FDA
20th October 2014

FDA Device Panel Narrowly Recommends Approval of Controversial Heart Device

The Circulatory System Devices Advisory Panel of the FDA’s Medical Advisory Committee gathered to review and evaluate the Watchman left atrial appendage closure.

FDA Device Panel Narrowly Recommends Approval of Controversial Heart Device

The Circulatory System Devices Advisory Panel of the FDA’s Medical Advisory Committee gathered to review and evaluate the Watchman left atrial appendage closure (LAAC) device, a device that exclusively blocks off the left atrial appendage (where clots have been known to form) to preempt the possibility of such clots lodging in an artery that feeds into the brain and resulting in stroke.


The Watchman device is manufactured by Boston Scientific, who 
is seeking approval for the Watchman device in patients who, because of their CHADS2 or CHA2DS2-VASc scores, would be recommended warfarin therapy to reduce their risk of stroke and systemic embolism. Currently, WATCHMAN is approved to be sold in at least 70 countries around the world.Specifically, LAAC is a treatment that prevents the formation of blood clot in patients diagnosed with atrial fibrillation (AF) which affects up to 20 percent of those with heart rhythm disorder. The Watchman device was developed to serve as a heart surgery backup designed to be permanently implanted in the left atrial appendage to trap blood clots and prevent stroke.

The panel voted 6-5 (with one abstention) in favor of device approval (i.e. the benefits outweighed the risks). All twelve panelists voted unanimously that the device is safe for its intended use/intended population, but only half believed that it is effective for its intended use/intended population. The materials from this meeting can be found HERE.

Nonetheless, the panel agreed that the device could work well and could be beneficial to people who are in need of a long-term anticoagulation device and couldn’t take a blood thinner warfarin.

The committee reviewed the results of the two randomized clinical trials, PROTECT AF and PREVAIL, as well as trials from the Continued Access Protocol (CAP) and CAP2. Clinical data for WATCHMAN included at least 2,400 patients and at least 6,000 patient-years in the subsequent clinical studies.

Shephal K. Doshi, an electrophysiologist at the Pacific Heart Institute and an investigator in the Watchman trials stated that, “We need an alternative treatment strategy for high-risk patients…For some of our patients, Watchman can be that option.”

The FDA is not bound by its advisory committees’ recommendations, but normally takes them into consideration. The FDA has previously not followed recommendations for approval of this device.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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