Medtronic has received the US Food and Drug Administration (FDA) approval for its Aurora extravascular implantable cardioverter-defibrillator (EV-ICD) MRI SureScan system.
The US regulator approved the Aurora EV-ICD system, together with the Epsila EV MRI SureScan defibrillation lead.
The defibrillator and defibrillation lead are intended to treat very high-speed heart rhythms (arrhythmias) that may lead to sudden cardiac arrest (SCA).
Medtronic designed the Aurora EV-ICD system to be in same size, shape, and durability as traditional transvenous ICDs, using its unique PhysioCurve design.
It provides the same benefits as traditional ICDs, including Anti-tachycardia Pacing (ATP) using low-energy pacing pulses, Pause-Prevention Pacing, and an estimated durability of 11.7 years.
The Aurora device will also deliver additional benefits from the Smart Sense, an advanced algorithm designed to reduce the potential for inappropriate shocks.
Unlike traditional ICDs, the system is implanted in the left mid-axillary region (below the left armpit) and the lead is placed under the sternum, using a minimally invasive approach.
The Global healthcare technology company intends to begin limited commercialisation of the Aurora EV-ICD system in the US, in the coming few weeks.
Medtronic Cardiac Rhythm Management business chief medical officer Alan Cheng said: “This FDA approval paves the way for patients to have a better overall experience with ICD therapy.
“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.”
The FDA approval, which includes the Aurora EV-ICD system and its unique procedure implant tools, was supported by the results from a global clinical trial.
The study evaluated the safety and effectiveness of the Medtronic EV ICD system in 356 patients, who are at risk of sudden cardiac death, at 46 sites in 17 countries.
In the study, the device delivered the defibrillation therapy at implant, with 98.7% accuracy.
The implant delivery did not result in any major intraprocedural complications, or unique complications related to the EV ICD procedure or system, compared to traditional ICDs.
In addition, the system helped avoid 33 defibrillation shocks and freed 92.6% of patients from major system- or procedure-related complications.
Study co-author Bradley Knight said: “The Aurora EV-ICD system is a tremendous step forward in implantable defibrillator technology.
“Placing the leads outside of the heart, rather than inside the heart and veins, reduces the risk of long-term complications, ultimately allowing us to further evolve safe and effective ICD technology.”
Furthermore, Medtronic will obtain real-world performance and safety data on the Aurora system in the Enlighten global post-approval registry in around 1,000 patients.
