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 an otherwise unmet clinical need for complete circulatory support during high-risk PCI procedures,” added St. Jude chief medical officer Dr. Mark Carlson. “The Shield I study results demonstrate the consistent and reliable circulatory support offered by the HeartMate PHP cardiac assist device, which was designed as a novel advancement to traditional catheter-based support devices.”
Here’s a look at other news coming out of TCT 2015:
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
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