Thoratec begins SHIELD II U.S. clinical trial to examine use of HeartMate PHP in patients undergoing high-risk PCI

Sep 4 2015

Thoratec Corporation (NASDAQ: THOR), a world leader in mechanical circulatory support therapies to save, support and restore failing hearts, announced today that it has begun enrollment in the SHIELD II U.S. clinical trial examining the HeartMate PHP™ in patients undergoing a high-risk PCI (percutaneous coronary intervention) procedure. The first case was performed by interventional cardiologist Dr. Robert Pyo at Montefiore Medical Center. "SHIELD II is off to an encouraging start as the HeartMate PHP was easily deployed and provided consistent hemodynamic stability during the first case," said Dr. Ulrich Jorde, Vice Chief of Cardiology and Section Head of Heart Failure, Cardiac Transplantation, and Mechanical Circulatory Support at Montefiore Medical Center, Albert Einstein College of Medicine, New York.

"SHIELD II marks the beginning of our clinical experience with PHP in the large and important U.S. market," said D. Keith Grossman, President and Chief Executive Officer. "We look forward to the significant clinical data expected from SHIELD II and the ultimate commercialization of PHP in the U.S.," he added.

HeartMate PHP is an acute cardiac assist device designed to uncouple the traditional relationship between size and flow in catheter-based support devices. The proprietary expandable catheter technology of HeartMate PHP is capable of generating average blood flow of four to five liters per minute following delivery through a true percutaneous insertion. The device has been designed for hemocompatibility, with typical operating speeds between 17,000-20,000 RPMs.

The SHIELD II (Supporting patients undergoing HIgh-risk PCI using a high-flow pErcutaneous Left ventricular support Device) U.S. clinical trial will randomize up to 425 patients at up to 60 sites against the Impella® 2.5 at a 2:1 ratio. Individual sites may immediately begin randomization after performing a series of one to three HeartMate PHP procedures for purposes of training and familiarity. The primary endpoint will measure non-inferiority based on a composite of adverse events at 90 days of follow-up. The study will be led by three National Principal Investigators: Dr. Ulrich Jorde of Montefiore Medical Center, Dr. David Kandzari of Piedmont Heart Institute, and Dr. Navin Kapur of Tufts University Medical Center. "We expect that data from SHIELD II will further demonstrate the clinical value of PHP, and could not only advance the rapidly emerging market for percutaneous hemodynamic support in complex coronary revascularization but also support further study in expanded indications," said Dr. Kandzari, Director of Interventional Cardiology and Chief Scientific Officer at Piedmont.