St. Luke’s Medical Center in Milwaukee was the first hospital in the state to sign on for an initial controlled introduction of a new temporary circulatory support system used for patients suffering from heart failure.
The AB5000 Circulatory Support System was launched April 26 by ABIOMED Inc. at the American Association for Thoracic Surgery annual meeting in Toronto, Canada.
The new system provides temporary support for one or both sides of the natural heart when a patient is suffering from heart failure. The new system is designed to give the patient’s heart an opportunity to rest and potentially recover, while giving surgeons the therapeutic flexibility to determine the best options for treatment, according to the company.
"This advanced life-saving system is an important option for the thousands of patients a year who require temporary circulatory support," said Michael Minogue, president and chief executive officer of ABIOMED. "We have had tremendous positive feedback from our early adopters and anticipate that this new product will set the stage in defining the standard of care for cardiac assist."
The AB5000 has two principal components: an advanced computer system that drives the blood pumps and a disposable blood pump capable of supporting both ventricles of the heart.
The new support system also is designed to be mobile and enable patients to leave their hospital rooms.
During the initial controlled introduction, ABIOMED signed on more than 20 hospitals in several states.
ABIOMED, which is based in Danvers, Mass., also recently announced that 12 patients have received implants of its AbioCor Implantable Replacement Heart.
A product of three decades of research, the AbioCor is the subject of an initial clinical trial that began when the first patient was successfully implanted in July 2001. Candidates for the clinical trial must suffer from biventricular heart failure, be ineligible for heart transplantation and not able to be helped by any other available therapy and have a high probability of dying in less than 30 days.
ABIOMED plans to seek initial approval from the U.S. Food & Drug Administration this year for the AbioCor to treat a defined subset of irreversible end-stage heart failure patients under a Humanitarian Device Exemption.
April 30, 2004 Small Business Times, Milwaukee
