US-based Thoratec has initiated patient enrolment in the Shield II US clinical trial, which is designed to evaluate the HeartMate PHP in patients undergoing a high-risk percutaneous coronary intervention (PCI) procedure.
The company is engaged in the research, development, manufacturing and marketing of medical devices.
HeartMate PHP is an acute cardiac assist device, which was developed to decouple the traditional relationship between size and flow in catheter-based support devices.
Albert Einstein College of Medicine Montefiore Medical Center Cardiology vice chief Dr Ulrich Jorde said: "Shield II is off to an encouraging start as the HeartMate PHP was easily deployed and provided consistent hemodynamic stability during the first case."
The first case was performed by Montefiore Medical Center interventional cardiologist Dr Robert Pyo.
In the Shield II clinical trial, 425 people will be randomised at 60 sites against the Impella 2.5 at a 2:1 ratio. The trial’s primary endpoint will measure non-inferiority based on a composite of adverse events at 90 days of follow-up.
The trial will be led by three national principal investigators, Dr Jorde from Montefiore Medical Center, Dr David Kandzari from Piedmont Heart Institute, and Dr Navin Kapur of Tufts University Medical Center.
Thoratec president 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 commercialisation of PHP in the US."
With operating speeds between 17,000RPM – 20,000RPM, the device has been designed for hemocompatibility.
The device’s expandable catheter technology can generate an average blood flow of 4l to 5l per minute following delivery through a true percutaneous insertion.
Piedmont chief scientific officer David Kandzari said: "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 revascularisation, but also support further study in expanded indications."