Clinical Trial at Sequoia Hospital Brings First Leadless Pacemaker to West Coast

REDWOOD CITY, Calif., Feb. 19, 2014 /PRNewswire/ -- Dignity Health Sequoia Hospital's Heart and Vascular Institute and the physicians at Silicon Valley Cardiology have been selected by St. Jude Medical to participate in a clinical trial that will bring the first leadless pacemaker to the West Coast.

The Nanostim™ Cardiac Leadless Pacemaker is smaller than a triple-A battery and is designed to be placed directly into the heart, requiring only a minimally invasive procedure. The device is not approved by the FDA for use in the United States, but is commercially available and has been used successfully in Europe. Cardiologists Dr. Hardwin Mead and Dr. Rob Patrawala have undergone special training on implanting the device and are leading the clinical trial at Sequoia's Heart and Vascular Institute as part of the process to seek approval in the U.S. The trial, sponsored by St. Jude Medical, aims to enroll more than 600 patients at 60 international sites.

"We have a history of working with Silicon Valley Cardiology to bring these kinds of clinical trials to fruition quickly and successfully," said Glenna Vaskelis, Sequoia Hospital President. "Sequoia is nationally recognized for cardiovascular services, and the hospital continues to lead the way with the most innovative cardiac care in our community."

The device has been implanted in only five other patients in the country – all east of the Mississippi River. In total, 10-20 patients will be a part of the trial at Sequoia. The first patient received the device at Sequoia this week and is doing well.

"The actual procedure is minimally invasive and efficient. There is no surgical scar and no insulated wires which is a big advantage for the patient over a conventional pacemaker," said Dr. Mead, who performed the procedure.

Silicon Valley Cardiology Associates has a 30-year history of bringing quality care and new cardiac technology to patients on the West Coast.

"Cardiologists have been talking about a leadless pacemaker for decades and the final engineering on this device is impressive," said Dr. Patrawala. "It is designed to be fully retrievable, has its own generator and battery, and can last eight to 10 years with normal use."

About Sequoia Hospital
Dignity Health Sequoia Hospital is an accredited, not-for-profit community hospital providing innovative and exceptional health care for generations of Bay Area residents. In 2014, the hospital will celebrate the opening of a rebuilt, state-of-the-art medical campus, including modernized emergency services and an all-new Pavilion with three floors of larger, private patient rooms.

Recognized for superior and sustained clinical quality, the hospital received the 2013 America's 50 Best Hospitals Award™ and the 2013 Distinguished Hospital Award for Clinical Excellence™ from HealthGrades®, a leading provider of comprehensive information about physicians and hospitals. Sequoia's Heart and Vascular Institute is a nationally known pioneer in advanced cardiac care. The hospital was voted "A Family Favorite 2013 Best Birth Center and Best Hospital" by readers of Bay Area Parent magazine.

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SOURCE Dignity Health Sequoia Hospital