Devices Cardiology

 News Release - April 7, 2010

CardiacAssist Expands Market Penetration of TandemHeart(R) among Heart Surgeons, Cardiologists and Electrophysiologists

Company reports 2,000th case for TandemHeart, now used in 90% of the ‘best’ U.S. heart and heart surgery hospitals

100 additional hospitals considering TandemHeart purchases in 2010

PITTSBURGH--(HSMN NewsFeed)--CardiacAssist Inc. announced today that its TandemHeart® extracorporeal circulatory support system has now been used in 2,000 cases. Further, TandemHeart is being used in 90% of the “Best U.S. Heart & Surgery Hospitals” as ranked by U.S. News & World Report. More than 100 additional U.S. hospitals are considering TandemHeart purchases in this calendar year.

“Since becoming commercially available in 2004, two thousand of the most dire cardiac patients at a vast majority of the finest hospitals across the United States have benefited from TandemHeart availability,” said Michael Garippa, CEO and President of CardiacAssist. “About 35% of these patients have been treated for ventricular dysfunction in a highly emergent setting, while approximately 65% have benefited from TandemHeart support during high-risk surgery or the riskiest of cardiac interventions.

“The fact is, despite great technologies approved for Destination Therapy and long-term support, in many cases TandemHeart is used first, or immediately after the IABP (Intra-Aortic Balloon Pump) or Impella, when those technologies simply do not provide adequate support. Therefore, TandemHeart success gives physicians the opportunity to evaluate and use the other technology options in due course. In short, TandemHeart is on the front lines of treating cardiovascular disease,” added Garippa.

“We have treated many patients who would otherwise not be alive had it not been for the left ventricular support of the TandemHeart system,” said TandemHeart pioneer Howard A. Cohen, M.D., Director of the Division of Cardiac Intervention and Co-Director of Cardiovascular Interventional Laboratories at Lenox Hill Heart & Vascular Institute of New York. Dr. Cohen also is Medical Director for CardiacAssist.

“TandemHeart has shifted the paradigm in the treatment of acutely decompensated patients requiring mechanical support. They can now be effectively stabilized in a very short time instead of going to the OR for a long, complex procedure with a significant morbidity and mortality,” said Alan Gass, M.D., Director of Advanced Cardiac Failure and Transplantation at Westchester Medical Center, Valhalla, N.Y., one of the newest high-users of TandemHeart.

“We believe that the TandemHeart is a highly innovative technology,” added Igor D. Gregoric, M.D., Associate Director of Cardiovascular Surgical Research and Director of Mechanical Circulatory Support at Texas Heart Institute, where more than 250 TandemHearts have been implanted, the largest experience in the U.S. “Our support for TandemHeart is the result of having successfully used the system in many ways to benefit our patients, and we have published the results of our efforts. At THI, the TandemHeart is an important component of our cardiac support service. With it, we have been able to successfully support patients who require short-term cardiac assistance.”

FDA-cleared TandemHeart can be placed rapidly by both interventional cardiologists in a cath lab and by cardiac surgeons in an operating room to provide short-term circulatory support to patients requiring additional cardiac assistance. The device provides effective and reliable temporary circulatory support for critically ill patients. Hemodynamic support includes a high net blood-flow rate of up to five liters per minute with percutaneous cannulation or up to eight liters per minute with direct cannulation—more than twice the amount of other available technologies—and is fully reimbursed by Medicare under existing DRG codes.

About CardiacAssist

Headquartered in Pittsburgh, privately held CardiacAssist is a growing and profitable medical technology company that develops, manufactures and markets cardiac assist devices. The Company has developed the world’s first and only proprietary platform, FDA-cleared and CE-Marked TandemHeart®, which provides a short-term extracorporeal circulatory support system for both cardiologists and cardiac surgeons.

Source: CardiacAssist

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