Medtronic to acquire Affera

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MedtronicMedtronic has announced that it has entered into an agreement to acquire medical technology company Affera.

Affera designs and manufactures cardiac mapping and navigation systems and catheter-based cardiac ablation technologies, including a differentiated, focal pulsed field ablation (PFA) solution, for the treatment of patients with cardiac arrhythmias including atrial fibrillation (AF). Medtronic, through its minority investment portfolio, has been a strategic investor in Affera and currently holds a 3% ownership stake in the company.

The acquisition expands the Medtronic portfolio of advanced cardiac ablation products and accessories to meet physician needs within a growing patient population, the company said in a press release.

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 (EPs) to diagnose arrhythmias and deliver cardiac ablation therapy, respectively.

The Affera full-suite of solutions and technologies will complement the existing Medtronic atrial and ventricular arrhythmia disease management portfolio, the company’s press release adds.

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

“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 US 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.


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