Industry News and Products

Medtronic Launches Global Clinical Trial Evaluating Outcomes From Comprehensive Attain® Family of Left-Heart Leads and Delivery Catheters

Medtronic, Inc announced the first enrollment in the global Attain Success trial that will evaluate implant success, complication rates and procedure times in the market-released Attain® Family of left-heart leads and delivery systems portfolio. Fifteen new Attain Family therapy delivery products were commercially released in the last two years, including 13 catheters and two Medtronic-exclusive left-heart leads — Attain StarFix® and Attain Ability®. Safwat Gassis, MD, with Associated Cardiologists at Pinnacle Health Harrisburg Hospital in Harrisburg, Pennsylvania, completed the first enrollment. “This broad portfolio of left-heart lead and catheter delivery tools help physicians address the needs of a range of patients, especially those with difficult-to-navigate anatomies,” said John Hummel, MD, electrophysiologist with The Ohio State University in Columbus, Ohio, and global principal investigator for Attain Success. “This trial will explore how well these easy-to-use tools work to simplify and reduce the procedure time for physicians.” “The Attain family is a comprehensive portfolio of left-heart technologies supported by clinical evidence demonstrating low dislodgment and high implant success rates,” said Marshall Stanton, MD, vice president of clinical research for the Cardiac Rhythm Disease Management business at Medtronic. “We are excited to do the first large global analysis to confirm our previous clinical results and gather procedure and handling information from physicians on this innovative portfolio.” Medtronic’s Attain Success trial is a prospective, post-market, global trial that will enroll approximately 2,000 subjects at 150 medical centers in 18 countries around the world. Data will be analyzed at baseline, implant and three months post-implant. Implant success and complication rates (up to three months), procedure times, handling feedback and physician survey data also will be captured in the Attain Success trial. A sub-study will assess final left-heart lead placement site. Results are expected in two and a half years. Study enrollees will have a Medtronic cardiac resynchronization therapy-defibrillator (CRT) device and use one of the following from the Attain family: • Attain StarFix® or Attain Ability® left-heart leads; • Attain Command®, Attain Select® II, Attain Select®, Attain® Deflectable, or Attain Prevail® catheters; or • Any other market-released Attain model of delivery catheters, left-heart leads or guidewires. ___________________

Remote Heart-Monitoring Platform Begins Validation

STMicroelectronics Collaborates with Mayo Clinic to Accelerate Development and Deployment of Innovative Telemedicine Solutions STMicroelectronics, one of the world’s leading semiconductor companies, and Mayo Clinic, a premier health-care organization, are collaborating on a novel platform for remotely monitoring patients with chronic cardiovascular disease. The platform will provide a comprehensive and unobtrusive solution that monitors person-specific data and physiological parameters and influences lifestyle and treatment choices. Telemedicine, which allows medical professionals to monitor or treat patients even when they are not in the same location, is widely recognized as an essential step in reducing the escalating cost of healthcare. Instead of entering a hospital or visiting a doctor for check-ups, the patient wears a small device that continually monitors a number of relevant physiological parameters. This approach has many potential benefits, including maintaining wellness, earlier detection of developing health conditions, improving lifestyle, and lowering healthcare costs. “Mayo Clinic has always committed the best available resources to caring for patients with cardiovascular disease. This collaboration, by enhancing our ability to record important physiologic information while patients are outside the medical environment and active in their daily lives, will extend our ability to prevent and treat illness,” said Paul Friedman, MD, a cardiology consultant and specialist in cardiovascular electrophysiology at Mayo Clinic, who added that an initial program of patient trials is already underway. This platform is the result of an R&D collaboration that combines ST’s expertise in developing innovative solutions using its advanced sensor, microprocessor and communication products and Mayo Clinic’s best-in-class medical expertise. It uses a combination of sensors, ultra-low-power microcontroller and wireless modules, and interfaces to provide information about the patient’s heart rate, breathing rate, physical activity and other measurements wirelessly obtained from external medical devices. “Combining the worldwide recognized clinical expertise of Mayo Clinic with our ability to provide highly integrated volume solutions at affordable costs, we are convinced we will open new frontiers to bring quality healthcare to everybody,” said Alessandro Cremonesi, Vice President, Advanced System Technology, STMicroelectronics. “ST is utilizing its strong expertise to develop advanced technologies and products satisfying the requirements of telemedicine platforms. This will allow medical device manufacturers and health-care providers to develop new products and services to enhance the quality of medical support for their customers and patients.” Telemedicine is expected to play an increasingly important role in helping solve the growing costs of healthcare monitoring and delivery, especially in the context of an aging population. For example, in the USA, which spent over $2 trillion on healthcare in 2007 — nearly twice the average per-capita spending of other developed countries — the Congressional Budget Office estimates that, with current trends, by 2025 some 25% of the national economy will be tied up in healthcare.1 In addition to better service to the patient, the potential benefits of remote monitoring may include: • lower costs due to reduced physician visits for routine check-ups; • earlier diagnosis of impending health problems, leading to earlier intervention, in turn reducing hospitalization, costs and enhancing the probability of successful recovery from illness; • lower environmental burden due to reduced necessity for travel; • acquisition of comprehensive and integrated data for epidemiology, drug safety, and other research studies to advance medical knowledge regarding diseases. Remote monitoring thus offers important opportunities to reduce healthcare costs and enhance patients’ quality of life. Further description of the platform for remote monitoring is available at https://www.mayoclinic.org/medical-edge-television-2009. Disclosure: Neither Mayo Clinic nor its investigators will receive any payment for the use of products developed via this collaboration in clinical trials with Mayo Clinic patients. 1 https://www.whitehouse.gov/issues/health-care ________________

Researchers Develop Innovative Imaging System to Study SCA

A research team at Vanderbilt University has developed an innovative optical system to simultaneously image electrical activity and metabolic properties in the same region of a heart, to study the complex mechanisms that lead to sudden cardiac arrest (SCA). Tested in animal models, the system could dramatically advance scientists’ understanding of the relationship between metabolic disorders and heart rhythm disturbances in humans that can lead to cardiac arrest and death, and provide a platform for testing new treatments to prevent or stop potentially fatal arrhythmias. The research is supported in part by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health. The design and use of the dual camera system is described in the Nov. 1 issue of Experimental Biology and Medicine. Additional support for the project has also been provided by the Vanderbilt Institute for Integrative Biosystems Research and Education (VIIBRE), the American Heart Association, and the Simons Center for Systems Biology at the Institute for Advanced Study. “The challenge in understanding cardiac rhythm disorders is to discern the dynamic relationship between multiple cardiac variables,” said one of the coauthors of the paper and the project’s principal investigator, John P. Wikswo, PhD, Gordon A. Cain University Professor and VIIBRE director. “This dual camera system opens up a new window for correlating metabolic and electrophysiological events, which are usually studied independently.” The 11-year-old research project would have been terminated this year due to lack of funding, according to Wikswo. But a $566,000 American Recovery and Reinvestment Act grant from the NHLBI is enabling the 13-member research team to continue developing and testing the innovative optical system. Recovery Act funds are also allowing the team to purchase a pair of $60,000 high-speed and highly sensitive digital cameras to record the changes in the metabolic and electrical activity of isolated cardiac tissue using low-intensity fluorescent dyes under conditions associated with heart failure, ischemia, fibrillation and other pathological circumstances. “Through the Recovery Act, the NHLBI is able to support promising research to develop and enhance innovative technologies to help us better understand the complex mechanisms involved in potentially fatal conditions such as sudden cardiac arrest,” said NHLBI Director Elizabeth G. Nabel, MD. “This research will allow us to better understand how to prevent and treat life-threatening cardiac rhythm disturbances and potentially save thousands of lives every year.” Each year, 250,000 to 450,000 people die in the United States as a result of sudden cardiac arrest, a condition that is triggered by arrhythmia. Usually, a complex series of electrical and metabolic changes precede sudden cardiac arrest. The Vanderbilt researchers created and tested an innovative way to visualize the electrical activity of the heart in relation to its structure and changing metabolic state under different pathological conditions. Their multimodal cardiac imaging technique uses a two-camera approach to integrate electrophysiological imaging with optical fluorescence imaging of metabolic activity associated with damaged heart tissue and tachycardia, or accelerated heart rate. The biochemical and electrochemical studies of heart tissue under controlled conditions will enhance scientists’ understanding of electrometabolic cardiac disorders and their clinical treatment. The advantages of this imaging system over others include rapid setup, two-color image separation, high spatial resolution, and an optional software camera calibration routine that eliminates the need for precise camera alignment. The authors provide a detailed description of a camera calibration procedure along with multiple examples. In addition, the multimodal imaging system will be a less-invasive, instrumental tool in helping scientists discover and test safe and effective ways to prevent or treat arrhythmias. _________________

BIOTRONIK Launches Evia Pacemaker Series

BIOTRONIK SE & Co. KG announced the European launch of its new, unified platform pacemaker series, Evia, and several new products to further strengthen its bradycardia portfolio. BIOTRONIK continues its product innovation stream with the launch of a completely new bradycardia product portfolio, including the Evia pacemaker series, the new Siello pacing leads as well as a new external pacemaker, Reocor, and a new pacing system analyzer, Reliaty. Evia is the first and only pacemaker with complete, wireless remote monitoring and follow-up capabilities. Patients with an Evia pacemaker can be remotely monitored through the BIOTRONIK Home Monitoring® wireless system with only one annual in-clinic visit. BIOTRONIK Home Monitoring® technology has been approved to safely and effectively replace conventional in-clinic device follow-up visits. Evia and BIOTRONIK Home Monitoring® open new ways to efficiently care for and manage the increasing number of patients with pacemakers. Now physicians have the choice to call in their patients to the clinic or perform remote follow-ups with complete access to all pertinent patient and device information, including high quality IEGM Online HD®. Importantly, BIOTRONIK Home Monitoring® has also received FDA and CE Mark approval for its early detection monitoring technology, which allows clinicians to access their patients’ clinically relevant event data more quickly so they can make immediate therapy decisions to improve patient care. Evia incorporates unique innovations for every step of advanced patient management from implant to follow-up. The small-sized pacemakers with extended longevities also provide several automatic functions to ensure a safe and convenient implantation procedure. In addition to the new platform features, Evia builds on established and proven innovations such as Closed Loop Stimulation® (CLS). CLS is the only rate regulation algorithm that provides appropriate heart rate response, during periods of emotional stress, for improved hemodynamics and increased quality of life. To meet individual patients’ needs, Evia also provides two new algorithms, Vp Suppression® and IRSplus®. These new Evia features are designed to reduce unnecessary ventricular pacing to a minimum, in order to lower patients’ risk of developing atrial fibrillation and heart failure. The new Siello pacing leads have been designed by BIOTRONIK to ensure long-lasting reliability and patient safety. The ultra-thin lead body (5.6 French) with a new polyurethane coating enables more successful implantation, especially in patients with smaller vessels and a more complex anatomy. Evia pacemakers are already designed to be MRI-conditional, and BIOTRONIK is planning to launch a new pacemaker-lead system that will be MRI-compatible under specific conditions during the first half of 2010. ___________________

Stereotaxis Receives Notice of European Approval of an Additional Magnetic Irrigated Catheter

Stereotaxis received notice that the Celsius® RMT ThermoCool® catheter has received CE Mark for distribution in the European market. The product is the fifth advanced ablation catheter resulting from the ongoing co-development agreement between Stereotaxis and Biosense Webster to design and distribute magnetically enabled catheters for use in the Niobe Magnetic Navigation System (MNS). A pre-market approval (PMA) application supplement for the Celsius® RMT ThermoCool® catheter was submitted to the U.S. Food and Drug Administration in September. The Celsius® RMT and NaviStar® RMT families of catheters are the only magnetic catheters accurately matched to the navigational software of the Niobe™ MNS for optimal performance and highly precise catheter manipulation. This catheter fills out the family of magnetic irrigated catheters to offer both localized and non-localized technology. Localized catheters are used for more complex arrhythmias requiring 3-D electroanatomic mapping for precise diagnosis, whereas non-localized catheters are typically used for simpler arrhythmias that can be treated using basic imaging and ECG recordings. __________________

Cardiome and Astellas Announce Initiation of Patient Enrollment in ACT 5 Trial

Cardiome Pharma Corp. and its co-development partner Astellas Pharma US, Inc. announced that patient enrollment has begun for the ACT 5 trial, a confirmatory Phase 3 clinical trial of KYNAPID™ (vernakalant hydrochloride) Injection, a drug product candidate under development for the rapid conversion of atrial fibrillation to sinus rhythm. The ACT 5 trial, previously announced in August 2009, is expected to be completed in the first half of 2011. The ACT 5 trial, “A Phase 3b Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Vernakalant Hydrochloride Injection in Patients with Recent Onset Symptomatic Atrial Fibrillation,” will enroll approximately 450 patients across approximately 100 centers focused in North America. The study is designed to measure the safety and efficacy of KYNAPID Injection in patients with recent-onset atrial fibrillation (more than 3 hours but less than 7 days). The study excludes patients with evidence or history of congestive heart failure. Further, the study will evaluate the influence of CYP2D6 genotype status on the pharmacokinetics and pharmacodynamics of vernakalant (and its metabolites), and also allows for an exploratory analysis of safety and healthcare resource utilization between vernakalant and electrocardioversion. Cardiome Pharma Corp. is a product-focused drug development company dedicated to the advancement and commercialization of novel treatments for disorders of the heart and circulatory system. Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. In the U.S., Astellas markets products in the areas of immunology, urology, anti-infectives, cardiovascular and dermatology. _________________

CardioNet, Inc. Provides Update on Mobile Cardiovascular Telemetry Reimbursement

CardioNet, Inc., a wireless medical technology company with an initial focus on the diagnosis and monitoring of cardiac arrhythmias, announced that the Centers for Medicare and Medicaid Services (CMS) has not established a national pricing reimbursement rate for mobile cardiovascular telemetry (CPT Code 93229) in the Medicare final rule for the physician fee schedule for calendar year 2010. Reimbursement for mobile cardiovascular telemetry will continue to be carrier priced by Highmark Medicare Services (HMS). Randy Thurman, Chairman, President and Chief Executive Officer of CardioNet, stated, “We are extremely disappointed that CMS has not established a national reimbursement rate for mobile cardiovascular telemetry and that it will continue to be regionally priced by HMS. CardioNet and other industry providers have now serviced nearly 400,000 patients nationally, of which a significant portion were Medicare patients. Since the unexpected announcement by Highmark on July 10, 2009, we provided CMS and HMS with substantial data that we believe justified a significantly higher national reimbursement rate and we will continue to work with CMS on a national price for 2011.” CMS also updated the national technical fees for event and Holter monitoring for the calendar year 2010. Event monitoring (CPT Code 93271) and Holter monitoring (CPT Code 93226) reimbursement will be reduced approximately 7% and 16%, respectively, compared to the 2009 rates. ___________________

Boston Scientific’s Most Advanced Devices to Treat Heart Failure and Sudden Cardiac Death Now Available in Japan

COGNIS® CRT-D and TELIGEN® ICD are the World’s Smallest and Thinnest High-Energy Devices Boston Scientific Corporation announced the launch of its COGNIS® cardiac resynchronization therapy defibrillator (CRT-D) and TELIGEN® implantable cardioverter defibrillator (ICD) in Japan. These devices were approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) in August and received reimbursement approval in September. COGNIS and TELIGEN are the result of a multi-year research and development effort to provide physicians enhanced clinical options for their patients. “COGNIS and TELIGEN are now part of Boston Scientific’s full product portfolio in Japan, which also includes the company’s newest and most advanced pacemaker — the ALTRUA™ 60,” said David McFaul, Boston Scientific Senior Vice President, International. “The significantly reduced size of these devices has been well received by physicians in the U.S. and Europe, resulting in more than 75,000 implants in less than two years,” said Ken Stein, MD, Associate Chief Medical Officer, Boston Scientific CRM. “In the past, physicians often had to make trade-offs among device size, battery longevity and features when prescribing a high-energy device. These devices eliminate those trade-offs without compromising therapy options.” The COGNIS CRT-D and TELIGEN ICD are the world’s smallest and thinnest high-energy devices at 32.5 cc and 31.5 cc respectively, while less than 10 mm thick. Both devices offer features based on substantial engineering advances, including extended battery longevity, self-correcting software and improved programming technology. Both devices offer a redundant hardware system called SafetyCore™, which provides life-saving shock therapy and basic pacing functionality in the unlikely event of a system error. The devices employ digital signal processing and are equipped with increased levels of digital memory, enabling more patient data to be captured and used by physicians. Key features of the COGNIS CRT-D include: • SmartDelay™ — quickly proposes programmable device settings, which enables physicians to tailor individualized pacing therapy for their patients. • Bi-V Trigger — helps physicians manage heart failure patients with frequent atrial arrhythmias. • Electronic Repositioning™ — provides physicians with six configurations for stimulating the left side of the heart even after implant, which may help avoid an additional surgical procedure. Key features of the TELIGEN ICD include: • Smallest and thinnest high-energy ICD device available in the world — the small size and physiological shape are designed with patient comfort in mind. • Quick Convert™ — provides the ability for patients to receive pacing therapy for ventricular tachycardias. • Reverse Mode Switch™ — provides physicians more options for minimizing right ventricular (RV) pacing.