Press Release.
Company’s TandemHeart(R) extracorporeal circulatory support device continues to gain traction among cardiologists and cardiac surgeons
Privately held CardiacAssist Inc. announced today nine-month financial results for 2009. TandemHeart System revenues were at new record levels compared to results for the same period in 2008.
FDA-cleared and CE-Marked 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 in the catheterization lab or up to eight liters per minute in the OR — more than twice the amount of competing technologies — and is fully reimbursed by Medicare under existing DRG codes.
“We continue to grow our Company’s TandemHeart revenues because customers are able to see right through the ‘myths’ spread by our main competition,”
said Michael Garippa, CEO and President.
“Indeed, our record-setting revenues for the nine months of 2009 bear strong witness to the indisputable fact that TandemHeart represents a breakthrough model for treating cardiac patients quickly and aggressively.
“For example, one myth is that the Impella 2.5 can support patients in cardiogenic shock with 2.5 liters per minute of blood flow. This is not true. Patients in profound cardiogenic shock often have heightened vascular resistance, thus limiting the flow provided by any device by 50 percent or more. Consequently, the Impella 2.5 would provide less than 1.0 liter per minute of blood flow to patients in cardiogenic shock, which is not enough to sustain such very sick patients,”
said Garippa.
“There also have been claims that the Impella 2.5 completely unloads the left ventricle. Actually, published data has shown the contrary.
“Furthermore,” added Garippa, “the Impella 5.0 cannot be inserted percutaneously in the overwhelming majority of the population. The 5.0’s 21-French catheter cannot be placed in an artery–the artery simply cannot be dilated to accept a sheath of that size, and surgical placement is the most likely option.
“These are just some of the reasons why we remain confident that TandemHeart is destined to become standard of care in extracorporeal circulatory support,”
Garippa concluded.
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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(R)–which provides a short-term extracorporeal circulatory support system for both cardiologists and cardiac surgeons.
