Medtronic (NYSE:MDT) said yesterday it launched a pilot study of its investigational Extravascular Implantable cardioverter defibrillator system, with the first patient implant already performed at New Zealand’s Christchurch Hospital.
The Fridley, Minn.-based company’s EV ICD system uses leads placed outside of the heart and veins to provide both defibrillation and antitachycardia pacing therapy. The initial implantation marks the first long-term use of the EV ICD system, the company said.
“The Medtronic EV ICD system has the potential to deliver the benefits of traditional ICDs while eliminating the risks that can occur when leads are implanted inside the veins and heart. We are incredibly pleased to contribute to this important research that will serve as a key step in establishing the safety and efficacy of this new approach,” principal investigator Dr. Ian Crozier of New Zealand’s Christchurch Hospital said in a prepared statement.
The system is intended to provide benefits of both traditional transvenous ICDs and bradycardia pacing to treat abnormally slow heart rates, and uses the same size and shape as traditional ICDs, but without leads. Medtronic said it expects that the device, which is implanted in the left mid-axillary region below the left armpit with a lead placed under the sternum, will have “similar longevity” to traditional ICDs
The pilot study aims to explore the EV ICD system in 20 patients at four sites across Australia and New Zealand, with routine checks for safety and device performance, Medtronic said.
“As a global leader in ICD innovation, Medtronic is developing new approaches for delivering lifesaving ICD therapy. This pilot study is a significant step forward in our EV ICD clinical development program, as we aim to offer patients the therapies of a traditional transvenous ICD, but without leads implanted in the heart,” Medtronic CRM biz GM Mike Marinaro said in a press release.
Earlier this week, the US Dept. of Homeland Security’s Industrial Control Systems Computer Emergency Response Team flagged two Medtronic devices for cybersecurity vulnerabilities that could allow attackers to obtain sensitive information