FDA approves extravascular ICD system with anti-tachycardia pacing
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Key takeaways:
- The FDA approved an extravascular ICD system to treat tachycardia that may cause sudden cardiac arrest.
- Placing leads outside of the heart may lower risk for long-term complications.
Medtronic announced it received FDA approval for its extravascular implantable cardioverter-defibrillator and defibrillation lead to treat tachycardia that may cause sudden cardiac arrest.
The FDA approval is based on the result of a pivotal study, published in The New England Journal of Medicine, in which, as Healio previously reported, the device (Aurora EV-ICD MRI SureScan) demonstrated 98.7% effectiveness in delivering defibrillation therapy at implant with no major complications related to the procedure or system compared with transvenous and subcutaneous ICDs, according to a company press release.
The system features a lead (Epsila EV MRI SureScan) placed under the breastbone to deliver lifesaving defibrillation, anti-tachycardia pacing and back-up pacing therapies via a device similar in size, shape and longevity to traditional, transvenous ICDs, according to the release.
The ICD system is implanted in the left mid-axillary region and the lead is placed under the sternum via minimally invasive approach. The lead is placed outside of the heart and veins and is designed to avoid complications such as vascular injury and vessel occlusion, according to the release.
The system is indicated for patients at risk for life-threatening arrhythmias, who have not undergone prior sternotomy and do not need chronic bradycardia pacing, according to the release.
"The Aurora EV-ICD system is a tremendous step forward in implantable defibrillator technology," Bradley P. Knight, MD, medical director of electrophysiology at Northwestern Medicine Bluhm Cardiovascular Institute and co-author of the pivotal study, said in the release. "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."
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