Medtronic completes enrollment in pivotal trial evaluating first-of-its-kind pulsed field ablation catheter for patients with atrial fibrillation

Rhea-AI Summary

Medtronic (NYSE:MDT) announced the completion of enrollment in the SPHERE Per-AF Trial, evaluating the Sphere-9 cardiac ablation catheter with the Affera mapping system for persistent atrial fibrillation. This pivotal trial, pivotal for FDA approval, included 477 patients across 23 centers in the U.S. and Europe. The Sphere-9 catheter uniquely offers both radiofrequency and pulsed field ablation in one device. Results will be assessed over 12 months. The trial follows Medtronic's acquisition of Affera in August 2022, enhancing its cardiac solutions portfolio.

Positive

• Successful enrollment of 477 patients in the SPHERE Per-AF Trial, indicating strong interest and potential market relevance.
• The Sphere-9 catheter offers dual energy sources for personalized treatment, addressing a significant need in cardiac care.
• Completion of final treatment in the trial marks a milestone in Medtronic's innovation and growth strategy.

Negative

• The Affera product portfolio is not yet approved for commercial sale, potentially delaying revenue generation.
• Trial results must prove efficacy and safety, posing an inherent risk to future approval and market entry.

SPHERE Per-AF will determine the safety and effectiveness of the Sphere-9 cardiac ablation and mapping catheter with the Affera mapping and navigation system

DUBLIN, Dec. 5, 2022 /PRNewswire/ -- Medtronic (NYSE:MDT) today announced the completion of enrollment and final treatment in the SPHERE Per-AF Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial designed to evaluate the safety and effectiveness of the first-of-its kind Sphere-9™ pulsed field (PF) and radiofrequency (RF) ablation, and high density (HD) mapping catheter with the Affera cardiac mapping and navigation platform for the treatment of persistent atrial fibrillation (AF).

The investigational Medtronic technology includes the Affera mapping/navigation platform, designed to improve efficiencies by enabling intuitive HD mapping to diagnose arrhythmias and treat patients with one catheter. The Sphere-9 catheter combines mapping, navigation, and therapeutic capabilities and is the only catheter capable of delivering both RF and PF energies for ablation, providing physicians with the ability to customize treatment based on a patient's needs during an ablation procedure.

"During the trial, my observations and experience with the novel Affera system have been very promising," said Devi Nair, M.D., FHRS, Director of Cardiac Electrophysiology & Research, St. Bernards Medical Center, Jonesboro, Arkansas, a participating site in the SPHERE Per-AF trial. "Unlike conventional technologies, I've been impressed with the ability to both map and ablate with the option of dual energy sources, with one catheter. I look forward to the results of the trial and remain optimistically enthusiastic as I continue to understand the safety and efficacy of the Sphere 9 ablation catheter."

The SPHERE Per-AF Trial is a global, prospective, multicenter, randomized clinical trial. Since the trial's commencement in December 2021, the trial enrolled 477 patients with persistent AF across 23 centers in the U.S. and Europe. Patients will be assessed for 12 months for safety and efficacy. 

"Treating the final patient in the fast-moving SPHERE Per-AF Trial builds on the exciting phase of innovation and growth at Medtronic over the last year, including the acquisition of Affera, our agreement to distribute a differentiated portfolio of left-heart access tools and devices to support a zero-exchange procedure workflow, and the continued progress in the development of PulseSelect, our organic PFA system," said Rebecca Seidel, president, Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. "Thanks to the innovation and expertise within Affera and the support of our Medtronic team, together we're able to continue to evaluate new, best-in-class solutions and commercialize a full, comprehensive portfolio to help physicians treat patients around the world."

Affera, Inc. was acquired by Medtronic in August 2022. The Affera product portfolio is not currently approved or available for sale or commercial use.

About Medtronic 
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow @Medtronic on Twitter and LinkedIn. 

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. 

Contacts:
Allison Kyriagis	Ryan Weispfenning
Public Relations	Investor Relations
+1-612-750-6061	+1-763-505-4626

 

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SOURCE Medtronic plc

FAQ

What is the SPHERE Per-AF Trial by Medtronic?

The SPHERE Per-AF Trial is a pivotal study evaluating the Sphere-9 cardiac ablation catheter for treating persistent atrial fibrillation.

How many patients were enrolled in the SPHERE Per-AF Trial?

A total of 477 patients were enrolled in the SPHERE Per-AF Trial across 23 centers in the U.S. and Europe.

When did Medtronic complete enrollment in the SPHERE Per-AF Trial?

Medtronic completed enrollment in the SPHERE Per-AF Trial on December 5, 2022.

What technology does the Sphere-9 catheter include?

The Sphere-9 catheter combines pulsed field and radiofrequency ablation capabilities with high-density mapping through the Affera system.

What are the next steps following the SPHERE Per-AF Trial?

Patients enrolled in the trial will be assessed for 12 months to determine the safety and efficacy of the Sphere-9 catheter.