FDA Approves Stroke-preventing Device Tested At Arizona Heart Hospital

by Lori Baker | Mar 17, 2015

PHOENIX (March 17, 2015) – The U.S. Federal Drug Administration has approved a stroke-preventing device that has been tested at Abrazo Health’s Arizona Heart Hospital for more than eight years.

Arizona Heart Hospital is the only Arizona hospital and among 48 sites nationally that have been conducting clinical studies on the Watchman Left Atrial Appendage Closure Device manufactured by Boston Scientific. This device is used for patients who have atrial fibrillation, an irregular heartbeat, and a left atrial appendage. Patients with this condition are five times more likely to develop a stroke, studies show.

“The device is an alternative to traditional blood thinners which often cause significant bleeding complications,” said Dr. Vijay Swarup, who is the principal investigator for the study at Arizona Heart Hospital in partnership with Arizona Heart Rhythm Center. “The approval of Watchman is an important step forward in the treatment of atrial fibrillation.’’

Arizona Heart Hospital ranks among the top sites as far as the number of devices implanted during the clinical trials, according to Boston Scientific.

Swarup said the FDA’s approval on March 13 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.

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.

One of the major risk factors for stroke is atrial fibrillation which affects about 2.2 million adults in the United States. It is, a common cardiac disorder characterized by cardiac arrhythmia and the absence of coordinated contractions, which increases the risk for clot formation and embolic stroke.

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 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.

 About Abrazo Health

The Abrazo system includes six acute care hospitals: Arizona Heart Hospital, Arrowhead Hospital, Maryvale Hospital, Paradise Valley Hospital, Phoenix Baptist Hospital and West Valley Hospital. In addition, the system consists of two emergency centers: North Peoria Emergency Center and West Valley Emergency Center; Abrazo Medical Group; Phoenix Health Plans; and School-Based Health Centers. Visit AbrazoHealth.com.

Disclaimer: Dr. Vijay Swarup is an independent physician and is not an employee, agent or representative of Abrazo Health’s Arizona Heart Hospital. He is solely responsible for the provision of his medical services to patients.