Summary: Boston Scientific will acquire Cortex, Inc, integrating its OptiMap cardiac mapping technology for enhanced AF treatment. The OptiMap System aims to improve ablation strategies, supported by clinical trials demonstrating its efficacy in treating persistent AF cases.

Key Takeaways:

  • The acquisition expands Boston Scientific’s cardiac mapping capabilities, aiding AF treatment with the FDA-cleared OptiMap System.
  • Clinical trials show OptiMap-guided ablation improves AF outcomes, marking potential advancements in patient care and procedural efficiency.

Boston Scientific Corporation announced it has entered into a definitive agreement to acquire Cortex, Inc, an Ajax Health company. Cortex is a privately held medical technology company focused on the development of a diagnostic mapping solution which may identify triggers and drivers outside of the pulmonary veins that are foundational to atrial fibrillation (AF).

Boston Scientific expects to complete the transaction in the first half of 2025, subject to closing conditions. Specific terms of the transaction have not been disclosed.

Cortex’s OptiMap System and Cardiac Ablation in AF Treatment

Cardiac ablation – the process of delivering energy to areas of the heart responsible for creating abnormal heart rhythms – is a common treatment for AF. During these procedures, physicians often use a mapping system to examine and analyze a heart’s electrical patterns to guide therapeutic applications. 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.

“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.”

FDA Clearance and Clinical Trials

Cortex received U.S. Food and Drug Administration 510(k) clearance for the OptiMap System in 2023 and recently completed the randomized, controlled FLOW-AF clinical trial with data demonstrating that OptiMap-guided treatment of AF sources in patients with persistent AF improved freedom from AF one year after an 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.”