Medtronic plc ( MDT Quick Quote 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.
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).
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