Medtronic completes Affera acquisition

Medtronic has completed the acquisition of Affera. This acquisition expands the company's cardiac ablation portfolio to include its cardiac mapping and navigation platform.

The investigational Affera technology is designed to provide solutions for patients with cardiac arrhythmias (irregular heartbeats) such as atrial fibrillation (AF). Through this acquisition Medtronic gains the Affera Prism-1 cardiac mapping and navigation platform, which will be compatible with Medtronic and multiple, competitive therapeutic catheters and technologies. The company also adds the Sphere-9 cardiac diagnostic and ablation catheter that enables the rapid creation of detailed electro-anatomical maps and delivers radio frequency (RF) and pulsed field (PF) cardiac ablation therapies. Additional Affera pipeline products such as the Arc-10 coronary sinus (CS) diagnostic catheter and Sphere PVI ablation catheter, which is a single shot device which delivers pulsed field ablation (PFA) energy, are also included.

Rebecca Seidel, president of the Cardiac Ablation Solutions (CAS) business, which is part of the cardiovascular portfolio at Medtronic, said: "This acquisition marks an important growth milestone for our cardiac ablation portfolio. 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."

The Affera suite of solutions will complement the existing Medtronic atrial and ventricular arrhythmia disease management portfolio. Currently, the prevalence of cardiac arrhythmias including AF, supraventricular tachycardia (SVT), and ventricular tachycardia (VT), is increasing rapidly. AF represents the largest disease segment, with nearly 60 million people affected worldwide.

Doron Harlev, founder and chief executive officer of Affera, said: "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. 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 announced the commencement of the recently approved SPHERE Per-AF Trial, a U.S. Food and Drug Administration Investigational Device Exemption pivotal randomised trial, to evaluate the safety and effectiveness of the Affera system for the treatment of persistent AF. As part of the closure, Medtronic will continue to support the SPHERE Per-AF Pivotal Trial. Affera's product portfolio is not currently approved or available for sale or commercial use.