Cara Medical has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the CARA system, a computed tomography angiography (CTA)-based platform that provides non-invasive, patient-specific three-dimensional (3D) visualisation of the cardiac conduction system.
The CARA system, which received FDA breakthrough device designation last year, enables visualisation of the location of the cardiac conduction system relative to surrounding cardiac structures during structural heart and pacing procedures.
The system is intended for the preplanning and guidance of medical interventions in areas known to contain or be adjacent to the cardiac conduction system. These include percutaneous or surgical procedures such as transcatheter aortic valve implantation (TAVI), as well as procedures in which physicians seek to deliver therapy to the patient’s cardiac conduction system or to a targeted location within it, including conduction system pacing (CSP).
The CARA system integrates two core components—the CARA Metis Simulator and CARA Atlas Navigator. The CARA Metis Simulator is a preprocedural planning software that utilises CTA-based anatomical landmarks to identify the cardiac conduction axis and generate a personalised 3D map of the patient’s cardiac conduction system. CARA Atlas Navigator is an intraprocedural guidance platform that overlays the patient-specific conduction system model generated by the Metis onto live fluoroscopic images to assist physicians during image-guided interventions.
“This FDA clearance represents a significant milestone for Cara Medical,” said Shlomo Ben-Haim, MD, founder and chairman of Cara Medical. “We look forward to launching the product in the USA and providing physicians with a validated tool designed to enhance visualisation of the cardiac conduction axis. Our growing body of clinical publications highlights Cara’s potential role in supporting procedural precision during TAVI and other valve interventions, and in facilitating physiologic lead targeting during conduction system pacing.”
The CARA system operates on a standard workstation platform, integrates with existing fluoroscopy systems, and does not have direct patient contact. The system utilises advanced image processing and artificial intelligence (AI)/machine learning (ML)-based algorithms to support CT segmentation, fluoroscopic metadata extraction, and catheter detection, with all outputs subject to physician review and confirmation.
Cara Medical expects to begin its US commercial launch in the coming months.
