Medtronic (NYSE:MDT) enrolled the first of up to 572 patients in its Fire & Ice trial, the largest clinical study to date to compare 2 atrial fibrillation ablation systems.
Medtronic will compare its Arctic Front cardiac cryoablation system to Biosense Webster’s Carto system-guided Thermocool catheter in a prospective, randomized, multinational European study spanning 20 medical centers.
Paroxysmal AF is a condition in which patients exhibit an intermittently irregular heartbeat that can last for minutes or days at a time, and patients enrolled in the Fire & Ice study have failed at least 1 antiarrhythmic drug, according to a press release.
Medtronic’s Arctic Front system blocks electrical signals that trigger erratic rhythms in the heart’s upper chambers by isolating the pulmonary veins using freezing. Traditional ablation methods isolate the triggers by heating with radiofrequency energy.
"The freezing helps the balloon maintain contact with the heart tissue during the procedure, allowing for greater catheter stability," according to a Medtronic press release. "Cryoablation has been shown to be faster for physicians to use than a point-by-point catheter, and it has been proven more effective than anti-arrhythmic drug therapy in treating patients with paroxysmal atrial fibrillation."
The study’s primary endpoint aims for absence of the erratic heart rhythms without the use of antiarrhythmic drugs and without persistent procedure-related adverse effects.
Atrial fibrillation is the most common and among the most under-treated heart rhythm disorders, affecting more than 7 million people worldwide, according to the release.
Medtronic obtained FDA pre-market approval for the Arctic Front cryoballoon ablation system in Dec. 2010. It notched first use in Jan. 2011 at the Mayo Clinic. More than 15,000 patients have received treatment with Arctic Front in more than 200 centers worldwide, according to Medtronic’s website.
The Fridley, Minn.-based med-tech titan recently hit an obstacle with another of its atrial fibrillation treatment devices when the FDA’s circulatory devices panel said “not yet” to Medtronic’s Phased radiofrequency ablation system.
Guided Therapeutics applies for CE Mark for cervical scan
Guided Therapeutics Inc. submitted the application for CE Mark approval for its LuViva(R) advanced cervical scan. Read more
Internal Fixation wins 510(k) for subtalar implants
Internal Fixation Systems (OTC:IFIX) received 510(k) clearance from the FDA to market subtalar implants, used to preserve motion at the ankle joint and to treat both trauma conditions and arthritis. Read more
Crux Biomedical touts CE Mark for IVC filter
Crux Biomedical won CE mark approval for its inferior vena cava filter with bi-directional retrieval, used to trap blood clots that can lead to a potentially fatal pulmonary embolism. Read more
Suspension Orthopaedic wins FDA clearance for surgical system
Suspension Orthopaedic Solutions received FDA 510(k) clearance for two new products – its Distal Clavicle Fracture Fixation System and a new plate designed to address repair of mid-shaft clavicle fractures. Read more
Cohera Medical lands IDE approval to begin pivotal trial os surgical adhesive
Cohera Medical Inc. received investigational device exemption approval to begin a prospective, multicenter, randomized clinical trial for its flagship TissuGlu surgical adhesive in the U.S. Read more
Cambridge Temperature Concepts wins 510(k) for ovulation monitor
Cambridge Temperature Concepts won 510(k) clearance for its DuoFertility ovulation monitor, comprised of a wearable sensor that measures ovulation patterns, MedGadget reported. Read more