CryoCath down under
This article was originally published in The Gray Sheet
Executive Summary
Montreal firm announces March 26 the introduction at two centers in Australia of its Arctic Front cryoablation balloon catheter for the treatment of paroxysmal, or episodic, atrial fibrillation. The device is already being used at 34 centers in Europe. CryoCath says it is on track to complete enrollment in its STOP AF pivotal U.S. trial in April, and anticipates a late 2009 PMA approval
You may also be interested in...
Research In Brief
CryoCath: Pulmonary vein isolation ablation with CryoCath's Arctic Front cryoballoon or Arctic Front plus the Freezor Max catheter resulted in maintenance of sinus rhythm in 74% of patients with paroxysmal atrial fibrillation (AF) and 42% of patients with persistent AF in a 346-patient trial led by Thomas Neumann, Kerckhoff Heart Center, Bad Nauheim, Germany. Treatment was considered successful if the patients were AF-free and off anti-arrhythmic drugs one year after a single procedure with the Arctic Front. The results appear in the July 22 Journal of the American College of Cardiology. CryoCath recently completed enrollment in the STOP AF pivotal U.S. trial for Arctic Front and expects FDA approval in late 2009. The device is already available in Europe (1"The Gray Sheet" March 31, 2008, In Brief)
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.