Medtronic, Inc. announced completion of enrollment in the TTOP-AF (Tailored Treatment of Permanent Atrial Fibrillation) clinical trial. The study is evaluating the use of the latest radiofrequency (RF) ablation technology, the Medtronic Ablation Frontiers Cardiac Ablation System, for the treatment of continuous atrial fibrillation (AF). A leading advancement from currently available RF ablation tools, the system is comprised of a RF generator (or energy source) and three anatomically shaped mapping and ablation catheters that target three areas of the heart for AF treatment. The system is approved for use in Europe and is under investigational use in the United States.
“Medtronic plans to be a leader in AF ablation by designing and delivering breakthrough atrial fibrillation therapies to help physicians treat the estimated seven million people worldwide suffering from this disease,” said Reggie Groves, vice president and general manager of Medtronic’s AF Solutions division. “Our goal is to provide safe, easy solutions that offer more predictable procedure times than current treatment methods and will allow physicians to customize care and reduce the reoccurrence of AF for their patients.”
The completion of enrollment follows Medtronic’s recent acquisitions of Ablation Frontiers, LLC, and CryoCath LP, to form Medtronic’s AF Solutions division. When combined with Medtronic’s existing EP Systems product portfolio, AF Solutions plans to offer a complete line of diagnostic, cryoablation (freezing technology) and radiofrequency ablation tools to treat the full range of AF patients.
“This unique system will offer physicians a way to tailor their care for treating continuous atrial fibrillation in their patients,” said John Hummel, M.D., professor, Division of Cardiovascular Medicine at The Ohio State University College of Medicine in Columbus, Ohio. “In this clinical trial, the anatomical design of each catheter allowed me to efficiently map and ablate broad areas in the left atrium. As a result, the simplified process helped me decrease procedure times.”
About the Medtronic Ablation Frontiers Cardiac Ablation System
The Cardiac Ablation System is a minimally invasive catheter and generator system that delivers customized radiofrequency energy designed to eliminate or isolate abnormal electrical impulses in the left atrium (upper left chamber of the heart) that initiate or sustain AF. The three-dimensional, multi-electrode catheters are designed to allow physicians to identify and selectively ablate a broader area of heart tissue without the use of current single point catheters and complex mapping and navigation equipment.
The Cardiac Ablation System includes:
- Pulmonary Vein Ablation Catheter (PVAC)™ – designed for mapping, ablating and verifying isolation of the pulmonary veins;
- Multi-Array Septal Catheter (MASC)™ – designed for mapping and ablating the left atrial septal wall;
- Multi-Array Ablation Catheter (MAAC)™ – designed for mapping and ablating the left atrial body; and
- GENius Multi-Channel Radiofrequency Generator – the unique RF energy delivery system allows physicians to tailor the location, depth and fill of each ablation lesion.