Medtronic to acquire cardiac arrhythmia devicemaker for $925M

MedTech News: Medtronic announced plans to acquire a privately held medical technology company that designs and manufactures cardiac mapping and navigation systems and catheter-based cardiac ablation technologies for the treatment of patients with cardiac arrhythmias such as atrial fibrillation (AF).

The strategic deal to acquire Affera expands Medtronic portfolio of advanced cardiac ablation products to meet clinician needs within a growing patient population.

“The EP ablation market is an exciting and fast-moving segment of cardiology,” said Rebecca Seidel, president of the Cardiac Ablation Solutions (CAS) business, which is part of the Cardiovascular Portfolio at Medtronic. “Bringing Affera into our organisation, with our established footprint in the cardiac ablation space, will strengthen our ability to provide innovative therapies and enable Medtronic entry into additional EP technology segments, such as mapping and navigation, for the first time.”

Affera’s technologies include the Affera Prism-1™ cardiac mapping and navigation platform and Sphere-9™ cardiac ablation catheter, investigational technologies designed to enable the rapid creation of detailed maps used by electrophysiologists (EP) to diagnose arrhythmias and deliver cardiac ablation therapy, respectively.

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“Affera offers technologies that support physician customers as they work to improve clinical workflows, procedural efficiencies, and ultimately optimise patient care,” said Dr Stacy Beske, vice president of strategy, CAS.

Within the $8 billion worldwide EP ablation market, the prevalence of cardiac arrhythmias is growing rapidly, and the need to provide treatment to the increasing patient population, which encompasses AF, supraventricular tachycardia (SVT), and ventricular tachycardia (VT), is increasing. AF represents the largest disease segment, with nearly 60 million people affected worldwide.

“This is an exciting day for patients who suffer from the burden of AF and other arrhythmias. This acquisition directly aligns with our vision of delivering novel solutions to address the rapidly growing demands for cardiac arrhythmia treatment,” said Doron Harlev, founder and chief executive officer of Affera. “We are excited to focus on the integration of our technology with Medtronic and are confident that together we can increase patient access to ablation therapies.”

In December 2021, Affera announced the commencement of the recently approved SPHERE PerAF Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal randomised trial, to evaluate the safety and effectiveness of the Affera system for the treatment of persistent AF. Affera’s product portfolio is not currently approved or available for sale or commercial use.

The buyout caps off the existing relationship between Medtronic and Affera as Medtronic is already a strategic investor in Affera, with a 3% ownership stake. The transaction is expected to close in the first half of Medtronic’s 2023 fiscal year, which begins May 1.