Thoratec has announced that its HeartMate PHP (Percutaneous Heart Pump) has received CE mark approval, permitting sale in the EU and other international countries. The approval was based on data from the first 30 patients enrolled in the HeartMate PHP SHIELD I CE mark trial, which is examining use of PHP to support patients undergoing a high-risk percutaneous coronary intervention (PCI) procedure. Data from all 50 patients enrolled in this study will be presented later in 2015.
A company press release reports that HeartMate PHP is an acute cardiac assist device designed to uncouple the traditional relationship between size and flow in catheter-based support devices. It adds that the proprietary expandable catheter technology of HeartMate PHP is capable of generating average blood flow of four to five litres per minute following delivery through a true percutaneous insertion. The device has been designed for haemocompatibility, with typical operating RPMs of 17,000–20,000.
Dariusz Dudek (Department of Cardiology and Cardiovascular Interventions at the University Hospital in Krakow, Poland) says: “”The SHIELD I clinical experience demonstrated both the performance and ease of use of HeartMate PHP, which was able to safely maintain or improve the hemodynamic profile of severely ill patients undergoing complex revascularisations.”
The HeartMate PHP European launch will include a measured rollout to targeted countries, staged through the balance of 2015 and 2016. Previously issued company guidance for 2015 financial results included the expected impact of revenue and costs associated with HeartMate PHP and the European launch, with internal resources principally focused on the HeartMate PHP US IDE study. The SHIELD II US IDE trial recently received unconditional approval from the FDA and is still expected to begin enrolment during the third quarter.