Medtronic Clinical Trial Evaluating The Newest Radiofrequency Ablation Tools For Atrial Fibrillation Completes Enrolment
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Medtronic, Inc. (NYSE:MDT) announced completion of enrollment in the TTOP-AF (Tailored Treatment of Permanent Atrial Fibrillation) clinical trial. The glance at is evaluating the appliance of the recent radiofrequency (RF) ablation technology, the Medtronic Ablation Frontiers Cardiac Ablation System, for the treatment of non-stop atrial fibrillation (AF). A substantial advancement from currently available RF ablation tools, the step is comprised of a RF generator (or force source) and three anatomically shaped mapping and ablation catheters that target three areas of the feelings for AF treatment. The action is approved for convenience in Europe and is under investigational application in the United States.
"Medtronic plans to be a leader in AF ablation by designing and delivering breakthrough atrial fibrillation therapies to corrective physicians treat the estimated seven million people worldwide suffering from this disease," said Reggie Groves, vice president and public chief of Medtronic's AF Solutions division. "Our goal is to add safe, clear solutions that submission also predictable procedure times than now treatment methods and testament allow physicians to customize care and shorten the reoccurrence of AF for their patients."
The completion of enrollment follows Medtronic's modern 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 overture a outright border of diagnostic, cryoablation (freezing technology) and radiofrequency ablation tools to treat the full scale of AF patients.
"This solitary system will offer physicians a way to clothier their burden for treating continuous atrial fibrillation in their patients," said John Hummel, M.D., professor, Division of Cardiovascular Medicine at The Ohio Administration 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 mechanism helped me intersect procedure times."
About the Medtronic Ablation Frontiers Cardiac Ablation System
The Cardiac Ablation Transaction 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 depart or sustain AF. The three-dimensional, multi-electrode catheters are designed to allow physicians to describe and selectively ablate a broader sphere of emotions tissue without the custom of ongoing single point catheters and involved mapping and semanship equipment.
The Cardiac Ablation Course 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
- Brain Multi-Channel Radiofrequency Generator - the unique RF vigour delivery system allows physicians to tailor the location, profundity and fill of everyone ablation lesion.
This pivotal probation is studying the safety and efficacy of the Cardiac Ablation Method in continuous AF patients. Patients were randomized to take ablation therapy or accept commonly used narcotic treatments. For every three patients enrolled, approximately two received an ablation and one was randomly assigned to the drug therapy group. The check allowed patients in the drug therapy group to accept an ablation provided they did not respond to drug therapy. Twenty-four centers enrolled 209 patients who will be followed for at least six months after the ablation procedure. Upon proof completion, results will be submitted in consideration for U.S. Menu and Drug State (FDA) approval for the Medtronic Ablation Frontiers Cardiac Ablation System.
About Atrial Fibrillation
Atrial fibrillation (AF or A Fib) is an irregular quivering or quick passion rhythm in the upper chambers (atria) of the heart. AF is the most common cardiac rhythm condition, construct in encompassing three million Americans and seven million people worldwide.Â Untreated AF patients have a two to seven times higher risk of stroke.2 Atrial fibrillation causes inefficient pumping of the heart and can facade to other rhythm problems including chronic weariness and congestive heart failure. Half of AF patients who apprehend treatment are non-responsive to drug therapy, making them credible candidates for ablation therapy.
Â Millenium Analysis Report; "Global Markets For Atrial Fibrillation Treatment Devices 2008," Hike 2008; 1. 2 T. Fetsch, EHJ. 2004;1385-1394.
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