Medtronic Inc. has begun what’s expected to be a 1,000-patient study of a catheter-based system that it hopes will become a less-invasive–and highly lucrative–alternative to open heart surgery for valve replacement.
Medtronic’s CoreValve system allows a replacement heart valve to be placed in a patient’s body via a catheter inserted in the femoral artery, which is near the groin. A catheter is a thin, flexible tube that can be inserted into a body cavity to open a passageway or to allow fluids to pass through.
The study will be significant for Medtronic because the company has made a big bet that so-called transcatheter systems will grow more widespread as a less-invasive means of implanting replacement heart valves. Valve replacements done with a catheter could be a better alternative for patients since such procedures don’t require surgeons to crack open a patient’s chest to replace a diseased heart valve.
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Last year, Medtronic spent more than $1 billion to acquire two companies developing transcatheter valve replacement systems–CoreValve Inc. in Irvine, Calif., and Ventor Technologies in Israel. Medtronic estimates that the market size for the procedure cold grow as large as $3.5 billion annually.
Medtronic expects to enroll in the study as many as 1,000 patients suffering from aortic stenosis, a condition in which a heart valve doesn’t open completely and obstructs blood flow. The study will take place at 90 clinical sites, mostly in Europe, and will follow patients for at least five years. The CoreValve system received regulatory clearance for sales in Europe in 2007, but is not cleared for use in the U.S., according to Medtronic.
