Thoratec Receives CE Mark Approval for HeartMate PHP, Will Begin US SHIELD II Trial in Q3 2015

July 13, 2015—Thoratec Corporation announced that the HeartMate PHP (percutaneous heart pump) received CE Mark approval, permitting sale in the European Union and other countries. The HeartMate PHP European launch will include a measured rollout to targeted countries that will be staged through the second half of 2015 and 2016, advised the company.

According to Thoratec, European approval was based on data from the first 30 patients enrolled in the HeartMate PHP SHIELD I CE Mark trial, which examined use of the PHP to support patients undergoing a high-risk percutaneous coronary intervention procedure. Data from all 50 patients enrolled in this study will be presented later in 2015, advised the company. 

Thoratec advised that the HeartMate PHP is an acute cardiac assist device designed to uncouple the traditional relationship between size and flow in catheter-based support devices. Thoratec’s expandable catheter technology used in the HeartMate PHP is capable of generating average blood flow of 4 to 5 L/min after delivery through a true percutaneous insertion. The device has been designed for hemocompatibility, with typical operating revolutions per minute of 17,000–20,000. 

Dariusz Dudek, MD,  served as the SHIELD I principal investigator. In the company’s press release, Dr. Dudek commented, “The SHIELD I clinical experience demonstrated both the performance and ease of use of HeartMate PHP, which was able to safely maintain or improve the hemodynamic profile of severely ill patients undergoing complex revascularizations.” Dr. Dudek is Physician in Chief, Department of Cardiology and Cardiovascular Interventions, at the University Hospital in Krakow, Poland.

Thoratec also advised that it recently received unconditional approval from the United States Food and Drug Administration for the SHIELD II United States investigational device exemption trial to investigate use of the HeartMate PHP in patients undergoing high-risk percutaneous coronary intervention. The trial is expected to begin enrollment during the third quarter of 2015. On May 26, Thoratec announced that the Food and Drug Administration had granted conditional approval for the trial pending resolution of certain routine technical questions. The SHIELD II United States clinical trial will randomize up to 425 patients at up to 60 sites against the Impella 2.5 (Abiomed, Inc.) at a 2:1 ratio. The primary endpoint will measure noninferiority based on a composite of adverse events at 90 days of follow-up, stated Thoratec.