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Medtronic's (MDT) Affera Ablation System Gets CE Mark

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Medtronic plc (MDT - Free Report) recently announced the receipt of a CE Mark for the Affera Mapping and Ablation System to treat atrial arrhythmias. The system includes the Sphere-9 Catheter and the Affera Prism-1 Mapping Software. The Affera Mapping and Ablation System will be commercially available in Europe and is investigational in the United States in the first half of 2023.

The Affera Mapping and Ablation System is the first of its kind, all-in-one Sphere-9 Catheter with pulsed-field ablation, radiofrequency, and high-density mapping combined with an intuitive mapping and navigation platform.

The recent development will likely fortify Medtronic’s Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio. 

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The Sphere-9 Catheter, with the integrated mapping and navigation system, rapidly generates sophisticated electro-anatomical maps enabling the physician to offer wide-area focal ablation lesions of choice between RF or PFA, based on the patient and procedure needs. The intuitive mapping software enhances user experience by providing efficient insights and feedback to aid procedure performance.

CE Mark approval is backed by results from clinical studies assessing the safety and performance of the Sphere-9 Catheter and Mapping System. Last December, the company completed participant enrolment in the FDA Investigational Device Exemption (IDE) randomized, pivotal Affera SPHERE Per-AF clinical trial. The trial was intended to evaluate the Affera Mapping and Ablation System’s effectiveness and safety in treating persistent atrial fibrillation.

Benefits of the Ablation Catheter

Per management, mapping, ablating and validating with the Sphere-9 Catheter allows the physician to remove the need to exchange catheters and authorizes them to choose the energy source, whether RF or PF, based on the patient's needs. This enhances the efficiency and safety of ablation procedures for our patients.

Together, the full system, through the unique integration of the Sphere-9 pulsed field ablation (PFA), radiofrequency (RF) and high density (HD) mapping catheter, generates a new paradigm in electrophysiology, which maps and ablates atrial arrhythmias (fast, abnormal heart rhythms) and offers real-time feedback through its intuitive mapping and navigation software.

Industry Prospects

Per a report by Allied Market Research, the global atrial fibrillation market size was $1,825.85 million in 2020 and is projected to reach $3,370.70 million by 2030, growing at a CAGR of 6.4%. The increase in the frequency of atrial fibrillation in the elderly population, technical developments and a preference for catheter ablation for cardiac arrhythmia therapy.

Recent Developments

In February 2023, Medtronic announced one-year data from the ADAPT study -- the first multi-national randomized controlled study evaluating the performance of the MiniMed 780G advanced hybrid closed loop system1 (AHCL) against multiple daily injections (MDI) of insulin with an intermittently scanned CGM (isCGM).  The study results were presented at the 2023 Advanced Technologies & Treatments for Diabetes (ATTD) Conference in Berlin.

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The same month, Medtronic announced the receipt of the CE mark for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation led to treating abnormal heart rhythms. The Aurora EV-ICD system is investigational in the United States.

Price Performance

Shares of the company have lost 28.1% in the past year compared with the industry’s fall of 41.1%.

Zacks Rank and Key Picks

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

Some better-ranked stocks in the overall healthcare sector include Haemonetics Corporation (HAE - Free Report) , TerrAscend Corp. and Akerna Corp. (KERN - Free Report) . Haemonetics and TerrAscend both sport a Zacks Rank #1, while Akerna carries a Zack Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Haemonetics’ stock has risen 42.1% in the past year. Earnings Estimates for Haemonetics have increased from $2.87 per share to 2.91 for 2023, and from $3.02 per share to $3.28 for 2024 in the past 30 days.

HAE’s earnings beat estimates in each of the last four quarters, delivering an average surprise of 10.98%. In the last reported quarter, it reported an earnings surprise of 7.59%.

Estimates for TerrAscend in 2023 have remained constant at a loss of 10 cents per share in the past 30 days. Shares of TerrAscend have declined 70.6% in the past year.

TerrAscend’s earnings beat estimates in one of the last three quarters and missed the mark in the other two, the average negative surprise being 136.11%. In the last reported quarter, TRSSF delivered an earnings surprise of 216.67%.

Akerna’s stock declined 95.7% in the past year. Its estimates for 2023 have remained constant at a loss of $1.91 per share over the past 30 days.

Akerna missed earnings estimates in each of the last four quarters, delivering a negative earnings surprise of 15.49%, on average. In the last reported quarter, KERN delivered a negative earnings surprise of 13.33%.

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