Ill patients caught in the middle of Medtronic heart valve patent dispute


A Wall Street Journal article, headlined 'My Father Is Going to Die From Red Tape' details how a patent dispute over an artificial heart valve is prompting a doctors to race to " treat desperately ill elderly patients" before a court injunction limits Medtronic's sale of one of the devices on Tuesday.

The Journal report is behind a paywall. The Business Journal has details of the story, which explains that a Delaware federal judge last week issued an injunction barring Medtronic from selling its new, minimally invasive heart implant in the U.S. In an ongoing patent battle, Edwards Lifesciences has claimed that Medtronic's Corevalve heart-valve device infringes on its patents. The injunction Edwards won in court goes into effect Tuesday and bars the sale of CoreValve.

Fridley-based Medtronic is appealing the ruling to the U.S. Court of Appeals and has asked that the injunction be delayed until the merits of its appeal are decided.

The injunction includes a provision to allow Medtronic to sell the CoreValve to patients who aren't eligible for the Edwards device. But the two companies can't come to an agreement on how to decide who can get one. In the meantime, the dispute puts some patients in limbo. The story said that physicians may not be able to find enough valves, or time, for the patients needing the device, creating a life-and-death scenario for some of them.

Forbes magazine published a story analyzing the complexities of the dispute. It notes that the fallout from the lawsuit could create long-lasting damage in the relationship between Edwards and the interventional cardiologists who use company products.

The devices in question are for patients with aortic stenosis, a hardening and narrowing of the valve that regulates blood flow out of the heart to the rest of the body. Most of those with the condition are elderly, and the diagnosis is considered fatal if not treated. Most patients have their valves replaced through open-heart surgery, but those considered too sick for a major operation can have the new valves implanted with catheters threaded into the heart via blood vessels.

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