Thoratec Corporation has announced that its CE mark clinical trial for HeartMate percutaneous heart pump (PHP) has commenced.
“We are excited to begin the CE Mark Clinical Trial for HeartMate PHP and look forward to successful execution of this important clinical study,” says Gary F Burbach, president and chief executive officer. “The HeartMate PHP addresses a significant clinical need for acute mechanical circulatory support and represents a new area of future growth for Thoratec,” he adds.
HeartMate PHP is a percutaneous device designed to deliver short-term support for patients needing acute cardiac assistance. Through a proprietary expandable catheter technology, HeartMate PHP seeks to deliver improvements in device size, performance and clinical outcomes compared with currently available acute support technologies.
A portion of the initial cases in the HeartMate PHP CE mark trial were performed by Juan F Granada, assistant professor of Medicine at Columbia University in New York and executive director and chief innovation officer at the CRF Skirball Center for Innovation. Granada performed these cases at the Instituto del Corazón in Bucaramanga, Colombia and comments, “HeartMate PHP offers clinicians a new and effective alternative to address the need for short-term acute cardiac support,” adding “the HeartMate PHP performance and ease of deployment are important advancements ideal for usage in this high-risk patient cohort that requires rapid and predictable haemodynamic stabilisation.”
Additional cases in the CE mark trial were performed by Adrian Ebner, chief of the Cardiovascular Department at Sanatorio Italiano in Asuncion, Paraguay, where the first human cases using PHP were also successfully completed in 2013.
The HeartMate PHP CE mark trial will enrol up to 50 patients at sites in Europe and South America. The study will focus on use during high-risk percutaneous coronary interventions and includes a primary endpoint of procedural success and avoidance of major adverse events for 30 days.
Dariusz Dudek, physician in chief, Department of Cardiology and Cardiovascular Interventions at the University Hospital in Krakow, Poland, and principal investigator of the HeartMate PHP CE mark trial comments, “On behalf of all the investigators, I wish to congratulate the teams in South America on the initiation of the clinical study. We look forward to treating patients in Europe with HeartMate PHP in the near future.”