- The European authority has agreed Medtronic plc 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 offers the benefits of traditional ICDs while avoiding certain risks by placing its lead (thin wire) outside of the heart and veins.
- The Aurora EV ICD System is in testing in the United States
- Also read: Medtronic is recalling over 22,000 hemodialysis catheters for potential hub defects.
- 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 effectiveness of the device in delivering defibrillation therapy at implant was 98.7%.
- In addition, the effectiveness of ATP – which stimulates the heart to interrupt and terminate a dangerous rhythm, potentially avoiding a defibrillation shock – was comparable to the effectiveness of anti-tachycardia pacing (ATP) in the EV-ICD study. with transvenous defibrillators.
- A total of 33 shocks were avoided by programming ATP to “on”.
- In addition, at six months, 92.6% of patients in the pivotal study were free of major systemic and/or procedure-related major complications.
- The Aurora EV ICD System is indicated for patients who are at risk of life-threatening arrhythmias, who have not had a prior sternotomy, and who do not require chronic bradycardia (abnormally slow heartbeat) pacing.
- Price promotion: MDT shares are down 0.49% to $83.76 on the latest check Friday.
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