Medtronic announces FDA clearance and first patient procedure with the Achieve mapping catheter


Medtronic announced FDA approval for use, and the first patient procedure using the Achieve mapping catheter, an intra-cardiac electrophysiology diagnostic catheter that can be used to assess pulmonary vein isolation when treating paroxysmal atrial fibrillation (PAF).

The new catheter technology is approved for use with Medtronic’s Arctic Front Cardiac CryoAblation catheter system to provide a more straightforward treatment approach by combining pulmonary vein diagnostic and ablation capabilities in a single system. The first patient procedure in the United States using Achieve was performed by Robert Kowal, electrophysiologist at the Baylor Heart & Vascular Hospital in Dallas, USA.

“In many cases, this new mapping catheter will allow real-time assessment of pulmonary vein isolation and provide valuable information regarding time-to-effect during the cryoablation procedure,” said Kowal.

The Arctic Front Cardiac CryoAblation catheter, approved by the FDA in December 2010, is the first and only cryoballoon in the United States indicated for the treatment of PAF. Baylor Heart and Vascular Hospital was the first in North Texas to offer this technology. The cryoablation treatment involves a minimally-invasive procedure that creates circumferential lesions around the pulmonary vein and blocks the conduction of atrial fibrillation in cardiac tissue through the use of a coolant.

Achieve 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 15mm and 20mm 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.

According to the company, approximately 15,000 Arctic Front procedures have been performed worldwide, including 1,000 procedures with the Achieve mapping catheter in Europe.

Medtronic introduced this new catheter at Heart Rhythm 2011, the Heart Rhythm Society’s 32nd Annual Scientific Sessions, in San Francisco, USA.