Industry News and Products

Biosense Webster Receives FDA Clearance for the Carto® 3 System

State-of-the-Art Navigational Mapping System Offers Unique Combination of Accuracy, Speed and Efficiency Biosense Webster, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared for marketing the Carto® 3 System, the most advanced three-dimensional imaging technology for use by electrophysiologists in treating cardiac arrhythmias. It is estimated that 20 million people in the United States suffer from some sort of arrhythmia. Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia, affecting between 2.3 to 5.6 million adults in the United States alone, and is the leading cause of stroke among people 65 years and older. The Carto® 3 System offers three unique features: Advanced Catheter Location (ACL) Technology, Fast Anatomical Mapping (FAM), and a streamlined workflow feature set referred to as CONNECTION OF CHOICE™. These three features work in tandem to enhance a physician’s ability to treat an array of simple and complex cardiac arrhythmias. ACL is a hybrid technology that allows for accurate catheter tip and curve visualization without spatial distortion. This helps the electrophysiologist to orient catheters with precision for diagnostic and therapeutic applications. The system can visualize up to five catheters simultaneously with clear distinction of all electrodes. FAM is a leading-edge technology that quickly and accurately creates high-resolution, CT-like maps as quickly as an EP can move his or her catheter throughout the cardiac chamber. FAM technology also permits detailed visual enhancement of a specific area of interest within the heart. CONNECTION OF CHOICE™ is enabled by the brand new Carto® System hardware configuration featuring a central connection point for all catheters and equipment while preserving the signal quality of intracardiac electrograms. Catheter connections have been redesigned for “plug-and-play” functionality and automatic catheter recognition. All of these enhancements have been developed to streamline and simplify workflow in the EP lab. “Procedure time is consistently cited by EPs as the most significant barrier to increased use of ablation therapy to treat cardiac arrhythmias,” said Shlomi Nachman, Worldwide President, Biosense Webster, Inc. “All of the enhancements offered by the Carto® 3 System have been developed to streamline and simplify workflow in the EP lab.” One of the leaders of the recent external evaluations, Vivek Y. Reddy, MD, offered praise for the Carto® 3 System. “The Carto® 3 System is an exciting technology that represents a major step forward for electrophysiologists. I was especially impressed with the Fast Anatomical Mapping feature. I was able to create a map quickly and the accuracy was excellent,” said Dr. Reddy, Director, Cardiac Arrhythmia Service, The Zeng and Michael A. Wiener Cardiovascular Institute, The Marie-Josee and Henry R. Kravis Center for Cardiovascular Health. Dr. Reddy is also Professor of Medicine at Mount Sinai School of Medicine in New York City. “In addition, I was pleased with how the system merged with our CT scan. Overall, the evaluation was a great experience for the whole lab team, who enjoyed the new quick system set up.” Dr. Reddy is compensated for his time as a consultant to Biosense Webster. _________________

Transoma Medical Enrolls First Patient in Clinical Study Comparing Use of External Recorders with Implantable Monitors to Track Recurrence of Atrial Fibrillation

Transoma Medical, Inc., manufacturer of Sleuth AT™, the wireless, automated implantable cardiac monitoring system with programmable and frequent electrocardiogram (ECG) sampling, announced the first enrollment and implant in the COMPLIANCE trial, a long-term study to compare external event recorders with implantable monitors in patients who have been prescribed catheter ablation therapy for atrial fibrillation (AF) at risk of post-procedure AF recurrence. Dr. Dhanunjaya Lakkireddy performed the first implant at the University of Kansas Medical Center, Kansas City, Kansas. Dr. Lakkireddy, director of the Center for Excellence in Atrial Fibrillation, Bloch Heart Rhythm Center, and associate editor of the Journal of Atrial Fibrillation, is the principal investigator for the clinical study. The company received FDA 510(k) marketing clearance for Sleuth AT, its next-generation product, in February 2009. “I am very excited about the potential for Sleuth AT to provide a unique method of long-term cardiac monitoring for AF recurrence after ablations,” said Dr. Lakkireddy. “The COMPLIANCE clinical trial will help compare cost-effectiveness and efficacy of external versus implantable monitoring after ablation of AF. We hypothesize that implantable loop recorders are superior in detection of atrial arrhythmias after AF ablation, and are much more cost effective and more user friendly, facilitating patient compliance.” The COMPLIANCE trial (Comparison of External Event Recorders with Implantable Monitor for Post Atrial Fibrillation Monitoring. Assessment of Cost and Efficacy) is a randomized study that is designed to compare the number of patients who develop recurrent AF at six months, one year and two years of an AF ablation procedure between the conventional external monitoring (combination of non-looping and looping event recorders), and implantable loop recorders. The study will collect and analyze information on the percentage of patients who develop stroke symptoms, and their medication use, quality of life, and time to diagnosis of the recurrence of AF between event recorders and implantable loop recorders to estimate cost effectiveness. The study will enroll 140 patients. “Current external monitoring options provide 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,” said Dr. Lakkireddy. “Often times, it is very inconvenient for patients to wear external event recorders. Many patients also have allergies to the sticky pads that are needed for most of the external monitoring devices. Implantable loop recorders have the advantage of detecting symptomatic and asymptomatic AF continuously. They also offer the convenience of monitoring for up to 18 to 24 months without significant patient discomfort.” Earlier studies have shown that conventional monitoring methods cannot detect AF in all cases, and that a prolonged duration of monitoring is required to effectively measure the absence or presence of AF post-ablation. Due to the asymptomatic and transient nature, paroxysmal (sudden onset) atrial fibrillation detection does not often occur within the bounds of the Holter monitors, event recorders or mobile out-clinic monitoring systems (MCOT). Addressing such diagnostic limitations, the Sleuth AT System provides implantable ECG monitoring, with wireless automatic event reporting. ECGs are periodically collected (up to eight times an hour). Sleuth AT is the only 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 AF. “Since clearance of the Sleuth AT system, we have seen tremendous interest in long-term monitoring of patients after AF ablation procedures, both by electrophysiologists performing catheter ablations as well as cardiac surgeons performing surgical ablations,” 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. We believe Sleuth AT is a unique and superior method for monitoring AF and the effects of current and future therapies.” ________________

Correlagen Announces Launch of Expanded Cardiac Genetic Testing Services

Comprehensive Diagnostic Testing Offered for All Major Genetic Causes of Cardiac Disease Using ‘Next Generation’ Sequencing Methods Correlagen announced the launch of its CardioGeneScan test, the first comprehensive genetic test for the diagnosis of familial cardiac disease. The CardioGeneScan tests for disease-causing variation in all genes known to be associated with familial cardiovascular diseases, including cardiomyopathy, arrhythmia, thoracic aortic aneurysm, Noonan Syndrome and related diseases, and early-onset coronary artery disease. Due to its unprecedented breadth of testing, the CardioGeneScan has clinical utility for a wide range of patients with a family history of cardiac disease. Physicians will be able to assess the cardiac genetic make-up of their patients through a single test at a price that is affordable to their patients. More focused disease- or gene-specific testing is also available. “Identifying the genetic cause underlying cardiac disease in an affected family can benefit generations of family members,” stated David Margulies, MD, Chairman and CEO of Correlagen. “Testing for the presence of familial disease variants can determine risk in young family members and help prevent sudden cardiac death through timely intervention. Early diagnosis can, for certain cardiac conditions, allow for early pharmacologic treatment, which can prevent severe disease and costly, painful interventions later. The CardioGeneScan test has a higher sensitivity than any other conventional genetic tests, since it looks for variation in more than 100 relevant genes.” The breadth of the CardioGeneScan is enabled through use of next-generation sequencing technology, which provides greater sequencing capacity at a lower per-gene cost than previous methods. As associations with inherited cardiac disease are demonstrated by researchers and clinicians in the field, Correlagen will add new genes to the CardioGeneScan to keep testing current. In addition, physicians will receive Correlagen’s signature ‘evergreen’ results report, which are revised periodically as new knowledge becomes available about the genetics of cardiac disease that impacts the clinical interpretation of previously identified variants. Such systematic report updating is enabled through Correlagen’s unique, evidence-based variant scoring protocols and result reporting processes. Physicians who are interested in this new test may contact Correlagen’s client services at or call client services at 781-647-0604. ________________

ATS Medical Announces Receipt of CE Mark for 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 receipt of CE Mark for the ATS CryoMaze® 10-S Surgical Cryoablation Probe for the treatment of cardiac arrhythmias. The first use of the 10-S probe in Europe was performed by Professor Friedrich W. Mohr at the Klinik fur Herzchirurgie (Clinic for Heart Surgery) in Leipzig, Germany. The ATS CryoMaze 10-S Probe complements the current product offering by adding a linear cryoablation probe that provides more controlled stiffness 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 controlled support of the ATS CryoMaze 10-S Probe will optimize the shape retention of the malleable probe, which is particularly useful in minimally invasive procedures. "I have been using the ATS CryoMaze system for several years," said Professor Mohr. "I now prefer the 10-S probe because I believe it will be useful to help me maintain good tissue contact, especially 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 Celsius compared to nitrous-oxide systems that only reach temperatures of -65 degrees Celsius. 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 can be repeatedly re-shaped 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. _________________

Relypsa Initiates Phase 2b Clinical Trial of RLY5016 for the Prevention of Hyperkalemia in Heart Failure Patients

Relypsa, Inc. announced the initiation of patient enrollment in the PEARL-HF study, a Phase 2b clinical trial of the company’s lead compound, RLY5016. A novel potassium binder designed for chronic use, RLY5016 is being evaluated in the prevention and treatment of hyperkalemia, for which there are no current satisfactory treatments. Hyperkalemia is a condition characterized by elevated serum potassium levels, which can lead to cardiac arrhythmia and sudden death. Heart failure patients are at particular risk for developing hyperkalemia, especially those patients with underlying chronic kidney disease treated with Renin-Angiotensin-Aldosterone-System (RAAS) inhibitors. RAAS inhibition in such patients provides a life-saving therapy, but has the undesirable side effect of increasing serum potassium. The PEARL-HF Phase 2b clinical trial is a multi-center, randomized, placebo-controlled study designed to assess the efficacy, safety and tolerability of RLY5016 for the prevention of hyperkalemia in heart failure patients. The study is being conducted at clinical sites worldwide and patient enrollment is underway. The Phase 2b clinical trial follows the successful completion of three clinical trials of RLY5016, including two Phase 1 trials and a Phase 2a trial. RLY5016 was well-tolerated in these studies. In healthy volunteers, RLY5016 demonstrated dose-related pharmacological effects. In a Phase 2a clinical trial of hemodialysis patients with hyperkalemia, RLY5016 lowered serum potassium, achieving proof-of-concept. “We are pleased to advance our lead compound RLY5016 into Phase 2b clinical testing, following very encouraging tolerability and efficacy results observed in Phase 1 and Phase 2a clinical trials,” said Detlef Albrecht, MD, Chief Medical Officer and Senior Vice President, Drug Development of Relypsa. “RLY5016 holds great promise in preventing and treating hyperkalemia, and thereby enhancing the use of life-saving drugs for heart failure patients. To date, we have been pleased by the interest received from clinical investigators and the positive enrollment trends observed in the first portion of the trial. We look forward to reporting interim results from the PEARL-HF Phase 2b clinical trial in the first quarter of 2010.” __________________

Boston Scientific Announces Exclusive Sponsorship and First Enrollments of MADIT-RIT Clinical Trial

Boston Scientific Corpora-tion announced its exclusive sponsorship and first enrollments of the MADIT-RIT clinical trial. This new trial follows in the tradition of three previous landmark trials: MADIT, MADIT II and MADIT-CRT, each exclusively sponsored by Boston Scientific and conducted under the leadership of Principal Investigator Arthur J. Moss, MD, Professor of Medicine at the University of Rochester. MADIT-RIT is designed to determine which device programming strategy best minimizes the occurrence of unnecessary therapy in patients who have received an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) and have no history of cardiac arrest. Unnecessary therapy has a significant impact on quality of life, especially for patients with no history of cardiac arrest. The MADIT-RIT trial is a prospective, randomized study that will enroll 1,500 patients at approximately 75 centers globally. "Clinical science has proved time and again that ICDs are highly effective in reducing death due to arrhythmias in high-risk cardiac patients," said Dr. Moss. "However, some patients receive unnecessary therapy, partly due to the programming of these devices at implant. MADIT-RIT will study the effects of programming on the occurrence of unnecessary therapy in these patients." The first enrollments in this worldwide trial occurred last month in Graz, Austria at the Medizinische Universitatsklinik Graz (Burkert M. Pieske, MD, and Daniel Scherr, MD); Basel, Switzerland at the Universitatsspital Basel (Beat Schaer, MD, and Christian Sticherling, MD); Detroit, Michigan at the St. John Hospital and Medical Center (Luis Pires, MD); and Little Rock, Arkansas at Arkansas Cardiology (Steven Greer, MD). ________________

Recommended Treatment for Heart Failure Often Underused

Less than one-third of patients hospitalized for heart failure and participating in a quality improvement registry received a guideline-recommended treatment of heart failure, aldosterone antagonist therapy, according to a study in the October 21 issue of JAMA. Clinical trials have established the benefits of aldosterone antagonist therapy (an agent that opposes the action of the adrenal hormone aldosterone) in patients with heart failure (HF), such that they were designated as “useful and recommended,” within the American College of Cardiology/American Heart Association (ACC/AHA) Chronic HF Guidelines. Adoption of aldosterone antagonists for treatment of HF has been mixed, according to background information in the article. “The Get With The Guidelines–HF (GWTG-HF) program is a national quality improvement program designed to promote adherence to guideline-based recommendations. It is unknown whether participation in a hospital-based quality program may lead to greater frequency of use of aldosterone antagonist therapy for appropriate indications as well as lower use in situations of increased risk,” the authors write. Nancy M. Albert, PhD, RN, of the Cleveland Clinic, Cleveland, and colleagues examined recent aldosterone antagonist use among hospitalized patients with HF, as well as temporal trends and appropriateness of use. The observational analysis included 43,625 patients admitted with HF and discharged home from 241 hospitals participating in the Get With The Guidelines–HF quality improvement registry between 2005-2007. In total, 12,565 patients (28.8 percent) from 201 hospitals met ACC/AHA management guidelines criteria, and 4,087 eligible patients (32.5 percent) received an aldosterone antagonist at hospital discharge. Treatment increased modestly from 28 percent to 34 percent over the study period. There was also wide variation in aldosterone antagonist use among hospitals (0 percent-90.6 percent). “Aldosterone antagonist use in eligible patients was associated with younger age, African American race/ethnicity, lower systolic blood pressure, history of implantable cardioverter-defibrillator use, depression, alcohol use, and pacemaker implantation, and with having no history of renal insufficiency,” the authors write. Applying certain appropriateness criteria, inappropriate and potentially inappropriate use of aldosterone antagonist therapy was low and did not change over the three-year study period. “These data confirm that in the context of a hospital-based performance improvement program, aldosterone antagonist therapy can be used according to guidelines with little inappropriate use. Given the substantial morbidity and mortality risk faced by patients hospitalized with HF and the established efficacy of aldosterone antagonist prescription in HF, a stronger uptake of aldosterone antagonist therapy indicated by evidence-based guidelines may be warranted,” the researchers conclude. _______________

Multaq® (dronedarone) Recommended for Approval in the European Union

Sanofi-aventis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion recommending to grant a marketing authorization in the European Union for Multaq® (dronedarone - 400mg Tablets). The CHMP has recommended the approval of Multaq® in adult clinically stable patients with history of or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate. In the Summary of Positive Opinion, the CHMP has acknowledged that dronedarone has been shown, in addition to its rhythm and rate-controlling properties, to decrease the risk of AF-related hospitalizations. The positive opinion from the CHMP needs now to be ratified by the European Commission. "Sanofi-aventis welcomes the positive CHMP recommendation for the approval of Multaq® in the European Union," said Jean-Pierre Lehner, Chief Medical Officer, sanofi-aventis. "This decision brings new hope to people whose lives are impacted by the potential cardiovascular complications of atrial fibrillation. We do think that Multaq® will contribute to fulfill significant unmet medical needs for the patients." The CHMP positive opinion is based on the submission of a comprehensive clinical data package including seven international, multi-center, randomized clinical trials involving more than 7,000 patients and including the landmark ATHENA trial. The ATHENA trial involved 4,628 patients with atrial fibrillation/atrial flutter or a recent history of these conditions and showed that Multaq® (dronedarone) in addition to standard therapy reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24% (pAtriCure Announces European Approval for its AtriClip™ System AtriCure, Inc. announced CE Mark approval for its AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion System. The AtriClip System is designed to safely and effectively exclude the left atrial appendage and is being launched in Europe through a phased approach during the fourth quarter. The system was successfully utilized recently in multiple European centers during both open-heart and minimally invasive cardiac procedures. The first cases were performed at the University of Zurich in Switzerland by Professor Volkmar Falk and Dr. Sacha Salzberg. “The AtriClip System was intuitive to use and resulted in a safe and complete exclusion of the left atrial appendage,” said Professor Falk. “This is a very promising advancement for exclusion of the left atrial appendage. We look forward to further use and evaluation of this system.” “We believe that the AtriClip System provides a safe, efficient and clinically superior method to exclude the left atrial appendage,” said David J. Drachman, President and Chief Executive Officer of AtriCure. “This key innovation represents a large and exciting new growth platform, and we look forward to full commercial release in Europe and the United States during 2010.” The AtriClip System includes a clip device that is designed to exclude the left atrial appendage, a hollow sac-like structure attached to the heart’s left atrium. The left atrial appendage has internal peaks and valleys, or trabeculations. During atrial fibrillation (AF), stagnant blood pools in the trabeculations of the left atrial appendage and is known to form clots that can migrate to other parts of the body. The AtriClip is designed to be implanted from the outside of the heart, avoiding contact with circulating blood and eliminating blood flow between the left atrial appendage and the atria. AtriCure, Inc. is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions in cardiac tissue. Medical journals have described the adoption by leading cardiothoracic surgeons of the AtriCure Isolator® bipolar ablation system as a treatment alternative during open-heart surgical procedures to create lesions in cardiac tissue to block the abnormal electrical impulses that cause AF. Additionally, medical journals and leading cardiothoracic surgeons have described the AtriCure Isolator system as a promising treatment alternative for patients who may be candidates for sole-therapy minimally invasive procedures. AF affects more than 5.5 million people worldwide and predisposes them to a five-fold increased risk of stroke. The FDA has cleared the AtriCure Isolator system and AtriCure’s multifunctional pen and Coolrail™ linear ablation device, for the ablation of cardiac tissue during surgical procedures. Additionally, the FDA has cleared AtriCure’s multifunctional pen for temporary pacing, sensing, stimulating and recording during the evaluation of cardiac arrhythmias and AtriCure’s Cryo1 system for the cryosurgical treatment of cardiac arrhythmias. To date, the FDA has not cleared or approved AtriCure’s products for the treatment of AF. ______________

BIOTRONIK Home Monitoring® Receives Industry’s First Approval to Safely Replace Hospital Visits for Cardiac Device Follow-Ups

BIOTRONIK SE & Co. KG announced the industry’s first European CE Mark approval for its remote patient monitoring technology. BIOTRONIK Home Monitoring® is now approved to safely replace in-hospital device follow-up visits. This new CE Mark follows the recently received equivalent FDA approval granted in May 2009. BIOTRONIK Home Monitoring® is the first and only fully wireless, mobile remote monitoring system for patients with implantable cardiac devices on the market today. This newly authorized EU approval for BIOTRONIK Home Monitoring® is based on the landmark TRUST Trial,1,2 which proved that BIOTRONIK Home Monitoring® can safely and effectively replace conventional in-hospital device follow-up visits. Patients can be remotely monitored securely through the BIOTRONIK Home Monitoring® wireless system with only one annual in-clinic visit. In addition, the TRUST trial also demonstrated that BIOTRONIK Home Monitoring® with its automatic daily surveillance provides early detection and notification of both symptomatic and asymptomatic arrhythmic events and device system anomalies, allowing for earlier physician intervention than conventional in-hospital follow-ups. By extending the time between routine in-hospital visits for periods up to 12 months, remote device follow-up with BIOTRONIK Home Monitoring® reduces the number of physician consultations in often overburdened cardiology hospitals without negatively impacting patients’ quality of care or safety. Physicians and clinic staff benefit from reduced workloads for routine cases, which allow them to afford greater attention to patients who urgently require a consultation for diagnostics and treatment. These new approvals are applicable across the entire BIOTRONIK product portfolio of pacemakers, implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) devices with BIOTRONIK Home Monitoring®. Marlou Janssen, Vice President Global Marketing and Sales, Cardiac Rhythm Management, BIOTRONIK, said “By implementing BIOTRONIK Home Monitoring®, physicians can enhance patient care while optimizing clinic efficiencies and workflows.” BIOTRONIK’s Home Monitoring technology has also just been nominated for the prestigious German Federal President’s “Deutscher Zukunftspreis” (German Innovation Award) for its pioneering achievement in medical technology. BIOTRONIK was first to develop and introduce an Internet-based, wireless remote monitoring system using the GSM telephone network. Today, more than 230,000 BIOTRONIK Home Monitoring® systems have been implanted in more than 55 countries worldwide, helping to optimize patient care. BIOTRONIK Home Monitoring® is available across the entire BIOTRONIK product portfolio of pacemakers, ICD and CRT devices enabling remote device follow-up at any time from anywhere in the world. Developed by a steering committee of electrophysiologists and cardiologists, with 1,443 patients enrolled from 105 North American sites, TRUST (Lumos-T Safely Reduces Routine Office Device Follow Up) is the first and largest study to test remote monitoring and rapid detection of symptomatic and asymptomatic cardiac events in a prospective, randomized trial. The study used BIOTRONIK Home Monitoring®, an automatic, fully wireless system that performs daily telemetric surveillance of the patient and the technical status of the implanted device, without requiring patient activation. 1 Varma N, et al. Evaluation of efficacy and safety of remote monitoring for ICD follow-up: the TRUST trial. Circulation 2008;118;2309-2317, Abstract 4078. 2 Varma N, et al. Eur Heart J 2009;30(Abstract Suppl.)Nr. 1909, P1656.