This won’’t be for me because I am a good patient on Warfarin.

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This won’’t be for me because I am a good patient on Warfarin.

Member Forum >> Atrial Fibrillation Protocol >> This won’’t be for me because I am a good patient on Warfarin.

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Posted: 3/14/2015 7:06:47 PM Edited: 3/30/2023 1:24:12 PM (1)

FDA Approves Boston Scientific’s Watchman Device FDA approved Watchman as an alternative to commonly used blood thinner warfarin to prevent stroke in patients with atrial fibrillation Joseph Walker March 14, 2015 2:41 p.m. ET 2 COMMENTS Boston Scientific Corp.’s controversial surgical device for preventing strokes has been approved for sale by the Food and Drug Administration, the company said on Friday, concluding a six-year effort to sell the Watchman device in the U.S. The approval is a victory for Boston Scientific, a Marlborough, Mass.-based company that needs new products to offset sluggish growth in its core markets of pacemakers and implanted defibrillators. Boston Scientific estimates the addressable global market for Watchman to be $500 million annually, though some analysts and physicians say use of the device will be limited because of newer treatment options that have emerged since Watchman was first submitted for approval in 2008. The FDA had twice before declined to approve the device because of concerns about its safety and effectiveness, including concerns about complications while implanting the device. In a display of how vexed regulators were by the device, the FDA convened three advisory committee meetings of outside experts to evaluate Watchman between 2009 and 2014. The FDA approved Watchman as an alternative to a commonly-used blood thinner to prevent stroke in patients with an abnormal heartbeat known as atrial fibrillation. The condition can cause blood to pool in a pocket of the heart called the left atrial appendage. If blood clots form and escape into the arteries, they can block the flow of blood to the brain, causing what’s known as ischemic stroke, the most common type. The Watchman works as a plug, sealing off the left atrial appendage so blood can’t coagulate and escape into the arteries. “We’re thrilled we finally got it across the goal line,” Boston Scientific Senior Vice President Kenneth Stein said in an interview. “It’s a complex device for the agency to evaluate, and that’s part of the reason it was more arduous than what we’re used to with other devices.” Boston Scientific said the Watchman’s FDA-approved labeling allows for the device to be used as an alternative to warfarin for patients who have had difficulty staying on warfarin in the past; have a history of major bleeding while taking blood thinners; or who are at high risk of major bleeding because they have active lifestyles or occupations that can lead to trauma-related bleeding. However, patients must be able to take warfarin for a short period after receiving the Watchman device. At the most recent FDA advisory committee meeting, held in October, Watchman was shown to be inferior to warfarin in preventing the most common type of stroke caused by blood clots. But the committee narrowly voted to recommend Watchman be approved, citing the need to treat patients who are ineligible for warfarin or refuse to take it. Warfarin, sold under the brand name Coumadin by Bristol-Myers Squibb Co., is known to carry side effects, including the risk of bleeding, which require patients to be closely monitored by their doctors. However, in the years since Watchman was first submitted for approval, new blood thinners with fewer side effects have entered the market, including Boehringer Ingelheim’s Pradaxa, which are likely to limit the Watchman’s use in clinical practice, some doctors said. The most serious risk of warfarin is so-called hemorrhagic, or bleeding, stroke, in which a blood vessel bursts and blood leaks onto the brain. Watchman was shown in a clinical trial to result in fewer bleeding strokes than warfarin. However, the new blood thinners—sometimes called new oral anticoagulants, or NOACs—have been shown to reduce the risk of bleeding strokes in most patients, Sanjay Kaul, a cardiologist at Cedars-Sinai in Los Angeles said in an email. “It is hard for any intervention, pharmacologic or non-pharmacologic, to improve upon the 60% to 70% reduction in hemorrhagic stroke offered by NOACs,” Dr. Kaul said. The FDA is requiring Boston Scientific to track patients who receive Watchman in a registry, and to conduct a post-approval study of the device’s clinical outcomes, Dr. Stein said. The device will initially be available at medical centers that have been trained to implant the device for the company’s previous clinical trials, with more doctors being gradually trained in the coming years. “We’re going to have a very slow, very controlled rollout of this device,” Dr. Stein said. There is a learning curve for doctors new to implanting the device, and the company plans to implement a “very rigorous training program,” he said. A Boston Scientific spokeswoman declined to say what the company will charge for Watchman. Boston Scientific is in discussions the Centers for Medicare and Medicaid Services to gain reimbursement for the procedure, the spokeswoman said. Write to Joseph Walker at joseph.walker@wsj.com Moderator note 2023-03-30: basenote date revised as a side effect of getting this older thread re-assigned to a more topical Inner Circle forum.
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