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Medical equipment industry

Medtronic Announces First Patient Enrolled in MAVErIC III Clinical Trial

Strategic Insights

— 1 min read

The first patient has been enrolled in the MAVErIC III Clinical Trial, a study evaluating the safety and efficacy of a new system of devices to treat blockages in the carotid arteries, which can lead to ischemic strokes. The trial, led by Robert Molnar, MD, at McLaren Regional Medical Center in Flint, Michigan, will gather data for submission to U.S. regulatory authorities. The MAVErIC III study aims to evaluate the combination of the Exponent Self-Expanding Carotid Stent System with the Interceptor PLUS Carotid Filter System for the treatment of carotid stenosis, a condition that affects millions of people worldwide.

Key Takeaways:

  • The MAVErIC III Clinical Trial will include 413 high-risk patients at 35 investigational sites in North America.
  • Principal investigators for the trial are Randall T. Higashida, MD of the University of California, San Francisco, and Stephen R. Ramee, MD, Ochsner Foundation Hospital, New Orleans, LA.
  • Carotid stenting offers a less invasive alternative to endarterectomy, the current standard of care in treating carotid stenosis.
  • The Interceptor PLUS carotid filter is designed to capture embolic materials that may be liberated during stent deployment, reducing the amount of debris passing into cerebral blood vessels.
  • The Exponent Self-Expanding Carotid Stent System is a tiny cylindrical mesh-like tube used to prop open the carotid artery to maintain optimum blood flow.
  • Medtronic's Endeavor Drug Eluting Coronary Stent system combines a drug-eluting stent with a polymer coating to reduce restenosis.
  • The Endeavor stent system utilizes the original Driver Coronary Stent, approved in both the United States and Europe for treating large and small vessels.
  • ABT-578 is a unique compound licensed to Medtronic by Abbott Laboratories, designed to inhibit the cellular process that leads to restenosis.
  • Medtronic has filed its Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration to begin its ENDEAVOR IV Clinical Trial in the United States and Canada.

Statistics:

  • A stroke occurs every 45 seconds in the United States, with 88% caused by ischemic disease (American Heart Association).
  • Carotid stenting is expected to grow from about 17,000 procedures this year to more than 125,000 worldwide in 2008.
  • About 245,000 interventions occur worldwide each year to prevent ischemic strokes.

Sources:

  • NewsRx.com & NewsRx.net
  • Medtronic, Inc. (NYSE:MDT)
  • American Heart Association
  • Abbott Laboratories
  • Biocompatibles, Ltd.

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