CoreMap Receives FDA IDE Approval to Expand Novel Atrial Fibrillation Mapping Technology Study to U.S.
核心洞察
CoreMap (搜索) has received FDA Investigational Device Exemption approval to extend its INvENI clinical study to the U.S., evaluating its proprietary electrophysiology mapping system in persistent atrial fibrillation (搜索) patients.
The company's ultra-high resolution mapping technology has demonstrated safety and acute effectiveness in over 50 patients, with the ability to identify AF driver regions not detectable by prior mapping methods.
The INvENI study is a multi-phase randomized controlled trial comparing CoreMap (搜索)-guided ablation plus pulmonary vein isolation against standard-of-care treatment in persistent AF patients.
CoreMap (搜索) announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (搜索) to extend its INvENI clinical study into the United States. The study is designed to evaluate the safety and effectiveness of the proprietary CoreMap™ Endocardial Electrophysiology (EP) Mapping System in patients with persistent atrial fibrillation (搜索) and long-standing persistent AF (搜索). To date, CoreMap has demonstrated safety and acute effectiveness of its EP Mapping system in over 50 patients.
Revolutionary Mapping Technology Addresses Current Limitations
The CoreMap (搜索) EP Mapping System represents a next-generation electrophysiology platform intended to guide patient-specific AF ablation using ultra-high resolution endocardial mapping. The system can record hundreds of thousands of electrical activations during a single AF map, addressing current limitations in AF mapping including low spatial resolution and inadequate signal density.
The CoreMap (搜索) Invenio™ EP Mapping Catheter features a dense array of micro-scale electrodes capable of capturing highly localized, high-fidelity electrograms with minimal fractionation. This patented breakthrough catheter design enables the use of novel algorithms to identify drivers of AF and support precise, targeted ablation strategies.
Dr. Vivek Reddy, the Helmsley Trust Professor of Medicine at the Icahn School of Medicine at Mount Sinai and Principal Investigator of the US IDE, commented: "CoreMap (搜索)'s novel AF mapping catheter and signal processing algorithms are able to identify AF driver regions not discernible in prior AF mapping attempts. I believe strongly that ablation strategies based on patient-specific electrical activation patterns, rather than a blind anatomic approach, will improve outcomes for patients with AF. I am excited to begin enrolling patients in the U.S."
Clinical Evidence and Compassionate Use Experience
Earlier this month at a renowned New York City hospital, the company conducted Compassionate Use cases guiding pulsed field ablation in patients with recurrent AF that had been unresponsive to multiple prior mapping and ablation procedures using commercially available technology.
Multi-Phase INvENI Study Design
The INvENI study is a multi-phase, multi-center clinical trial that began enrollment in July 2024 at Na Homolce Hospital (搜索) in the Czech Republic under Principal Investigator Professor Petr Neuzil. Phase 1 of the study assessed acute safety in 14 patients, while Phase 2 demonstrated acute safety and effectiveness in 15 patients receiving CoreMap (搜索)-guided tailored ablation.
Phase 3 represents a randomized controlled study evaluating the effectiveness of CoreMap (搜索)-guided ablation in de novo persistent AF patients. The treatment group will undergo pulmonary vein isolation (PVI) plus CoreMap-guided ablation targeting AF drivers, while the control group will receive standard-of-care PVI and Posterior Wall Isolation (PWI). Patients will be followed for 12 months to assess freedom from AF, atrial tachycardia (搜索), and atrial flutter (搜索) recurrence.
Company Background and Mission
CoreMap (搜索)'s cofounders Dr. Peter Spector, a clinical electrophysiologist, and CEO Sarah Kalil, an industry veteran, founded the company to improve outcomes for the millions of people affected by AF. The company's micro-electrode technology and novel algorithms specifically address today's limitations in AF mapping.
"This IDE approval marks a major milestone for CoreMap (搜索) as we expand our clinical research into the U.S.," said Sarah Kalil, CEO and Co-founder of CoreMap. "We are encouraged by our clinical data as we seek to transform treatment for AF patients globally and look forward to building on the strong safety and effectiveness data already demonstrated in Europe."