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Medtronic Receives FDA Approval For Micro-Driver Stent |
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02 May 2006 |
MINNEAPOLIS, IN, USA | May 01, 2006 | Medtronic, Inc. (NYSE: MDT) said today that it has received U.S. Food and Drug Administration approval for the Micro-Driver coronary stent system, a bare metal system designed specifically to perform in small vessels and tortuous anatomies. This cobalt alloy stent is the first bare metal stent for small vessels with an indication for new or untreated vessels (a de novo indication), addressing an important need in the treatment of coronary artery disease.
Based on the popular Medtronic Driver® stent platform, the Micro-Driver stent has a rounded, modular design for excellent deliverability. The ultra-low crossing profile helps physicians access the difficult-to-reach lesions often encountered in patients with small vessels. These patients otherwise could have limited treatment alternatives, according to Michael Ball, M.D., St. Vincent Hospital in Indianapolis and the Heart Center of Indiana.
“This stent fulfills an essential need that we have in cardiology,” said Dr. Ball, a clinical investigator in the Micro-Driver clinical trial and study’s top patient enroller. “When you do small vessel stenting, you want the stent to be small and you want it to be flexible. That’s the whole idea behind Micro-Driver. It conforms well to the anatomy and allows you to take care of more lesions. I think more patients should be able to benefit from this technology.”
Even with the rapid acceptance of drug-eluting stents (DES) during the last three years, bare metal stents still play a critical role in the medical practice of interventional cardiologists. Many physicians choose bare metal stents for patient care in small-vessel cases, and the Micro-Driver stent offers them an important treatment option.
“A stent can be effective only if it gets to the lesion. Micro-Driver is highly deliverable and is designed specifically for ease-of-use in these types of patients,” said Sean Salmon, Medtronic vice president and General Manager of Medtronic Vascular’s coronary business. “We believe there always will be an important role for bare metal stents, especially when they can address specific clinical needs as this stent does.”
Made from an advanced cobalt alloy that is more radiopaque than stainless steel, the Micro-Driver stent replaces the Medtronic S660 stainless steel model. Micro-Driver is available in diameters of 2.25 mm, 2.50 mm and 2.75 mm, and lengths of 8, 12, 14, 18, and 24 mm, and on both over-the-wire and Medtronic MX2 delivery platforms.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Quarterly Report on Form 10-Q for the quarter ended January 27, 2006. Actual results may differ materially from anticipated results.
SOURCE: Medtronic, Inc |
