TGH PLAYS SIGNIFICANT ROLE IN CLINICAL STUDY THAT LEADS TO FDA APPROVAL OF REVOLUTIONARY DEVICE TO TREAT ADVANCED HEART FAILURE

Published: Apr 30, 2008
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HeartMate II Is The First Continuous Flow Chronic Left-Ventricular Assist System (LVAS) to Receive Approval in the U.S.

Tampa (April 30, 2008) – As one of only 44 centers in the country to participate in the landmark Thoratec® HeartMate II® Clinical Trial, Tampa General Hospital announced today that the HeartMate II Left Ventricular Assist System (LVAS) has received FDA approval as a bridge-to-transplantation (BTT) treatment option for patients suffering from advanced-stage heart failure.  The device is the first continuous flow chronic LVAS to receive FDA approval for BTT in the U.S.
Tampa General was the only trial site in West Central Florida, with Shands Hospital in Gainesville being the only other Florida hospital involved in the trial.

Tampa General remains among select cardiac centers in the nation to offer the state-of-the-art therapy to thousands of advanced heart failure patients for whom there is a critical care need.  Tampa General has performed 102 successful implantations of various ventricular assist devices (VADs) in recent years, including seven HeartMate II implants since 2005 when the national HeartMate trial began.  The center offers a wide range of the latest heart failure treatment options.  Seventy-One patients have been successfully bridged from VAD to heart transplant.

“The FDA approval of the HM II LVAS represents the beginning of a new era in the transplantation of the most severe and deadly form of end-stage heart failure.  As participants in this investigation, our center has demonstrated the safety, durability, and effectiveness of the device to save the lives of patients who have no other option for survival.  Finally we have a device which promises durability and long term effectiveness in restoring patients to a relatively normal lifestyle while they await transplantation.” said Dr. Cedric Sheffield, Surgical Director, Artificial Heart Center and Thoracic Transplant Programs at Tampa General Hospital.

About the HeartMate II Clinical Trial
FDA approval of the HeartMate II for BTT, followed a successful national clinical trial involving 46 centers in the U.S. and Canada and approximately 450 BTT patients, including those enrolled under Continued Access Protocols and a unanimous recommendation for approval from the FDA Circulatory System Devices Advisory Panel last November.  The approval was based on data from the first 194 patients enrolled in the trial.  Clinical evidence supported improved survival rates and quality of life for a broad range of patients.  Highlights of the data in the final PMA submission included:

  • The median duration of support was 132 days, and the cumulative patient support in the trial was 109 years.
  • Survival to cardiac transplantation, recovery or ongoing was 80% at six months and 77% at one year.
  • Eighty four percent of the patients survived to hospital discharge or transplantation.
  • Significant improvements were observed across all measures of functional status and quality of life as compared to baseline status.
  • The incidence of major adverse events with comparable definitions—including infections, strokes and bleeding requiring surgery—was significantly lower than what was clinically observed in the previous BTT study of the HeartMate VE LVAS.
  • The majority of patients demonstrated vast improvement progressing from severe heart failure symptoms even at rest to being able to resume normal activities with little or no limitation as noted by 85% improved to NYHA Class I or II and 15% improved to NYHA Class III.

About Heart Failure
The American Heart Association estimates that about five million Americans are affected by congestive heart failure, with 550,000 new cases diagnosed each year.  The prognosis for patients with advanced heart failure is poor, with projected one-year mortality rates exceeding those of other terminal diseases such as AIDs, leukemia, and lung cancer.  According to the American Heart Association, cardiovascular disease remains the No. 1 cause of death in the United States.  Though transplants offer hope for approximately 2,000 advanced heart failure patients each year, more than 250,000 patients have no viable treatment option and are considered at high risk for repeated hospitalizations, severely diminished quality of life and limited life expectancy.

HeartMate II LVAS As a Treatment Option 
The HeartMate II LVAS is a mechanical circulatory support device intended for a broad range of advanced-stage heart failure patients.  A rotary, continuous-flow device, the HeartMate II is designed to provide long-term cardiac support.  The device is implanted alongside a patient’s native heart and is designed to take over the pumping ability of the weakened heart’s left ventricle – it can pump up to 10 liters of blood per minute covering the full output of a healthy heart.  It is designed for easier implantation, and with only one moving part, the HeartMate II is designed to provide exceptional reliability and improved patient quality of life.  An external system controller regulates pump speed, and a power cable connects the device to a small monitor and power base unit.  The device is designed to have a much longer functional life than the previous generation of devices and to operate more simply and quietly.  It is much smaller than the earlier device model.

Visit www.thoratec.com for more information.