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Medtronic, the Health Technology Company, Acquired Affera

Written by Stephen Vicinanza

Just a couple of weeks ago, Medtronic announced its acquisition of Affera, to expand its cardiac ablation portfolio to include first-ever cardiac mapping and navigation. A platform that encompasses a differentiated, fully integrated diagnostic, focal pulsed field, and radiofrequency ablation solution.

On Affera’s investigational side, the technology is designed to provide solutions for patients with cardiac arrhythmias (irregular heartbeat), like atrial fibrillation (AF). The gain for Medtronic is Affera’s Prism-1 cardiac mapping and navigation platform. This technology will be compatible with Medtronic’s, and multiple competitive therapeutic catheters and technologies.

Affera had just added the Sphere-9 cardiac diagnostic and ablation catheter that enables rapid creation of detailed electro-anatomical mapping. It also delivers radio frequency (RF) and pulsed-field (PF) cardiac ablation therapies. In the Affera pipeline are the Arc-10 coronary sinus (CS) diagnostic catheter and Sphere PVI ablation catheter, which is a single shot device that delivers pulsed field ablation (PFA) energy, which is also included.

Sphere 9 Cardiac Diagnostic and Ablation Catheter

“The Affera team is very excited to be joining Medtronic Cardia Ablation Solutions. The acquisition enhances and accelerates our ability to treat millions of patients around the world suffering from cardiac arrhythmia with our innovative technology.” Said Doron Harlev, founder and chief executive officer of Affera.

He went on in the statement, “Our team designed the Affera platform with physicians and patients in mind to advance the field of electrophysiology while supporting safe and efficient cardiac ablation procedures.”

Affera’s portfolio in the Sphere Per-AF trial, by the U.S. Food and Drug Administration Investigational Device Exemption pivotal randomized trial, to evaluate safety and effectiveness for the treatment of persistent AF, is not yet approved for commercial sale or use.

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Consistent with the financial impact disclosed in January 2022 when the transaction with Affera was announced, Medtronic expects the total transaction to be less than 1% dilutive to Medtronic’s adjusted earns. This would be per share in of the first three years, and neutral to accretive thereafter. The company continues to expect dilution of approximately 5 cents in both years 1 and 2 and approximately 3 cents in year 3. The total dilution for this transaction given the announcement date would be 3 to 4 cents in the fiscal year 2023, about 5 cents in fiscal 2024, and 4 cents in the fiscal year 2025.

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For the past 8 years, I have been writing about embedded technologies, added to my technical, academic, and medical editorial experience, with companies like Elsevier and Cambridge University Press. I tell people to read what I write, not try to pronounce my last name. I am always available for comments and suggestions you can reach me at product-editor@circuitcellar.com and I promise I will take the time to reach back out to you. I live in the North East with my wonderful family.

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Medtronic, the Health Technology Company, Acquired Affera

by Stephen Vicinanza time to read: 2 min