Healthcare Industry News: Surgical Ablation System
News Release - November 8, 2006
Medtronic Announces Initiation of U.S. Feasibility Trial to Evaluate Surgical Ablation Techniques to Treat Lone Atrial Fibrillation
Trial Initiation Coincides with Launch of The Cardioblate Navigator Tissue DissectorMINNEAPOLIS--(HSMN NewsFeed)--Announcing a significant step toward the surgical treatment of lone atrial fibrillation (AF), Medtronic, Inc. (NYSE:MDT ), today announced FDA approval to initiate the Feasibility of the Lone Atrial Fibrillation Clinical Trial (FACT). The trial initiation coincides with the launch of Medtronic's Cardioblate® Navigator(TM) Tissue Dissector.
The purpose of the FACT feasibility clinical trial is to evaluate the use of the Cardioblate® Surgical Ablation System thorascopically in paroxysmal atrial fibrillation patients. The prospective, non-randomized, feasibility clinical trial will enroll 15 patients at three U.S. medical centers including Scott & White Memorial Hospital (Temple, TX), Beth Israel Hospital (Boston, MA), and LDS Hospital (Salt Lake City, UT). The primary endpoints of the trial are to evaluate the freedom of symptomatic paroxysmal AF episodes using Cardioblate surgical ablation devices in lone AF patients.
While none of the devices used in the trial are investigational, results of the trial will be used to design U.S. pivotal studies for an additional indication of use for the Cardioblate Surgical Ablation System in the U.S. to treat paroxysmal atrial fibrillation. The commercial release of the Navigator Tissue Dissector complements Medtronic's Cardioblate family of bipolar solutions with technology for this stand-alone, surgical ablation procedure.
"We've adopted this minimally invasive approach for stand-alone ablation because it is relatively easy to learn and utilizes standard surgical skills," said Dr. Erik Beyer, Scott & White Memorial Hospital. "With more than 2.2 million patients suffering from AF in the United States, this approach to treating AF will be a far more attractive procedure for both the patient and the surgeon versus a traditional sternotomy."
"The launch of our Navigator Tissue Dissector for surgical ablation, in combination with the initiation of our FACT feasibility trial to evaluate surgical ablation efficacy in lone AF patients, continues to demonstrate Medtronic's commitment to the cardiac surgeon and to providing more choices to customize care," said Dr. John Liddicoat, vice president Atrial Fibrillation Technologies and Transcatheter Valves, for the Cardiac Surgery business at Medtronic. "The approval to commence our feasibility clinical trial further demonstrates Medtronic's commitment and leadership in identifying new and improved means for treating rhythm disorders. With more than 50,000 ablation procedures combined with our 50-plus-year heritage in the rhythm management business, Medtronic is well poised to provide the best means for improving the treatment of atrial fibrillation today and in the future."
According to the American Heart Association, atrial fibrillation is a disorder found in about 2.2 million Americans. During atrial fibrillation, the heart's two small upper chambers (the atria) quiver instead of beating effectively. An individual may spontaneously alternate between normal rhythm and atrial fibrillation, called paroxysmal atrial fibrillation, or may continue with AF as the dominant cardiac rhythm without reverting to the normal rhythm (chronic atrial fibrillation). In either case, blood isn't pumped completely out of the atria, so it may pool and clot. If a piece of a blood clot in the atria leaves the heart and becomes lodged in an artery in the brain, a stroke results. About 15 percent of strokes occur in people with atrial fibrillation.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Editor's Note:
Physicians and Medtronic Cardiac Surgery spokespeople are available for interviews to discuss the FACT Feasibility Clinical Trial and the Navigator(TM) Surgical Ablation System in the U.S. Broadcast quality animation, photos and additional information is also available at (www.medtronicnavigator.com). Contact Angela Pennington at 303.399.4109 to arrange interviews.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
Source: Medtronic
Issuer of this News Release is solely responsible for its
content.
Please address inquiries directly to the issuing company.
Related News Items
Affera(TM) momentum continues as Medtronic announces CE Mark in Europe and U.S. IDE First Cases for Sphere-360™ PFA Catheter to Treat Paroxysmal Atrial FibrillationRestore Medical Appoints Former Medtronic Executive Chris Cleary as Chairman of the Board
Medtronic Initiates U.S. IDE Clinical Study Evaluating Hugo(TM) Robotic-Assisted Surgery System for Gynecological Procedures
