April 3, 2012 – Abiomed Inc. today announced the successful first human use of the Impella cVAD device, a new, percutaneous Impella ventricular assist device (VAD) that provides peak flow of approximately 4 liters of blood per minute. The Impella cVAD is designed to provide temporary circulatory support and reduce the workload of the heart muscle via a minimally invasive, catheter-based pump that is inserted percutaneously in the cardiac catheterization lab, without the need for surgical intervention.
The Impella cVAD provides cardiologists with the clinical flexibility to offer increased flow for patients requiring more hemodynamic support. The increased flow is delivered on the same console platform, 9 French catheter and introducer as the Impella 2.5 system.
An 85-year-old patient with complex coronary artery disease, compromised left heart function (ejection fraction of 20 percent) and prior myocardial infarction was percutaneously implanted with the Impella cVAD. The device generated an average blood flow of 3.5 liters and peak blood flow of approximately 4 liters per minute. Post-procedure, the patient reported relief of angina; the Impella was explanted after 25 hours of support and the patient is currently awaiting discharge.
For the first-in-man experience, the Impella cVAD was implanted at the McGill University Health Centre (MUHC) in Montreal, Quebec, Canada, by Dr. Giuseppe Martucci, co-director of the adult intervention congenital and structural health disease laboratory at the MUHC. Martucci was accompanied by doctors Renzo Cecere, Luc Bilodeau and Nicolo Piazza.
“The Impella cVAD gave my patient a very high level of hemodynamic support, allowing me to conduct extensive revascularization and treat his triple-vessel coronary artery disease in one procedure — all while avoiding the accompanying risk of complications,” said Martucci.
“This is another example of how the MUHC has made a safe, innovative and minimally invasive procedure accessible to our patients. The device’s excellent blood flow gave us great flexibility and support and will allow the MUHC now to treat coronary artery disease patients who previously had limited treatment options and were unable to undergo traditional open-heart surgery,” added Cecere.
The Impella cVAD is not currently cleared for sale or use in the United States. Abiomed said it hopes to have U.S. Food and Drug Administration approval for the new VAD by the summer of 2012.
For more information: www.abiomed.com