Mechanical circulatory support device specialist, Thoratec Corporation, has announced the start of its CE Mark Clinical Trial for HeartMate PHPTM (Percutaneous Heart Pump).
Thoratec might be pleased to be able to announce some good news to coincide with the release of its quarterly financials, because the sales numbers, ten percent off for the most recent quarter, compared with a year ago, look like they need their own form of support. That sales drop came on the back of a good first quarter, but more than offset the Q1 growth, leaving sales for the first six months 2 percent lower than a year ago. As for its core Heartmate line, this was the main culprit for the shortfall, sales being down 12 percent.
One of the company’s bigger hopes for future revenue, 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.
The HeartMate PHP CE Mark trial will enroll up to 50 patients at sites in Europe and South America. The study will focus 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.
A portion of the initial cases in the HeartMate PHP CE Mark trial have already been performed by Juan F. Granada M.D., Assistant Professor of Medicine at Columbia University in New York and Executive Director and Chief Innovation Officer at the CRF Skirball Center for Innovation.
Dr. Granada performed his first cases at the Instituto del Corazón in Bucaramanga, Colombia and commented, “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 hemodynamic stabilization.”
Additional cases in the CE Mark trial were performed by Adrian Ebner M.D., Chief of the Cardiovascular Department at Sanatorio Italiano in Asuncion, Paraguay, where the first human cases using PHP were also successfully completed in 2013.
Dariusz Dudek M.D., 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 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.”
Speaking of the financial position, Gary F. Burbach, President and Chief Executive Officer stated; “We are disappointed with the shortfall in our financial results as near-term factors are having a greater than expected negative impact on our business. However, our confidence in the long-term outlook for our business remains unchanged, and we will focus on executing to realize these opportunities while working diligently on implementing actions to improve near-term results”.
On the CE mark trial he commented; “We are excited to begin the CE Mark Clinical Trial for HeartMate PHP and look forward to successful execution of 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”.
Source: Thoratec Corporation, PR Newswire