Medtronic announced FDA approval and initial application in the U.S. of the Achieve Mapping Catheter for use with the Arctic Front Cardiac CryoAblation Catheter for treatment of paroxysmal atrial fibrillation. It is used for assessment of pulmonary vein isolation during cryoablation, giving surgeons live status assessment of how the procedure is working.
More about the product from the announcement:
The cryoablation treatment involves a minimally-invasive procedure that creates circumferential lesions around the pulmonary vein (the source of erratic electrical signals that cause atrial fibrillation) and blocks the conduction of atrial fibrillation in cardiac tissue through the use of a coolant.
The Achieve Mapping Catheter is deployed through the Arctic Front guide wire lumen enabling the Arctic Front procedure to be performed using a single transseptal puncture with minimal catheter exchanges. It is available in 15 mm and 20 mm loop diameters, enabling physicians to map electrical conduction between the left atrium and pulmonary veins in order to assess pulmonary vein potentials before, during and after cryoablation with Arctic Front.
The Arctic Front Cardiac CryoAblation Catheter System is designed to be used with fluoroscopy and does not require the use of complex, three-dimensional mapping systems. The technologies currently offered in the system include:
• The Arctic Front Cryoballoon, which inflates and fills with coolant to ablate the tissue where the pulmonary veins enter the left atrium;
• The FlexCath® Steerable Sheath, which helps deliver and position the cryocatheter in the left atrium;
• The Freezor® MAX Cardiac CryoAblation Catheter, which is a single-point catheter used to provide additional ablations, as needed; and
• The CryoConsole, which houses the coolant, electrical and mechanical components that run the catheters during a cryoablation procedure.
Press release: Medtronic Announces FDA Clearance and First Patient Procedure with the Achieve™ Mapping Catheter
Product page: Achieve Mapping Catheter
Flashback: Achieve Mapping Catheter for Arctic Front Cryoablation System Wins European Go Ahead