Boston Scientific Corporation has entered into a definitive agreement to acquire Cortex, Inc., an Ajax Health company. The transaction is expected to be completed in the first half of 2025. 

Cortex is a privately held medical technology company focused on the development of a diagnostic mapping solution that may identify triggers and drivers outside of the pulmonary veins that are foundational to atrial fibrillation (AF).

“We believe the addition of the Cortex technology complements our electrophysiology portfolio with a differentiated cardiac mapping offering to assist with complex AF 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.² 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 OptiMap System developed by Cortex uses a basket catheter and proprietary algorithm to identify potential active AF sources, providing physicians with precise insights to efficiently deliver an individualized ablation strategy for their patients. 

The OptiMap System received 510(k) clearance from the FDA in 2023 and recently completed a randomized, controlled FLOW-AF clinical trial. Data demonstrated that OptiMap-guided treatment of AF sources in patients with persistent AF improved freedom from AF one year after ablation by 51% compared with patients who received conventional pulmonary vein isolation therapy alone. 

Earlier this year, the company initiated a 300-patient, global clinical trial, RESOLVE-AF, evaluating the effectiveness of the OptiMap System in identifying extra-pulmonary vein sources.  

“Cortex was established to provide physicians with a more intelligent and precise solution for patients with AF,” said Duke Rohlen, chief executive officer, Cortex. “Joining Boston Scientific will allow us to further develop this technology, which we believe has the ability to transform the treatment of AF for patients around the world.” 

References:

²Reddy VY, Langbein A, Petru J, Szili-Torok T, Funasako M, Dinshaw L, Wijchers S, Rillig A, Spitzer SG, Bhagwandien R, Metzner A, Kong MH, Neuzil P. A Randomized Trial of Electrographic Flow-Guided Redo Ablation for Nonparoxysmal Atrial Fibrillation (FLOW-AF). JACC Clin Electrophysiol. 2024 Aug;10(8):1856-1869. doi: 10.1016/j.jacep.2024.03.040. Epub 2024 Jun 5. PMID: 38842972.