Dr. Adrian Ebner at Sanatorio Italiano in Asuncion, Paraguay, used HeartMate PHP to stabilize a patient for an hour on the operating table during a percutaneous coronary procedure. Two other patients were subsequently treated with the catheter-based heart pump.
Pleasanton, Calif.-based Thoratec is planning additional clinical investigations into the HeartMate PHP device’s efficacy in high-risk percutaneous and cardiogenic episodes, which have a high mortality rates. Thoratec said the current pilot study will continue and a CE Mark study will begin later this year.
"We are delighted to have participated in the 1st human experience with HeartMate PHP," said Ebner in prepared comments. "Without PHP in place during this high-risk procedure, we might not have been able to achieve complete revascularization."
Thoratec recently won investigational device exemption in the U.S. for a clinical trial to evaluate the HeartMate II system, which the company says is a complimentary device to the HeartMate PHP. The Heart Mate II study will enroll 100 plus patients and has a supporting budget of up to $11 million.
"This 1st-in-human experience with HeartMate PHP demonstrates Thoratec’s commitment to our mission of providing physicians with superior MCS solutions, for both chronic and acute support needs, in order to dramatically improve patient outcomes," said CEO Gary Burbach in prepared remarks.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.