US firm Guidant has received Food and Drug Administration approval for its Multi-Link Vision Coronary Stent System, marking the introduction of the first in a new class of coronary stents in the USA. The use of the cobalt chromium alloy allows for a thinner strut design and a lower profile, which enables physicians to access challenging coronary blockages. Guidant plans to use its cobalt chromium stent technology in future programs including drug-eluting stents and vulnerable plaque therapies.
The US approval was received for the Multi-Link Vision in 3.0mm-4.0mm diameters and 8mm-28mm lengths. Guidant says that the Multi-Link Vision stent has demonstrated positive clinical results, with a six-month clinically-driven target lesion revascularization rate of 1.9%. TLR is defined as a repeat procedure at the original lesion site any time during the follow-up period.
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