Medtronic has announced that it has completed the acquisition of Affera. The acquisition will expand Medtronic’s cardiac ablation portfolio to include its first cardiac mapping and navigation platform.
Among Affera’s offerings is the Affera Prism-1 cardiac mapping and navigation platform, which will be compatible with Medtronic and multiple, competitive therapeutic catheters and technologies. Medtronic 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.
“This acquisition marks an important growth milestone for our cardiac ablation portfolio,” said Rebecca Seidel, president of the Cardiac Ablation Solutions (CAS) business, which is part of the Cardiovascular Portfolio at Medtronic. “We are 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 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 differentiated, safe, and effective cardiac ablation solutions, Medtronic’s press release adds.
“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,” said Doron Harlev, founder and chief executive officer of Affera. “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 US Food and Drug Administration (FDA) investigational device exemption pivotal randomised trial, to evaluate the safety and effectiveness of the Affera system for the treatment of persistent atrial fibrillation (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.