TORONTO – Kardium Inc. has secured US$115 million in private money to accelerate commercial growth in Europe of a mapping and ablation system for atrial fibrillation (AF), and conduct a clinical study for FDA approval of the system. Led by Fidelity Management & Research Co. LLC, this funding tranche follows a US$40 million investment in Kardium in 2018 driven by T. Rowe Price Associates Inc., which also invested this time around.
Medtronic plc received U.S. FDA premarket approval of its Diamondtemp Ablation (DTA) system for treatment of patients with recurrent, symptomatic paroxysmal atrial fibrillation. The temperature-controlled radiofrequency (RF) ablation system features industrial-grade diamonds, which provide 200 to 400 times the thermal conductivity seen in conventional ablation and enable more efficient delivery of energy to regions of the heart responsible for the erratic electrical signals underlying atrial fibrillation (AF).
Using Rhythm AI Ltd.'s stochastic trajectory analysis of ranked signals (STAR) mapping system with pulmonary vein isolation terminated and eliminated recurrence of persistent atrial fibrillation (AF) at much higher rates than other ablation procedures in a study published in the Journal of Cardiovascular Electrophysiology. The artificial intelligence-driven STAR mapping process collects and analyzes thousands of heart signals to precisely identify the areas of the heart responsible for the errant electrical signals causing atrial fibrillation, enabling more thorough and accurate ablation.
TORONTO – The 2-French Electrophysiology Catheter (2F) had its Canadian launch in mid-December at Toronto’s Sunnybrook Health Sciences Centre where electrophysiologist Benedict Glover used it to map the small, tortuous branches of the coronary sinus in a patient suffering from cardiac arrhythmia. Developed by Toronto-based Baylis Medical Inc., the 2F is expected to work in tandem with the company’s larger 6F catheter to help diagnose comparatively rare but complex heart arrhythmias.
Ablacon Inc. has revealed the close of a $30 million series B financing, with Zeus Health joining as new lead investor. The company intends to use the funds to advance its product portfolio and expand patient access to the Ablamap system, which has the CE mark.
The U.S. FDA cleared Alivecor Inc.'s Kardia AI V2 interpretive electrocardiogram (ECG) algorithm for use in its personal ECG app and devices. Currently, the Kardia line permits consumers to take a 30-second medical grade ECG at home and instantly see whether they are exhibiting symptoms of atrial fibrillation, bradycardia, tachycardia or have normal heart rhythm.
Medtronic plc's cryoablation could soon put drug therapy on ice in parts of the atrial fibrillation (AF) market, based on results of studies published in the New England Journal of Medicine (NEJM) and presented at the American Heart Association Scientific Sessions 2020.
Adagio Medical Inc., a company focused on the treatment of atrial fibrillation (AF) and ventricular tachycardia (VT), has scooped up $42.5 million in a series E equity financing. The funds are earmarked for the ongoing IDE trial of its intelligent Continuous Lesion Ablation System (iCLAS). They will also be used to accelerate the European VT CE mark study, advance the commercialization of iCLAS in CE-mark countries and further development and clinical validation of its pulsed field cryoablation technology.
San Carlos, Calif.-based Galaxy Medical Inc., which has developed pulsed electric field (PEF) technology for the treatment of cardiac arrhythmias, revealed the first treatments in the ECLIPSE-AF study, which is evaluating the Centauri system. The trial will assess the safety and efficacy of the Centauri as the company looks forward to obtaining a CE mark.
Biosense Webster Inc. reported U.S. FDA approval of its Thermocool Smarttouch SF ablation catheter for the treatment of patients with persistent atrial fibrillation (persistent AF). This follows results of the prospective, multicenter Precept study, which showed the catheter to be safe and effective for 80% of patients over 15 months of ablation therapy with clinically meaningful improvement in quality of life.
