TandemHeart Included in New Treatment Guidelines
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
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.
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.