Thoratec receives CE mark for new blood pump to assist patients during complex procedures

Deploying the HeartMate Percutaneous Heart Pump--Courtesy of Thoratec

Thoratec ($THOR) received a CE mark for its HeartMate Percutaneous Heart Pump (PHP), following a 30-person clinical trial.

The acute cardiac assist device can generate average blood flow of four to five liters per minute after percutaneous insertion. The device's motor runs at 17,000 to 20,000 revolutions per minute, the company says. It's designed to keep patients' blood flowing during complex procedures like stent implantation.

"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," said principal investigator Dr. Dariusz Dudek, a cardiologist at University Hospital in Krakow, Poland.

A measured European launch is planned. And the device recently earned FDA permission for use in the U.S., with enrollment expected to commence during Q3.

"PHP is an entirely new opportunity for Thoratec. Although the current catheter pump market outside the U.S. is relatively small, we look forward to gaining valuable clinical and commercial experience through a targeted European launch of HeartMate PHP in the coming months," said Thoratec CEO Keith Grossman in a statement.

The company's main product is the HeartMate left ventricular assist device. It is a bridge to transplantation for patients awaiting a heart transplant and can also be used as a long-term "destination therapy."

Thoratec is testing the third generation of the device in the U.S. for FDA approval and Europe, where the company is testing implantation of the device using less invasive surgical techniques.

- read the release