Boston Sci Indulges in a Little M&A for PFA

There have been numerous developments in the pulsed-field ablation market throughout these last few weeks.

Those developments range from approvals to paused trials. Now Boston Scientific is adding another layer – M&A.

The Marlborough, MA-based firm said it has agreed to acquire Cortex, an Ajax Health company. The deal is for an undisclosed sum and is set to be completed in the first half of 2025.

Cortex is focused on the development of a diagnostic mapping solution that could identify triggers and drivers outside of the pulmonary veins that are foundational to atrial fibrillation (Afib).

The Menlo Park, CA-based company has developed the OptiMap system, which uses a basket catheter and algorithm to identify potential active Afib sources. The device received FDA clearance in 2023.

Cortex recently completed the controlled FLOW-AF clinical trial with data demonstrating that OptiMap-guided treatment of Afib sources in patients with persistent Afib improved freedom from Afib one year after ablation by 51% compared with patients who received conventional pulmonary vein isolation therapy alone. Earlier this year, Cortex initiated a 300-patient, global clinical trial, RESOLVE-AF, evaluating the effectiveness of the OptiMap System in identifying extra-pulmonary vein sources.  

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"We believe the addition of the Cortex technology complements our electrophysiology portfolio with a differentiated cardiac mapping offering to assist with complex Afib cases," said Nick Spadea-Anello, global president, Electrophysiology, Boston Scientific. "The OptiMap System has demonstrated it can help physicians devise a targeted ablation strategy for complex cases, which can lead to improved procedural efficiency and outcomes in patients with challenging atrial arrhythmias. We look forward to advancing this technology and driving future clinical evidence generation with the goal of making it accessible to physicians and patients globally in the years ahead." 

The deal comes on the heels of Boston Scientific winning FDA approval for the Farawave Nav Ablation Catheter, which provides visualization for Farpapulse procedures. It also comes a few days after Boston Scientific paused the AVANT GUARD Trial, which Is looking at how the Farapulse PFA could treat a new patient population of drug-naïve persistent Afib patients.

The company paused AVANT GUARD because of unanticipated observations in the study.