Boston Scientific to Acquire AFib Ablation Company Cortex

Boston Scientific Corporation (Marlborough, MA, USA) has entered into a definitive agreement to acquire Cortex, Inc. (Santa Clara, CA, USA), the developer of a diagnostic mapping solution designed to identify triggers and drivers outside the pulmonary veins that contribute to atrial fibrillation (AF). The acquisition is expected to be completed in the first half of 2025, subject to customary closing conditions.

Cardiac ablation is a widely used treatment for AF, a heart rhythm disorder that affects nearly 38 million individuals worldwide. This procedure involves delivering energy to specific areas of the heart that generate abnormal rhythms. During ablation, physicians typically utilize a mapping system to analyze the heart's electrical activity, guiding therapeutic interventions. Cortex has developed the OptiMap System, which employs a basket catheter along with a proprietary algorithm to detect potential active AF sources, offering physicians detailed insights for formulating personalized ablation strategies for their patients.

In 2023, Cortex received 510(k) clearance from the U.S. Food and Drug Administration for the OptiMap System and recently completed the FLOW-AF clinical trial, which demonstrated that OptiMap-guided treatment of AF sources in patients with persistent AF resulted in a 51% improvement in freedom from AF one year after ablation compared to those who underwent traditional pulmonary vein isolation therapy alone. Earlier this year, the company launched a global clinical trial called RESOLVE-AF, which aims to evaluate the effectiveness of the OptiMap System in identifying sources beyond the pulmonary veins in a cohort of 300 patients.

"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. 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."

"Cortex was established to provide physicians with a more intelligent and precise solution for patients with AF," added 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."

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