Medtronic plc (NYSE: MDT), a Dublin, Ireland-based global healthcare technology company, completed the acquisition of Affera, Inc., a Newton, MA-based medical technology company dedicated to delivering innovative solutions to address the demands for cardiac arrhythmia treatment.
This acquisition expands the company’s cardiac ablation portfolio to include its cardiac mapping and navigation platform that encompasses a differentiated, fully integrated diagnostic, focal pulsed field and radiofrequency ablation solution.
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.
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.
Led by Doron Harlev, founder and chief executive officer, Affera is a medical technology company dedicated to developing a comprehensive integrated platform to efficiently deliver durable therapy for a broad set of cardiac arrhythmia 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.
In December 2021, Affera announced the commencement of the recently approved SPHERE Per-AF Trial, a U.S. 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.
FinSMEs
30/08/2022