Devices Cardiology

 News Release - February 25, 2009

Life-Saving TandemHeart from CardiacAssist Has Now Been Adopted by 100 of the Nation's Elite Cardiac Centers, Including All of the Top-10 as Ranked by U.S. News & World Report

Heart Attack Treatment Milestone:

Cardiac Centers Using TandemHeart(R) Reduce Deaths from Cardiogenic Shock by up to 50% Compared with National Average 1

“There is no question in my mind that TandemHeart saves lives, and that is the most important reason why utilization of TandemHeart should increase in ORs and cath labs across the country.”

Igor D. Gregoric, MD, Cardiac Surgeon

PITTSBURGH--(HSMN NewsFeed)--CardiacAssist Inc., a fast-growing and profitable medical device company, today announced a heart attack treatment milestone: 100 of the nation’s elite cardiac centers—including all of the top-10 as ranked by U.S. News & World Report— have now adopted its TandemHeart® System. Cardiac centers using TandemHeart have reduced deaths from cardiogenic shock by up to 50% compared with the national average.

TandemHeart is the only percutaneous "extracorporeal circulatory support" device approved by the FDA for sale in the United States. All other heart-assist devices are labeled by the FDA to be used for "partial circulatory support" because of their limited capacity to pump blood. On the other hand, the TandemHeart device is FDA-cleared without restriction for circulatory support of critically ill patients and can be placed rapidly in a cath lab or an operating room. In addition, the TandemHeart System is fully reimbursed by Medicare under existing DRG codes.

“TandemHeart sets a whole new paradigm for treating heart attack patients quickly and aggressively. But in addition to being used to treat emergency heart attack victims with cardiogenic shock, TandemHeart also preserves a failing heart’s function and the viability of vital organs by not allowing patients to deteriorate, even die, while they are waiting for complex elective surgery such as a coronary artery bypass graft (CABG), or a high-risk percutaneous coronary intervention (PCI),” said CardiacAssist CEO Michael Garippa. “TandemHeart is also routinely used to support patients undergoing high-risk PCI (percutaneous coronary intervention) procedures as well as pre- and post-surgical patients. We are extremely pleased to realize this historic milestone for the TandemHeart System, designed to become standard of care in extracorporeal circulatory support.”

Cardiogenic shock is a state in which a weakened heart is not able to pump enough blood to meet the body’s needs. It is a medical emergency and is fatal if not treated right away. The most common cause of cardiogenic shock is damage to the heart muscle from a severe heart attack. Not everyone who has a heart attack develops cardiogenic shock. But when cardiogenic shock does occur, it is very dangerous. For people who die from a heart attack in a hospital, cardiogenic shock is the most common cause of death.

TandemHeart is the only circulatory support system that can be deployed by both the cath lab and the operating room while providing unparalleled support of 5-to-8 liters of blood per minute. The most frequent uses of TandemHeart are in the cath lab for treating emergent cardiogenic shock, most likely due to an acute myocardial infarction (heart attack); and as prophylactic support in patients undergoing high-risk percutaneous interventions; and in the surgical suite for pre- and post-surgical support in high-risk heart surgeries.

The 100 U.S. hospitals that have used the TandemHeart System: Albert Einstein • Allegheny General Hospital • Arizona Heart Institute • Baptist Memorial • Barnes-Jewish • Baylor Heart-Plano • Baylor University Medical Center • Brigham & Women’s • Cape Cod Hospital • Carolina’s Medical Center • Cedars Sinai • Christus St. Patrick • Clear Lake Hospital • Cleveland Clinic • Dartmouth-Hitchcock • Deborah Heart & Lung • Detroit Medical • Duke University • Emory University • Florida Medical Center • Geisinger Medical Center • George Washington Hospital • Good Samaritan Hospital-LA • Harrisburg Hospital • Hospital of the University of Pennsylvania • Integris Baptist • Jackson Memorial • Jewish Hospital • JFK Medical Center • Johns Hopkins • LA County • Lahey Clinic • Lancaster General Hospital • LDS Hospital • Lenox Hill • Loyola University Hospital • Massachusetts General • Mayo Clinic • Medical City Dallas • Medical University of South Carolina • Memorial Hermann • Mercy Medical Center • Methodist Hospital-Indiana • Methodist-Debakey • Montefiore Medical Center • Moore Regional • Mt. Sinai-Miami • Mt. Sinai-NY • New York Presbyterian • North Carolina Baptist • Northwestern University • Penn Presbyterian • Piedmont Hospital • Providence Hospital Alaska • PSU/Milton S. Hershey • Sacred Heart-Spokane • Salt Lake Regional Medical Center • San Antonio Methodist • Sarasota Memorial • Sharp Medical • Shawnee Mission • Sherman Hospital • St. Joseph’s-Maryland • St. Joseph’s Hospital of Atlanta • St. Luke’s Kansas City • St. Vincent Heart Center of Indiana • St. Vincent’s-Worcester • Temple University Hospital • Terrebonne General • Texas Children’s Hospital • Texas Heart Institute • Thomas Jefferson • Tuft’s New England Medical Center • UAB • UC Davis • UC Irvine • UCLA • University Medical Center-Tucson • University of Chicago • University of Iowa • University of Maryland • University of Miami • University of Michigan • University of Minnesota • USC • University of Virginia • University of Miami • University of Washington • University of Wisconsin • University of Pittsburgh • UT Southwestern • VAMC Birmingham • VAMC Cleveland • VAMC Houston • VAMC Nashville • Vanderbilt University • Washington Hospital Center • Weiler-Einstein • Westchester Medical Center • William-Beaumont.

To date, the TandemHeart System has been used in 29 countries by more than 300 cardiologists and cardiac surgeons.

1 Source: Natixis Bleichroeder

Source: CardiacAssist

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