patients with life-threatening rhythms in the lower ventricles of the heart—a common cause of sudden cardiac death. The Vitality ICD is implanted near the collarbone and continuously monitors heart rhythms. It delivers electrical therapy when required to protect against abrupt loss of cardiac function.

The new ICD incorporates Guidant's proprietary AV search hysteresis. According to the company, results from recent studies suggest that unnecessary pacing in the right ventricle may have a harmful effect on the heart. Guidant's AV search hysteresis is intended specifically to reduce unnecessary pacing of the right ventricle by periodically searching for the heart's intrinsic rhythm.

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