Industry News and Products

Pope Benedict XVI Accepts Gift of Defibtech Automated External Defibrillator Churches Can Be Leaders in Public Access Defibrillator Programs

Defibtech is a designer and manufacturer of AEDs, which revive potential victims of sudden cardiac arrest (SCA) caused by ventricular fibrillation. Vaisnys and Rangoni met with the Pope at a recent papal audience where Vaisnys presented the AED while Rangoni explained to the leader of the world’s Roman Catholics how defibrillators can save victims of SCA. “Pope Benedict was genuinely interested and immediately grasped how a defibrillator can save lives,” Vaisnys said. Health experts estimate that sudden cardiac arrest kills over 400,000 Americans each year. Vatican City is one of the world’s most popular tourist destinations: approximately 17,000 visitors arrive each day to see St. Peter’s Square and Basilica, the Vatican Museums including the Sistine Chapel, the Vatican Gardens and Grottos, and other attractions. “Because so many people come to the Vatican each day, it’s an important place to have a defibrillator,” Vaisnys said. “It is very important that AEDs are located in areas frequented by many people — public areas, workplaces, airports, schools and churches, health clubs, hotels and so on.” Churches have been the scenes of numerous defibrillator life-saves, and in many cases, have been leaders in bringing AED programs into their communities. Having an AED where many people congregate is important because immediate resuscitation is vital. Studies show that more than 70 percent of SCA victims who are defibrillated within a minute or two after arrest survive. If defibrillation is delayed for more than 10 minutes, less than 5 percent live. Defibtech and the Italian distributor Mortara previously partnered to deploy 148 AEDs at the 2006 Winter Olympics in Turin, Italy. Defibtech AEDs can be found throughout the United States, Canada and Europe; in China, India, the Middle East and other parts of Asia, as well as in Australia, South America and Africa. ______________________

St. Jude Medical Announces Japanese Approval of the Merlin Programmer for Pacemakers, ICDs and CRT Devices

The System is designed to allow quick and efficient programming at the time of implant and at patients' follow-up visits. The Merlin Patient Care System is a powerful, portable computer that is designed to help physicians efficiently conduct cardiac tests, analyze therapeutic and diagnostic data, and program implanted devices for optimal patient care. Physicians can quickly make changes to device therapy through the System's LCD touch-screen to decrease follow-up time. Patients with ICDs, pacemakers or CRT devices require regular follow-up examinations to ensure devices are programmed to provide appropriate therapy and to review a patient's response to programmed therapy. If a patient's condition has changed, clinicians can reprogram device parameters with the Merlin Patient Care System to help protect the patient from abnormal heart rhythms. "We developed the Merlin Patient Care System by observing clinicians in their working environments," said Eric S. Fain, MD, president of the St. Jude Medical Cardiac Rhythm Management Division. "We sought clinicians' input and listened to their needs, then responded by creating an intuitive system that streamlines workflow and simplifies the programming process." Japan represents the second-largest market for medical devices in the world, and St. Jude Medical (formerly known in Japan as Getz Bros.) has been serving that market since 1925. With an increasingly aging population, there is a strong focus to offer state-of-the-art medical devices in Japan. The Merlin Patient Care System includes numerous benefits for physicians and patients: • A user interface that makes the entire system fast to learn and use. This interface mimics the natural workflow of a clinic to make it easier for clinicians to operate. • Enhanced presentation of diagnostics, which consolidates and displays patient information so clinicians can make decisions more quickly. • State-of-the-art hardware and flexible options for future programmer features and accessories. The hardware increases speed and consumes less energy, allowing the system to weigh less. A lighter-weight programmer makes it easier for physicians and nurses to carry and store the programmer between both hospital and patients' office visits. • A session summary screen, which shows a summary of tests performed during an implantable cardioverter defibrillator or pacemaker patient's follow-up exam. "The Merlin Patient Care System offers significant advantages for clinicians in Japan, including access to a more comprehensive, streamlined patient implant and follow-up system," said Paul Bond, president of St. Jude Medical Japan Co., Ltd. ______________________

BIOTRONIK Announces First Implants of Lumax 540 Series

After receiving CE Mark approval, BIOTRONIK GmbH & Co. KG announced the first implantations of the new Lumax 540 implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices in 11 hospitals in seven countries. The new Lumax 540 platform is part of BIOTRONIK´s most technologically advanced tachycardia product portfolio, providing extended therapy options for individualized patient device programming as well as BIOTRONIK Home Monitoring® technology for wireless remote monitoring of patient’s cardiovascular status. A comprehensive set of diagnostic capabilities are further technical advancements included on the Lumax 540 devices to help physicians identify clinically relevant atrial fibrillation and early detection of worsening heart failure status. Due to the advantage of developing its own batteries and years of engineering research, BIOTRONIK has achieved longevity for the Lumax 540 platform, which extends the life of the devices up to 10 years. “Patients could benefit from this extended battery longevity due to the need for fewer device replacements over time, thereby improving quality of life and at the same time helping to reduce healthcare costs,” commented Marlou Janssen, Vice President Global Marketing and Sales, Cardiac Rhythm Management, BIOTRONIK. “In fact, we are so confident in the advantages of our new battery technology, BIOTRONIK will further extend our warranty for the Lumax 540 ICDs.” Professor Dr. Josep Brugada Terradellas, Hospital Clínic i Provincial de Barcelona, Barcelona, Spain, President of the European Heart Rhythm Association, implanted one of the first Lumax 540 HF-T and emphasized, “the future focus of heart failure therapy is to shift our effort toward preventing the patient from deteriorating rather than treating advanced disease states. Lumax 540 provides the technology that takes the first step in this direction. Furthermore, the device provides the state-of-the-art therapy that modern implant clinics require.” In response to the increasing number of implanted cardiac devices, technologies that ease complex programming, enable remote monitoring and simplify patient follow-up have become increasingly important. Therefore, Lumax 540 series was specifically designed to improve effective tachyarrhythmia programming and facilitate patient follow-up with an innovative set of functionalities that help physicians efficiently automate the in-office follow-up of patients with BIOTRONIK devices. Furthermore, in combination with BIOTRONIK Home Monitoring® technology, the new Lumax 540 platform sets the standard for remote monitoring of patients with cardiac devices. This exclusive technology enables continuous automatic daily data transmissions of the patient’s cardiovascular status and clinically significant events to the physician from anywhere in the world using an antenna integrated in the Lumax 540 devices and the mobile telephone network. "Lumax 540 gives me the opportunity to continuously check my patients using the wireless BIOTRONIK Home Monitoring solutions,” said Professor Dr. Werner Jung, Schwarzwald-Baar Klinikum, Villingen-Schwenningen, Germany. Welcoming the enhanced functionality of the new devices, Professor Dr. Jung also added, “Clinically important changes in patient status are brought to our immediate attention with Home Monitoring®. Despite the growing number of cardiac device patients visiting our clinic, this new cardiac device with comprehensive telemonitoring capabilities allows me to focus more on those patients who need urgent care.” Lumax 540 devices offer the unique combination of advanced tachycardia therapy management, diagnostic capabilities and remote monitoring technologies, which support physicians in creating efficient care pathways for their patients with cardiac devices and further improve patient care. "We already remotely monitor all of our BIOTRONIK ICD patients; however, now with Lumax 540 ICD/CRT-D devices and BIOTRONIK Home Monitoring®, we can continuously monitor virtually all clinically significant device-related parameters for enhanced patient care,” confirmed Professor Dr. Luc Jordaens, Erasmus Medical Centre, Rotterdam, The Netherlands, who also implanted one of the first Lumax 540 devices. “Furthermore, Lumax 540 devices together with Home Monitoring® enable us to optimize our resources while providing improved patient management.” BIOTRONIK would like to extend its sincere thanks to all the physicians that participated in first worldwide implantations of the Lumax 540 series ICD and CRT-D cardiac devices: Professor Dr. med. Angelo Auricchio, Cardiocentro Ticino, Lugano, Switzerland; Professor Jean-Claude Deharo, CHU La Timone Marseille, Marseille, France; Dr. med. Anja Dorszewski, Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany; Professor Dr. Luc Jordaens, Erasmus Medical Centre, Rotterdam, The Netherlands; Professor Dr. Werner Jung, Schwarzwald-Baar Klinikum, Villingen-Schwenningen, Germany; Professor Antonis Manolis, Evangelismos General Hospital, Athens, Greece; Professor Dr. med. Tiziano Moccetti, Cardiocentro Ticino, Lugano, Switzerland; Dr. med. Dirk Müller, Charité Berlin Kampus UKBF, Berlin, Germany; Professor Nicolas Sadoul, CHU Brabois Nancy, Nancy, France; Dr. med. Alexander Schirdewan, Charité Berlin Kampus UKBF, Berlin, Germany; Dr. Raed Sweidan, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia; Dr. Professor Josep Brugada Terradellas, Hospital Clínic i Provincial de Barcelona, Barcelona, Spain; Dr. med. Jürgen Vogt, Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany; and Dr. med. Thomas Zerm, Asklepios St.Georg Hospital, Hamburg, Germany. ______________________

CryoCath Introduces Arctic Front in Australia

On March 13 and 14, a group of nine Australian electrophysiologists attended the training program for the Arctic Front system in Melbourne, Australia. Leadership of this program was in the hands of Dr. Jeff Alison, Head of Electrophysiology and Pacing of the Monash Medical Centre in Melbourne, Australia, and Dr. Yves Van Belle of the Thorax Centrum at the Erasmus University in Rotterdam, The Netherlands. Dr. Van Belle is one of the most experienced users of the Arctic Front system and the author of the first publication on this device in a peer-reviewed journal. Dr. Alison has received training on the system both in Germany as well as in Montreal. He has also performed the first Arctic Front procedure in Australia in late 2007. “Arctic Front holds the promise of a breakthrough therapy in the treatment of paroxysmal atrial fibrillation. The data out of Europe strongly supports this belief and we’re excited to be able to offer a potentially safer and effective treatment to our patients,” said Dr. Alison. “Thousands of Australians suffer from the symptoms of PAF, and a safe and effective therapy can bring a substantial benefit to these patients.” Solid professional education is the foundation of a successful introduction of a new technology. In the first Arctic Front Masters Program (AFMP) held in Australia, nine physicians from two centers were trained on the new technology. As part of the curriculum, they observed two successful procedures performed by Dr. Alison. Through the efforts of Life Systems Medical Inc., CryoCath’s exclusive distributor in Australia, an extensive follow-up training program was completed. As a result of this successful program, several first Arctic Front procedures were performed in two further hospitals across Australia over the past few days. “We’re happy to see the rapid growth in the use of Arctic Front now expanding beyond Europe,” said Jan Keltjens, President and CEO of CryoCath. “I am impressed with the efforts of Life Systems Medical and the support from thought leaders in Australia. Well over 2,000 patients across 34 centers in Europe have been treated to date with Arctic Front. The introduction in Australia will further accelerate this momentum and bring the benefits of this breakthrough therapy to large groups of patients.” ______________________

Medicare to Now Cover INR Self Testing for Patients on Anticoagulants for Chronic Atrial Fibrillation and Venous Thromboembolism

The Centers for Medicare & Medicaid Services (CMS) Expansion of Coverage for Warfarin Self-Testing Affects Millions The recent announcement from the Centers for Medicare & Medicaid Services (CMS) that Medicare coverage for at-home blood testing of prothrombin time (PT)/International Normalized Ratio (INR) will be expanded is welcome news to the millions of patients who take anticoagulants daily and will now have easier access to proactive, improved quality of health care. In addition to mechanical heart valve patients (for whom CMS approved weekly self-testing in 2002), the new decision expands coverage of home testing to those patients who take warfarin, an anticoagulant medication, for chronic atrial fibrillation or venous thromboembolism. “Warfarin — a blood thinner used chronically by a large population of patients for a variety of medical conditions — is a very critical, black-box drug whose dosage needs to be managed closely in order to minimize serious complications from continual use, including blood clots, stroke and hemorrhage,” says Jack Ansell, MD, an internationally recognized expert in hemostasis and thrombosis, and Chairman of Medicine at Lenox Hill Hospital in New York City. “The scientific research and success of mechanical heart valve patients with INR home testing for the past six years serve as proof that weekly patient home self-testing helps patients remain in their therapeutic range, thereby reducing the risk of costly — and deadly — complications.” Dr. Ansell, whose main area of research focuses on the application of new modes of delivering and monitoring anticoagulants, is the founder and immediate past Chair of the Anticoagulation Forum, a network of anticoagulation clinics throughout North America. “This new CMS decision removes a substantial barrier to the wider use of patient self-testing for INR that we are hopeful will happen in the near future,” he says. International Normalized Ratio is the standard unit for reporting the clotting time of blood, which must be tested on a regular basis in order for a person on anticoagulants to remain in his or her prescribed "range" For those with chronic atrial fibrillation or venous thromboembolism, it can mean monthly trips to the physician, clinic or lab for blood work, which imposes a tremendous burden on both the patient and the physician. “Now that CMS has expanded coverage for these two additional patient groups on anticoagulation therapy, more Medicare beneficiaries will be eligible to self-test their INR more regularly in the comfort and convenience of their own homes,” says David Phillips, vice president of marketing at HemoSense®, manufacturer of the INRatio® PT/INR Monitoring System, an easy-to-use, portable device designed for home INR testing that is already being used successfully by thousands of mechanical heart valve patients on daily anticoagulants. “This decision helps bring the patient into the healthcare team to be more proactive in maintaining their own INR levels, which is a major step in preventing complications, and improving compliance.” At-home INR testing, done with a finger prick and a specialized, FDA-cleared meter (similar to the process utilized by diabetics for glucose monitoring), includes a simple blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot. “The optimal therapeutic range for patients with atrial fibrillation or venous thrombosis is an INR between two and three,” explains Dr. Ansell. “Should the patient’s level fall out of therapeutic range, it will be more readily detected with the weekly self-testing, allowing the doctor to make timely dosage changes in response.” Atrial fibrillation is the most frequently encountered and sustained cardiac arrhythmia in clinical practice, affecting millions of patients nationwide. Venous thromboembolism, which includes deep vein thrombosis and pulmonary embolism, affects upwards of 500,000 people. “There is now the potential for these patients to take an active role in monitoring their own health via the self-testing of their INR levels,” concludes Dr. Ansell. ______________________

EACTS Launches International Atrial Fibrillation Registry

The European Association for Cardio-Thoracic Surgery (EACTS), in association with Dendrite Clinical Systems, has announced the launch of the International Atrial Fibrillation Registry (IAFR). The IAFR is designed to capture data and report inpatient outcomes following surgical treatment of atrial fibrillation. “The goal is to collect data from across Europe to enable us to make better informed judgments on the appropriate surgical treatment approaches for the management of atrial fibrillation,” commented Mr. Steven Hunter, Registry Chairman, Cardiothoracic Division, The James Cook University Hospital, Middlesbrough, UK. “The IAFR was developed as a follow [up] from the original registry that was launched in 2003 by Professor Melo.” The key objective of the IAFR is to accumulate sufficient data to allow the publication of a comprehensive report (published by Dendrite Clinical Systems) on the outcomes following atrial fibrillation surgery. This will be achieved through the collection of data at the individual patient level, which can then be used to track individuals and groups of patients. The reports will be made freely available to all contributors. “It is important that we gather the data to understand where, how and why these procedures are being done and what type of devices are being used, and importantly, after follow up, how effective the treatment is,” added Mr. Hunter. “The best way to assess whether something is effective would be a randomized controlled trial. However, with so many different devices treating different lesions and having to standardize the data across so many different countries, with follow up out to five years, to run such a trial would be near impossible. Whereas a registry with a database of thousands of patients, which can show how effective the procedures and devices are would have a lot more weight scientifically.” The IAFR can be accessed using a standard web browser, allowing registrants to enter data without the need to install additional software or perform any complex system configurations. This web-based system allows the individual clinician to enter patient information onto a database, whether at a hospital from an office-based practice or even at home. Clinicians can add as many cases as they wish, and where possible, they will be encouraged to put on retrospective data (if applicable). All data collected through the Registry will remain the property of the contributing surgeon and EACTS. Some of the key features on the Registry include: • Comprehensive tracking of all forms of surgical AF treatment. • Intuitive data capture with online data validation. • A “Download Document” option that allows users to download PDF copies of the dataset questions, training manuals and other useful information. • “Export my Data” – this feature allows users to extract their submitted data at any time to report/perform their own analysis. This ensures registrants at all times have easy access to their own data. ______________________

Results Announced for First Cardiac Pacing Exam for Japanese Allied Professionals

Initial Japan-based Exam Scores Comparable to Those in U.S. Results released from the first standardized cardiac pacing examination for Japanese allied professionals show a notable pass rate amongst candidates. The exam, administered by the International Board of Heart Rhythm Examiners (IBHRE) and designed to test professional competency in cardiac pacing, defibrillation and electrophysiology, is the first standardized cardiac pacing examination tailored to the needs of a health care system outside of the U.S. In the debut of the Japan-based exam, 638 candidates participated in the first round, resulting in an overall pass rate of 66 percent. While U.S.-based pacing exams for allied professionals average a 75 percent pass rate, the Japan-based exam pass rate is notable given this was the first round of the exam. Japanese exam candidates represent a wide cross section of professionals from more than 85 companies including Medtronic Japan, Biotronik Japan, GM Medical, Boston Scientific Japan and St. Jude Medical. “We are very pleased with the pass rate of this first round exam,” said Charles J. Love, MD, FACC, FAHA, FHRS, CCDS, and President of the IBHRE Board of Directors. “We believe the gap will narrow significantly between U.S. and Japanese pass rates now that the expectations are known by the candidates. This was a very successful first round of the exam and we look forward to hosting the second round in January of 2009. I applaud the efforts of all of those who took the time and effort to challenge the examination and to become certified in cardiac rhythm device therapy.” The knowledge base of the exam, which includes device functions, is a global standard. Patient management questions, however, and an understanding of the clinical culture and medicines used in Japan were considered when tailoring the examination. Close collaboration with the Japanese Heart Rhythm Society to tailor the exam for Japan’s specific needs resulted in an examination appropriate for this group of candidates. It also provides a model that can be used to offer the exam in other countries. “With the ICD growth rate around 50 percent and no signs of decreasing, the importance of credentialing Japanese professionals is all the more urgent,” said Love. “Given the growing number of heart rhythm patients around the world and the variations of health care systems globally, the need for certification and credentialing is of utmost importance to achieve optimal patient care.” The Japanese Ministry of Health has mandated that allied professionals, sales representatives, technical advisors and anyone else having contact with patients from the medical device industry be “certified”. This mandate is meant to ensure a meaningful standard of knowledge for those involved in assisting physicians and other health care workers in the implantation and management of pacemakers and ICDs. With the goal of continuing to expand internationally, IBHRE hopes its partnership with the Japanese Heart Rhythm Society will serve as the model for future exam tailoring and administration in countries such as China, Russia and India. An affiliate, independent body of the Heart Rhythm Society, IBHRE is enriched by cardiac arrhythmia health care professionals who strive for excellence and optimal health care by passing this distinguished exam. Participation in the exam is consistent with the Heart Rhythm Society’s overall purpose to improve the care of patients by promoting research, education and optimal health care policies and standards. Working together to standardize the profession, IBHRE and the Heart Rhythm Society provide the most current testing and professional development tools with advances in heart rhythm management to enhance knowledge and delivery of health care to patients. ______________________

Siemens Addresses Cost vs. Value Issues In Healthcare and Technology

Representatives from Capitol Hill Are Briefed on Challenges Facing the Healthcare Industry Siemens Healthcare, in association with U.S. News & World Report, hosted an exclusive panel discussion titled “Health Care and Technology: Cost vs. Value,” at the National Press Club in Washington, D.C. The event, attended by Congressional staff, senior business executives, and the press, examined the “value paradigm” between advances in technology and rising healthcare costs. A diverse panel of experts weighed in on the topics of early and frequent use of imaging in shortening initial clinical evaluation, cost effectiveness and accessibility of imaging, the role of patient education, and lessons in deploying health technology and what the industry can expect to deliver in the near term. The panel also examined practical ways in which government and the healthcare industry can create consistent and generally accepted standards for measuring new technologies, maintaining the quality of procedures while reducing costs, and working together for future healthcare innovation. “Sooner or later, all of us are patients. So, when we go through these deliberations, it is always helpful to use this to guide our decisions in the future,” said Dr. Bernadine Healy, health editor, U.S. News & World Report, who also served as panel moderator for the discussions. The panel debated how to measure the value of medical imaging and how to best reconcile costs in an era of personalized medicine. The audience also heard from the government panelists on how technology is reviewed for potential funding and the need for evidence development when making recommendations on medical imaging technologies. During the question and answer period, the potential of healthcare information technology (HIT) to improve efficiency, workflow, and outcomes was discussed. Additionally, the use of HIT to broaden and deepen clinical knowledge of medical imaging and its impact on cost-effectiveness could be used to further evaluate, drive the efficiency and the matrix of medical imaging. “It is indisputable that advanced medical imaging has led to earlier detection of disease, faster and more accurate diagnosis, and enables precise minimally invasive procedures for treatment of such serious conditions, such as cardiovascular disease and cancer,” said Thomas Miller, chief executive officer, Workflow and Solutions, Siemens Healthcare, who presented opening remarks to attendees at the event. “Physicians are ordering these tests more frequently as they believe that the result is safer treatment and better outcomes for their patients. Therefore, the fundamental discussion is actually whether advanced medical imaging capabilities are a driver of escalating healthcare costs or a stabilizing factor.” The panel included: Kerry Weems, acting administrator, Centers for Medicare and Medicaid Services; Dr. Carolyn Clancy, director, Agency for Healthcare Research and Quality; Peter R. Orszag, director, Congressional Budget Office; the Honorable Gene Green (D-TX), U.S. House of Representatives, member, Subcommittee on Health (Energy & Commerce); Dr. Judd E. Hollander, professor and clinical research director, Department of Emergency Medicine, University of Pennsylvania, and president of the Society for Academic Emergency Medicine; and Hala Moddelmog, president and chief executive officer, Susan G. Komen for the Cure.