Medtronic has set its sights on acquiring Affera, a privately held maker of cardiac mapping and navigation systems and catheter-based cardiac ablation technologies, for $925 million.

While Medtronic did not disclose the price of the deal, analysts at Piper Sandler told the Star Tribune its value, which includes $250 million that's contingent upon Affera receiving FDA approval for its nascent technology.

Already an investor, Medtronic holds a 3% ownership stake in Affera. It expects that adding Affera to its family will enhance its portfolio of advanced cardiac ablation solutions and accessories.

Driving its decision is the growing prevalence of cardiac arrhythmias amidst an increasing patient population. The largest and increasingly most common form of the condition is atrial fibrillation, a progressive disease that affects nearly 60 million people worldwide and can cause patients over time to experience more frequent and longer episodes. This can lead to serious complications including heart failure, stroke and increased risk of death, with medication and catheter ablation becoming less effective.

Rebecca Seidel, president of the cardiac ablation solutions (CAS) business, which is part of the cardiovascular portfolio at Medtronic, said in a statement that the worldwide EP ablation market is now $8 billion as a result of the increasing number of cases. "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.”

Medtronic has already built up its presence in the market over the past year by obtaining FDA expanded approval for its Arctic Front family of cardiac cryoablation catheters for recurrent symptomatic paroxysmal atrial fibrillation, and FDA clearance for its two AccuRhythm AI algorithms for use with the LINQ II insertable cardiac monitor to better diagnose and treat abnormal heart rhythms.

Affrea’s catheter technologies are designed to generate detailed maps that guide doctors on where in the heart to apply focal pulsed-field and radiofrequency ablation. The catheters apply electrical or thermal energy to scar cardiac tissue, to block abnormal signals from moving through the heart. This helps treat AF as well as other irregular heartbeats including supraventricular tachycardia (SVT), and ventricular tachycardia (VT).

Affera brings to Medtronic its Affera Prism-1 cardiac mapping and navigation platform, the Arc-10 Linear coronary sinus catheter and the Sphere-9 cardiac ablation catheter, which offers both focal ablation therapy and HD mapping capabilities. The addition of these technologies is expected to bolster Medtronic’s atrial and ventricular arrhythmia disease management portfolio.

Affera also just closed a $75 million Series C financing round in December, according to the Star Tribune. That same month, it commenced its SPHERE PerAF Trial. The FDA investigational Device Exemption (IDE) pivotal randomized trial will evaluate the safety and effectiveness of the Affera system for the treatment of persistent AF.

“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.

Affera’s product portfolio is not currently approved or available for sale or commercial use.

The acquisition is expected to close in the first half of Medtronic’s fiscal year 2023, which begins May 1, according to the Star Tribune. The deal is subject to certain customary closing conditions. The transaction is expected to be less than 1% dilutive to Medtronic’s adjusted earnings per share in each of the first three years, and neutral to accretive thereafter.