Medtronic has announced that it has entered into a definitive agreement to acquire Affera, Inc., a Boston area-based, privately held medical technology company. Affera designs and manufactures cardiac mapping and navigation systems and catheter-based cardiac ablation technologies, including a differentiated, focal pulsed field ablation solution, for the treatment of patients with cardiac arrhythmias (irregular heartbeats) such as 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. 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 (EP) 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 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 the Cardiac Ablation Solutions (CAS) 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.”
“Affera offers technologies that support physician customers as they work to improve clinical workflows, procedural efficiencies, and ultimately optimize patient care,” said Stacy Beske, Ph.D., vice president of strategy, CAS.
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 (SVT), and ventricular tachycardia (VT), is increasing. AF represents the largest disease segment, with nearly 60 million people affected worldwide1. AF is a progressive disease, meaning over time patients can experience more frequent, and longer episodes, and medication as well as catheter ablation can become less effective. Additionally, AF is associated with serious complications including heart failure, stroke, and increased risk of death.2-345
“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 U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal randomized 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.
1 Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
2 Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
3 Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
4 Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
5 Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126