IRELAND – Medtronic has completed its US$1 billion acquisition of cardiac mapping and ablation technology developer Affera, a medtech company based in Newton, Massachusetts.

The transaction expands the company’s cardiac ablation portfolio to include its first-ever cardiac mapping and navigation platform that encompasses a differentiated, fully-integrated diagnostic, focal pulsed field, and radiofrequency ablation solution.

In January, Medtronic announced an agreement to acquire Affera, with CEO Geoff Martha labeling the deal as a nearly US$1 billion transaction at the J.P. Morgan Healthcare Conference, adding that it includes a US$250 million contingent consideration.

The company had been a strategic investor in Affera through its minority investment portfolio. Prior to the acquisition, Medtronic held a 3% stake in the company.

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.

The Affera suite of solutions and technologies will complement the existing Medtronic atrial and ventricular arrhythmia disease management portfolio and support the company’s efforts to offer differentiated, safe and effective cardiac ablation solutions.

The company also has pipeline products like 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,

The Affera suite of solutions and technologies will complement the existing Medtronic atrial and ventricular arrhythmia disease management portfolio and support the company’s efforts to offer differentiated, safe and effective cardiac ablation solutions.

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.

In December 2021, Affera announced the commencement of the recently approved SPHERE Per-AF Trial, a US Food and Drug Administration Investigational Device Exemption pivotal randomized 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.

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