USA — Medtronic has obtained FDA approval for the groundbreaking Aurora EV-ICD MRI SureScan, a revolutionary Extravascular Implantable Cardioverter-Defibrillator.
Medtronic has also received FDA approval for the Epsila EV MRI SureScan defibrillation lead, marking a significant advance in treating rapid heart rhythms that may result in sudden cardiac arrest (SCA).
The Aurora EV-ICD system marks a pivotal advancement, offering the life-saving benefits of traditional transvenous ICDs, but with a groundbreaking twist—a lead placed under the breastbone, outside the heart and veins.
This innovative system delivers defibrillation, anti-tachycardia pacing (ATP), and back-up (pause-prevention) pacing therapies via a device that closely resembles the size, shape, and longevity of traditional, transvenous ICDs.
The FDA’s green light for the Medtronic Aurora EV-ICD system encompasses the proprietary implant tools, and it was underpinned by global pivotal trial results, which affirm the system’s safety and efficacy.
These influential findings were even featured in The New England Journal of Medicine. In the near future, the Aurora EV-ICD system is set to become commercially available in the United States, albeit on a limited basis.
Notably, the pivotal study demonstrated the system’s remarkable effectiveness, boasting a 98.7% success rate in delivering defibrillation therapy at implant.
Furthermore, this milestone was achieved without encountering any significant intraprocedural complications.
There were no distinctive complications observed concerning the EV ICD procedure or system when compared to transvenous and subcutaneous ICDs.
An additional advantage of the Aurora EV-ICD system is the avoidance of 33 defibrillation shocks, thanks to ATP—an ingenious feature that paces the heart to interrupt and terminate dangerous rhythms—programmed “on.”
Six months down the line, a remarkable 92.6% of patients, according to Kaplan-Meier estimates, remained free from major system and/or procedure-related complications such as hospitalization, system revision, or death.
ICDs have long been recognized for their exceptional capacity to provide life-saving therapy to patients at risk of SCA, which arises from electrical issues in the heart, manifesting as dangerously fast heart rates (ventricular tachycardia) or irregular rhythms (ventricular fibrillation).
If left untreated, SCA typically results in sudden cardiac death, emphasizing the critical importance of swift intervention.
Traditional ICDs are conventionally implanted below the collarbone, with leads carefully threaded through the veins and into the heart.
The Aurora EV-ICD system stands as a game-changing alternative, bearing striking similarities in size, shape, and longevity to conventional transvenous ICDs.
However, what sets it apart is its minimally invasive approach, involving implantation below the left armpit (in the left mid-axillary region) and the placement of the lead under the breastbone (sternum).
The Epsila EV defibrillation lead, positioned outside of the heart and veins, substantially reduces the risk of complications often associated with transvenous leads, such as vascular injuries and vessel occlusion (narrowing, blockage, or compression of a vein).
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