HeartMate PHP is a percutaneous device, which has been designed to provide short-term support for patients needing acute cardiac assistance.
The HeartMate PHP CE Mark trial will be carried on around 50 patients at sites in Europe and South America.
The study will concentrate on use during high-risk percutaneous coronary interventions (high-risk PCI) and includes a primary endpoint of procedural success and avoidance of major adverse events for 30 days.
Columbia University Medicine assistant professor and CRF Skirball Center for Innovation executive director and chief innovation officer Juan Granada has performed a portion of the initial cases in the HeartMate PHP HeartMate PHP CE Mark trial.
Dr. Granada has performed these cases at the Instituto del Corazón in Bucaramanga of Colombia.
Granada said that HeartMate PHP provided 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," Granada added.
Thoratec president and CEO Gary Burbach said the firm has commenced the CE Mark clinical trial for HeartMate PHP and look forward and look forward to successfully execute this important clinical study.
"The HeartMate PHP addresses a significant clinical need for acute mechanical circulatory support and represents a new area of future growth for Thoratec," Burbach added.
Image: Thoratec has commenced CE Mark clinical trial for HeartMate PHP. Photo: courtesy of Penn State University.
