Industry News and Products

Innovative Atrial Fibrillation Catheter Ablation System From Ablation Frontiers is Subject of Two Abstracts at Heart Rhythm Congress UK

Investigators Call the System “A Genuine Advance in AF Ablation Technology” Ablation Frontiers, Inc., announced that two important abstracts that evaluated its innovative atrial fibrillation (AF) cardiac ablation system were presented at the 5th Annual Heart Rhythm Congress. The studies, conducted independently, were led by Dr. Steve Murray of James Cook University Hospital in Middlesborough, UK, as well as Dr. Simon James and Dr. John Bourke of the Freeman Hospital in Newcastle upon Tyne, UK. The Heart Rhythm U.K. Congress was held from October 19-22, 2008 in Birmingham, UK. Dr. Murray's abstract contrasted AF ablation results using a conventional ablation catheter with the aid of a 3-D mapping system against his current approach using the new Ablation Frontiers System. The system consists of the advanced multi-channel phased GENius RF generator and a set of 3-D anatomically designed catheters (PVAC, MASC and MAAC) capable of mapping, ablating and pacing at target sites throughout the right and left atria. Using this new technology, a total of 62 patients underwent AF ablation for either persistent (n=23) or paroxysmal AF (n=39). Sinus rhythm was acutely restored in 100% of patients and there were no major complications. For those patients with persistent AF, the advanced form of the disease process, 17 were first-time ablation patients and six had received an ablation using alternate ablation technologies. For 16 patients that had been followed for 6 months or more, 10 were free of symptoms and had their anti-arrhythmic drug therapy discontinued. Within the paroxysmal AF patient cohort, 31 of the patients were undergoing their first ablation, while 8 had failed their previous ablation using an alternate ablation technique. Procedure times were consistently under 90 minutes. At an average of 6 months follow-up, 35 of the 39 (90%) patients were free of AF symptoms and no longer taking anti-arrhythmic medication. "In light of the clinical success rates, significantly reduced complication rates, and reduced procedure times, our center is fully adopting this new technology," stated Dr. Murray. "Prior to this approach, our drug-free success rate in one series of 63 patients with persistent and paroxysmal AF treated by conventional catheter ablation technology was 68% with a 7% complication rate." The second abstract, authored by Dr. James and Dr. Bourke, evaluated 65 patients with drug-refractory AF, of which 17 had persistent AF and 48 had paroxysmal AF. Pulmonary vein isolation (PVI) was performed, with further ablation for sites of complex fractionation, as needed (n = 31). Acute success was achieved in 64 of the 65 patients and, at a mean follow-up time of 9.1 months, 88% of patients were free of AF as measured by 7-day continuous monitoring. The mean procedure time was 165 minutes for both types of AF, which was significantly shorter than the reported 208 minutes when using conventional ablation technology. "The PVAC catheter is a genuine advance in AF-ablation technology," stated Dr. James. "With conventional RF technology for PVI, physicians are faced with a challenging and time-consuming procedure with variable success rates. We found that with the Ablation Frontiers technology, we could achieve high acute success rates and low recurrence rates of AF with significantly shorter procedure times. Medium-term follow-up data is encouraging." These results are similar to findings presented recently at other leading scientific sessions from several studies using Ablation Frontiers novel technology. "We are committed to the ongoing research of our innovative AF ablation technology and look forward to long-term results from these and other studies," stated Keegan Harper, Chief Executive Officer of Ablation Frontiers. "We are very grateful to the investigators and their colleagues, who have been most diligent in thoroughly investigating Ablation Frontiers technology and reporting their findings. It is their work that helps us develop the technology that will one day overcome the growing challenge of atrial fibrillation." ______________________________

510(k) Clearance Enables Ascent to Reprocess EP Catheters from All Major Original Manufacturers

Ascent Healthcare Solutions announced that it has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) to reprocess the full line of IBI diagnostic electrophysiology (EP) catheters and cables originally manufactured by Irvine Biomedical Inc., a St. Jude Company. These include the Inquiry™ Fixed and Steerable, AFocus™, AFocus II™ and Optima™ product families that offer one of the largest selection and variety of curve designs for varying anatomies. With this new clearance added to its previously cleared 510(k)s, Ascent is the only device manufacturer that can reprocess diagnostic EP catheters from all major original manufacturers. Ascent focuses on reprocessing high-cost, high-volume devices such as diagnostic EP catheters to help its hospital partners allocate resources to optimize patient care and to help protect the environment through reprocessing as well as recycling and material reclamation. Reprocessing IBI diagnostic EP catheters saves EP/cath labs approximately 55 percent over the cost of an original device. A high-volume EP lab using these catheters can expect to save about $175,000 annually. “EP labs have a long history of safely utilizing reprocessed EP catheters, and Ascent is committed to continuing to provide the industry’s most comprehensive reprocessing program for diagnostic EP catheters,” explained Ascent COO Rick Ferreira. “These expensive devices are essential to ensure that patients with irregular heart rhythms are properly diagnosed and prudent supply chain cost management is vital to ensure that these patients receive high-quality, timely care.” ______________________________

NIH Awards Thermedical $3.6 Million to Test for Prevention of Sudden Cardiac Death

Company to Test Radiofrequency Electrical Energy to Treat Myocardial Infarctions to Prevent Ventricular Tachycardia Thermedical announced that it has received a $3.6 million Competing Phase 2 Renewal Grant from the National Heart, Lung and Blood Institute. The three-year grant will fund continued development and testing of the company’s Saline Enhanced Radiofrequency Ablation (SERF) system, which is designed for use in ablation treatment for ventricular tachycardia (VT). Michael G. Curley, PhD, founder of Thermedical and principal investigator on the project, said “The funding from the National Heart Lung and Blood Institute will allow us to assess whether SERF Ablation™ is useful for treating the arrhythmogenic tracks that are left within infarct scars following a myocardial infarction, or heart attack. Physicians feel these tracks are critical to the occurrence of VT and can lead to sudden cardiac death.” In Thermedical’s previously funded Phase 2 Grant, the company documented for the first time that remnant healthy myocardium within infarct scar (the channels thought responsible for a portion of the VT circuit) has been ablated throughout the scar’s depth. The practical implication of these results is that SERF Ablation should eliminate the VT circuits associated with the infarct scar. “These results not only show that SERF Ablation could be a successful and efficient therapy to improve the quality of life of patients with ICDs; the results also hold the hope that, since nearly all of the scar-related VT circuits are ablated, SERF Ablation could be used as a primary therapy for VT,” continued Dr. Curley. “If our development is successful, SERF Ablation would be a low-cost alternative to ICD therapy and could save the U.S. healthcare system approximately 75 percent of the cost of treating patients with VT,” said Dr. Curley. SERF Ablation uses radiofrequency (RF) electrical energy to overheat, and as a result, kill myocardial tissue. The energy is delivered by a catheter-delivered needle that simultaneously injects warm saline into the tissue. The saline alters the physics of energy delivery through the tissue, potentially allowing treatment of much larger volumes than can presently be treated using RF alone. The proceeds from the grant will be used to gather the data needed to apply for U.S. Food & Drug Administration (FDA) Investigational Device Exemption for clinical trials for ablation of myocardial infarct scars. These data will be gathered in a multi-institutional, pre-clinical trial led by Douglas L. Packer, MD, Professor in Medicine, Mayo Clinic. The trial will also be carried out by David J. Wilber, MD, Director, Division of Cardiology, Loyola Stritch School of Medicine, David J. Callans, MD, Associate Director of Electrophysiology and Francis E. Marchlinski, MD, Director of Electrophysiology at the University of Pennsylvania School of Medicine, and Roy M. John, MD, Director, Experimental Arrhythmia Research and Laurence Epstein, MD, Director, Electrophysiology and Pacing Laboratory, Brigham and Women’s Hospital. ______________________________

FDA Approves Ranexa® for First-Line Anti-Anginal Use and Adds New Claims for Reduction of Ventricular Arrhythmias, Bradycardia, New Atrial Fibrillation and HbA1c

CV Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new, first-line indication for Ranexa® (ranolazine extended-release tablets) for the treatment of chronic angina. The new labeling also provides information showing that Ranexa reduced arrhythmias including ventricular arrhythmias, new onset atrial fibrillation and bradycardia in patients with coronary artery disease. In addition, the new labeling states that Ranexa reduces hemoglobin A1c (HbA1c) in patients with diabetes. According to the revised labeling, Ranexa is indicated for the treatment of chronic angina and may be used alone or in combination with traditional therapies for chronic angina, such as beta blockers, calcium channel blockers and nitrates, and common cardio-protective treatments for cardiovascular disease such as anti-platelet therapy, lipid-lowering therapy, ACE inhibitors and angiotensin receptor blockers. Ranexa may now be used as part of an optimal medical therapy regimen for chronic angina patients, regardless of whether or not they receive a stent or other medical intervention. Ranexa does not reduce heart rate or blood pressure and, unlike long-acting nitrates, Ranexa can be prescribed for patients taking oral erectile dysfunction treatments. "This important FDA action allows the benefits of Ranexa to be extended to more patients. The new labeling clearly describes the substantial proven safety and efficacy of Ranexa for the treatment of chronic angina," said Louis G. Lange, CV Therapeutics chairman and chief executive officer. “Our commercial organization will actively focus on educating new and existing prescribers about these significant new labeling improvements," Lange added. The most frequently reported adverse reactions during treatment with Ranexa in clinical trials were dizziness, headache, constipation and nausea. Complete updated prescribing information will be available at http://www.ranexa.com. "Ranolazine may now take optimal medical therapy to an entirely new level, and may afford enhanced symptom relief," said Dr. William Boden, clinical chief, division of cardiovascular medicine, University at Buffalo Schools of Medicine & Public Health and principal investigator of the COURAGE study. "As we have seen in the MERLIN-TIMI 36 trial and in clinical practice, patients with ischemia and angina can be at increased risk for arrhythmias and also often have diabetes. Considering its mechanism of action, established cardiovascular safety and observed reductions in arrhythmias and HbA1c, ranolazine now becomes an even more important drug in our treatment of chronic angina," said Dr. Eugene Braunwald, Distinguished Hersey Professor of Medicine at Harvard Medical School and chairman of the TIMI Study Group. These significant new labeling changes were supported by a supplemental new drug application submitted in September 2007 that included data from the 6,560 patient MERLIN-TIMI 36 trial, which showed no adverse trend in death or arrhythmia in a high-risk acute coronary syndromes patient population. The revised labeling includes new language noting that there was a significantly lower incidence of arrhythmias (ventricular tachycardia, bradycardia, supraventricular tachycardia and new atrial fibrillation) in patients treated with Ranexa versus placebo. This difference in arrhythmias did not lead to a reduction in mortality, a reduction in arrhythmia hospitalization or a reduction in arrhythmia symptoms. The revised labeling also includes new language noting that Ranexa produces small reductions in HbA1c. Though Ranexa should not be considered a treatment for diabetes, Ranexa may be a particularly useful medication for the reduction of chronic angina in this patient population, which is difficult to treat because some anti-anginal medications such as beta blockers increase HbA1c. More than 150,000 patients have been prescribed Ranexa since its initial launch in March 2006. ______________________________

New Research Reveals Predictors of and Safer Treatment for Atrial Fibrillation

New research reveals age, diabetes and heart failure as independent predictors of atrial fibrillation (AF) progression. The new study published in the November edition of the HeartRhythm Journal, the official journal of the Heart Rhythm Society, also concludes that early catheter ablation rather than antiarrhythmic drug therapy (ADT) reduces AF recurrences, delaying arrhythmia progression in almost all patients. The study is the first to prospectively assess the progression of AF according to recent guideline classifications and management. In addition, while prior studies were based on retrospective data using older guidelines and did not include the potential influence of catheter ablation, this five-year prospective study is also the first to include catheter ablation as an alternative to conventional antiarrhythmic drug therapy. The long-term, prospective follow-up study, led by Carlo Pappone, MD, provides new insights on the progression of AF and shows that over a five-year follow-up, patients with lone AF, defined as AF occurring in the absence of structural heart disease, are at a very low risk to progress from the first detected episode to permanent AF. However, patients with AF and comorbidities, the presence of two or more disease processes, require treatment to avoid AF recurrences and arrhythmia progression. Among 402 screened patients with a first episode of AF, 106 patients were selected and followed for five years. Of the 106 patients selected, 50 percent had lone AF and 49 percent had comorbidities. Results at the end of the five-year follow-up included: • 54 patients, 61 percent of those with lone AF, had no further recurrence after five years. • 45 patients received antiarrhythmic drug therapy; 24 of whom developed persistent AF and then 16 of whom went on to develop permanent AF. • 11 patients underwent catheter ablation resulting in no AF recurrences or AF progression. “Many prior studies reported predictors of AF development, but did not report predictors of arrhythmia progression; through this study, we found age, diabetes and heart failure to predict final progression,” stated author Dr. Pappone, Department of Cardiology, San Raffaele University Hospital, Milan, Italy. “By identifying key arrhythmia progression predictors, patients at risk of AF progression will be better managed from an early ablation stage.” Unlike previous research, the study also shows that catheter ablation significantly reduces AF recurrences, delaying arrhythmia progression in almost all patients as compared to antiarrhythmic drug therapy. This has an important clinical impact in the growing AF population, considering the difficulty to maintain long-term sinus rhythm with antiarrhythmic drugs and the association of poor safety implications. ______________________________

Risk of Sudden Cardiac Death Appears Increased Within 30 Days of Heart Attack

The risk of sudden cardiac death following a heart attack has declined significantly in the past 30 years, although patients appear to be at elevated risk for sudden cardiac death for the first month after having a heart attack, after which time their risk decreases unless they develop heart failure, according to a study in the November 5 issue of JAMA. “Sudden cardiac death is a devastating complication of myocardial infarction,” the authors write as background information in the article. Determining which patients are at risk for this complication remains challenging, they note. Currently, risk prediction approaches are based on characteristics assessed shortly after heart attack — a strategy that may be insufficient. Other factors that occur in the days to weeks following heart attack, such as heart failure or recurrent ischemia, may be associated with risk of sudden cardiac death. A. Selcuk Adabag, MD, MS, of Veterans Affairs Medical Center, Minneapolis, and colleagues at Mayo Clinic, Rochester, Minnesota, studied 2,997 residents (average age 67; 59 percent men) who had a heart attack in Olmsted County, Minnesota, between 1979 and 2005. Patients were followed through medical records for a median of 4.7 years, through Feb. 29, 2008. During this time, 1,160 patients died, including 282 (24 percent) from sudden cardiac death. The 30-day cumulative incidence of sudden cardiac death was 1.2 percent, which is four times higher than expected. For each following year, however, the rate of sudden cardiac death was constant at 1.2 percent per year — lower than the rate among the general population. The cumulative five-year incidence of sudden cardiac death among heart attack patients was 6.9 percent. A total of 842 patients developed recurrent ischemia, 365 developed heart failure and 873 developed both. Recurrent ischemia was not associated with sudden cardiac death. However, compared with patients who did not experience heart failure during follow-up, those who did had a 2.5 percent higher risk of sudden cardiac death within 30 days of heart attack and in each year thereafter. “The risk of sudden cardiac death has declined significantly over time for myocardial infarctions that occurred between 1997 and 2005 compared with between 1979 and 1987,” the authors write — a decline of more than 40 percent over the past 25 years. This decline predates the widespread use of defibrillators but coincides with other drastic changes in therapy for heart attacks, including secondary prevention and reperfusion therapy, which re-opens blocked arteries. “In the community, the risk of sudden cardiac death is the highest during the first month after myocardial infarction when it markedly exceeds the rate in the general population,” the authors conclude. “Among 30-day survivors, the risk of sudden cardiac death declines rapidly but it is markedly increased by the occurrence of heart failure during follow-up. This underscores the importance of continued surveillance of patients after myocardial infarction and the dynamic nature of risk stratification.” (JAMA. 2008;300[17]:2022-2029.)