Healthcare Industry News:  Impella 

Devices Cardiology

 News Release - December 3, 2007

Texas Heart Institute at St. Luke's Episcopal Hospital Participates in Ground-Breaking Heart Recovery Technology Study

Abiomed(TM) Impella(R) Heart Pump Supports Local Man's Heart in FDA-Approved Patient Trial

HOUSTON--(HSMN NewsFeed)--Texas Heart Institute at St. Luke’s Episcopal Hospital reaffirms its ongoing commitment to heart recovery by highlighting its recent participation in the FDA-approved PROTECT I patient safety trial for Abiomed’sTM Impella® 2.5 catheter-based heart pump device.

Texas Heart Institute at St. Luke’s Episcopal Hospital was one of the few facilities chosen to participate in the Abiomed PROTECT I trial for the Impella 2.5, the first FDA-approved trial for prophylactic, or preventative, use of a device during high-risk percutaneous coronary intervention (PCI) procedures.

In February 2007, Mr. Binson Cheng, 36, of Houston, Texas was one of 20 patients enrolled in the Impella 2.5 PROTECT I trial. Mr. Cheng had undergone an unsuccessful coronary artery bypass surgery 8 months prior to enrollment in the trial. He was not a candidate for additional surgical revascualarization. Due the critical location of blockage in the left main coronary artery, and his weakened heart muscle, Mr. Cheng was considered too high risk for standard percutaneous coronary intervention (PCI) procedures. He had severe chest pain despite medical therapy and had exhausted all standard options for treatment. He was referred to the Texas Heart Institute at St. Luke’s Episcopal Hospital, and his case was reviewed by Dr. Pranav Loyalka, Dr. Biswajit Kar, and Dr. Andrew Civitello. Mr. Cheng was enrolled in the Protect I Trial, which was designed to evaluate the Impella 2.5 system as a support device to allow PCI procedures in very high risk patients.

The Impella 2.5 device was advanced into Mr. Cheng’s heart via his femoral artery in the hospital’s cardiac catheterization lab. While the Impella system supported his weakened heart, multiple stents were safely inserted into the coronary arteries, relieving the obstructions. Mr. Cheng returned to a normal life shortly after the Impella 2.5 supported procedure and remains free of chest pain nine months after the procedure.

Abiomed’s Impella 2.5 is a left ventricular assist device (VAD) which is inserted percutaneously in the cardiac catheterization lab, providing patients with up to 2.5 liters of blood flow per minute. It is the world's smallest VAD and has been used to treat conditions such as acute myocardial infarction (heart attack), cardiogenic shock and low output syndrome under CE Mark approval in Europe. Due to a rise in conditions such as triple vessel disease in patients with poor cardiac function, which is caused by coronary vessel blocks in three vessels of the heart, the Impella 2.5 provides a new treatment option that aims to improve patient outcomes. The Impella 2.5 can be quickly inserted into the left ventricle through the femoral artery, into the ascending aorta, across the valve and into the left ventricle and can remain in place for short-term support.

“We are pleased to have enrolled four patients in this important safety and feasibility study; more than any other institution in the U.S.,” said Dr. Andrew Civitello, Principal Investigator of the PROTECT I trial at Texas Heart Institute at St. Luke’s Episcopal Hospital. “Mr. Cheng was a very sick patient with limited options. The Impella system allowed us to safely treat a patient population previously considered too high risk for standard PCI procedures.

Dr. Pranav Loyalka, a co-investigator in the trial, added “In the future, we hope to treat other patient populations including those in cardiogenic shock or those that have recently suffered from an acute myocardial infarction (or heart attack) and revolutionize the way coronary artery disease is treated.”

Full results of the PROTECT I study were announced by Abiomed at this year’s Cardiovascular Research Foundation's (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) Scientific Symposium. Texas Heart Institute at St. Luke’s Episcopal Hospital will also participate in the PROTECT II trial currently being conducted by Abiomed.

The Texas Heart Institute, founded by world-renowned cardiovascular surgeon Dr. Denton A. Cooley in 1962, is a nonprofit organization dedicated to reducing the devastating toll of cardiovascular disease through innovative and progressive programs in research, education and improved patient care. Together with its clinical partner, St. Luke’s Episcopal Hospital, it has been ranked among the top ten cardiovascular centers in the United States by U.S. News & World Report’s annual guide to “America’s Best Hospitals” for the past 17 years. The Texas Heart Institute is also affiliated with the University of Texas (UT) System, which promotes collaboration in cardiovascular research and education among UT and THI faculty at the Texas Heart Institute and other UT components. For more information about the Institute, please visit www.texasheart.org.

St. Luke’s Episcopal Health System comprises the flagship St. Luke’s Episcopal Hospital in the Texas Medical Center, founded in 1954 by the Episcopal Diocese of Texas; St. Luke’s Community Medical Center–The Woodlands, opened in 2003; St. Luke’s Episcopal Health Charities, a charity devoted to assessing and enhancing community health, especially among the underserved; and Kelsey-Seybold Management, LLP, overseeing 21 area clinic locations. St. Luke’s Episcopal Hospital is home to the Texas Heart® Institute, founded in 1962 by Denton A. Cooley, MD, and is consistently ranked among the top 10 cardiology and heart surgery centers in the nation by U.S. News & World Report. Affiliated with several nursing schools and two medical schools, St. Luke’s serves as the primary adult teaching hospital for Baylor College of Medicine. St. Luke’s was the first hospital in Texas named a Magnet hospital for nursing excellence, and the Health System has been recognized by FORTUNE as among“100 Best Companies to Work For” and by Houston Business Journal as a top employer in Houston. For more information about St. Luke’s, please visit www.stlukestexas.com.

Based in Danvers, Massachusetts, 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.


Source: Abiomed

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