EP Lab Digest - April 2008 - (Page 57)

APRIL 2008 NEWS 57 Boston Scientific Announces European Approval of New Heart Failure Lead ACUITY Spiral Lead Offers Flexibility for Placement in Small, Medium and Large Veins Continued from page 1 ® T he product features a spiral design and small lead tip profile (4 French) for placement of the lead even in difficult-to-access veins of varying sizes. “The ability to place a left ventricular lead precisely where it will stimulate the heart most effectively is a key factor in providing patients with optimal cardiac resynchronization therapy,” said Fred Colen, Executive Vice President, Operations and Technology, Boston Scientific Cardiac Rhythm Management. “ACUITY Spiral has the smallest lead tip profile in the industry and offers physicians the flexibility to place the lead in veins they may have avoided in the past.” The ACUITY Spiral lead is Boston Scientific's seventh U.S. or European regulatory approval in the past nine weeks. The ACUITY Spiral lead is pending approval by the U.S. Food and Drug Administration and is not available for sale in the United States. ATS Medical Announces Initial Clinical Results of Stand-Alone Atrial Fibrillation Procedures Using ATS CryoMaze Product Line A TS Medical, Inc., manufacturer and marketer of state-of-the-art cardiac surgery products, announced initial clinical results of standalone ablation procedures and an overall expansion into the stand-alone market, using the ATS CryoMaze™ product line. This line of surgical products, indicated for the treatment of cardiac arrhythmias, is designed to replicate the original cut-andsew Maze procedure (also known as Cox-Maze-III) by freezing lines in the heart to re-direct electrical impulses.The Maze procedure is a widely known surgical technique developed by Dr. James L. Cox in the 1980s to treat atrial fibrillation (AF) with a high rate of long-term success. In Ft. Lauderdale on January 27, Dr. Evelio Rodriguez of East Carolina University presented on six-month results of stand-alone AF ablations using ATS Medical cryoablation products. In the presentation, Dr. Rodriguez described the East Carolina University technique of performing a complete standalone Maze procedure using cryoablation and robotic technique. This technique is facilitated by the use of the da Vinci® Surgical System from Intuitive Surgical, Inc., to manipulate the cryoablation probe inside of the heart. East Carolina University has treated 57 patients with fully robotic stand-alone cryoablation. Prior to the procedure, 54 of these patients had continuous AF, the most difficult type of AF to ablate. At six months of follow-up, over 90% of the patients were in sinus rhythm and only five of these patients were using antiarrhythmic medication. Dr. Rodriguez said,“Stand-alone ablation using the ATS cryoablation probes is a reliable method of replicating the complete Maze procedure, with initial success rates that are similar to Dr. Cox's original procedure, which was an extensive, open-chest surgical procedure.” East Carolina University is not alone in using ATS CryoMaze for stand-alone AF ablation. More than 15 centers in the United States have adopted ATS cryoablation products in stand-alone procedures. Like East Carolina University, several hospitals are leveraging the da Vinci® Surgical System as a part of the procedure while others are performing ATS CryoMaze ablations by manipulating the cryogenic probe by hand. The strengths of the stand-alone procedure using ATS CryoMaze are that it can be done through a small incision, which is appealing to the patient, and provides clinical results similar to the original cutand-sew full Maze procedure — even in the patient populations that are historically the most difficult to ablate, especially for cardiologists.The clinical success of this procedure, combined with the minimally invasive access site, is leading to an adoption of this procedure for surgical stand-alone procedures. “Over the past several months ATS Medical has made significant progress in advancing its therapies for the surgical treatment of cardiac arrhythmias on a stand-alone or sole therapy basis,” said Michael Dale, CEO and President of ATS Medical. “Specifically, we have proven that our current ATS CryoMaze products offer a successful, less invasive approach to treating cardiac arrhythmias.” The most common surgical ablation procedure today is the concomitant procedure in which an ablation is performed in conjunction with other cardiac surgery, most typically a mitral valve repair or replacement. The ATS development team is focused on providing next-generation tools to provide better ergonomics and access to the lesion sites required by the Maze procedure. The company anticipates introducing a new ATS CryoMaze probe and clamp combinations during mid 2008. As described above, several approaches have been used to perform ATS CryoMaze ablations on a less invasive, closed-chest basis. The company's efforts under the guidance of Dr. Cox will be focused on supporting the procedures and bringing new products to market that enable these procedures in an easily reproducible method with the gold-standard success rates of the original Cox Maze procedure.

Table of Contents Feed for the Digital Edition of EP Lab Digest - April 2008

EP Lab Digest - April 2008 Pediatric Electrophysiology Medical Relief Work on the Yucatan Peninsula: A Labor of Love EP 101: Considerations for the Elderly EP Patient Contents Letter from the Editor Spotlight Interview: University of Maryland A Summary of the ACC/AHA/Physician Consortium 2008 Clinical Performance Measures for Adults with Nonvalvular Atrial Fibrillation or Flutter Can Psychosocial Characteristics Predict Fatal Outcomes in Patients? Interview with Jonathan S. Steinberg, MD, FACC 10-Minute Interview: Diane D. Sheffield, RN, BSN AED Access for All: An Organization for SCA Survivors New Column: 5 Quick Clues to AV Nodal Reentry Tachycardia CMS 2008 OPPS Final Rule Review New Online AED and CPR Training Opportunities: Q & A with Keith Weaver Highlights from the 5th Annual International Arrhythmia Winter School Email Discussion Group Events Calendar Second Annual Salary Survey Industry News and Products Classifieds Advertisers Index

EP Lab Digest - April 2008

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