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Press Release

Ellis performs Capital Region's first WATCHMAN FLX Pro (LAAC) Surgery

Friday, February 9, 2024

Patient Successfully Implanted With WATCHMAN FLX Pro LACC Device

Permanent heart implant featuring a coating is designed to reduce stroke risk in patients with non-valvular atrial fibrillation

Schenectady, NY, February 9, 2024, Dr. Steven Giovannone performed the institution’s first patient implant of the new WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device. Ellis Medicine is the first in the Capital Region to offer this latest LAAC technology that is designed to reduce stroke risk and serve as an alternative to the lifelong use of blood thinners for people with atrial fibrillation not caused by a heart valve problem (also known as non-valvular AF or NVAF). Built upon the proven safety and procedural performance of the WATCHMAN FLX LAAC Device, the WATCHMAN FLX Pro device features a permanent polymer coating (HEMOCOAT technology) that is designed to reduce the risk of device-related thrombus, visualization markers for enhanced placement and a broader size matrix to treat a wider range of patients.

February is American Heart Month, which serves as a timely reminder of the increased risk of stroke among people living with AF.1,2

An estimated seven million Americans are estimated to be affected by AF – an irregular heartbeat that can feel like a quivering heart.3 People with AF have a five times greater risk of stroke4 than those with normal heart rhythms. The WATCHMAN FLX Pro device closes off an area of the heart called the left atrial appendage (LAA) to keep harmful blood clots that can form in the LAA from entering the blood stream and potentially causing a stroke. By closing off the LAA, the risk of stroke may be reduced and, over time, patients may be able to stop taking their blood thinner. The latest technology is enhanced with a non-drug-eluting coating designed to reduce the risk of device-related thrombus and enable faster, controlled healing and endothelization of the device surface. It is also available in a larger size to treat patients with larger LAA anatomies.

“Building upon the well-established WATCHMAN technology, the WATCHMAN FLX Pro device is the latest-generation device designed to reduce stroke risk in patients with non-valvular atrial fibrillation (NVAF) who need an alternative to oral anticoagulation therapy,” said Dr. Giovannone. “I’m proud to have performed the first implant of this device technology at our institution, as it offers another patient a potentially life-changing stroke risk treatment and will allow us to treat a broad range of patients thanks to the expanded size matrix.”

The WATCHMAN technology has been implanted to treat more than 300,000 patients worldwide and is done in during a one-time procedure. This permanent device doesn’t have to be replaced and can’t be seen outside the body. The procedure is done under general anesthesia and takes about an hour. Patients commonly stay in the hospital overnight and leave the next day.

 

About Atrial Fibrillation

 

Atrial fibrillation (AF) is a heart condition where the upper chambers of the heart (atria) beat too fast and with irregular rhythm (fibrillation). AF is the most common cardiac arrhythmia, currently affecting up to 6 million Americans.3,5 Stroke is the most common complication of AF, and AF-related strokes are also more frequently fatal and disabling.1,2 In people with non- valvular AF, more than 90% of all stroke-causing clots that come from the heart form in the LAA.6 The most common treatment to reduce stroke risk in patients with AF is blood-thinning medication. While very effective at reducing the risk of stroke, blood thinners increase the risk of serious bleeding over time and come with certain requirements and restrictions.

For more information on the WATCHMAN FLX Pro device, visit www.watchman.com/flxpro.

 

1. Hart RG, Halperin JL., Ann Intern Med. 1999; 131:688–695.

2. McGrath ER, Neurology 2013; 81:825-832.

3. Colilla S, Crow A et al. Estimates of Current and Future Incidence and Prevalence of Atrial Fibrillation in the U.S. Adult Population. Am J Cardiol 2013;112:1142-1147..

4. National Stroke Association. Atrial fibrillation. https://www.stroke.org.uk/what-is-stroke/are-you-at-risk-of-stroke/atrial- fibrillation. Accessed July 11, 2023.

5. “Atrial Fibrillation Fact Sheet.” Centers for Disease Control and Prevention. https://www.cdc.gov/heartdisease/atrial_fibrillation.htm.

6. Price MJ, Reddy VY, Valderrábano M, et al. Bleeding outcomes after left atrial appendage closure compared with long-term warfarin. JACC Cardiovasc Interv. 2015;8(15):1925-1932

 

Safety information for the WATCHMAN FLX Pro Left Atrial Appendage Closure Device is available here.

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