Medtronic's (MDT) Sphere-360 PFA Study Outcome Favorable

Medtronic plc MDT recently presented positive clinical trial safety and efficacy results for Sphere-360 -- an investigational single-shot mapping and ablation catheter using pulsed field (PF) energy The catheter is intended for treatment of patients with paroxysmal atrial fibrillation (AFib).

The European Heart Rhythm Association (EHRA) 2024 Annual Meeting featured a late-breaking clinical trial showcasing interim findings from the first-in-human Sphere-360 investigation.

About Sphere-360 Catheter

The Sphere-360 catheter was designed to simplify the atrial fibrillation process while increasing efficiency and giving long-lasting lesions. Its distinctive design comprises a wide, tissue-conformable lattice tip for efficient energy delivery. It eliminates the need to twist the catheter numerous times in the exact location because the entire lattice tip transmits PF energy.

The catheter is fully integrated with the Affera Mapping and Ablation System, providing total visibility inside the heart and electroanatomical mapping. It is an actual all-in-one single-shot catheter for mapping, ablation, and validation.

Study Detail

The Sphere-360 study, a prospective, single-arm, multi-center trial with 85 patients in three European centers, showed 81.8% freedom from atrial arrhythmias after one year of follow-up, with 100% freedom in the sub-group treated with the most recent pulse configuration. The treatment time, or the time from the first to the last PF application, averaged 10 minutes.

A sub-study of patients treated with the optimized pulse underwent remapping procedures; 96% of those patients displayed maintained lesion durability, and of all the pulmonary veins (PV) treated in this group, 99% remained isolated after 75 days of the index surgery.

The study also found that the catheter had a perfect safety profile, with no cases of esophageal events, pulmonary vein stenosis, phrenic nerve injury, or cardiac tamponade.

Significance of Study Outcomes

Electrophysiologists are looking for new catheter alternatives to address the various cardiac anatomies seen in patients. As the population with atrial fibrillation grows, catheter adaptability will become more critical than ever to achieve the best results. The recent findings are highly encouraging since they demonstrate that the Sphere-360 catheter has the potential to be a major component of next-generation AFib therapy.

Medtronic is thrilled that the Sphere-360 study results validate its commitment to the goal of an all-in-one single-shot mapping and pulsed-field ablation catheter that is fully integrated with the Affera Mapping and Ablation System. Its unique design can conform to any pulmonary vein anatomy and can be used with a single transeptal access, and no exchange. All of these aspects make the procedure more efficient and predictable.

Industry Prospects

Per a report, the global cardiac ablation market size was $3.29 billion in 2021 and is expected to register a revenue CAGR of 14.2% by 2030. A growing number of patients suffering from cardiovascular diseases, increasing technological advancements in cardiac ablation equipment, and rising demand for minimally invasive procedures are a few of the key factors driving the market.

Progress in Cardiac Ablation Device Among Peers

Companies like Abbott Laboratories, Inc. ABT, Boston Scientific Corporation BSX and GE Healthcare Technologies, Inc. GEHC are also making significant progress in the field of cardiac ablation devices.

In January 2024, Abbott announced the first global procedures have been conducted using the company's new Volt Pulsed Field Ablation (PFA) System to treat patients battling common abnormal heart rhythms such as atrial fibrillation (AFib). Over 30 patients were recently treated in Australia as part of Abbott's Volt CE Mark study, a pre-market, multi-center clinical study designed to evaluate the safety and effectiveness of Abbott's Volt PFA System.

Boston Scientific too in January 2024, received FDA’s approval for the FARAPULSE Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF). It is a unique new alternative to standard-of-care thermal ablation treatment.

The same month, GE Healthcare announced the launch of Caption AI artificial intelligence (AI)-driven software for rapid cardiac assessments at the point of care on Vscan Air SL. The new launch also includes CardioVisio for Atrial Fibrillation, a digital, patient-centric clinical decision support tool, which consists of the most recent ACC guidelines. The launch of Vscan Air SL with Caption AI joins the 60 AI-enabled medical device authorizations from GE HealthCare in the United States. Of these, approximately 30 are AI-enabled ultrasound innovations.

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