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TandemHeart Approved for Expanded Reimbursement

Medicare intermediary decision increases treatment options for patients with severe cardiac dysfunction


News provided by

CardiacAssist, Inc.

Jul 12, 2011, 08:00 ET

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PITTSBURGH, July 12, 2011 /PRNewswire/ -- The TandemHeart circulatory support system has been granted expanded reimbursement coverage by NHIC, Corp., the Medicare Administrative Contractor (MAC) serving over 1.3 million beneficiaries and over 53,000 healthcare providers in the Northeast region of the United States.

"We are extremely pleased with the decision by NHIC to expand coverage of the TandemHeart system," said Kraig McEwen, President and CEO of CardiacAssist, Inc.  "Supported by the growing body of clinical evidence on the use of TandemHeart, the action taken by NHIC ensures that health care providers in the Northeast receive adequate reimbursement coverage when caring for critically ill patients.  We are also extremely grateful to the independent societies and physicians that worked with NHIC to ensure that patients have access to the best possible care."

Physicians have utilized the TandemHeart device to provide critical heart support to over 2,500 patients at more than 170 of the top cardiac centers in the United States.  The system is composed of a small centrifugal pump, a series of cannulae which connect the pump to the patient and an electro-mechanical controller.  Starting from a small incision in a patient's leg, cannulae are inserted into the blood vessels and up to the heart.  The TandemHeart pump is then activated, allowing damaged heart muscle to rest while augmenting the flow of blood to the patient's vital organs and the rest of the body.

NHIC's Local Coverage Determination (LCD) for Percutaneous Ventricular Assist Devices (L31518) became effective July 8, 2011, and provides coverage of TandemHeart as a primary treatment option for a wide range of indications.  It applies to Medicare beneficiaries throughout NHIC's jurisdiction, including those located in Maine, Massachusetts, New Hampshire, Rhode Island and Vermont.

About TandemHeart

The FDA-cleared TandemHeart system is the only heart assist device which can provide a high degree of circulatory support with a minimally invasive, percutaneous procedure.  With flow rates up to 5.0 liters per minute, the TandemHeart delivers as much as 5 times the hemodynamic support as the standard of care intra-aortic balloon pump and twice the support of any other available percutaneous technology.

About CardiacAssist

Headquartered in Pittsburgh, PA, privately held CardiacAssist is a growing medical technology company that develops, manufactures and markets cardiac assist devices. The company developed the TandemHeart system, the world's first FDA-cleared and CE-marked short-term extracorporeal circulatory support system for both cardiologists and cardiac surgeons.

SOURCE CardiacAssist, Inc.

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