Thoratec has started the enrollment of patients in the Shield II US clinical trial, which is designed to assess the HeartMate PHP in patients undergoing a high-risk percutaneous coronary intervention (PCI) procedure.
The company will randomize around 425 patients at around 60 sites against the Impella 2.5 at a 2:1 ratio in the supporting patients undergoing high-risk PCI using a high-flow percutaneous left ventricular support device (Shield) II clinical trial.
According to the firm, the primary endpoint will assess non-inferiority based on a composite of adverse events at 90 days of follow-up.
HeartMate PHP is an acute cardiac assist device, which has been developed to decouple the traditional relationship between size and flow in catheter-based support devices.
With typical operating speeds between 17,000-20,000 RPMs, the device has been designed for hemocompatibility.
The device’s expandable catheter technology can generate average blood flow of four to five liters per minute following delivery through a true percutaneous insertion.
Thoratec president and CEO Keith Grossman said: "Shield II marks the beginning of our clinical experience with PHP in the large and important US market.
"We look forward to the significant clinical data expected from Shield II and the ultimate commercialization of PHP in the US."