ACCF/AHA/HRS Add Pradaxa to Leading Practice Guidelines for Atrial FibrillationPradaxa® (dabigatran etexilate mesylate) capsules is now recommended as an alternative to warfarin to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (NVAF) in the Guidelines on the Management of Patients With Atrial Fibrillation, which were jointly developed by the American College of Cardiology Foundation (ACCF), American Heart Association (AHA) and Heart Rhythm Society (HRS).1 The addition of PRADAXA to the guidelines appeared as a "Focused Update" to the section on emerging antithrombotic agents and is published in Circulation: Journal of the American Heart Association, Journal of the American College of Cardiology and HeartRhythm Journal.1 PRADAXA was approved by the U.S. Food and Drug Administration in October of 2010 to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation2 and is the only approved treatment that has demonstrated significant reductions in the risk of stroke compared to warfarin.2 PRADAXA 150mg capsules taken twice daily has been shown to reduce stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin2 dosed to a target international normalized ratio (INR) of 2.0 to 3.0.2 The effects of PRADAXA compared to warfarin were more apparent in patients with lower levels of INR control.2 "The atrial fibrillation management guidelines were updated following the approval of dabigatran to reflect a consensus of expert opinions about the role of this important new treatment,” said Eric Prystowsky, MD, director of Clinical Electrophysiology Laboratory at St. Vincent Indianapolis Hospital. “I applaud the guideline committee for acting so quickly to include dabigatran as an important therapeutic option to reduce the risk of stroke in patients with non-valvular atrial fibrillation. For the first time in decades, physicians have an alternative to warfarin for this patient population." For reducing the risk of stroke, the updated Practice Guidelines on the Management of Patients With Atrial Fibrillation recommend PRADAXA as a useful alternative to warfarin for patients with paroxysmal to permanent atrial fibrillation, and risk factors for stroke or systemic embolization, who do not have a prosthetic heart valve, hemodynamically significant heart valve disease, severe renal failure or advanced liver disease.1 "The swift update of the guidelines following the FDA approval of PRADAXA demonstrates the importance of having an alternative to warfarin for non-valvular atrial fibrillation," said Christopher Corsico, MD, MPH, medical director, Boehringer Ingelheim Pharmaceuticals, Inc. "Boehringer Ingelheim is proud to offer this innovative new treatment, which demonstrated significant stroke risk reduction over warfarin in patients with non-valvular atrial fibrillation."
- Wann LS, et al. 2011 ACCF/AHA/HRS Focused Update on the Management of Patients with Atrial Fibrillation(Update on Dabigatran): A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 2011;123:00-00.
- Pradaxa Prescribing Information.
Cameron Health Announces Launch of EFFORTLESS S-ICD Registry to Capture Long-Term Outcomes of S-ICD® System Designed to Treat Sudden Cardiac ArrestCameron Health Inc. announced the first patient enrollment in the company's landmark EFFORTLESS S-ICD® System Registry by Dr. Marcoen Scholten, Medisch Spectrum Twente, Enschede, The Netherlands. The S-ICD System (Subcutaneous-Implantable Cardioverter Defibrillator) is designed to provide life-sustaining therapy to patients at risk of sudden cardiac arrest (SCA). The device received CE mark in Europe in 2009 and has been implanted in over 500 patients worldwide. In the United States, the S-ICD is being studied in a 45-center FDA clinical trial. The EFFORTLESS S-ICD Registry (Evaluation of Factors Impacting Clinical Outcome and Cost Effectiveness of the S-ICD System) is an international, multicenter Registry being led by Dr. Pier Lambiase of The Heart Hospital, London and is designed to document and measure early, mid- and long-term clinical and cost-effectiveness outcomes associated with the implantation of the S-ICD System. The Registry will enroll patients who were implanted with the technology since its commercial release in 2009. Data will be collected from approximately 1,000 patients for up to five years from the date of their device implant. “The S-ICD System represents a potentially groundbreaking advance in ICD technology and there is significant interest within the medical community regarding its long-term efficacy,” said Dr. Scholten. “The EFFORTLESS S-ICD Registry is designed to rigorously collect long-term clinical outcome data, which demonstrates the commitment of Cameron Health to understanding and characterizing the performance of the S-ICD in the real world environment.” The S-ICD System is unique in that the implantation of the system is entirely under the skin but outside the ribcage, eliminating the need for leads to be placed within or on the heart. It quickly detects any disorganized heart rhythms and provides a shock to restore the heart’s normal rhythm and prevent SCA. Left unaddressed, these disorganized heart rhythms are fatal approximately 95% of the time. Conventional implantable defibrillators (ICDs) require at least one wire to be routed through the vascular system which is then directed to the desired placement within or on the heart. While the therapy these conventional transvenous systems offer is lifesaving, occasionally, the wires have to be extracted or replaced. Extraction of a transvenous lead from the heart is complex and not without significant risk. “ICD therapy is one of today’s most effective medical technologies, but it can also be associated with a number of significant complications,” explains Kevin Hykes, President and CEO of Cameron Health, Inc. “The S-ICD is designed to reduce complications and simplify ICD therapy, allowing more patients to be protected from SCA.”
Vascular Solutions Introduces the OptiSeal™ Valved Peelable IntroducerVascular Solutions, Inc. announces the immediate availability of the OptiSeal™ valved peelable introducer, a unique, ergonomic peel-away introducer sheath to facilitate placement of device leads and catheters in the venous system. The OptiSeal combines a sheath constructed from PTFE with a proprietary valve for optimal insertion and sealing, preserving the integrity of the lead or catheter. The locking hub prevents separation of the sheath and dilator during insertion into the vessel, and a smooth sheath-to-dilator transition provides atraumatic vessel access. The OptiSeal system advances safety and simplicity, with symmetric, ergonomically designed handles allowing for a smooth, unidirectional crack and peel, designed to reduce risk of air embolism as well as limit the clinician’s exposure to blood-borne pathogens. Each OptiSeal system contains a 13cm peel-away valved introducer sheath with a locking dilator, a 60cm 0.035” guidewire, an 18 gauge needle, and a 12cc syringe. OptiSeal introducers are available in seven sizes, from 6F to 12F, color coded by French size for easy identification. The OptiSeal valved peelable introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system, and is available in the United States through Vascular Solutions, Inc. Vascular Solutions, Inc. is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company’s product line consists of over 50 products in three categories: catheter products, hemostat products and vein products. For more information, visit www.vascularsolutions.com. OptiSeal is a trademark of Greatbatch Medical.
Medtronic Receives FDA Approval for First and Only Pacemaker System in the U.S. Designed for Use in the MRI EnvironmentMedtronic, Inc. announced that the U.S. Food and Drug Administration (FDA) approved its Revo MRI™ SureScan® pacing system, the first and only pacemaker in the U.S. specifically designed for use in an Magnetic Resonance Imaging (MRI) environment and approved as MR-Conditional. Shipments of Revo MRI will begin immediately. Until now, MRI procedures had been contraindicated for patients with implanted pacemakers due to the potential for serious adverse events.1-4 Each year, an estimated 200,000 pacemaker patients in the United States have to forgo MRI scans, which are critical for making a wide range of health diagnoses.4 “The new Revo MRI pacemaker is a major technological breakthrough for patients who need access to MRI,” said Dr. J. Rod Gimbel of Cardiology Associates of East Tennessee in Knoxville, TN. “Providing pacemaker patients with access to MRI allows detection and treatment of serious medical conditions such as stroke, cancer, and a wide variety of important neurologic and orthopedic conditions.” As the population ages, the use of pacemakers is growing, with approximately 5 million patients worldwide who currently are implanted with a pacemaker or implantable cardioverter-defribrillator.4 At the same time, the use of MRI as a diagnostic tool is increasing, with approximately 30 million scans completed in 2007.5,6 Individuals over age 65 are twice as likely to need an MRI compared with younger patients, and between 50 and 75 percent of patients with electronic cardiac devices will likely need an MRI over their device’s lifetime.7 “For the first time, patients will have access to a state-of-the-art pacemaker that is designed to work safely and effectively in an MRI environment,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. Prior to the introduction of Revo MRI, pacemaker patients could face serious complications if they were exposed to the powerful magnetic fields generated by MRI machines, which can be as much as 30,000 times more powerful than the Earth’s magnetic field.8 Complications to exposure could include interference with pacemaker operation, damage to system components, or a change in pacing capture threshold, which is the minimum amount of current required to evoke a cardiac contraction.1-4 Revo MRI, when programmed into SureScan mode prior to an MRI scan, is designed to be safe for the MRI environment when used per the specified MR Conditions for Use.9 Revo MRI is considered MR-Conditional, a term used to indicate that a device may be used in the MRI environment under certain conditions, such as a particular type of MRI scanner and scanner settings. About Revo MRI™ SureScan® Pacing System Revo MRI was designed from the ground up to address safety concerns around MRI procedures for patients who have implanted pacemakers. The pacemaker system includes hardware modifications to the device and leads that are designed to reduce or eliminate several hazards produced by the MRI environment. In addition, since MRI scanners may cause other current pacemakers to misinterpret MRI-generated electrical noise and withhold pacing therapy or deliver unnecessary pacing therapy, this new pacemaker includes a proprietary SureScan feature that sets the device into an appropriate mode for the MRI environment. The Revo MRI pacing system must consist solely of a Medtronic Revo MRI SureScan device and two CapSureFix MRI™ SureScan Model 5086MRI leads. Prior to scanning a patient, refer to the Revo MRI Pacing System MR Conditions for Use located in the device manuals. “We are continuing to work with the FDA toward a final resolution to the Mounds View warning letter and are optimistic that we are making progress toward this goal,” concluded Pat Mackin.
- Faris OP, Shein M. Food and Drug Administration perspective: Magnetic resonance imaging of pacemaker and implantable cardioverter-defibrillator patients. Circulation 2006;114:1232-1233.
- Roguin A, Schwitter J, Vahlhaus C, et al. Magnetic resonance imaging in individuals with cardiovascular implantable electronic devices. Europace 2008;10:336-346.
- Levine GN, Gomes AS, Arai AE, et al. Safety of magnetic resonance imaging in patients with cardiovascular devices: an American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention: endorsed by the American College of Cardiology Foundation, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance. Circulation 2007;116:2878-2891.
- Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. PACE 2005;28:326-328.
- IMV, “Benchmark Report: MRI 2007,” IMV Medical Information Division. Des Plaines, IL. 2008.
- Zhan C, Baine WB, Sedrakyan A, et al. Cardiac device implantation in the United States from 1997 through 2004: A population-based analysis. J Gen Intern Med 2008;23(Suppl 1): 13-19.
- Global Industry Analysts, Inc. Magnetic Resonance Imaging (MRI) Equipment – A Global Strategic Business Report. San Jose, CA. 2002.
- Shellock FG. (2009) "MRI Safety and Neuromodulation Systems." In: EP Krames, H Peckham, and AR Rezai (Eds.), Neuromodulation (pp. 243-282) London: Academic Press.
- Wilkoff B, et al. Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. Heart Rhythm 2011;8:65-73.
Endosense Completes Enrollment in EFFICAS I Clinical StudyEFFICAS is a study series intended to demonstrate that, in patients with paroxysmal atrial fibrillation (AF), the use of contact force control during cardiac ablation utilizing the company’s TactiCath® force-sensing catheter1 results in superior outcomes as compared to ablations performed with a standard catheter. EFFICAS I is a 45-patient, single-arm, prospective, multi-center European clinical trial designed to demonstrate the correlation between contact forces applied during pulmonary vein isolation (PVI) and AF treatment efficacy at three months. The endpoint for the study is the occurrence of reconduction (or “gap”) areas in the PVI lines, relative to the contact forces applied during lesion formation. While investigators perform the procedure with the TactiCath, they are blinded to contact force measurements; however, the contact forces applied are recorded. Patients are re-assessed with a mapping catheter at three months to identify potential gaps in the PVI lines. Contact force parameters from initial procedures are then analyzed to determine the relationship with lesion formation. “We believe that the data from EFFICAS I will greatly advance the scientific understanding of contact force and the role it plays in the catheter ablation treatment of AF, as the data will allow us to better identify those force parameters that will deliver optimal patient outcomes,” said Eric Le Royer, president and chief executive officer of Endosense. The next study in the EFFICAS series is EFFICAS II, in which investigators will take full advantage of the real-time, objective TactiCath contact force control features to improve their ablation technique during lesion creation. Endpoints for EFFICAS II will include reduction in PVI gaps as compared to EFFICAS I. Outcomes data from EFFICAS I and II will help in the design of future, larger EFFICAS randomized studies with clinical endpoints. EFFICAS II enrollment is currently underway. “The EFFICAS studies represent a scientifically rigorous approach to quantifying the importance of contact force in catheter ablation,” said Karl-Heinz Kuck, MD, Asklepios Klinik St. Georg, Hamburg. “Never before have we looked at each ablation point with such level of detail. A preliminary analysis of the 24 patients who have completed their three-month follow-up indicates some truly groundbreaking findings. We look forward to communicating the results to our fellow electrophysiologists, as we believe these studies will result in actionable recommendations that will have a meaningful impact on catheter ablation effectiveness.” The TactiCath force-sensing ablation catheter and the TactiSys™ system are indicated for the treatment of AF and supraventricular tachycardia. BIOTRONIK is the exclusive distributor of the TactiCath in Europe, Latin America, Canada, Africa and the Middle East. The TactiCath is not yet available in the United States. 1Caution: TactiCath is an investigational device. Limited by Federal (or United States) law to investigational use.
Therapy to Prevent Heart Failure More Effective in Women than MenA new study, published in the Journal of the American College of Cardiology, found that women receive a significantly greater benefit — a 70 percent reduction in heart failure and a 72 percent reduction in death — from cardiac resynchronization therapy with defibrillator (CRT-D) than men. “In prior cardiac studies, men and women generally received similar benefit from preventive medical therapy,” said cardiologist Arthur J. Moss, MD, professor of Medicine at the University of Rochester Medical Center and lead author of the study. “Our finding was unexpected, but extremely important because this is the only heart treatment that is clearly better in women than men.” Historically, heart disease has been dominated by its association with men. But, thanks to successful awareness campaigns in recent years, such as the American Heart Association’s Go Red for Women initiative, women have started to take note of their risks and take action to protect their health. On all fronts, women receiving CRT-D therapy to prevent heart failure progression had significantly better outcomes than men receiving the therapy. Reduction of heart failure in females was twice that of males — 70 percent versus 35 percent. In women with mild heart failure, CRT-D therapy effectively prevented deterioration of the heart, otherwise known as cardiac remodeling, by preventing enlargement of the heart with more effective contraction of the heart. Study authors investigated the reasons for the significantly better result in women than men. Women in the study were more likely to have non-ischemic heart disease, a disorder typically characterized by inflammatory scarring of the heart muscle, while men had a greater likelihood of ischemic heart disease — otherwise known as coronary artery disease — where narrowed arteries restrict the flow of blood and oxygen to the heart. Additionally, more women had left bundle branch block, a condition that results in disorganized electrical activity throughout the heart. Because left bundle branch block and non-ischemic heart disease lead to diffuse, as opposed to localized, heart problems, study authors reasoned women were more responsive to CRT-D therapy, a treatment that strengthens the overall mechanical pumping action of the heart and coordinates the heart’s electrical activity. “It’s not that men did poorly in the trial, but rather, women had really fantastic results, likely due to the type of heart disease we see more commonly in women,” noted Moss. The CRT-D device, developed by Boston Scientific, was originally approved to treat patients with severe heart failure. In September 2010, the Food and Drug Administration extended the approval of the Boston Scientific device to patients with mild heart failure to prevent progression to advanced heart failure. With the new indication, nearly 4 million more Americans are candidates for treatment with the CRT-D. The study is a sub-analysis of the MADIT-CRT trial that was published in 2009 in the New England Journal of Medicine. The study involved 1,820 participants from 110 medical centers in the United States, Canada and Europe and compared the effectiveness of CRT-D versus ICD therapy in reducing heart failure and death during four and one-half years of follow-up. Twenty-five percent, or 453 of the study participants, were female. Currently, 42 million American women are living with heart disease. It is the leading killer of women in the United States, each year claiming more women than men. In 2005, cardiovascular disease claimed the lives of more than 450,000 women, while all forms of cancer claimed the lives of approximately 265,000 women, according to the American Heart Association. The study was a joint effort between Boston Scientific and the University of Rochester Medical Center, with the participation of patients from medical centers throughout the world. Aysha Arshad, MD, and Jonathan Steinberg, MD, from St. Luke’s and Roosevelt Hospitals and Columbia University College of Physicians and Surgeons in New York City are the major co-authors of the article. Editor’s Note: Moss holds no stock in any device company, has never been a member of any corporate speakers’ bureau, and since Dec. 1, 2008, has chosen not to accept honoraria from Boston Scientific for any professional activity.
Most Medical Devices Recalled Because of Serious Risks Did Not Undergo Clinical TrialsMost medical devices recently recalled by the Food and Drug Administration because of very serious risks were initially approved through an expedited process or were exempt from regulatory review, according to a report posted online that will be published in the June 14 print issue of Archives of Internal Medicine, one of the JAMA/Archives journals. “Unlike prescription drugs, medical devices are reviewed by the U.S. Food and Drug Administration (FDA) using two alternative regulatory standards: 1) premarket approval, which requires clinical testing and inspections; or 2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device),” the authors write. “The second standard is intended for devices that the FDA deems to involve low or moderate risk.” Diana M. Zuckerman, PhD, of the National Research Center for Women & Families, Washington, D.C., and colleagues analyzed the FDA’s list of high-risk device recalls from 2005 to 2009. Using FDA data, the authors determined whether recalled devices were approved by the more rigorous premarket approval process, the less stringent 510(k) process or were exempt from FDA review. Between 2005 and 2009, 113 devices were recalled because the FDA determined those devices could cause serious health problems or death. Of these, 21 (19 percent) had been approved through the premarket approval process, 80 (71 percent) were approved through the 510(k) process and eight (7 percent) were exempt from regulation. “Of the recalled devices cleared for market through the 510(k) process, 12 percent were marketed for risky or life-sustaining Class III indications, which are required by law to undergo a full premarket approval regulatory review,” the authors write. The high-risk recalls included devices with a broad range of clinical applications, but the most common were cardiovascular devices (31 percent). Of these, two-thirds (23, or 66 percent) were approved using the expedited 510(k) process and 12 (34 percent) were cleared through the postmarket approval process. “The FDA’s implementation of the 510(k) process has received considerable criticism from public health advocates and from other federal agencies in reports, medical journal articles and testimony before Congress,” the authors write. US courts have also recognized the shortcomings of the expedited process. However, the relatively small division of the FDA charged with device approvals does not receive sufficient funding from Congress to conduct premarket approval on every device, the authors note. “When devices that were intentionally exempt from any FDA review were added to the 510(k) devices, they comprise more than three out of four of the high-risk recalls during the last five years,” they conclude. “Thus, the standards used to determine whether a medical device is a high-risk or life-sustaining medical product prior to approval are clearly very different from the standards used to recall a medical device as life threatening. Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy.” Arch Intern Med. Published online February 14, 2011.doi:10.1001/archinternmed.2011.30. Editor’s Note: This study was funded by individual donations to the National Research Center for Women & Families, which does not accept contributions from medical device companies. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
New Multicenter Study Shows that a Medical Imaging Technique Could Potentially Be Used to Predict and Prevent StrokesResearchers at the University of Utah’s Comprehensive Arrhythmia and Research Management (CARMA) Center have found that delayed-enhancement magnetic resonance imaging (DE-MRI) holds promise for predicting the risks of strokes, the third leading cause of death in the US. Their latest study on a novel application of this technology appears in the February 15 issue of the Journal of the American College of Cardiology. The study included 387 patients who were treated for atrial fibrillation (AF) at either the University of Utah (Salt Lake City) or Clinical Center Coburg (Coburg, Germany). AF affects more than 3.5 million Americans and causes more than 66,000 deaths a year. Individuals with AF are 2–7 times more likely to suffer a stroke than the general population. The purpose of the study was to determine if there was an association between an AF patient’s heart damage (i.e., left atrial [LA] fibrosis), which was detected using DE-MRI, and commonly used markers for the risk of stroke, specifically the CHADS2 index. Although further prospective studies are needed, the preliminary results indicate that DE-MRI-based detection of LA fibrosis is independently associated with prior history of strokes. The findings also provide preliminary evidence that the physiological features of the LA could be used, in addition to clinical features, when identifying stroke risk in patients. “We believe this method can be a valuable tool for clinicians to use in conjunction with the CHADS2 index for risk analysis and decisions about anticoagulation medications when treating AF patients,” said Dr. Nassir Marrouche, the Executive Director of the CARMA Center and Director, Cardiac Electrophysiology Laboratories, for the University of Utah’s Division of Cardiology. “Potentially, this will lead to improvement in current risk stratification schemes and enhance our understanding of the risks of thromboembolic (stroke) events in AF patients. We also hope this will lead to the development of effective strategies for stroke prevention.” Although the anticoagulant warfarin is highly effective in preventing strokes, the drug also is associated with life-threatening hemorrhaging and requires intensive dosage monitoring. Risk stratification schemes have been developed to tailor anticoagulation therapy to the patients’ risk, and the CHADS2 index is the most accepted risk stratification model. Yet while this index is a valuable tool for predicting cerebrovascular events in high-risk patients, clinicians rely more heavily on clinical judgment when predicting thromboembolic risk in moderate-risk patients, a substantial portion of the AF population. The identification of novel, independent risk factors by DE-MRI may supplement existing tools to help guide clinician judgment in better allocating anticoagulation therapeutic strategies, especially with moderate-risk AF patients. The study concluded that LA fibrosis as determined through the use of DE-MRI is “associated with an increased risk of thromboembolism in AF patients. Clinician use of both a CHADS2 index and a quantified measure of atrial fibrosis has the potential to provide a more rigorous risk assessment and improve future risk stratification schemes.” The University of Utah CARMA Center is conducting the world’s most innovative research on the use of MRIs to treat atrial fibrillation. In 2009, it opened the first integrated electrophysiology (EP)-MRI research and clinical laboratory in North America. This year, it has begun a worldwide patient evaluation program at 16 international medical centers to investigate the use of delayed enhancement MRI to stage the progression of the disease. The CARMA Center also has developed the Utah AF Staging System, which enables early detection and “personalized” treatment and management for each atrial fibrillation patient.
BIOTRONIK Introduces New Unique Reliaty Pacing System AnalyzerBIOTRONIK SE & Co. KG announced the European launch of the Reliaty pacing system analyzer after CE approval and successful pre-market evaluation. The pacing system analyzer (PSA) is used during an implantation of implantable pacemakers, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) systems to ensure adequate lead placement, maintenance of basic cardiac functions, and to evaluate pacing parameters for customized device programming. “Using the Reliaty allows me to be more flexible during implant procedures. It can be set up and moved very quickly from one location to another whenever necessary,” says Dr. Richard Derksen, Cardiologist in the Rijnstate Clinic Arnhem, The Netherlands. “Reliaty streamlines the workflow of procedures with a focused set of exactly the analytics that are required intraoperatively and for which I would otherwise have to use a programming device which is bulkier and less mobile, especially in the constrained space of the cath lab.” BIOTRONIK is the only company manufacturing a hand-held PSA such as Reliaty. The new intuitive user interface and option for connecting to a larger external screen allows for quick and easy testing when time is of the essence, supporting safe and accurate measurements. Reliaty also now features an additional test channel that allows for testing of up to three implanted cardiac leads to more easily accommodate CRT cases. It is battery powered to last for more than 12 hours of service daily, and additionally offers a universal stationary power cord that can be used worldwide. The measurement data can be exported from the PSA to a memory stick or printed via Bluetooth®. “Reliaty is part of a completely new external device portfolio from BIOTRONIK,” states Marlou Janssen, Vice President, Global Marketing and Sales, Cardiac Rhythm Management, BIOTRONIK. “Together with the new external pacemaker Reocor and the upcoming new programmer Renamic, BIOTRONIK is setting new standards in offering the highest quality portfolio of external CRM devices.”