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Medtronic (MDT) Reports Favorable SPHERE Per-AF Trial Outcome

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Medtronic plc (MDT - Free Report) recently announced positive results demonstrating the safety and efficacy of the Affera Mapping and Ablation System with the Sphere-9 Catheter. The SPHERE Per-AF study, an FDA Investigational Device Exemption (“IDE”) pivotal trial, compared Sphere-9 to the conventional Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto 3 System.

The late-breaking clinical data was presented at the Heart Rhythm Society 2024 Annual Meeting and simultaneously published in Nature Medicine. The latest development comes as a significant boost for the Cardiac Ablations Solutions business, part of Medtronic’s Cardiovascular portfolio.

Importance of the Study and Findings

Medtronic’s Sphere-9 Catheter is an all-in-one pulsed field (PF) and radiofrequency (RF) ablation and high-density mapping catheter for the treatment of persistent atrial fibrillation (AFib). As one of the most common and undertreated heart rhythm disorders, AFib often begins as paroxsymal AFib (presents intermittently) and progresses to persistent (lasts for more than seven days without stopping), increasing the risk of serious complications, including heart failure, stroke and death.

The prospective, multicenter SPHERE Per-AF clinical trial evaluated the Sphere-9 Catheter with the Affera Mapping and Ablation System for the treatment of persistent AFib. The subjects were randomized 1:1 to receive treatment with either the Sphere-9 Catheter with the Affera Mapping and Ablation System or the Thermocool SmartTouch SF RF ablation catheter with the Carto 3 System. For the primary analysis, a total of 420 patients were enrolled across 23 sites in the United States, Czech Republic and Israel. All patients in both arms of the trial received pulmonary vein isolation and linear lesions based on their needs.

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The Sphere-9 Catheter demonstrated a positive safety profile with a primary safety endpoint rate of 1.4%. No safety events, including pulmonary vein stenosis, esophageal events or cardiac tamponade, were reported. More than 95% of Sphere-9 procedures used a single transeptal puncture compared to 62% in the control arm.

Additionally, Sphere-9 demonstrated 73.8% freedom from AFib compared with 65.8% observed in the control arm. Following 100% acute isolation of pulmonary veins and linear lesions, Sphere-9 Catheter-treated patients also observed less recurrence of atrial arrhythmias throughout the 12-month follow-up period.

Moreover, treatment with the Sphere-9 Catheter demonstrated superior efficiency over the control arm for procedural characteristics, including skin-to-skin procedural time, time between the first and last ablation and energy application time. The patients treated with the Sphere-9 Catheter are reported to have experienced improvements in the quality of life in both mental and physical well-being.

More on the News

As pioneers in cardiac ablation treatment, including cryoablation and PFA, the company is thrilled to share these results, which provide compelling evidence for the use of an all-in-one catheter that can be used without any need for a second catheter. The Affera Mapping and Ablation system with Sphere-9 Catheter demonstrates a positive safety, efficacy and efficiency profile, which can potentially amplify Medtronic’s innovative and trusted portfolio. The results bring them closer to introducing this technology to the United States and beyond.

The investigational Affera Sphere-9 Catheter was recently filed for the FDA’s approval by the company and is not presently approved for sale or distribution. In March last year, the Affera Mapping and Ablation System, which includes the Sphere-9 Catheter, received CE Mark approval.

Industry Prospects

Per a Research report, the global AFib device market was valued at $2.04 billion in 2021 and is expected to witness a CAGR of 12% by 2029.  A growing prevalence of AFib among the adult population is likely to push the demand for the devices in the global market. 

Other Developments in the Cardiovascular Portfolio

In a separate release, Medtronic announced late-breaking data from the global Lead Evaluation for Defibrillation and Reliability Pivotal Trial, which demonstrated that its investigational OmniaSecure defibrillation lead achieved the primary safety and effectiveness endpoints and exceeded prespecified performance goals. The design of the OmniaSecure defibrillation lead is based on the Medtronic SelectSecure Model 3830 pacing lead, which has offered safe and effective treatment to patients for more than 20 years.

Price Performance

In the past year, MDT shares have dropped 4% compared with the industry’s decline of 0.6%.

Zacks Rank and Key Picks

Medtronic currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the broader medical space are Hims & Hers Health (HIMS - Free Report) , High Tide (HITI - Free Report) and Medpace (MEDP - Free Report) . Each of them sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks Rank #1 stocks here.

Hims & Hers Heath stock has rallied 53.3% in the past year. Earnings estimates for the company have risen from 10 cents to 18 cents in 2024 and from 23 cents to 32 cents in 2025 in the past 30 days.

HIMS’ earnings beat estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 79.2%. In the last reported quarter, it posted an earnings surprise of a staggering 150%.

Estimates for High Tide’s 2024 earnings per share have remained breakeven in the past 30 days. Shares of the company have surged 57.9% upward in the past year against the industry’s fall of 0.6%.

HITI’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 91.7%. In the last reported quarter, it delivered an earnings surprise of 100%.

Estimates for Medpace’s 2024 earnings per share have moved up to $11.29 from $10.53 in the past 30 days. Shares of the company have surged 87.6% in the past year compared with the industry’s 5% growth.

MEDP’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 12.8%. In the last reported quarter, it delivered an average earnings surprise of 30.6%.

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