Medtronic presents feasibility study of extravascular ICD therapy
Medtronic (NYSE:MDT) presented results at HRS that touted the feasibility of an approach to delivering pacing and defibrillation therapy in which a lead is placed under the sternum, outside of the heart and veins.
The study’s findings confirmed that an investigational, extravascular ICD lead can sense, pace and defibrillate the heart.
“Clinicians are highly interested in the potential for an extravascular ICD solution to provide both pacing and lifesaving defibrillation therapy without leads placed inside the heart or vasculature,” Dr. Lucas Boersma, a cardiologist at St. Antonius Hospital and a professor of cardiology at the University of Amsterdam, said in prepared remarks.
For the ASD2 study, 79 patients who were already slated to receive elective cardiac surgery or a subcutaneous or transvenous ICD implant had Medtronic’s investigational EV-ICD lead inserted temporarily under the sternum and evaluated with either a defib patch or a defib emulator.
The ICD lead was designed to sense activity in the heart’s ventricles, give pacing to the ventricles and deliver a 30-J shock after ventricular fibrillation was induced.
Medtronic said its results were consistent with studies of existing ICDs – ventricular pacing was successful in 97% of patients and shocks successfully ended 83% of episodes. In six of the 79 patients, seven adverse events were reported.
“The ASD2 feasibility experience is an important step in our investigational extravascular defibrillation program, and the results give us confidence to continue with this research,” Mike Marinaro, VP & GM of Medtronic’s cardiac rhythm management business, added. “We look forward to our next clinical evaluation – a first-in-human, chronic study to assess the safety and efficacy of the investigational Medtronic EV-ICD system in an ICD patient population.”