- The European authority has approved Medtronic plc's MDT Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation lead for fast heart rhythms that can lead to sudden cardiac arrest.
- The Aurora EV-ICD system provides the benefits of traditional ICDs while avoiding certain risks because its lead (thin wire) is placed outside the heart and veins.
- The Aurora EV-ICD system is investigational in the U.S.
- Also Read: Medtronic Recalls Over 22,000 Hemodialysis Catheters For Potential Hub Defect.
- The Aurora EV-ICD is implanted below the left armpit (in the left mid-axillary region), and the Epsila EV lead is placed under the breastbone (sternum) using a minimally invasive approach.
- In the pivotal study, the device's effectiveness in delivering defibrillation therapy at implant was 98.7%.
- Further, the efficacy of ATP – which paces the heart to interrupt and terminate a dangerous rhythm, potentially avoiding a defibrillation shock – in the EV ICD study was comparable to anti-tachycardia pacing (ATP) efficacy in transvenous defibrillators.
- In total, 33 shocks were avoided by having ATP programmed "on."
- Additionally, at six months, 92.6% of patients in the pivotal study were free from major system and/or procedure-related major complications.
- The Aurora EV-ICD system is indicated for patients at risk of life-threatening arrhythmias who have not had a prior sternotomy and do not need chronic bradycardia (abnormally slow heartbeat) pacing.
- Price Action: MDT shares are down 0.49% at $83.76 on the last check Friday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in
