Industry News & Products

Transoma Medical Announces First Patient Enrollment in Clinical Study to Evaluate Recurrence of Atrial Fibrillation Post Catheter Ablation

Transoma Medical, Inc., manufacturer of Sleuth AT™, a wireless, automated implantable cardiac monitoring system with programmable and frequent electrocardiogram sampling, announced the first patient enrollment and implant in a long-term study to monitor patients who have been prescribed catheter ablation therapy for atrial fibrillation (AF) at risk of recurrence of AF after the procedure. The implant was performed on July 27, 2009, by Dr. Safwat Gassis, a cardiac electrophysiologist with Associated Cardiologists in Harrisburg, Pennsylvania. The primary investigator for the study at Harrisburg Hospital, part of the Pinnacle Health System, is Dr. David Scher, director of cardiac electrophysiology for Pinnacle Health System and Associated Cardiologists. The company received FDA 510(k) marketing clearance for Sleuth AT, its next-generation product, on Feb. 11, 2009. “I am very excited about the potential for Sleuth AT in terms of providing a unique method of long-term cardiac monitoring for AF recurrence after ablations,” said Dr. Scher. “Previous monitoring options provided shorter monitoring durations or limited memory capacity, which is not ideal when trying to determine appropriate ongoing therapy for my AF patients who have undergone catheter ablation. Due to the nature of paroxysmal AF, it may remain undetected by standard diagnostic methods. In addition, most atrial fibrillation episodes following catheter ablation occur without symptoms. With Sleuth AT, we can continuously monitor the patient for AF over a prolonged period (up to two years) to determine if, when and for how long atrial fibrillation is present.” The IMAGINE (Implantable Monitoring for AF Ablation Generating Insight and New Evidence) clinical study is designed for long-term evaluation of AF recurrence after ablation using the Sleuth AT system. The timing and true degree of recurrence in post-ablation paroxysmal AF patients has not been studied until now due to technology limitations. Conventional cardiac monitors that rely on symptomatic activation of ECG storage carry the risk of missing asymptomatic events. Additionally, current external monitoring systems are limited by duration of monitoring and other factors including skin irritation from regular application of electrodes and general patient compliance. Sleuth AT is a cardiac monitoring system that allows physicians to program the capture of high-quality ECG strips at frequent intervals, providing a new level of insight into complex arrhythmias that are often asymptomatic and frequently changing. These captured ECG strips are automatically transferred to a 24/7 monitoring center, staffed by certified cardiac technicians, who analyze, classify and notify physicians of the presence of a wide variety of cardiac arrhythmias, such as ventricular tachycardia, bradycardia, supraventricular tachycardia and atrial fibrillation. “The IMAGINE study will provide us with information that we’ve never been able to access before,” said Dr. Steven Rothman, principal investigator for the study from Lankenau Hospital, Main Line Health Heart Center in Wynnewood, Pennsylvania. “The data from this study will allow us to take a new look at atrial fibrillation post-ablation and to evaluate the best course of action regarding future treatment. Continuous, long-term rhythm monitoring in AF patients is indispensible to define the true absence, presence and burden of the arrhythmia.” “Since clearance of the Sleuth AT system, interest in long-term monitoring of patients after AF ablation procedures, both by electrophysiologists performing catheter ablations and cardiac surgeons performing surgical ablations, has been tremendous,” said Brian Brockway, Transoma Medical founder and CEO. “Physicians are looking for a continuous monitoring system that provides improved detection and monitoring capabilities over existing options while minimizing patient compliance issues.” ___________________________

MULTAQ® (dronedarone) for Atrial Fibrillation or Atrial Flutter Now Available in Pharmacies

Sanofi-aventis announced that MULTAQ® (dronedarone) 400 mg Tablets is now available in pharmacies in the United States. MULTAQ is an anti-arrhythmic drug indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥50 mm or left ventricular ejection fraction [LVEF] >40%), who are in sinus rhythm or who will be cardioverted. MULTAQ was recently approved by the U.S. FDA on July 1, 2009. "MULTAQ may help patients with atrial fibrillation or atrial flutter stay out of the hospital, which is an important factor in treatment that is often not addressed," said Gerald V. Naccarelli, MD, Chief, Division of Cardiology, Pennsylvania State University College of Medicine. "We welcome a new option that may help patients with atrial fibrillation or atrial flutter manage their disease." In the landmark ATHENA trial, the efficacy and safety of MULTAQ was evaluated in patients with AF/AFL or a recent history of these conditions (71% of these patients had no heart failure, 29% had NYHA class I-III stable heart failure). This trial showed that MULTAQ 400 mg BID, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24% (pMADIT-CRT Trial Results to be Presented at ESC and HFSA Meetings Boston Scientific Corporation announced that additional results from the landmark MADIT-CRT trial have been accepted as a Hot Line Session at the European Society of Cardiology (ESC) Congress in Barcelona on September 1st. The results have also been accepted as a late-breaking clinical trial at the Heart Failure Society of America (HFSA) Scientific Meeting in Boston on September 14th. MADIT-CRT’s preliminary results were reported last month and showed Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) to be associated with a significant 29 percent reduction (p=0.003) in death or heart failure interventions when compared to traditional implantable cardioverter defibrillators (ICDs). High-risk, asymptomatic or mildly symptomatic, New York Heart Association (NYHA) Class I and II patients were enrolled in MADIT-CRT. “Boston Scientific is proud to be the exclusive sponsor of MADIT-CRT and all the MADIT trials,” said Fred Colen, President, Boston Scientific CRM. “MADIT-CRT is an important continuation of our legacy of supporting landmark clinical trials and our nearly 20-year association with Dr. Arthur Moss and the University of Rochester. We look forward to the presentation of results in Barcelona and Boston, and we are hopeful they will eventually lead to a wider population of heart failure patients being treated with CRT-D therapy.” CRT-Ds improve the heart’s pumping ability by delivering small electrical impulses that help synchronize contractions of the walls of the left ventricle. In addition, CRT-Ds monitor the heart for potentially fatal rhythms. If such a rhythm is detected, a life-saving shock is delivered, restoring normal heart rhythm and preventing sudden cardiac death. MADIT-CRT is the world’s largest randomized NYHA Class I/II CRT-D trial, with more than 1,800 patients enrolled at 110 centers in 14 countries. The trial is providing insight into the potential of CRT-D therapy to intervene earlier in the natural progression of heart failure. Currently, patients must be in NYHA Class III/IV heart failure to be indicated for CRT-D therapy. However, approximately 70 percent of all heart failure patients in the U.S. fall into Class I or II. Nearly 22 million people worldwide, including approximately 5.5 million Americans, suffer from some form of heart failure. ___________________________

More than 2,500 Cases Completed With the Magnetic Irrigated Catheter

Stereotaxis, Inc., announced that clinicians have performed more than 2,500 procedures with the magnetic irrigated catheter since its commercial release. The clinical performance of the catheter in these cases has been exceptional. The major adverse cardiac event rate for magnetic procedures remains at 0.1%. "The irrigated tip is a great asset for creating deep lesions in patients with ventricular tachycardias in the setting of structural heart disease," said Dr. Raul Weiss, associate professor of medicine at The Ohio State University and an electrophysiologist at the Ross Heart Hospital in Columbus. "The ThermoCool magnetic catheter creates deeper lesions because the catheter remains in contact with the beating heart. The irrigation allows me to deliver more energy, creating a larger lesion. You don't have to push on the catheter like you do with a manual catheter, so the likelihood of perforation, I think, is significantly reduced." Overall, the Niobe Remote Magnetic Navigation System has been utilized in nearly 23,000 cases worldwide. These include ablations of a wide variety of cardiac arrhythmias in all four chambers of the heart and across a broad spectrum of patients ranging from pediatric to geriatric. Included in the Niobe clinical experience are several very compelling procedures in patients with congenital heart defects and patients with peripheral vascular occlusive disease. Altogether this represents the broadest range of cardiovascular applications achieved with any commercial remote magnetic, robotic or mechanical navigation system presently in the marketplace. "The addition of the magnetic irrigated catheter has broadened the capabilities of the Stereotaxis system, further demonstrating the potential of our remote magnetic navigation technology as a platform for all manner of cardiac and vascular interventions," said Michael P. Kaminski, Stereotaxis President and CEO. ___________________________

ATS Medical Announces First Use of the New ATS CryoMaze 10-S Probe

ATS Medical, Inc., manufacturer and marketer of state-of-the-art cardiac surgery products and services, announced the first commercial use of the new ATS CryoMaze™ 10-S Surgical Cryoablation Probe for the treatment of cardiac arrhythmias. The cryoablation procedure was performed by Niv Ad, MD, Chief of Cardiac Surgery at the Inova Heart & Vascular Institute in Falls Church, Virginia, a premier heart center in the United States. The ATS CryoMaze 10-S Probe complements the current product offering by adding a linear cryoablation probe that is more rigid than the current ATS CryoMaze Probes. The increased support throughout the length of the 10-S probe addresses the preference of some surgeons to have more probe leverage to achieve contact with targeted tissue that is difficult to reach. In addition, the increased stiffness of the ATS CryoMaze 10-S Probe will optimize the shape retention of the malleable probe, which is particularly useful in minimally invasive procedures. The new cryoablation probe leverages the second-generation, argon-based ATS CryoMaze System that quickly achieves the coldest probe temperatures available for cardiac arrhythmia surgery. The argon-based cryoablation system routinely reaches probe temperatures of -160 degrees C compared to first-generation nitrous-oxide systems that only reach temperatures of -65 degrees C. The colder probe temperatures provide faster, deeper lesions yielding greater confidence that transmural, linear lesions are being achieved, especially in clinical situations in which varying tissue thickness is the rule. The proprietary design utilized in all ATS CryoMaze Probes allows them to be easily shaped by hand without the need for a tool to control the radius of the bends. The probe tip can be repeatedly re-shaped intraoperatively to meet the different anatomic requirements of the individual patient and procedure. The "bellows" design of the ATS CryoMaze Probes facilitates this durable probe malleability without kinking and/or fractures. "The ATS CryoMaze System is very well equipped for minimally invasive stand-alone surgery for atrial fibrillation. The new, more rigid 10-S probe is a great addition that makes it easier to apply lesions and complete full biatrial Maze-III procedures," said Dr. Ad. "Under guidance of our ATS Cryoablation Surgical Advisory Board, we will continue to advocate complete, biatrial Maze-III lesion sets to achieve the best possible patient outcomes. The surgical approach continues to demonstrate excellent clinical outcomes in treating cardiac arrhythmias," said Michael Dale, President and CEO of ATS Medical. ___________________________

Delays in Defibrillation Not Explained by Traditional Hospital Factors

Traditional hospital factors, such as case volume and academic status, do not appear to predict whether patients with cardiac arrest at that facility are likely to experience delays in receiving defibrillation, according to a report in the Archives of Internal Medicine, one of the JAMA/Archives journals. The American Heart Association recommends that defibrillation be performed within two minutes of cardiac arrest, according to background information in the article. Longer delays to defibrillation are associated with lower survival rates following cardiac arrest in the hospital. Previous studies have found that factors associated with individual patients, such as being admitted to the hospital for a non-cardiac diagnosis and experiencing cardiac arrest on evenings and weekends, predicted delayed defibrillation. However, less is known about whether differences between hospitals are associated with these delays. Paul S. Chan, MD, MSc, of the Saint Luke’s Mid-America Hospital Institute, Kansas City, Missouri, and colleagues analyzed records from 7,479 adult inpatients with cardiac arrest (average age 67 years) at 200 hospitals included in the National Registry of Cardiopulmonary Resuscitation (NRCPR). Hospitals participating in the NRCPR in 2006 were asked to complete a detailed survey, including information about location, hospital teaching status, number of patient beds and the availability of automatic external defibrillators. Rates of delayed defibrillation — defined as longer than the two-minute standard — varied substantially among hospitals and ranged from 2.4 percent to 50.9 percent. Differences between hospitals accounted for a significant amount of the variation between patients; for instance, patients with identical characteristics had 46 percent greater odds of experiencing a defibrillation delay at one randomly selected hospital compared with another. “However, many of the individual hospital characteristics that we explored — such as volume, academic status and hospital-wide mortality rate — were unrelated to hospital performance in defibrillation time,” the authors write. Only the number of beds and the location of the cardiac arrest (for example, in or out of the intensive care unit) were associated with the rate of defibrillation delays, whereas there was no association between delays and geographical location, rate of cardiac arrest per 1,000 patient admissions, existence of an automatic external defibrillator program or most other hospital-related factors assessed. “This lack of correlation between ‘conventional’ hospital-level factors and defibrillation time suggests that other unmeasured characteristics are responsible for certain institutions achieving extremely low rates of delayed defibrillation.” Patients at hospitals with fewer defibrillation delays were less likely to die in the hospital — the odds of survival were 41 percent higher in the one-fourth of hospitals with the fewest defibrillation delays than in the one-fourth of hospitals with the most delays. “Given extensive differences in defibrillation time across institutions and the recognized impact of delayed defibrillation on survival, new approaches to improve hospital performance in defibrillation time could represent a critical area for quality improvement,” the authors conclude. Source: Arch Intern Med 2009;169[14]:1265-1273. *The American Heart Association provides operational funding for the NRCPR. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. ___________________________

Study Reveals Mounting Evidence of Fish Oil’s Heart Health Benefits

There is mounting evidence that omega-3 fatty acids from fish or fish oil supplements not only help prevent cardiovascular diseases in healthy individuals, but also reduce the incidence of cardiac events and mortality in patients with existing heart disease. A new study, published in the August 11 issue of the Journal of the American College of Cardiology, extensively reviews data from a broad range of studies in tens of thousands of patients and sets forth suggested daily targets for omega-3 consumption. “This isn’t just hype; we now have tremendous and compelling evidence from very large studies, some dating back 20 and 30 years, that demonstrate the protective benefits of omega-3 fish oil in multiple aspects of preventive cardiology,” said Carl Lavie, MD, FACC, medical director of Cardiac Rehabilitation and Prevention, Ochsner Medical Center, New Orleans, LA, and lead author of the article. “The strongest evidence of a cardioprotective effect of omega-3s appears in patients with established cardiovascular disease and following a heart attack with up to a 30 percent reduction in CV-related death.” Dietary intake of fish oil can also decrease the risk of atherosclerosis, arrhythmias, heart attack, sudden cardiac death and even health failure. Dr. Lavie adds that although there is a smaller benefit in reducing heart failure death — 9 percent mortality benefit in a major recent randomized controlled trial — this is still very impressive given patients’ grave prognosis. “If we translate this finding, it means that we only need to treat 56 patients for four years to prevent one death,” he said. “And we are talking about a very safe and relatively inexpensive therapy.” Most of the evidence for the cardioprotective benefits supports the use of DHA (docosahexaenoic acid) and EPA (eicosapentaenoic acid), the long-chain fatty acids in the omega-3 family. According to Dr. Lavie, EPA and DHA work by getting into the membranes of cells and, in doing so, may help to improve the heart’s electrical activity, vascular tone, plaque stabilization and blood pressure, among other benefits. Studies show that the reduction in CV events is inversely related to the tissue level EPA and, even more so, DHA. Based on these findings, and because the body does not produce its own essential fatty acids, the authors recommend that healthy individuals should consume 500 mg daily of omega-3 fish oil containing EPA and DHA, and people with known heart disease or heart failure aim for at least 800 to 1,000 mg daily. “There are clear health and heart benefits associated with increasing one’s intake of foods that are rich in omega-3s, including oily fish like salmon, sardines, trout, herring, and oysters,” said Dr. Lavie. Dr. Lavie and his team came across only a few negative studies, including a recent one that showed no benefit in post-MI patients, but it has raised the possibility that omega-3 fatty acids may not provide as much additional protective benefits in low-risk patients already receiving extensive and rigorous post-MI therapies. “It was a one-year study that enrolled fewer than 4,000 patients and the majority were using aspirin, clopidogrel, statins, beta-blockers and ACE-inhibitors — the best of modern medicine,” he said. “It may be that their risk was so low to start, that a larger study with longer follow-up would be required to better assess the true efficacy of omega-3 in such relatively low-risk patients.” Authors say further studies are needed to investigate and determine optimal dosages, as well as the relative ration of DHA and EPA that provides maximal heart protection in those at risk of cardiovascular disease, and in the treatment of atherosclerosis, arrhythmias and heart attacks. Interestingly, culture has historically played a role; sometimes dubbed the “Eskimo factor”: research shows cultures that have traditionally supported a diet rich in fish oil (Asian and Alaskan American populations) had a lower prevalence of cardiovascular disease and mortality, including a reduced prevalence of atherosclerosis and heart disease, compared to European and United States populations where consumption of fish is lower. Ironically, the introduction of Western dietary practices into Asian and Native American cultures may be diluting the cardioprotective benefits enjoyed by these populations by both reducing the overall intake of fish oils, as well as overwhelming its benefits with other deleterious dietary practices, including high intakes of saturated and trans fats and cholesterol. ___________________________

Myocardium Technologies Launches New Precision Recorder to Acquire Micropotential Cardiac Signals

Myocardium Technologies, USA, announced the launch of its Microcardiograph Recorder in the United States. The recorder is part of the MTECGx product series based on the company's precision non-invasive technologies. The technologies are the result of the company's extensive research on arrhythmogenesis, cardiac disease causing mechanisms, the substrates that sustain them, and factors that directly or indirectly impact the heart. The heart's abnormalities and its disease-causing conditions can be better determined if their pathophysiological evidence can be acquired in its original form. Non-invasive capture of such signals from the body surface by separating noise and unwanted signals, presents significant challenges. Complex signal processing corrupts the original signals. The Microcardiograph Recorder features up to 8 channels of continuous recording of cardiac micropotentials in their pristine form. The Microcardiograph Recorder software provides simultaneous capture, display, and prints of the recordings. As a portable hand-held device, the product easily connects to a company-certified laptop or battery-operated computer, with the recorder software installed. "The ability to acquire micropotentials non-invasively with the Microcardiograph Recorder is a significant achievement for us in commercializing our technologies, said Suresh Narayanaswamy, CEO and chief scientist of Myocardium Technologies. "The launch of the Microcardiograph Recorder allows the physician to track beat-to-beat cardiac variations in disease-causing situations. This innovation will greatly benefit the medical centers in their research while enhancing patient care." A pioneer in advanced, non-invasive cardiology products, the Myocardium Technologies team includes original contributors of high-resolution electrocardiography and electrophysiology. With research and development dating back to 1996, the company intensified its efforts to commercialize its technologies over the past few years. In addition to cardiology products, the company provides product customizations as a service to customers. The Microcardiograph Recorder is commercially available only to medical centers and hospitals for research purposes. ___________________________

Marketing Application for Vernakalant Intravenous (IV) Filed in Europe for the Treatment of Atrial Fibrillation

Merck & Co., Inc., Whitehouse Station, NJ, USA, which operates in many countries as Merck Sharp & Dohme Limited, announced that the European Medicines Agency (EMEA) accepted for review the company’s Marketing Authorization Application (MAA) for regulatory approval of vernakalant intravenous (IV). The proposed indication for vernakalant IV is for the treatment of acute atrial fibrillation (AF). AF is an erratic and often rapid heart rate where the electrical activity of the heart's two small upper chambers is not coordinated, resulting in inefficient pumping of blood and an increased risk of developing a blood clot in the heart, which could lead to stroke. "Acute atrial fibrillation represents a significant unmet medical need, particularly for older adults," said Stefan Oschmann, president, Europe, Middle East, Africa and Canada, Merck Global Human Health. “The decision by EMEA to review vernakalant IV represents an important milestone in our long history of developing novel therapeutics for cardiovascular disease.” Vernakalant is an investigational compound being developed in two formulations, oral and IV, to address multiple unmet needs in the management of atrial fibrillation. Vernakalant IV is being developed for rapid-acting cardioversion, or restoration of normal heart rhythm, of patients suffering from acute AF. Vernakalant oral is being developed for daily maintenance of normal heart rhythm in patients with atrial fibrillation to prevent reoccurrence of atrial fibrillation. Oral vernakalant is currently in Phase II development. Merck & Co., Inc. announced a collaboration and licensing agreement with Cardiome Pharma Corp. in April for the development and commercialization of vernakalant. The agreement provides Merck & Co., Inc. with exclusive global rights to the oral formulation of vernakalant, and provides the Merck affiliate, MSD Switzerland GmbH, exclusive rights to the I.V. formulation outside of the United States, Canada and Mexico. ___________________________

T-Wave Morphology Parameters Open New Door to Cardiovascular Mortality Prognosis

New research reveals T-wave morphology parameters contain predictive value for mortality in the general population, independent of other clinical risk factors. A study published in the August edition of the HeartRhythm Journal, the official journal of the Heart Rhythm Society, indicates that T-wave morphology parameters may allow health care professionals to better assess arrhythmia vulnerability in patients, and the prognostic value is uniquely related to cardiovascular mortality and seems to be gender specific. The study, led by Kimmo Porthan, MD, Department of Cardiology at Helsinki University Central Hospital in Finland, aims to equip health professionals with a dependable prognosis tool that has never been available through traditional electrocardiographic QT intervals. The study was the largest of its kind and conducted by assessing 5,917 adults participating in the Finnish population-based Health 2000 Study. “The study shows that, unlike ECG QT intervals, T-wave morphology parameters contain predictive value for mortality in the general population,” said Dr. Porthan. “The study results deepen our existing knowledge about the predictive value of several ECG repolarization parameters and will potentially help plan future clinical trials assessing cardiac repolarization.” In this large, population-based prospective study, ECG T-wave morphology parameters, but not heart rate-corrected QT interval, provide independent prognostic information specifically on cardiovascular mortality. Of the 335 deaths that occurred between the start of the study and a mean follow-up of nearly six years, 131 were cardiovascular deaths. Additionally, T-wave morphology parameters show gender specificity in their performance, suggesting that T-wave morphology parameters should be assessed gender specifically in order for clinical risk indicators to be as precise as possible. T-wave morphology parameters measure abnormalities during the ventricular repolarization phase and are potentially interrelated with arrhythmia vulnerability. As researchers learn more, T-wave morphology parameters may eventually help health professionals select specific treatment strategies.