Workflow
Cardiac arrhythmia treatment
icon
Search documents
Adagio Medical to Participate at the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference
Businesswire· 2026-02-02 13:05
Core Insights - Adagio Medical Holdings, Inc. is participating in the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on February 10, 2026, in Snowbird, UT [1] - The company specializes in catheter ablation technologies for treating cardiac arrhythmias, focusing on its proprietary Ultra-Low Temperature Cardiac (ULTA) ablation technology [1] - Adagio's vCLAS™ Cryoablation System is currently under evaluation in the FULCRUM-VT U.S. Pivotal IDE Trial, which has fully enrolled 209 patients [1] - The results from the FULCRUM-VT trial will be used to apply for FDA premarket approval for the vCLAS™ Cryoablation System [1] - The vCLAS™ Cryoablation System is commercially available in Europe and select other regions but is limited to investigational use in the U.S. [1] Recent Business Highlights - Adagio Medical closed a private placement on October 20, 2025, with gross proceeds of up to $50 million, led by healthcare-dedicated institutional investors [1]
Adagio Medical to Present at the Small Cap Growth Virtual Investor Conference February 5th
Globenewswire· 2026-01-30 13:35
Company Overview - Adagio Medical Holdings, Inc. is a medical device company based in Laguna Hills, California, specializing in catheter ablation technologies for treating cardiac arrhythmias [4] - The company focuses on developing and commercializing its proprietary Ultra-Low Temperature Cardiac (ULTA) ablation technology, which aims to create large, durable lesions in both diseased and healthy cardiac tissue [4] Recent Developments - The company will present live at the Small Cap Growth Virtual Investor Conference on February 5, 2026, allowing real-time interaction with investors [1] - Adagio has appointed Sean Salmon, a former Senior Executive from Medtronic, to its Board of Directors [8] - The company closed financing of up to $50 million, led by existing and new healthcare-dedicated institutional investors [8] Clinical Trials - Adagio's vCLAS™ Cryoablation System is currently under evaluation in the FULCRUM-VT U.S. Pivotal IDE Trial, which has fully enrolled 209 patients with structural heart disease [5] - The FULCRUM-VT trial aims to assess the feasibility of ultra-low temperature cryoablation for recurring monomorphic ventricular tachycardia and will be used to apply for FDA premarket approval [5] - Preliminary results from the FULCRUM-VT study indicate a 97% acute effectiveness rate and favorable safety profile [8] Product Availability - The vCLAS™ Cryoablation System is commercially available for treating monomorphic ventricular tachycardia in Europe and select other regions, but is limited to investigational use in the United States [5]
Catheter Precision (VTAK) Announces Expansion of LockeT into an Eighth European Country Since Receipt of CE Mark
Globenewswire· 2025-12-18 13:00
Core Viewpoint - Catheter Precision, Inc. has secured its first purchase order and a multi-year commitment for its LockeT device at Mater Private Hospital, Ireland's largest electrophysiology center, marking a significant step in the company's global expansion strategy and commitment to enhancing cardiac care safety and efficiency [1][4]. Group 1: Company Overview - Catheter Precision is a U.S.-based medical device company focused on developing innovative solutions for cardiac arrhythmias, emphasizing collaboration with physicians to advance electrophysiology procedures [6]. - The LockeT device is a suture retention device designed to assist in wound closure after percutaneous venous punctures, classified as a Class 1 device registered with the FDA and has received CE Mark approval [5]. Group 2: Product Implementation - The implementation of LockeT at Mater Private Hospital involved a rapid onboarding process, with the chief nurse training 52 staff members in just two days, highlighting the device's intuitive design and operational efficiency [3]. - Mater Private Hospital performs over 1,000 electrophysiology procedures annually, making it a crucial institution for arrhythmia treatment and innovation in Europe [2]. Group 3: Strategic Importance - The partnership with Mater Private Dublin is viewed as a major achievement for Catheter Precision, validating the technology and strengthening its position in the global electrophysiology market [4]. - The acceptance of LockeT at this hospital underscores the company's focus on expanding its international market presence and promoting technologies that enhance clinical outcomes [4].
Adagio Medical Unveils Preliminary Acute Results from FULCRUM-VT U.S. Pivotal Study in Late Breaking Session at VT Symposium
Businesswire· 2025-10-10 19:40
Core Insights - Adagio Medical Holdings, Inc. announced preliminary results from the FULCRUM-VT Study, demonstrating 97.4% acute clinical success in treating Sustained Monomorphic Ventricular Tachycardia (SMVT) using their proprietary Ultra-Low Temperature Cryoablation (ULTC) technology [1][2][5] Study Overview - The FULCRUM-VT Study involved 207 patients across 19 sites in the U.S. and Canada, focusing on both ischemic and non-ischemic cardiomyopathy [2][8] - The study reported a mean procedure duration of 206 minutes and a 2.5% rate of major adverse events, including four peri-procedural deaths [2][4] Efficacy and Safety Results - Acute clinical success was defined as the non-inducibility of target ventricular arrhythmias, achieved in 97.4% of cases, with 96.7% of patients having all clinically relevant ventricular tachycardias eliminated [2][4] - The safety profile of the ULTC system was deemed favorable, with a low rate of major adverse events [4][5] Future Outlook - The company plans to present six-month primary efficacy endpoint results at the Heart Rhythm 2026 conference, indicating ongoing commitment to research and development [4][5] - The FULCRUM-VT Study aims to support FDA premarket approval for the vCLAS™ Cryoablation System, potentially leading to broader indications for treating scar-mediated VT [8][9]
Catheter Precision Announces First Procedures in France as LockeT Expansion Continues
GlobeNewswire News Room· 2025-08-28 12:00
Core Insights - Catheter Precision, Inc. has successfully completed the first LockeT procedures in France, marking a significant step in the adoption of its cardiac electrophysiology technologies in Europe [1][2] - The procedures were conducted at CHU Rennes, which is also a commercial partner for the company's VIVO product line [2] - The LockeT device is designed to improve procedural efficiency and patient outcomes following cardiac ablation procedures, indicating a strong market need in Europe [3] Product Information - LockeT is a suture retention device aimed at assisting in wound closure after percutaneous venous punctures, classified as a Class 1 device with FDA registration and CE Mark approval [4] - VIVO (View Into Ventricular Onset) is a non-invasive 3D imaging system that helps identify the origin of ventricular arrhythmias before procedures, thus streamlining workflow and reducing procedure time; it has also received FDA marketing clearance and CE Mark [5] Company Overview - Catheter Precision is a U.S.-based medical device company focused on developing innovative solutions for the treatment of cardiac arrhythmias, emphasizing collaboration with physicians and continuous product advancement [6]
Catheter Precision, Inc. Announces First Purchase Order From University Hospital in Rennes, France
Globenewswire· 2025-07-07 12:00
Group 1 - Catheter Precision, Inc. has received its largest purchase order to date from Centre Hospitalier Universitaire (CHU) de Rennes for its VIVO product line [1] - CHU Rennes serves nearly 500,000 patients annually and is recognized for its mission in teaching, research, and innovation [2] - The hospital performs over 150 ventricular ablations (VA) per year, positioning it as one of the largest centers for this procedure in Europe [3] Group 2 - The VIVO system is a non-invasive 3D imaging technology that helps physicians identify the origin of ventricular arrhythmias before procedures, enhancing workflow and reducing procedure time [4] - Catheter Precision focuses on developing innovative solutions for cardiac arrhythmias and collaborates with physicians to advance its product offerings [5]