March 28, 2013 — Thoratec Corp. announced that it has successfully completed the first human use of HeartMate PHP (percutaneous heart pump). The first PHP patient was supported for over 60 minutes during a high-risk percutaneous coronary intervention (HR PCI). The patient was hemodynamically stable during the procedure, which involved three-vessel intervention on a patient with an ejection fraction less than 30 percent. Two additional patients were treated as part of this first-in-man series. The procedures were performed by Adrian Ebner, M.D. at Sanatorio Italiano in Asuncion, Paraguay. Ebner is the chief of the Cardiovascular Department at Sanatorio Italiano.
The HeartMate PHP system is a catheter-based heart pump designed to provide hemodynamic left ventricular support. Upon insertion into the femoral artery via an integrated 12 French introducer sheath, the PHP catheter is advanced into the left ventricle where the distal end of the catheter expands to 24 French, allowing for enhanced blood flow with low levels of hemolysis. Thoratec has designed the PHP system to facilitate rapid insertion using an intuitive control console and to provide 4-5 liters per minute of mean flow for support durations up to several days.
"We are delighted to have participated in the first human experience with HeartMate PHP," said Ebner. "The PHP technology represents a potential breakthrough in MCS therapy, providing the support required for hemodynamically unstable patients. Without PHP in place during this high-risk procedure, we might not have been able to achieve complete revascularization."
"I am pleased with the level of support the PHP system provided in this milestone case," said Michael Ennen, vice president and general manager of Thoratec's Interventional Business. "In just three years, our team has taken PHP from concept to clinical utilization, and we look forward to advancing our evaluation of this next-generation percutaneous support system."
Thoratec intends to pursue clinical investigations on the use of HeartMate PHP to support patients undergoing high-risk percutaneous interventions as well as those in cardiogenic shock, a population with persistently high mortality rates. The company is planning a continuation of the pilot study during the second quarter and anticipates initiating a CE mark study in the second half of 2013. The PHP system complements Thoratec's surgical-based MCS pump platforms such as HeartMate II and CentriMag, providing a complete continuum of circulatory support products.
"This First-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 Gary Burbach, Thoratec's president and CEO.
For more information: www.thoratec.com