Cardiostim 2008 Meeting Highlights

The AtriCure Minimally Invasive Platform Highlighted by Prominent Cardiac Surgeons and Electrophysiologists at Cardiostim in Nice, France AtriCure, Inc. announced that its minimally invasive platform was highlighted during Cardiostim. On June 18, Dr. Kenneth Ellenbogen, Vice Chairman of Cardiology and Director of Clinical Cardiac Electrophysiology and Pacing at the Medical College of Virginia, chaired a symposium entitled “The Epicardial Frontier: Minimally Invasive Ablation for Atrial Fibrillation.” The session focused on the current indications and investigation of the AtriCure minimally invasive platform as a treatment alternative for atrial fibrillation (AF). Dr. Vigneshwar Kasirajan, a leading cardiothoracic surgeon and colleague of Dr. Ellenbogen, presented their patient selection criteria and patient results. European cardiothoracic surgeon Dr. Wim Jan van Boven presented his experience utilizing the AtriCure minimally invasive platform to perform 125 totally thoracoscopic ablation procedures. In this totally thoracoscopic series, the procedure times reported were routinely 60 minutes and patients were discharged from the hospital in two days or less. Additionally, Dr. Warren Jackman presented the importance of electrophysiology mapping during surgical ablation and the expanding role of this minimally invasive platform as a treatment alternative for chronic AF patients. “There is a growing interest in this minimally invasive approach within the electrophysiology community as a treatment alternative for a subset of patients that are generally not candidates for catheter ablation procedures,” said Dr. Ellenbogen. “Additionally, we are enthusiastic regarding our investigation of an expanded ablation procedure using the Coolrail system for patients with persistent and longstanding persistent AF.” Dr. Kasirajan commented, “In our experience the results using this minimally invasive approach are very encouraging. We are actively working with AtriCure to further optimize these products and minimally invasive techniques.” David J. Drachman, AtriCure’s President and Chief Executive Officer commented, “This symposium highlighted our building momentum resulting from our highly encouraging minimally invasive sole-therapy, off-pump clinical results which, importantly, are based on the use of long-term continuous monitoring. Procedure times of 60 minutes and patients discharged from the hospital at two days or less, combined with our clinical results are clear indicators of our large and growing opportunity.” Lumax 540 Cardiac Devices Launched at Cardiostim BIOTRONIK GmbH & Co KG announced the launch of the Lumax 540 series. This technologically advanced series, which includes implantable cardioverter defibrillators (ICDs) and a cardiac resynchronization therapy defibrillator (CRT-D), has many features to save and enhance patients’ lives. This together with BIOTRONIK Home Monitoring® enables continuous automatic daily data transmission of the patient’s cardiovascular status. The information is available to the physicians online allowing them to continuously check their patients’ cardiac and device status. “Lumax 540 has an excellent range of high quality features that allow physicians to tailor the treatment to our individual patients. Coupled with the BIOTRONIK Home Monitoring technologies, we are able to access patient data online anywhere in the world,” said Professor Panos Vardas, Cardiology Department, University Hospital, Heraklion, Crete, Greece. The Lumax 540 series has a unique set of state-of-the-art features to ensure that patients receive the appropriate therapy adapted to their individual needs while maintaining optimal safety. SelectSense has various presettings to adapt sensing characteristics to individual patient needs to ensure accurate arrhythmia detection. The Defibrillation Threshold Manager ensures that life-saving shock therapy is delivered successfully. In addition, the Automatic Threshold Monitor performs daily threshold measurements. The Heart Failure Monitor detects changes in heart failure conditions with an extensive range of clinical predictors. A comprehensive set of diagnostic capabilities included in the Lumax 540 devices help physicians with the identification of clinically relevant atrial fibrillation and the early detection of worsening heart failure status. BIOTRONIK’s extensive engineering research has produced batteries which extend the life of the Lumax 540 devices up to 10 years. “Patients could benefit from this extended battery life 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. The number of patients with cardiac devices who require follow-up has increased dramatically and is putting clinics under considerable pressures to meet these needs. The innovative set of functionalities of the Lumax 540 series help physicians efficiently and easily automate the in-office follow up of patients with BIOTRONIK devices. For the first time all essential follow up data are ready for review, print-out and automatic data storage within 20 seconds after device interrogation. The same data is also available to the physician via the BIOTRONIK Home Monitoring® technology for daily automatic event detection and on-demand online patient status reviews. The 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. Greatbatch Announces Issuance of Key MRI Patent Greatbatch, Inc. announced that the U.S. Patent and Trademark Office has issued the company patent 7,363,090. The patent provides Greatbatch with the exclusive right to incorporate band stop filtering technology into an implantable medical lead. This technology attenuates MRI-specific RF frequencies during MRI scanning, thereby eliminating the potential for lead system heating. Active Implantable Medical Devices (AIMD) systems are primarily targeted for use in the cardiac rhythm management and neuromodulation markets. Greatbatch is currently completing the development of its eM-able Brady (bradycardia) pacing lead, which incorporates the aforementioned technology and is expected to cross additional milestones this summer. MRI Conditional products in AIMDs are a critical initiative for device manufacturers because an MRI is often the major diagnostic tool for patients. MRI Conditional AIMD’s will keep the MRI diagnostic tool in the physician’s hands after an implant — allowing patients to receive the greatest possible level of care. Greatbatch showcased its eM-able line of MRI Conditional technologies at this month’s Cardiostim meeting in Nice, France. Qualitative Study Presented at Cardiostim Gives Voice to Pacemaker, Defibrillator and Resynchronizer Patients The fiftieth anniversary of the first pacemaker implant has been celebrated at Cardiostim, which took place from June 18-21 in Nice. The first pacemaker implant marked the beginning of a new era, leading to the development of increasingly advanced devices (pacemakers, defibrillators and resynchronizers) that now make it possible to prolong life for many patients for whom rhythm disorders were once a death sentence. How do these patients perceive diagnosis of the disease and implantation of a cardiac rhythm management device? How do they perceive daily life after the operation? In order to better understand these patients, a qualitative study was performed by the IPSOS institute on behalf of Sorin Group on the experience of implanted patients. Patients agreed to report their experience, from diagnosis of their disease to “life after implantation,” relating their emotions, fears and hopes to the survey takers. They explained how this implanted device has impacted their daily life. Several themes emerge from these thorough interviews: • The tangible presence of death: patients are very aware of the severity of their disease and the risks associated to their heart condition and they are grateful to their physician. While this keen awareness of their fragility can sometimes produce anxiety, it motivates the majority of them to live life to the fullest and to enjoy the regained vitality offered by the technology (e.g., “I feel like I have a second chance”). • This regained vitality is based on trust in the technology. The implant is there to make up for a failing heart (e.g., “If I have an implant, it's precisely to keep from dying in a situation like that!” or “I tell myself that if there is a problem, it will take care of it!”) • The role of the relationship with the cardiac rhythm management physician is essential: adviser, confidant and expert, the physician is there to guide them and reassure them in day-to-day and special situations (e.g., “What should I eat? How will I manage stress at work? Is it OK to have sex? What sports can I do? Can my heart handle the emotion of my son's marriage?”) The rhythm specialist is there to listen, identify the real and false risks of all of these situations, which are sometimes worrisome for the recently implanted patient, in order to accompany patients in “their return to life.” Implanted patients, who are very attached to regular visits with their rhythm specialist, generally do not intend to have them at greater intervals, even if they had the possibility of using a remote monitoring device. • While the trust relationship with the physician contributes to accelerating the patient's recovery, relationships with close friends and especially family can become difficult. Indeed, the family is often much more worried than the patients themselves, and places pressure on the patients to take care of themselves, in particular by asking them to reduce their activity and watch their diet. These anxiety-inducing requests from the family are often hard on the patients, who sometimes feel trapped in an unnecessarily constrained situation, ultimately creating tension in their most important personal relationships. The study was presented at Cardiostim, as part of the Jacques Mugica Special Conference on Friday, June 20, 2008. For more information about Cardiostim, please visit: www.cardiostim.fr/