Medtronic Scores CE Mark For Extravascular Defibrillator System For Abnormal Heart Rhythms

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.

Market News and Data brought to you by Benzinga APIs

-

-

-

-

-

-

-

25% Off Benzinga's Most Powerful Trading Tools

-

-

-

-

-

-

-