Two Arizona Heart Hospital patients today became the first in Arizona to receive an implant of a stroke-preventing device since it was approved by the U.S. Federal Drug Administration.

The Watchman Left Atrial Appendage Closure Device manufactured by Boston Scientific BostonSci_Watchman_Brochure_v12received FDA approval on March 13. It is used for patients with atrial fibrillation, the most common cardiac arrhythmia, affecting more than 5 million patients in the United States. With atrial fibrillation, the upper chambers of the heart beat abnormally fast and people are five times more likely to develop a stroke.

Carol Burns, 78, of Tahuya, Wash., is one of two patients who had the device implanted this morning at Arizona Heart Hospital in Phoenix.

“I have been waiting for more than a year to get the Watchman. I am looking forward to not having to take blood thinners anymore,’’ said Burns who spends winters in El Mirage.

Heather Henderson, 73, of Phoenix, who also had the device implanted today, said she is no longer is worried about having a stroke.

“The Watchman will protect me and I will be able to live my life better,’’ she said.

Dr. Vijendra Swarup
Dr. Vijendra Swarup

Dr.  Vijay Swarup, who is Burns’ and Henderson’s physician, said the FDA’s approval means that more patients will have access to this Watchman device, an umbrella mesh-like device that is implanted in the heart via a catheter through a vein in a patient’s upper leg. The device has been commercially available internationally since 2009.

“The device is an alternative to traditional blood thinners which often cause significant bleeding complications,” Swarup said.

The Arizona Heart Hospital had been conducting clinical studies on the Watchman device for the past eight years. Swarup is the principal investigator for the clinical studies at Arizona Heart Hospital in partnership with Arizona Heart Rhythm Center.

Arizona Heart Hospital is the only Arizona hospital and among 48 sites nationally that have been conducting clinical studies on the Watchman device. Arizona Heart Hospital ranks among the top sites as far as the number of devices implanted during the clinical trials, according to Boston Scientific.

According to the U.S. Center for Disease Control, stroke is the leading cause in the United States of serious long-term disability and the third leading cause of death.

The Watchman study is one of several clinical studies being conducted at Arizona Heart Hospital.

“Arizona Heart Hospital is an industry leader with a broad range of vascular research with multiple clinical trials underway, said Arizona Heart Hospital President Stephen Harris.

With skilled physicians, state-of-the-art equipment and innovative techniques, Arizona Heart is at the forefront of identifying innovative solutions and utilizing research to attack and overcome heart and vascular disease.  Areas of specialty include cardiac ablations treatment for arrhythmia disease, structural heart disease treatments such as valve replacement surgery; and a Vascular Surgery Fellowship.

Arizona Heart Hospital has received several awards including recognition as one of Truven Top 50 hospitals for Heart Care and it ranks among the top of Tenet’s 80 hospitals for quality and growth.