Cathvision ApS received U.S. FDA clearance for two artificial intelligence (AI) models, the PVI Analyzer, and Signal Complexity, which are part of a suite of algorithms designed to help electrophysiologists improve the diagnosis and treatment of complex atrial arrhythmias, including atrial fibrillation. The two algorithms are part of Cathvision’s Cardialytics suite of AI-powered analytics integrated into its Ecgenius system, an electrophysiology recording system that helps with electrogram interpretation.
It's one thing to ablate a lesion to treat a cardiac arrhythmia “but you can’t ablate the right place if you don’t know where it is,” said Nikki Sidi, U.S. President ofBiosense Webster Inc. Sidi was commenting on the July 24 U.S. launch of the high-density diagnostic Optrell mapping catheter with Trueref technology powered by its Carto 3 software.
Pharmaceutical agents took center stage in Washington on the first full day of the 2022 scientific sessions of the American College of Cardiology, such as an April 2 presentation on the use of the mavacamten for obstructive hypertrophic cardiomyopathy (OHC). Milind Desai of the Cleveland Clinic said 16-week data for this cardiac myosin inhibitor showed well in reducing heart failure class status, but there are data arising from studies in China which suggest that radiofrequency (RF) ablation might also work for these patients.
Physicians occasionally go over the line where Medicare services are concerned, but the U.S. Department of Justice announced Sept. 15 that a cardiologist in Orlando, Fla., went farther than the ordinary illicit billing.
Robotic technologies company Stereotaxis Inc. is scaling up its footprint in the Chinese med-tech market, with a deal to commercialize its robotic technology for heart rhythm therapy in China with Shanghai Microport EP Medtech Co. Ltd. The St. Louis-based Stereotaxis aims to introduce a second-generation robot called Genesis to the Chinese market that uses a magnetic navigation technology to treat heart rhythm disorders. Its partner, Shanghai Microport EP Medtech, is a division of one of China's largest med-tech manufacturers, Shanghai-based Microport Scientific Corp.
Catheter ablation for atrial fibrillation has enjoyed an uneven reputation at best over the years, but the prospect of eliminating anti-arrhythmic drugs has proven difficult for both patients and clinicians to ignore. A new analysis of data from the Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) study seems to answer the cost effectiveness question for ablation, however, representing yet another piece of evidence that should support increased sales of these devices in the coming years.
Acutus Medical Inc. appears to have solved one of the more vexing problems in cardiology, the sheer persistence of persistent atrial fibrillation despite treatment. In a study recently published in Heart Rhythm, the Carlsbad, Calif.-based company demonstrated that 73% of patients undergoing ablation using the new pulmonary vein isolation plus core-to-boundary guided approach experienced acute termination of AF after one procedure, compared to 10% of patients undergoing ablation with the traditional posterior wall isolation approach.
Atricure Inc. has received the green light from the FDA for its Epi-Sense guided coagulation system with Visitrax technology to treat patients diagnosed with long-standing, persistent atrial fibrillation (AF). The device was previously cleared via a 510(k) for the coagulation of cardiac tissue, and is already available in the U.S. The FDA approval represents the first and only minimally invasive ablation therapy for the more than 3 million Americans with longstanding AF.
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).