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Adds mapping and navigation platform to the company's cardiac ablation portfolio.
August 30, 2022
By: Sam Brusco
Associate Editor
Medtronic has completed its acquisition of Affera, adding a cardiac navigation platform that includes a differentiated, fully integrated diagnostic, focal pulsed field (PF) and radiofrequency (RF) ablation solution to its cardiac ablation portfolio. Medtronic began the deal for Affera in January of this year. Affera’s investigational technology is intended as a solution for cardiac arrhythmia patients. Medtronic aims to make the Affera Prism-1 cardiac mapping and navigation tool compatible with its own therapeutic catheters as well as multiple competitive ones. Medtronic also gains the Sphere-9 cardiac diagnostic and ablation catheter for rapid creation of detailed electro-anatomical maps and delivers RF and PF cardiac ablation. Other products include the Arc-10 coronary sinus (CS) diagnostic catheter and Sphere PVI ablation catheter, a single-shot device for pulsed field ablation (PFA). “This acquisition marks an important growth milestone for our cardiac ablation portfolio,” Rebecca Seidel, president of Medtronic’s Cardiac Ablation Solutions (CAS) business, told the press. “We’re incredibly proud to have led the industry with the introduction of the proven safe and effective cryoablation technology; and now these new additions to our portfolio help support a leap forward in our commitment to build a comprehensive portfolio and help physicians achieve the best outcomes for patients.” Affera’s portfolio will complement Medtronic’s atrial and ventricular arrhythmia disease management portfolio. “The Affera team is very excited to be joining Medtronic Cardiac 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 CEO of Affera. “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.” In December 2021, Affera began itsrecently approved SPHERE Per-AF Trial, an FDA IDE pivotal randomized trial, to evaluate the safety and effectiveness of the Affera system for the treatment of persistent atrial fibrillation. As part of the closure, Medtronic will continue to support the SPHERE Per-AF Pivotal Trial.
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