Implantable cardioverter-defibrillators (ICDs) play a crucial role in saving lives by treating patients at risk of sudden cardiac arrest (SCA), which can be fatal if not addressed immediately. SCA is usually caused by a rapid heartbeat or an irregular heart rhythm. Traditional ICDs are typically inserted beneath the collarbone, and their leads run through the veins directly into the heart. Now, a first-of-its-kind ICD system offers a single device and single procedure with the lead positioned outside the heart and veins to minimize the risk of long-term complications.

Medtronic plc (Dublin, Ireland) has received U.S. Food and Drug Administration (FDA) approval for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation lead to treat dangerously fast heart rhythms that can lead to SCA. This is the first system of its kind to offer the benefits of conventional ICDs while placing the lead beneath the breastbone, outside of the heart and veins. The Aurora EV-ICD has a form factor, size, and lifespan similar to traditional ICDs that utilize leads passing through the veins.

In contrast to conventional ICDs, the Aurora EV-ICD is implanted under the left armpit and the lead is positioned under the breastbone using a less invasive method. The Epsila EV lead avoids certain complications related to traditional transvenous leads, such as damage to blood vessels or obstructions. The device provides essential defibrillation, anti-tachycardia pacing (ATP), and back-up pacing therapies, similar to those available in standard Medtronic transvenous ICDs. The FDA has approved the Aurora EV-ICD system along with its specialized implantation tools, supported by pivotal global trials proving its safety and effectiveness.

The pivotal study revealed a 98.7% effectiveness rate for the device's defibrillation capabilities at the time of implantation. Furthermore, neither any significant complication was observed during the procedure, nor any unique complication when compared to traditional and subcutaneous ICDs. Importantly, the ATP feature prevented 33 unnecessary defibrillation shocks, and 92.6% of patients remained free from the major system or procedure-related complications, like hospitalization or death, six months post-implantation. The Aurora EV-ICD system will soon be available commercially in the U.S. on a restricted basis. Those who receive the device will also benefit from the inclusion of Smart Sense, a unique algorithm designed to reduce the likelihood of inappropriate shocks.

"This FDA approval paves the way for patients to have a better overall experience with ICD therapy," said Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. "ICDs remain the gold standard for prevention of sudden cardiac death, and while the subcutaneous ICD avoids certain complications associated with transvenous defibrillators, it has limitations that may affect a patient's comfort and quality-of-life. With the Aurora EV-ICD system, patients can benefit from the only ICD placed outside the vascular space that provides ATP and back-up pacing, in a device that is nearly half the size and with 60% greater projected battery longevity compared to the competitor's subcutaneous ICD." 

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