Industry News & Products

Hansen Medical Unveils Next-Generation Robotic Catheter System and Two New Catheters Offering Advanced Navigation Within the Heart

Robotic Irrigated Ablation Catheter for European Union to Offer Stability During Treatment of Atrial Fibrillation Hansen Medical, Inc. announced it has received U.S. FDA clearance for its next-generation Sensei® X Robotic Catheter System and introduced the Artisan Extend™ Control Catheter. The company also introduced the Lynx™ Robotic Ablation Catheter, a small, flexible irrigated ablation catheter for customers in Europe. The new Sensei X platform provides physicians with improved procedural planning and workflow, and enhancements in catheter control within the heart during EP procedures. During clinical evaluations, physicians indicated that the Sensei X system and the Artisan Extend control catheter improved their technical capabilities during EP procedures, while continuing to reduce radiation exposure to both patient and physician. The new Lynx robotic ablation catheter, which the company plans to launch in the European market, is supported by the Sensei X platform and leverages the navigation capability of the Artisan Extend catheter, but in a smaller and more flexible integrated profile for the treatment of atrial fibrillation (AF) and other electrophysiology disorders. Offering a 7 French irrigated ablation tip with a standard sized sheath, the new Lynx catheter has six degrees of freedom that facilitates placement in difficult to reach anatomic locations. Pending CE mark approval, the Lynx catheter is expected to be available in the European Union within the first half of 2010. The Lynx catheter is not currently available for sale in the U.S. “The Lynx catheter is thinner and safe, and its ablations were consistent with my prior experience with other irrigated ablation devices,” said Josef Kautzner, MD, PhD, FESC, Head, Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague. “In addition, the learning curve for the new catheter may be shorter, which I believe will help a broader group of physicians to perform complex ablation procedures for the treatment of AF with greater effectiveness.” The new Sensei X system is the next-generation flexible robotic platform that integrates advanced levels of 3D catheter control with 3D visualization, a synergistic technology combination that provides accuracy and stability to the physician. The Sensei X platform supports the new Artisan Extend control catheter, which increases the reachability and navigation properties of the existing Artisan catheter by offering more than 20 percent improvement in both bend and reach. As a result, physicians have the ability to place catheters deliberately and accurately within the heart. In addition, the Artisan Extend catheter offers improvements in setup and workflow, designed to improve usability and reduce procedure time. The Sensei X platform also supports Hansen Medical’s CoHesion™ 3D Visualization Module, which integrates the 3D motion control of the Sensei X system with the 3D visualization of the St. Jude Medical EnSite™ system. Two features of the Sensei X system designed to improve procedural planning and workflow include Workspace Visualization, an enhancement that allows physicians to see the catheter’s reach on a 3D map prior to navigation, and EndoView, a feature that allows physicians to quickly change the orientation to a standard endoscopic view. “During evaluation of the Sensei X system, we were able to navigate and control the catheter in 3D with greater stability and enhanced responsiveness, which improved our ability to perform complex arrhythmia mapping procedures safely and successfully,” said Rahul N. Doshi, MD, Director, Arrhythmia Services and Chair, Cardiothoracic, St. Jude Medical Center, Fullerton, California. According to Amin Al-Ahmad, MD, Assistant Professor of Cardiology, Stanford University Medical Center, who also evaluated the Artisan Extend catheter, “The improved flexibility and bend radius with the Artisan Extend catheter allows access to the right inferior pulmonary vein and other cardiac targets that are typically harder to reach when mapping with manual technique. In addition, the set up for the new catheter is simplified, so our procedure time will be reduced.” “Our goal was to develop the next-generation robotic platform for EP that is a step towards addressing many of the clinical needs of electrophysiologists and extends the procedural capabilities of robotic catheter control during EP procedures,” said Frederic Moll, MD, president and CEO, Hansen Medical. “The positive feedback to the Sensei X system and the two new catheters demonstrates the potential of this new platform to continue to increase the adoption and utilization of robotics in EP procedures.” The company plans to begin shipping the new Sensei X system in the third quarter of 2009 in the U.S. and the E.U. The company will begin shipping the Artisan Extend catheter in the U.S. in the third quarter of 2009 and expects that the Artisan Extend catheter will receive the CE mark in the fourth quarter of 2009. ______________________

Implantable Defibrillators Not Associated With Reduced Risk of Death in Women With Heart Failure

Implantable cardioverter-defibrillators do not appear to be associated with a reduced risk of death in women with advanced heart failure, according to a meta-analysis of previously published research in the September 14 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Heart failure affects about 5.3 million Americans, almost half of them women, according to background information in the article. Patients with heart failure are six to nine times more likely than the general population to experience sudden cardiac death. In addition to medication, treatment for heart failure involves preventing sudden cardiac death through the implantation of a cardioverter-defibrillator. This therapy is supported by numerous clinical trials, the authors note. However, questions remain regarding the benefits in certain patient subgroups, including women. Hamid Ghanbari, MD, and colleagues at Providence Hospital Heart Institute and Medical Center, Southfield, Michigan, searched for randomized clinical trials of implantable defibrillator therapy for heart failure patients published between 1950 and 2008 that included data on the risk of death for female patients. Five eligible trials that included 934 women were identified. None of the five trials demonstrated a significant benefit of defibrillator implantation over medical therapy for women. When the researchers pooled the data and performed a meta-analysis, the implantable cardioverter-defibrillator was not associated with decreased all-cause mortality in women. Among the 3,810 men in the studies, however, a statistically significant decrease in death rate was found in each of the five trials alone and in the combined meta-analysis. There are several possible reasons for the sex differences in these results, the authors note. Among patients with heart disease, women have about one-fourth the risk of sudden cardiac death as men. This may be because women have different patterns of arrhythmias and also because they have more co-occurring illnesses that may increase their risk of death from other causes. Therefore, a larger study population may be needed to show any benefit of defibrillator implantation in women. “Most clinical trials have been heavily weighted toward men; therefore, generalization of the results to women remains questionable. The best answer to this problem would be to perform a clinical trial that specifically targets women with heart failure to test the hypothesis of whether implantable cardioverter-defibrillator implantation reduces their overall mortality [death] rate,” the authors write. Because clinical guidelines already recommend defibrillator treatment to prevent sudden cardiac death, such a trial may be difficult to propose, they note. “However, on the basis of our findings it seems that a trial targeting women is needed, and a meta-analysis such as ours may be an appropriate first step to explore this hypothesis.” Source: Arch Intern Med 2009;169[16]:1500-1506. ______________________

IMPROVE HF, a Guideline-Focused Performance Improvement Study, Demonstrates Significantly Improved Outpatient Heart Failure Quality of Care

New IMPROVE HF Findings Showed Increase in Guideline-Recommended Treatments on Six of Seven Quality Measures A process improvement program significantly improved the quality of care on six of seven guideline-recommended care measures in the largest U.S. outpatient heart failure clinical study. Twenty-four month findings from IMPROVE HF, (The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting), funded by Medtronic, Inc., demonstrated that clinics using the process improvement program increased adherence to evidence-based, guideline-recommended care by 82 and 62 percent, respectively, for cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillator (ICD) use, and 80 percent for aldosterone antagonist use, all relative to baseline results. Use of angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin receptor blockers (ARB), beta blockers and heart failure education also showed significant improvement. IMPROVE HF is the first of its kind, large-scale, prospective study involving approximately 35,000 heart failure patients from 167 U.S. cardiology practices. All study data were collected and analyzed by an independent clinical research organization. Results were presented as a late breaking clinical trial at the 13th Annual Scientific Meeting of the Heart Failure Society of America (HFSA) in Boston. “These compelling results serve as a call to action for the need to transform heart failure care delivery in the outpatient practice setting,” said Gregg C. Fonarow, MD, co-chair of the IMPROVE HF Scientific Steering Committee and Professor of Cardiovascular Medicine at the University of California at Los Angeles. “By monitoring care and applying a practice-specific performance improvement system to better meet guideline recommendations, cardiology practices can markedly increase the quality of care for their heart failure patients.” With a primary endpoint of 20 percent relative improvement on at least two of the seven quality measures (of which four were on drug therapy, two on device therapy and another on heart failure education), IMPROVE HF 24-month data showed significant improvement on six of the seven measures. Full results include: • Greater than 60 percent relative improvement on three quality measures (CRT utilization increased 82 percent, aldosterone antagonist use increased 80 percent, ICD utilization increased 62 percent); and • Significant improvement on three other guideline-recommended care measures (ACE inhibitors and ARB use increased 8 percent, beta blocker use increased 9 percent and heart failure education use increased 15 percent); and • No significant increase in the use of anticoagulation for atrial fibrillation. The quality measures apply only to patients documented to be eligible for treatment according to current guidelines and without any recorded contraindications, intolerance, or other rationale for not treating. IMPROVE HF baseline data, collected prior to any performance improvement intervention, demonstrated inconsistencies in care for women and elderly and underutilization of lifesaving device therapies for heart failure patients. Specifically, of those patients eligible, only 38 percent received a CRT device, 49 percent received an ICD, and 34 percent received aldosterone antagonist drug therapy. The 24-month data, which were gathered after implementing the practice-specific performance improvement interventions, showed higher utilization with CRT therapy increasing to 69 percent, ICD use increasing to 79 percent and aldosterone antagonist drug therapy increasing to 62 percent utilization. ACE inhibitors/ARB use increased to 87 percent, beta blocker use increased to 94 percent and heart failure education use increased to 71 percent. “We are proud to support research that helps physicians provide more consistent, guideline-driven care for the 22 million heart failure patients worldwide,” said Marshall Stanton MD, vice president of clinical research for the Cardiac Rhythm Disease Management business at Medtronic. “The 167 clinical sites participating in IMPROVE HF are paving the way for practice improvement efforts that will have a meaningful impact on improving the quality of care for heart failure patients.” ______________________

St. Jude Medical Announces Opening of European Advanced Learning Center For Continuing Physician Education in Heart Disease Therapies

St. Jude Medical, Inc. announced the official opening of the St. Jude Medical Advanced Learning Center, in Brussels, Belgium, offering education and training in advanced, evidence-based therapies for physicians who treat heart disease. The center’s curricula include cardiac rhythm management, electrophysiology treatments of heart rhythm conditions, heart valve replacement and repair, vascular closure after interventional procedures and the repair of openings in the septum, the wall that separates the heart’s left and right sides. Presented in small groups and including simulations, the training programs are designed to increase physician familiarity and experience with various technologies and procedures. “The opening of St. Jude Medical’s first Advanced Learning Center demonstrates our commitment to physicians as they seek to improve patient outcomes and lower risks,” said Denis Gestin, president of the St. Jude Medical International Division. “The training and hands-on experiences at the center will help develop physician knowledge and skills on the safe, effective use of St. Jude Medical products to enhance patient care.” The center’s curriculum in interventional electrophysiology (EP) has received Continuing Medical Education (CME) accreditation from the European Board for Accreditation in Cardiology (EBAC). It is designed to train physicians in ablation therapy for the treatment of heart rhythm conditions. Prof. G. Hindricks, MD, of Herzcentrum Leipzig in Leipzig, Germany and P. Della Bella, MD, of Centro Cardiologico Monzino in Milan, Italy, are the center’s course directors for the Interventional EP Curriculum. In addition to learning in instructional sessions, course participants gain first-hand experience in the use of St. Jude Medical advanced medical technology through innovative training tools. The center is equipped with virtual reality simulators that enable physicians to practice implanting leads in the left and right sides of the heart, ablating targeted heart tissues using EP procedures to treat abnormal heart rhythms and performing transseptal procedures. A wet lab allows physicians to increase effectiveness in valve replacement and repair, and a cardiac rhythm simulator lets physicians hone their skills in programming pacemakers, ICDs and cardiac resynchronization therapy devices. “For physicians who treat heart disease, the arrival of new advanced technologies continuously challenges us to learn about them, gain hands-on experience and achieve control in their use,” said Peter T. Mortensen, MD, of Skejby University Hospital, Aarhus, Denmark. “The St. Jude Medical Advanced Learning Center provides physicians with a new option for gaining valuable experience that, when used according to best practices, leads to improved patient outcomes in the clinic.” ______________________

Promising Results of Drug Trial Could Herald a Replacement for Popular Blood Thinner

Researchers published promising results for a drug that could lead to a replacement for the very effective but difficult-to-use blood thinner Coumadin® (sold generically as warfarin), taken by millions of Americans to reduce their risk of stroke. In the New England Journal of Medicine, lead U.S. researcher, clinical cardiologist and Vice President of the Lankenau Institute for Medical Research Dr. Michael Ezekowitz hailed the study results as “the first breakthrough in 60 years for preventing stroke in patients with atrial fibrillation.” The study by German pharmaceutical manufacturer Boehringer Ingelheim was the largest stroke prevention trial ever conducted among patients with atrial fibrillation. Involving 18,113 patients in 44 countries, the clinical trial compared the new drug, Dabigatran, to warfarin. “The magnitude of these results cannot be understated,” Dr. Ezekowitz said. “For years, the primary drug option cardiologists have had in preventing strokes in patients with atrial fibrillation is the anticoagulant Coumadin. Although it is highly effective, it is very difficult to control.” “This study points to another solution that is potentially more effective and safer. This should be welcome news for patients with atrial fibrillation who are at risk for stroke.” Dr. Ezekowitz listed the following features of Dabigatran: • Like Coumadin, it can be taken by mouth, but unlike Coumadin — which takes four days to work — Dabigatran acts within two hours; • Dabigatran, unlike Coumadin, has very few drug-to-drug interactions and, unlike Coumadin, does not require patient monitoring; • Dabigatran is superior to Coumadin at the higher dose without compromising safety, and is safer than Coumadin at the lower dose without compromising effectiveness. According to Dr. Ezekowitz, “Another remarkable aspect is that we identified precisely the correct dosage of Dabigatran to give to patients. If the dosage of a blood thinner is too high, the patient can experience bleeding. If it’s too low, a stroke can occur. This trial not only identified a drug that is more effective than Coumadin, it also revealed the precise dosage that needs to be administered.” Additional information can be found at https://www.LIMR.org and https://www.mainlinehealth.org/oth/Page.asp?PageID=OTH000886. ______________________

Asymptomatic Heart Failure Detection Device from NI Medical Receives FDA Approval

NI Medical Ltd, a privately held Israeli biotech company, has received FDA approval for its NICaS CS, an essential new device for the assessment of left ventricular systolic dysfunction (LVSD), which helps doctors to detect heart failure in its pre-clinical, asymptomatic phase. The basic NICaS device uses impedance technology for measuring fundamental cardiac functions like cardiac output, cardiac index, cardiac power, stroke index, total peripheral resistance, etc. This device is characterized by exceptionally accurate results, revealing a bioequivalence with the thermodilution technique. A new algorithm, the Granov Goor Index (GGI), has recently been added to the NICaS, now called NICaS CS. By adding this new apparatus to the primary care physician’s personal kit, one will now be able to detect the cardiac entity LVSD in the pre-clinical or asymptomatic phase during an ordinary physical examination in the office. The introduction of the GGI to medicine is of specific relevance to a certain fraction of coronary deaths called sudden cardiac death (SCD). Of the total 650,000 annual deaths from coronary heart disease in the United States, approximately 350,000 succumb to SCD. To use the NICaS, a doctor, nurse, or medical technician simply places one double electrode on the patient’s wrist and one on the ankle, meaning the patient need not undress, nor be shaved. The entire process requires only three to four minutes. The NICaS electrodes are connected to the impedance device, which is situated within a laptop computer in place of the CD-ROM, and the laptop's screen serves as the monitor. The Framingham Study determined the diagnostic parameters of the so-called asymptomatic LVSD in 2003. It was because of the high economic burden of screening the population for the treatment of this malady that this enterprise was abandoned. However, with the advent of the GGI, which proved that the parameters determined by the Framingham Study are accurate, and the nominally priced NICaS CS, at least 40% of asymptomatic LVSD cases will now have the opportunity for diagnosis and cure. “The prevalence of asymptomatic LVSD is age-related,” concludes Prof. Goor, Chairman and Chief Investigator at NI Medical. “Once this exam becomes routine in patients over 60, its impact on life salvation will be dramatic.” ______________________

Siemens and SurgiVision to Develop MRI-Guided Cardiac Electrophysiology System

Team at the University of Utah Leading Clinical Research Effort Siemens Healthcare and SurgiVision, Inc. announced an agreement for the co-development and commercialization of a real-time magnetic resonance image (MRI)-guided cardiac electrophysiology (EP) system. The two companies are collaborating with the University of Utah to bring to the clinic a fully integrated, ground-breaking EP-MRI system that promises to improve conventional catheter-based cardiac procedures. “By bringing together Siemens’ capabilities with SurgiVision’s technologies and expertise in real-time MRI-guided interventions, we are well-positioned to deliver a fully integrated hardware, software and catheter system that will provide real-time visualization within an intuitive physician interface and a procedure that eliminates radiation exposure,” said Kimble Jenkins, chief executive officer of SurgiVision. He added, “Our close research collaboration with the University of Utah rounds out our team with deep clinical expertise and broad research capabilities.” “We are excited to work with SurgiVision in the development of these important technologies that have the potential to significantly improve therapies for patients suffering from cardiac arrhythmias, in particular atrial fibrillation,” said Walter Märzendorfer, chief executive officer, Magnetic Resonance, Siemens Healthcare. “Both companies have long believed in the power of MR to play a significant role in EP procedures. Our collective vision is to provide the physician with the ability to monitor the EP therapy in real-time and to visualize the lesions,” said Dr. Christine Lorenz, director, Center for Applied Medical Imaging, Siemens Healthcare and Siemens Corporate Research, Inc. "We are refining image-based cardiac ablation procedures using MRI, which our research indicates has the potential to improve the accuracy of the ablation, prevent complications, and decrease the number of repeat procedures," said Dr. Nassir F. Marrouche, electrophysiologist and director of the University of Utah’s Atrial Fibrillation Program. In May, University Health Care took another step forward in this regard by opening an integrated EP-MRI clinical and research lab, which provides real-time delayed enhancement MRI for treating atrial fibrillation patients. Atrial fibrillation is the most common cardiac arrhythmia, affecting more than 3 million people in the United States and more than 7 million people worldwide. Atrial fibrillation is a leading cause of stroke among people 65 years or older and is associated with increased risk of morbidity and mortality as well as a reduced quality of life. Treatment of atrial fibrillation represents a significant health care burden with the annual costs estimated at $7 billion.