*CARA Medical’s products are Investigational Devices and are limited by law to investigational use.
Our technology aims to improve outcomes in cardiac procedures requiring precise knowledge of the conduction pathway. Particularly in the rapidly expanding fields of conduction system pacing and various structural valve interventions including Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Mitral Valve Replacement (TMVR) and Transcatheter Tricuspid Valve Replacement (TTVR) procedures.
Market Impact
Over 2 million procedures annually will benefit from conduction system localization.
Conduction system pacing is gaining popularity as a preferred pacing method in the U.S.
TAVR procedures are increasing as a broader group of patients becomes eligible due to expanding low risk indications.
Solution
Our solution provides clinicians with non-invasive, patient-specific insights into the conduction system’s location within the heart’s 3D structure.
CARA Metis simulation of the conduction pathway relative to various cardiac structures.
Our solution is based on methodical translational studies investigating the three-dimensional location of the conduction system relative to cardiac structures visible on clinical imaging and validated in clinical studies. This information helps reduce procedural risk and supports:
A.
Visibility of the conduction system to optimize lead placement andprevent damage during procedures
— CARA Metis simulation for Left Anterior Fascicular Pacing (LAFP)
— CARA Metis simulation for Left Septal Fascicle Pacing (LSFP)
— CARA Metis simulation of the conduction path relative to the aortic valve annulus
— CARA Metis simulation of the conduction path relative to the tricuspid valve annulus
B.
Precise guidance for heart failure pacing interventions and information on the location and accessibility of a patient’s conduction system
— CARA Atlas navigation for TAVR
— CARA Atlas navigation for Pacing
Products
Our products address the critical need for patient specific knowledge of the conduction system’s location for successful procedure planning and execution
01.
CARA Metis™
Our Metis software uses CT angiography to identify anatomical landmarks and provide a personalized, visual representation of the conduction system. The software also supports 3D segmentation and landmark setting, allowing clinicians to simulate the cardiac conduction system’s exact location.
02.
CARA Atlas™
Designed for real-time use, the Atlas provides 3D visualization of the conduction system during procedures, showing the relationship between tools and the patient’s conduction pathway. The system captures real-time fluoroscopic and electrophysiological data and integrates it with the CT angiography based 3D conduction system mapping.
Clinical Experience
Over 2,000 patient CTs analyzed
Studies:
Completed TAVR observational study
Cara CDRS (Conduction Disturbance Risk Score) 1.0 (CDRS)
Cara CDRM (Conduction Disturbance Risk Monitor) 2.0 (Cara CDRM)
Ongoing TAVR Single Center Study; Retrospective
Ongoing TTVR Single Center Study; Retrospective
Ongoing CARA Imaging Correspondence with Post Procedure CTA of CSP procedures; Multicenter, Retrospective
Ongoing CARA Conduction System Imaging for CSP – Multicenter, Retrospective
Ongoing CARA Retrospective Atlas CSP Study – Multicenter
Ongoing CARA Prospective Atlas CSP Study – Multicenter
Ongoing CARA Imaging Correspondence with Electro-anatomical Mapping Study; Single Center
Ongoing CARA Conduction System Imaging for TAVR – Multicenter, Prospective
Clinical Collaborators
Scientific Meetings
Heart Rhythm 2025
April 24-27, 2025
— San Diego Convention Center, San Diego, CA.
Technology and Heart Failure Therapeutics (THT) 2025
February 11-13, 2025
— Omni Boston Hotel at The Seaport, Boston, MA.
19th Annual International Symposium on Ventricular Arrhythmias
October 11-12, 2024
— New York Marriott at the Brooklyn Bridge
8th Annual International Physiology of Pacing Symposium
October 25, 2024
— Crystal Gateway Marriot, Arlington, Virginia
Publications
Electrophysiological characteristics and clinical outcomes of truncal, fascicular and left ventricular septal pacing in patients receiving left bundle branch area pacing.
Shunmuga Sundaram Ponnusamy, Shlomo Ben Haim, Justin Tretter, Kenneth A Ellenbogen, Pugazhendhi Vijayaraman. Accepted LBCT THT 2025
A new dimension in cardiac imaging: Three-dimensional exploration of the atrioventricular conduction axis with hierarchical phase-contrast tomography. Heart Rhythm, 2024.
Justin T. Tretter, Jayanthi N. Koneru, Diane E. Spicer, Kenneth A. Ellenbogen, Robert H. Anderson, Shlomo Ben Haim
Novel cardiac CT method for identifying the atrioventricular conduction axis by anatomic landmarks. Heart Rhythm, 2025
Justin T. Tretter, Francisco Bedogni, Josep Rodes-Cabau, Ander Regueiro, Luca Testa, Mackram F. Eleid, Shmuel Chen, Attilio Galhardo, Kenneth A. Ellenbogen, Martin B. Leon, Shlomo Ben-Haim.
