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TandemHeart Included in New Treatment Guidelines

November 17, 2011 By AxoGen, Inc.

PITTSBURGH–(BUSINESS
WIRE
)–The TandemHeart circulatory support system has been added to the
2011 treatment guidelines coauthored by the American College of Cardiology
Foundation (ACCF), the American Heart Association (AHA) and the Society for
Cardiovascular Angiography & Interventions (SCAI). After extensive review
of the body of clinical science and published literature, the societies
released updated guidelines on November 7, 2011.

The TandemHeart system is now included in several updated
recommendations, including:

  • 5.2.3 Cardiogenic Shock. “A hemodynamic support device is
    recommended for patients with cardiogenic shock after STEMI who do not quickly
    stabilize with pharmacological therapy,” and “refractory cardiogenic shock
    unresponsive to revascularization may necessitate institution of more intensive
    cardiac support with a ventricular assist device or other hemodynamic support
    devices to allow for myocardial recovery or subsequent cardiac transplantation
    in suitable patients.”

    (Recommendation Class: I, Level of Evidence: B)

  • 5.6 Percutaneous Hemodynamic Support Devices. “Elective
    insertion of an appropriate hemodynamic support device as an adjunct to PCI may
    be reasonable in carefully selected high-risk patients.”

    (Recommendation Class: IIb, Level of Evidence: C)

“The expansion of the ACCF/AHA/SCAI Guidelines is an
extremely positive development for patients in need of advanced hemodynamic
support,” said Kraig McEwen, President and CEO of CardiacAssist, Inc. “We
congratulate the societies and physicians involved in the process who
synthesized a growing body of clinical evidence in order to encourage adoption
of the best patient care practices.”

The full 2011 ACCF/AHA/SCAI Guidelines for PCI can be viewed
here: http://content.onlinejacc.org/cgi/content/full/j.jacc.2011.08.007

About TandemHeart

The TandemHeart system is FDA-cleared for up to 6 hours of
extracorporeal circulatory support and provides 5.0 liters per minute of flow
with percutaneous cannulation. It has been used by physicians to provide
critical heart support to over 2,500 patients at more than 170 of the top
cardiac centers in the United
States.

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 worlds
first FDA-cleared and CE-marked short-term extracorporeal circulatory support
system for both cardiologists and cardiac surgeons.

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