EP Lab Digest - April 2008 - (Page 59)

APRIL 2008 NEWS 59 Sorin Group Announces FDA Approval of New Defibrillation Leads LA Medical Inc., a Sorin Group company, announced the U.S. Food and Drug Administration's approval to market ISOLINE™,1 its latest generation of defibrillation leads. The ISOLINE™ defibrillation leads have a multi-lumen structure with a silicone body and include an ETFE-protective coating placed around the cables leading to the electrodes. This redundant insulation2 is also made by a third layer of protection consisting of a polyurethane overlay to provide better abrasion resistance. Both ends of the defibrillator electrodes are securely connected to the cables. Abrasion resistance materials such as polyurethane have much better3 friction coefficients than other materials such as silicone. Avoiding lead abrasion is very important in maximizing lead longevity and protecting patients' safety. Results of an internal study demonstrated that a similar lead with the same polyurethane overlay was at least 201 times more resistant to abrasion than a non-polyurethane coated lead. “ISOLINE™'s FDA approval is a big step towards strengthening our position in E the US market and offering a Cardiac Rhythm Management complete solution to patients and physicians”, said Fred Hrkac, President of Sorin Group's Cardiac Rhythm Management (CRM) division. ISOLINE™ leads are steroid-eluting, dual coil defibrillation leads available in active and passive fixation models. A clinical trial showed that with a fully isodiametric 7.8 F lead body, ISOLINE™ ensures very good maneuverability and overall handling characteristics. ISOLINE™ leads also offer EASYTURN™: a quick lead placement system for positioning the lead and extending the helix with a single stylet, and Easy Mapping to obtain pacing thresholds without helix extension. The ISOLINE™ leads family was successfully launched two years ago in Europe. 1 Active fixation models: Isoline 2CR5 (58 cm) IJ27U and 2CR6 (65 cm) IJ24U Passive fixation models: Isoline 2CT5 (58 cm) IJ26U and 2CT6 (65 cm) IJ23U 2 Redundant Insulation: ETFE coating, Silicone Scheuer-Lesser M, et al. Polyurethane Leads, pg 456, PACE vol. 6, March – April 1983 3 HUYA Bioscience International Announces Clinical Advisory Team for New AntiArrhythmic Compound Sourced from China UYA Bioscience International (HUYA) announced the clinical advisory team for its new anti-arrhythmic compound, HBI-3000. The new compound is set to begin enrollment under the final Phase I clinical trial protocol after successful completion of three previous Phase I protocols in China.The advisory team consists of world-class biomedical researchers who will provide guidance to HUYA and its Chinese partner, Shanghai Institute of Materia Medica (SIMM), throughout the course of an innovative U.S./China co-development process for HBI-3000. The advisory team consists of: • Peter R. Kowey, MD, Professor of Medicine and Clinical Pharmacology at Jefferson Medical College and a pioneer in the development of many anti-arrhythmic drugs and anti-tachycardia devices; • Eric Topol, MD, Chief Academic Officer for Scripps Health, former chairman of Cardiovascular Medicine at the Cleveland Clinic for 15 years and recognized by the Institute of Scientific Information as one of the top 10 cited researchers in medicine over the past decade; • Benedict R. Lucchesi, PhD, Professor of Pharmacology at the University of Michigan Medical School Department of Pharmacology for more than 40 years, and contributor to more than 370 publications in basic pharmacology and drug development; • Denis Roy, MD, Montreal Heart Institute, Professor H and Chair of the Department of Medicine at the University of Montreal and Principal Investigator of the recently completed Atrial Fibrillation and Congestive Heart Failure multi-center international trial; • Jefferson L. Anderson, MD, Professor of Medicine, University of Utah and Chief of Cardiology, Intermountain Medical Center, a major contributor to cardiovascular research over a broad area including antiarrhythmic therapies, genetic polymorphisms and new risk factors for cardiovascular disease; and • Stanley Nattel, MD, Paul-David Chair in Cardiovascular Electrophysiology, Professor of Medicine, University of Montreal, Director, Electrophysiology Research Program Montreal Heart Institute Research Center, University of Montreal. Mireille Gingras, PhD, CEO of HUYA, says “We're thrilled to have each of these renowned scientists on our advisory team and look forward to working closely with them on this promising new anti-arrhythmic compound, HBI-3000. Our tightly integrated co-development effort with our Chinese partners represents a true breakthrough in Sino-American pharmaceutical development and we're proud to undertake that effort with this outstanding group of advisors.” In a separate announcement, HUYA discussed the completion of enrollment and evaluation under three Phase I clinical trial protocols in China of its anti-arrhythmic compound, HBI-3000, a balanced multi-ion channel blocker, originally licensed from SIMM. The data from the trials — in combination with pre-clinical data generated separately and in collaboration by HUYA and SIMM — support a desirable safety profile; most significantly, a lack of life-threatening pro-arrhythmic activity. Anti-arrhythmic drugs are used today to treat patients with atrial fibrillation (AF), a serious condition that afflicts 5.6 million Americans. Anti-arrhythmic agents have also been used for the treatment of ventricular arrhythmias, although most have failed to demonstrate a survival advantage, and in some cases carry significant safety risk. The main concern with anti-arrhythmic drugs is an increased risk of sudden death (Torsade de Pointes) in patients with underlying organic heart disease such as coronary artery disease, prior history of myocardial infarction and heart failure. A large subset of individuals with atrial and ventricular arrhythmias suffers from these conditions, precluding treatment with most existing antiarrhythmic drugs. Development of safe anti-arrhythmic agents for use in these patients is needed. Pre-clinical data developed by HUYA and its Chinese partner, along with the Chinese clinical trial data, suggest that HBI-3000 may have safety advantages over other anti-AF agents and exhibits broad spectrum ion channel inhibition without pro-arrhythmic activity that suggests it may also be safer to use in treatment of ventricular arrhythmias.

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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