The acquisition will complement Boston Scientific’s electrophysiology portfolio with an FDA-cleared solution to advance the treatment of complex atrial fibrillation.
Summary: Boston Scientific has announced plans to acquire Cortex Inc, developer of the FDA-cleared OptiMap System, which uses advanced mapping technology to guide cardiac ablation for complex atrial fibrillation cases. This acquisition is set to strengthen Boston Scientific’s electrophysiology portfolio, enabling more precise and targeted treatment of atrial fibrillation by identifying arrhythmia triggers outside the pulmonary veins. The OptiMap System, which has shown promising results in improving patient outcomes, will undergo further clinical trials under Boston Scientific to expand global accessibility and clinical evidence.
Key Takeaways:
- Enhanced AF Treatment Capabilities: The acquisition of Cortex’s OptiMap System will support Boston Scientific’s portfolio, allowing physicians to map complex atrial fibrillation sources for individualized ablation strategies.
- Clinical Validation of Effectiveness: OptiMap-guided treatment demonstrated a 51% improvement in freedom from atrial fibrillation one year post-ablation compared to conventional methods in the FLOW-AF trial.
- Future Global Expansion: Boston Scientific plans to advance clinical evidence and global access to OptiMap.
Boston Scientific Corp announced it has entered into a definitive agreement to acquire Cortex, Inc, a privately held medical technology company focused on developing a diagnostic mapping solution that may identify triggers and drivers outside of the pulmonary veins that are foundational to atrial fibrillation.
Cardiac ablation, the process of delivering energy to areas of the heart responsible for creating abnormal heart rhythms, is a common treatment for atrial fibrillation. 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, an Ajax Health company, uses a basket catheter and proprietary algorithm to identify potential active atrial fibrillation 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 [atrial fibrillation] cases,” says Nick Spadea-Anello, global president of electrophysiology at Boston Scientific, in a release. “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.”
Atrial Fibrillation Improvement With OptiMap
Cortex received US 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 atrial fibrillation sources in patients with persistent atrial fibrillation improved freedom from atrial fibrillation 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 [atrial fibrillation],” says Duke Rohlen, chief executive officer of Cortex, in a release. “Joining Boston Scientific will allow us to further develop this technology, which we believe has the ability to transform the treatment of [atrial fibrillation] for patients around the world.”
Boston Scientific expects to complete the transaction in the first half of 2025, subject to customary closing conditions. The transaction is expected to have an immaterial impact on adjusted earnings per share in 2025 and is expected to be slightly dilutive on a GAAP basis due to amortization expense and acquisition-related net charges. Specific terms of the transaction have not been disclosed.
Photo caption: OptiMap System
Photo credit: Boston Scientific
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