TCT 2015 Roundup: St. Jude Medical’s new HeartMate PHP pump

St. Jude Medical (NYSE:STJ) said today that its newly acquired HeartMate PHP heart pump met its safety and efficacy endpoints in the Shield I trial used to back its CE Mark approval last summer. The results from Shield I’s 1st 30 patients led to the CE Mark nod in July. Today St. Jude said data from 46 subjects passed the primary safety endpoint of a composite of major adverse events and the primary efficacy endpoint of freedom from hemodynamic compromise during percutaneous coronary intervention. The study results, released today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco, also showed low complication rates, including no incidence of device-related cardiac death, myocardial infarction or intraprocedural hypotension. St. Jude acquired the HeartMate PHP when it paid $3 billion for Thoratec last week. “We are excited to share the results of Shield I, which support the safety and performance of the HeartMate PHP device,” principal investigator Dr. Dariusz Dudek, of the University Hospital in Krakow, said in prepared remarks. “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.” “Globally, there’s a significant opportunity for patients to benefit from cardiovascular pumps that address a...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Catheters Clinical Trials Elixir Medical Corp. Micell Technologies Inc. St. Jude Medical Stentys TCT 2015 Tryton Medical Inc. Source Type: news