USA — Medtronic has received CE mark approval for its Aurora EV-ICD MRI SureScan, an extravascular implantable cardioverter-defibrillator (ICD), and the Epsila EV MRI SureScan defibrillation lead to treat rapid and life-threatening heart rhythms that may lead to sudden cardiac arrest.
CE mark approval was based in part on data taken from the Medtronic-funded Extravascular ICD Pivotal Study; findings from that analysis were published in The New England Journal of Medicine in October 2022.
Medtronic’s global pivotal study demonstrated a 98.7% efficacy rate for delivering defibrillation therapy at implant, and the ATP efficacy was comparable to transvenous defibrillators.
Medtronic-funded Extravascular ICD Pivotal Study showed that the extravascular ICDs were implanted safely and able to detect and terminate induced ventricular arrhythmias at the time of implantation.
The Aurora EV-ICD provides the same life-saving benefits as traditional ICDs while avoiding some of the associated risks, as its lead is placed outside the heart and veins.
The device offers defibrillation, anti-tachycardia pacing (ATP), and backup pacing therapies through one implanted device that is similar in size, shape, and longevity to traditional ICDs.
Other features of the newly approved solution include anti-tachycardia pacing, pause prevention pacing, and Medtronic’s PhysioCurve design, which aims to improve patient comfort.
The new system also includes proprietary implant tools and features pause prevention pacing, which provides backup pacing for brief, intermittent heartbeat pauses.
The system has an up to 11.7-year projected longevity, and 40 Joule defibrillation energy delivers life-saving shocks in a device the size of transvenous ICDs.
Medtronic’s goal is to provide a defibrillation solution that treats sudden cardiac arrest while improving the patient experience, and this approval marks a significant milestone. The U.S. Food and Drug Administration has not yet approved the system for commercial use.
Medtronic has had several recent milestones and achievements. In January 2023, the company signed the Zero Health Gaps Pledge, which outlines ten areas where committed organizations agree to help drive progress and advance health equity.
The pledge includes goals such as expanding access to care, promoting health equity, and increasing diversity and inclusion within the healthcare industry.
However, in 2022, Medtronic faced some challenges as well. In December, the company issued a product recall for its HeartWare HVAD heart pump due to a potential issue with the device’s power connector pins.
The medical technology started the recall on 28 June 2022, and has since recalled 23,372 devices that were sold between January 1, 2009, and the present.
On a more positive note, in November 2022, Medtronic announced the launch of its Customer eXperience Center in Singapore.
The center serves as a hub for training and education for healthcare providers in the Asia-Pacific region, as well as a showcase for the company’s innovative medical technologies.
The center is part of Medtronic’s broader efforts to expand its global presence and provide better support to healthcare providers and patients worldwide.