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World’s Smallest Heart Pump Under Study at UPMC

Open heart surgery not required with the Abiomed Impella 2.5 heart pump

PITTSBURGH , May 22, 2008 — A miniature heart pump is under evaluation at the University of Pittsburgh Medical Center (UPMC) to determine whether or not it could eliminate the need for emergency open heart surgery in patients undergoing high-risk coronary catheter procedures. The research study will determine its safety and efficacy in high-risk patients.

UPMC is the third leading enroller in the research study among U.S. heart centers participating in the PROTECT II pivotal trial with Abiomed’s Impella 2.5 System -- the world’s smallest heart pump only slightly larger in diameter than a drinking straw. Researchers hope to enroll 150 patients overall during the two-year multi-center clinical feasibility trial, which is being funded by Abiomed. 

“This is an important study because it will allow us to evaluate how we can improve treatment of patients undergoing high-risk percutaneous coronary intervention procedures, especially with a growing aging population,” said Suresh Mulukutla, M.D., assistant professor of medicine, Division of Cardiology, University of Pittsburgh School of Medicine, and principal investigator of the Impella trial. “Furthermore, this clinical trial highlights the growing trend of non-surgical treatments for heart patients.”

The Impella 2.5 System is an investigational device that has not yet been approved by the U.S. Food and Drug Administration. The heart pump is inserted much the same as a balloon angioplasty and stent, inside the cardiac catheterization lab. Once the heart pump is secured, the regular balloon angioplasty and/or stent procedure is completed. This pump is being tested to determine if the patient’s heart can rest and recover by reducing the heart’s workload and oxygen intake and to improve heart function even after the procedure. Patients will be supported on the device during the cardiac catheterization procedure. However, if the cardiologist decides that the patient’s heart should be supported for a longer time, the Impella can be left in place for up to five days.

According the National Heart Lung and Blood Registry for Percutaneous Coronary Intervention, more than 1 million cardiac catheterization procedures are performed in the United States each year. Due to the rise in multiple-vessel disease in patients with poor cardiac function, which is caused by coronary vessel blocks in three or more vessels of the heart, the researchers hope to demonstrate that the Impella 2.5 provides a new treatment option that aims to improve patient outcomes.

“One of the potential main advantages of the Impella is that it may eliminate the need for major surgery with an open chest incision and placement of the patient on heart/lung bypass. This miniature pump is placed percutaneously with a small incision at the groin and inserted much the same way as a balloon tip or cardiac stent, which means less recovery time, fewer complications and shorter hospital length-of-stay,” said Michael P. Siegenthaler, M.D., associate professor of surgery, division of cardiac surgery, UPMC Heart Lung and Esophageal Surgery Institute and co-investigator of the Impella trial. 

About UPMC

UPMC is an integrated global health enterprise headquartered in Pittsburgh and one of the leading nonprofit health systems in the United States. As western Pennsylvania’s largest employer with 48,000 employees and nearly $7 billion in revenue, UPMC is transforming the economy of the region into one based on medicine, research and technology. By integrating 20 hospitals, 400 doctors’ offices and outpatient sites, long-term care facilities and a major insurance plan, UPMC has advanced the quality and efficiency of health care and developed internationally renowned programs in transplantation, cancer, neurosurgery, psychiatry, orthopaedics and sports medicine, among others. UPMC is commercializing its medical and technological expertise by nurturing new companies, developing strategic business relationships with some of the world’s leading multi-national corporations, and expanding into international markets including Italy, Ireland, the United Kingdom and Qatar. For more information about UPMC, go to www.upmc.com.

About Abiomed

Based in Danvers Mass., Abiomed Inc., is a leading provider of medical devices that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery. Our products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart. For additional information, please visit www.abiomed.com.

Note to editors:

To see video of the Impella 2.5 procedure inside the cath lab, click here.

To see the Abiomed’s graphic animation video of how the Impella 2.5 heart pump works, go to http://www.abiomed.com/products/impella.cfm

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