Thoratec Begins HeartMate PHP CE Mark Trial

August 6, 2014—Thoratec Corporation announced that it has commenced the CE Mark clinical trial for its HeartMate PHP percutaneous heart pump. The HeartMate PHP features the company’s expandable catheter technology and is designed to deliver short-term support for patients needing acute cardiac assistance. 

According to the company, the study will focus on use during high-risk percutaneous coronary interventions. The primary endpoint is procedural success and avoidance of major adverse events for 30 days. The trial will enroll up to 50 patients at sites in Europe and South America. 

Dariusz Dudek, MD, is Principal Investigator of the HeartMate PHP CE Mark trial and Physician-in-Chief, Department of Cardiology and Cardiovascular Interventions at the University Hospital in Krakow, Poland. In the company’s press release, Dr. Dudek commented, “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.”
 
The company advised that a portion of the initial cases in the HeartMate PHP CE Mark trial were performed by Juan F. Granada, MD. Dr. Granada is Assistant Professor of Medicine at Columbia University in New York, New York, and Executive Director and Chief Innovation Officer at the CRF Skirball Center for Innovation. Dr. Granada performed these cases at the Instituto del Corazón in Bucaramanga, Columbia. Additional cases in the CE Mark trial were performed by Adrian Ebner, MD, Chief of the Cardiovascular Department at Sanatorio Italiano in Asuncion, Paraguay, where the first human cases using PHP were successfully completed in 2013.

In the company’s press release, Dr. Granada commented, “HeartMate PHP offers clinicians a new and effective alternative to address the need for short-term acute cardiac support. 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 hemodynamic stabilization.”