New FDA-Approved Device May Reduce Stroke Risk, Eliminate Blood Thinners for Patients with Irregular Heartbeat

May 19, 2015 – Englewood Hospital and Medical Center is among the first in northern New Jersey to offer a life-changing device developed to lower the risk of stroke and eliminate the need for blood-thinning medications for patients with an irregular heartbeat called atrial fibrillation (AF).

The Watchman® implant, manufactured by Boston Scientific Corporation, was approved by the Food and Drug Administration (FDA) in March. EHMC had performed northern New Jersey’s firstWatchman implant during the second phase of its national clinical trial back in 2012.

AF is a common condition, affecting more than five million people in the United States. It causesblood to pool in an area of the heart called the left atrial appendage (LAA), which sometimes leads to the formation of clots that can then break loose and travel up to the brain, potentially causing a stroke.The Watchman® implant is designed to work as a safety net, closing off the LAA and catching those harmful blood clots before they enter the bloodstream.

Currently, one of the most common treatments for patients with AF is blood-thinning medication, which carries its own risk of complications and is not a viable option for some patients.

“Patients with AF are frequently stuck between a rock and a hard place when it comes to managing their condition,” explained Grant Simons, MD, FACC, FHRS, Chief of Electrophysiology atEnglewood Hospital and Medical Center. “While blood thinners reduce the risk of stroke-causing clots, they increase the risk of bleeding complications. This means something as simple as a fall or as major as a car accident could cause harmful – and sometimes fatal – internal bleeding. The Watchman device is an alternative treatment that may help patients with AF to return to their active lifestyles with less fear and fewer challenges because it allows them to stop taking blood thinning medications.”

The Watchman® is implanted through a small needle puncture in the groin and is then guided through a catheter up into a patient’s heart where it can filter potential blood clots and prevent a possible stroke.

”This is minimally invasive; it does not require an incision or major surgery,” said Dr. Simons. “The implant can be done in fewer than two hours with little or no post-procedure discomfort. Patients are usually up and walking within five hours, causing very little interruption to their daily routine. For us, it’s about improving quality of life. If we can do that for just one person, we’ve already succeeded.”

Disclosure: Dr. Simons was the EHMC principal investigator for the Prevail trial. He declares no financial ties or other interests in Boston Scientific Corporation.

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