St. Jude Medical’s coronary interventions in high-risk patients using a novel percutaneous left ventricular support device (SHIELD I) trial has confirmed that HeartMate PHP cardiac assist device provides consistent and dependable cardiac support during high-risk percutaneous coronary intervention (PCI) procedures.
The study showed that consistent and stable hemodynamics have been maintained during revascularization, when HeartMate PHP device was used.
The trial is a prospective, non-randomized, open-label, and multicenter study, which assessed the efficacy of the HeartMate PHP cardiac assist device in patients who required hemodynamic (circulatory) support during complex PCI procedures.
According to the firm, the trial reached both endpoints for primary performance, freedom from hemodynamic compromise during PCI, and safety.
The minimally invasive HeartMate PHP cardiac assist device is placed through catheter to temporarily support circulation by continuously pumping blood during PCI, allowing physicians to treat high-risk patients effectively.
HeartMate PH holds capacity to generate an average blood flow of four to five liters per minute, which is the normal amount of blood pumped out by the left ventricle.
St. Jude has reported the trial results from the first 46 patients, at the 27th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation in San Francisco, US.
Shield I trial principal investor Dr. Dariusz Dudek said: "The data from Shield I demonstrate that the HeartMate PHP device is a highly promising technology that should be considered for high-risk patients, such as those with advanced heart failure or who may be at risk of cardiogenic shock, undergoing PCI procedures."
In July, Thoratec received CE mark approval for HeartMate PHP, based on data from the first 30 patients of the HeartMate PHP Shield I trial.
Earlier this month, St. Jude Medical completed the $3.3bn acquisition of Thoratec that develops mechanical circulatory support (MCS) technology to treat advanced heart failure (HF).