Joins Two Noted Cardiothoracic Surgeons to Lead Pivotal Trial
ANN ARBOR, Mich., March 17 /PRNewswire/ -- Terumo Heart Inc. today announced that it has appointed David Seth Feldman, MD/PhD, FACC, FAHA to be the Co-Principal Investigator for its Bridge-to-Transplant trial in the United States, studying the new, third generation DuraHeart(TM) Left Ventricular Assist System (LVAS). Dr. Feldman joins Dr. Francis Pagani, Director of the Heart Transplant and Center for Circulatory Support at University of Michigan, and Dr. Yoshifumi Naka, Director of cardiac transplantation at NewYork-Presbyterian Hospital/Columbia University Medical Center, in this role.
Dr. Feldman is Director of Heart Failure and Cardiac Transplantation and Director of Heart Failure and Transplant Fellowship Program at The Ohio State University Medical Center. He is Associate Professor of Medicine and Cardiology, with joint faculty positions in physiology and cell biology; Integrated Biological Program and the School of Pharmacy. A renowned heart failure cardiologist, Dr. Feldman holds numerous leadership positions within The Ohio State University, including the Heart Lung Research Institute, Transplant Consortium and Congestive Heart Failure Guidelines Implementation Committee, as well as the National Merit Review Grants-Cardiovascular Section and International Program Committee of the International Society of Heart and Lung Transplantation. Additionally, Dr. Feldman is a reviewer for leading American and European journals and is a molecular biologist with an actively funded NIH Laboratory. He has authored more than 50 peer-reviewed articles and eight book chapters. Dr. Feldman has held leadership roles in 26 clinical trials, as well as presented in numerous national and international medical meetings.
“I am excited to be part of this trial designed to offer new treatment options for patients with advanced heart failure,” said David Feldman, MD. “The DuraHeart device offers a unique design that facilitates the surgical procedure, and the only centrifugal pump with an actively levitated impeller, which is intended to optimize oxygenated blood flow from the left ventricle to the aorta and into the body.”
“We are honored to have Dr. Feldman as co-PI,” said Chisato Nojiri, MD, PhD, Terumo Chairperson and Chief Medical Officer. “Dr. Feldman’s credentials as a heart failure cardiologist, combined with Dr. Pagani’s and Dr. Naka’s experience as cardiothoracic surgeons, bring tremendous added benefit to the execution and completion of this trial. We look forward to working closely with Dr. Feldman, Dr. Pagani and Dr. Naka to accelerate the start-up and ongoing delivery of the trial, in order to ensure the highest level of quality and optimal clinical results.”
The DuraHeart System features a small pump that is implanted in a pocket created in the abdomen. When the pump is activated, the impeller position is precisely controlled by the electromagnets and sensors to keep it centered within the blood chamber. Magnets in the motor couple to the impeller so that when the motor spins, it causes the impeller to rotate and pump blood from the heart to the body. Once the DuraHeart is running, blood flows from the left ventricle, through the pump and directly to the body via the aorta. In its weakened state, the heart is not strong enough to supply sufficient blood for normal activities. The DuraHeart is intended to supplement the natural flow produced by the heart by increasing total flow to near normal levels.
About Heart Failure
More than 22 million people suffer from heart failure worldwide with approximately one million new patients diagnosed annually. In the setting of an aging global population, heart failure is the number one reason for hospitalization. The most severely ill patients need heart transplants in order to recover. More than 8,000 people worldwide are on the list of eligible candidates for heart transplants annually, but less than 4,000 will receive a transplant each year. A large number of people who suffer from severe heart failure do not qualify for transplantation due to other health issues. An alternative for these patients is access to artificial mechanical assist devices. Left Ventricular Assist Systems (LVAS) are a type of mechanical circulatory device specifically designed to improve the lives of patients waiting for donor hearts, as well as those who are ineligible for a heart transplant.
About Terumo Heart, Inc.
Terumo Heart, Inc. is a U.S. subsidiary of Terumo Corporation with headquarters and manufacturing facilities in Ann Arbor, Michigan. The company’s focus is the innovation and introduction of products to improve the quality of healthcare for heart failure patients. Terumo Corporation, located in Tokyo, Japan, is a leading developer, manufacturer and global marketer of a wide array of medical products. DuraHeart is limited to investigational use only in the United States, and is CE marked in Europe. For more information, visit www.terumoheart.com.
CONTACT: Martin Schildhouse, +1-305-606-3577, or Robert Murphy,
+1-908-276-0777, of The Storch-Murphy Group, Ltd.
