Medtronic kicked off the week with news that it plans to strengthen its cardiac ablation buiness with the acquisition of Affera for an undisclosed sum. The deal also provides Medtronic with an entry into the cardiac mapping and navigation space.
Newton, MA-based Affera makes cardiac mapping and navigation systems and catheter-based cardiac ablation technologies, including a differentiated, focal pulsed field ablation solution, for the treatment of cardiac arrhythmias such as atrial fibrillation (AF). Medtronic is already a strategic investor in Affera and currently holds a 3% ownership stake in the company. The acquisition is expected to close in the first half of Medtronic's fiscal year 2023.
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. Medtronic says Affera's technologies will complement the existing Medtronic atrial and ventricular arrhythmia disease management portfolio and support the company’s efforts to offer simple, safe, and effective cardiac ablation solutions to improve patient outcomes.
“The EP ablation market is an exciting and fast-moving segment of cardiology,” said Rebecca Seidel, president of cardiac ablation solutions business, which is part of the cardiovascular portfolio at Medtronic. “Bringing Affera into our organization, 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.”
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, and ventricular tachycardia, is increasing, Medtronic noted. 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, Affera's founder and CEO. “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 launched SPHERE PerAF, a FDA investigational device exemption pivotal randomized trial, to evaluate the safety and effectiveness of the Affera system for the treatment of persistent AF.