Medtronic's Cardiac Ablation Course Represents A Breakthrough Technology Platform
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Medtronic, Inc. (NYSE:MDT - News) announced completion of enrollment in the TTOP-AF (Tailored Treatment of Permanent Atrial Fibrillation) clinical trial. The glance at is evaluating the capitalization of the fresh radiofrequency (RF) ablation technology, the Medtronic Ablation Frontiers Cardiac Ablation System, for the treatment of continual atrial fibrillation (AF). A leading advancement from currently available RF ablation tools, the system is comprised of a RF generator (or strength source) and three anatomically shaped mapping and ablation catheters that goal three areas of the passion for AF treatment. The system is approved for use in Europe and is under investigational operate in the United States.
"Medtronic plans to be a leader in AF ablation by designing and delivering breakthrough atrial fibrillation therapies to maintenance physicians treat the estimated seven million people worldwide suffering from this disease," said Reggie Groves, vise head of the state and typical executive of Medtronic's AF Solutions division. "Our cause is to afford safe, child's play solutions that pass amassed predictable procedure times than now treatment methods and testament allow physicians to customize care and reduce the reoccurrence of AF for their patients."
The completion of enrollment follows Medtronic's latest acquisitions of Ablation Frontiers, LLC, and CryoCath LP, to embodiment Medtronic's AF Solutions division. When combined with Medtronic's existing EP Systems product portfolio, AF Solutions plans to feeler a complete line of diagnostic, cryoablation (freezing technology) and radiofrequency ablation tools to treat the full range of AF patients.
"This rare process will propoundment physicians a way to costumier their care for treating continuous atrial fibrillation in their patients," said John Hummel, M.D., professor, Division of Cardiovascular Medicine at The Ohio Management University Institute of Medicine in Columbus, Ohio. "In this clinical trial, the anatomical design of everyone catheter allowed me to efficiently map and ablate wide areas in the left atrium. As a result, the simplified system helped me divide procedure times."
About the Medtronic Ablation Frontiers Cardiac Ablation System
The Cardiac Ablation System is a minimally invasive catheter and generator method that delivers customized radiofrequency energy designed to eliminate or isolate abnormal electrical impulses in the left atrium (upper left hospital ward of the heart) that initiate or sustain AF. The three-dimensional, multi-electrode catheters are designed to concede physicians to identify and selectively ablate a broader earth of heart tissue without the end of ongoing single location catheters and elaborate mapping and steering equipment.
The Cardiac Ablation Action 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 development allows physicians to tailor the location, depth and fill of each ablation lesion.
This pivotal analysis is studying the safety and efficacy of the Cardiac Ablation System in continuous AF patients. Patients were randomized to receive ablation therapy or receive commonly used drug treatments. For every three patients enrolled, approximately two received an ablation and one was randomly assigned to the narcotic therapy group. The trial allowed patients in the drug therapy group to corral an ablation if 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 evaluation completion, results will be submitted in consideration for U.S. Menu and Drug Administration (FDA) approval for the Medtronic Ablation Frontiers Cardiac Ablation System.
About Atrial Fibrillation
Atrial fibrillation (AF or A Fib) is an irregular quivering or rapid heart rhythm in the upper chambers (atria) of the heart. AF is the most common cardiac rhythm condition, found in on all sides of three million Americans and seven million mortals worldwide.1 Untreated AF patients carry a two to seven times higher risk of stroke.2 Atrial fibrillation causes inefficient pumping of the heart and can lead to other rhythm problems including chronic tiredness and congestive love failure. Half of AF patients who grip treatment are non-responsive to drug therapy, making them doable candidates for ablation therapy.
1. Millenium Research Report; "Global Markets For Atrial Fibrillation Treatment Devices 2008," Hike 2008; 1.
2. T. Fetsch, EHJ. 2004;1385-1394.
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