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Medtronic (MDT) Receives CE Mark Approval For Aurora System

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Medtronic plc (MDT - Free Report) recently announced the receipt of the CE mark for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation lead to treating abnormal heart rhythms. The Aurora EV-ICD system is investigational in the United States.

For investors’ note, CE Mark approval is backed by the Pivotal Study of Extravascular Implantable Cardioverter Defibrillator (EV ICD), demonstrating its safety and effectiveness endpoints. The data was presented as late-breaking science at the European Society of Cardiology 2022 and simultaneously published in The New England Journal of Medicine.

The recent development is likely to fortify Medtronic’ Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio.

More about Aurora EV-ICD system

The Aurora EV-ICD system offers the life-saving benefits of traditional ICDs while evading certain risks because its lead (thin wire) is placed outside the heart and veins. The system is indicated for patients at risk of life-threatening arrhythmias, who have not had a prior sternotomy and who do not require chronic bradycardia (abnormally slow heartbeat) pacing.

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) with a minimally-invasive approach. Placing the lead outside of the heart and veins is intended to help dodge long-term complications that may be associated with transvenous leads, such as vessel occlusion (narrowing, blockage or compression of a vein) and risks for blood infections.

The Aurora EV-ICD system is likely to be commercially available in autumn 2023 in select countries in Europe.

Benefits of Aurora EV-ICD system

The growing awareness by patients and physicians about the risks that come with placing leads in the heart or veins is addressed by the Aurora EV-ICD system that offers an extravascular solution and maintains the traditional ICD benefits of pacing and defibrillation therapy.

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Per Medtronic’s management, it is the first company to offer a complete one-system, one-procedure extravascular ICD solution, which maintains the patient benefits of traditional, transvenous ICDs without the risk of leads in the heart and vasculature. This approval is a noteworthy milestone in achieving the goal of providing a defibrillation solution that treats sudden cardiac arrest while improving the patient experience.

Industry Prospects

Per a report by Grand View Research, the global cardiac rhythm management devices market size was $18.1 billion in 2021 and is estimated to expand at a CAGR of 6.5% by 2030. The growing prevalence of various cardiovascular diseases, such as arrhythmia and atrial fibrillation, are driving the market.

Recent Developments

In December 2022, Medtronic announced the enrolment of the first patient in the Expand URO U.S. clinical trial for the Hugo robotic-assisted surgery (RAS) system. The robotic prostatectomy was performed at Duke University Hospital in Durham, N.C. The Hugo RAS system and Touch Surgery Enterprise provide a smart, digitally-enabled surgical experience. Outside the United States, the Hugo RAS system is utilized in hospitals across three continents in an array of procedures within urology, gynecology and general surgery.

In the same month, Medtronic announced the completion of enrollment and final treatment in the SPHERE Per-AF Trial, FDA Investigational Device Exemption (IDE) pivotal trial. SPHERE Per-AF Trial is intended to assess the safety and effectiveness of the first-of-its-kind Sphere-9 pulsed field, radiofrequency ablation and high-density mapping catheter with the Affera cardiac mapping and navigation platform for treating persistent atrial fibrillation.

Price Performance

Shares of the company have lost 15.7% in the past six months compared with the industry’s fall of 35.5%.

Zacks Rank and Key Picks

Currently, Medtronic carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are AMN Healthcare Services, Inc. (AMN - Free Report) , Cardinal Health, Inc. (CAH - Free Report) and Merit Medical Systems, Inc. (MMSI - Free Report) .

AMN Healthcare, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 3.3%. AMN’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 10.9%.

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

AMN Healthcare has gained 5.4% against the industry’s 19.6% decline in the past year.

Cardinal Health, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 11.6%. CAH’s earnings surpassed estimates in two of the trailing four quarters and missed the same in the other two, the average beat being 6.4%.

Cardinal Health has gained 48.7% against the industry’s 0.8% decline in the past year.

Merit Medical, flaunting a Zacks Rank #2 at present, has an estimated long-term growth rate of 11%. MMSI’s earnings surpassed estimates in all the trailing four quarters, the average beat being 25.4%.

Merit Medical has gained 28.1% against the industry’s 0.8% decline in the past year.

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