Medtronic (NYSE:MDT) said today that it launched a worldwide pivotal study to evaluate its extravascular implantable cardioverter defibrillator device for treating dangerously fast heart rhythms.
The EV ICD system uses a device that is the same size as traditional, transvenous ICDs, but with a lead wire placed outside the heart and veins, designed to deliver defibrillation and pacing therapy. Medtronic said the device is expected to have similar longevity compared to traditional ICDs, while providing the same benefits in a single system and implant procedure.
The Fridley, Minn.-based company said it plans to assess up to 400 patients in North America, Europe, Asia, Australia, New Zealand and the Middle East in the single-arm, non-randomized study.
The primary effectiveness endpoint of the study is defibrillation testing success rate at implant, while the primary safety objective is freedom from major system and/or procedural complications a six months. Patients will be observed at two weeks, three months, six months and every six months for the three-year term of the study, according to a news release and ClinicalTrials.gov.
The upcoming study comes in the wake of a successful first-in-human chronic EV ICD pilot study of 21 patients in New Zealand and Australia. Medtronic said the first study implant procedures were performed by Dr. Ian Crozier (Christchurch Hospital, Christchurch, New Zealand) and Dr. John Scherschel (Prairie Heart Institute at HSHS St. John’s Hospital, Springfield, Ill).
Mayo Clinic chair of the midwest department of cardiovascular medicine Dr. Paul Friedman will be the principal investigator for the study.
“With the EV ICD system, we aspire to deliver a new standard in ICD therapy for patients who are at significant risk of life-threatening rhythms in the lower chambers of the heart,” Medtronic chief medical officer & vice president of medical affairs in the cardiac rhythm and heart failure division Dr. Rob Kowal said in prepared remarks. “Our engineers have spent years developing this innovative system, and we appreciate the high level of interest and collaboration among our expert investigators and regulatory authorities worldwide to carry out the EV ICD pivotal study.”
“Along with the other study investigators, I am enthusiastic to evaluate the safety and efficacy of this new approach, and its potential to deliver lifesaving ICD therapy without the risks associated with leads inside the veins and heart, and without compromising on the features available in traditional ICDs,” added Dr. Bradley Knight, medical director of the Center for Heart Rhythm Disorders at Northwestern Medicine’s Bluhm Cardiovascular Institute at Northwestern Memorial Hospital.
Shares of MDT were down -0.6% at $107.95 per share in mid-afternoon trading today.
