Sharp Memorial Hospital Implants First Patient in California with Next-Generation Mechanical Heart Pump

Patient receives the HeartMate® II Left Ventricular Assist Device in national clinical trial

Sharp Memorial Hospital is the first California Hospital to implant the HeartMate® II Left Ventricular Assist System (LVAS) for permanent support for late-stage heart failure, otherwise known as Destination Therapy (DT). The 72-year-old male patient received the heart pump as part of a US Phase II pivotal study by Thoratec® Corporation, manufacturer of the device and other mechanical circulatory support devices for hemodynamics restoration in a wide range of heart failure patients.

 HeartMate II Left Ventricular Assist System

The primary surgeon on the procedure performed on October, 5, 2005, was Robert Adamson, MD, Medical Director, Sharp Memorial Hospital Cardiac Transplant Program.

“By participating in the HeartMate II trial, we have the opportunity to advance cardiac care while improving the quality of life for our patients,” said Adamson. “The more options we have for our patients, the better chance we can find just the right fit for each and every patient.”

The HeartMate II is a small, quiet, and advanced blood pump designed to restore hemodynamic function and improve patient outcomes and quality of life. Through the rotations of a single moving part, the HeartMate II LVAS pumps blood from the heart throughout the body at up to 10 liters per minute, the full output of a healthy heart. An implantable LVAS powered by a rotary pumping mechanism weighs approximately 14 ounces (400 grams), making it significantly smaller than current FDA premarket approved devices. The HeartMate II is designed for reliable long-term support and to operate more simply and quietly. It is also smaller and easier to implant than pulsatile devices, making it suitable for smaller patients.

About the HeartMate II Trial
The HeartMate II pivotal trial is a multicenter evaluation of the HeartMate II LVAS for advanced-stage heart failure patients. It will determine the safety and efficacy of the device as a Destination Therapy in advanced-stage heart failure patients who do not qualify for cardiac transplantation. A total of 200 patients at up to 40 sites will participate in the study. Currently, Thoratec’s HeartMate XVE is the only device commercially available LVAS approved for Destination Therapy by the United States Food and Drug Administration. In a separate arm of the study, the HeartMate II will be evaluated as a bridge-to-transplantation for advanced-stage heart failure patients who are eligible for cardiac transplantation but in need of temporary support until a donor heart becomes available. Up to 25 sites will enroll a total of 133 patients the bridge-to-transplant arm.

 For more information about the HeartMate II clinical trial program at Sharp Memorial Hospital, the HeartMate or Destination Therapy, visit www.sharp.com or www.thoratec.com.

About Sharp Memorial Hospital
Sharp Memorial Hospital is the largest Sharp HealthCare hospital and is a designated trauma center for San Diego County. Located in Kearny Mesa off Highway 163, it maintains 341 acute-care beds, including 35 beds for critical care services. The hospital is especially known for outstanding programs in cardiac and vascular care, cancer treatment, pulmonary care services, rehabilitation, women's health and multi-organ transplantation. Sharp Memorial Hospital also offers extensive outpatient services and prevention programs in support of Sharp's overall emphasis on health and wellness.

Last Updated: April 16, 2009