Clinical and Industry News

AngelMed Guardian System Wins Medical Design Excellence Award Angel Medical Systems announced that the AngelMed Guardian System has received a 2010 Medical Design Excellence Award. The Guardian is an implantable cardiac monitoring and alerting system that detects rapid ST shifts that may indicate thrombotic coronary occlusions caused by vulnerable plaque ruptures. The device uses wireless technology to alert patients to seek immediate medical attention. The Medical Design Excellence Awards competition (www.MDEAwards.com) is organized and presented by Canon Communications LLC (Los Angeles) and is the only awards program that exclusively recognizes contributions and advances in the design of medical products. Entries are evaluated on the basis of their design and engineering features, including innovative use of materials, user-related functions that improve healthcare delivery and change traditional medical attitudes or practices, features that provide enhanced benefits to the patient, and the ability of the product development team to overcome design and engineering challenges so that the product meets its clinical objectives. A comprehensive review of the entries was performed by an impartial, multidisciplinary panel of third-party jurors with expertise in biomedical engineering, human factors, industrial design, medicine, and diagnostics. “We are honored that the MDEA judges have recognized AngelMed out of the many excellent companies that were considered,” said Jonathan Harwood, Chief Operating Office for AngelMed. “The AngelMed Guardian is currently in a Phase II clinical trial in 30+ sites around the U.S., with more sites added each month. The Guardian is also commercially available in Brazil, and will soon be available in Europe.” The 2010 Medical Design Excellence Award winners will be honored at a presentation ceremony on June 9 in New York City’s Jacob K. Javits Convention Center, in conjunction with the Medical Design & Manufacturing East Conference and Exposition, June 8–10. Gold and silver award recipients will be announced at this time. ___________________ Improved Radiation Protection Device to be Unveiled at HRS Lemer Pax, the manufacturer of the CATHPAX radiation protection cabin, will unveil an improved version of its physician radiation protection device at HRS 2010 in Denver. The CATHPAX is used by electrophysiologists during catheter ablation procedures. The CATHPAX’s continuous 2mm lead equivalent radiation protection provides full-body protection for the electrophysiologist during ablation. During clinical evaluations, the CATHPAX has demonstrated reduced radiation exposure to the operator’s head by more than 50 times. The new version of the CATHPAX radiation protection cabin, displayed at booth #2238 at HRS 2010, will provide the same level of radiation protection, but the cabin will have a lighter, more mobile frame and a better field of view for the operator. The improvements are expected to further improve performance of the CATHPAX, which is currently being used in more than 150 labs around the world. Radiation exposure from fluoroscopy is becoming an increasing concern for the electrophysiologist, as the number and complexity of cases continues to expand. The high cumulative radiation exposure may contribute to increased risk of carcinogenesis. In addition, physicians who wear leaded apparel for long procedures have a 25% incidence of neck and back problems. The CATHPAX is designed to provide the highest degree of radiation protection available while also removing the burden for physicians in having to wear leaded aprons, thyroid protectors, and glasses. In addition, lab staff and scrub nurses may benefit from the additional radiation protection in the lab during use of the CATHPAX. ___________________ BIOTRONIK Gains European Approval for Complete Series of MRI-Conditional Pacemakers and Leads BIOTRONIK announced the European approval of its new ProMRI Pacing Systems — Evia pacemaker series and Safio S pacing leads — providing European patients the first portfolio of bradycardia systems that are compatible with Magnetic Resonance Imaging (MRI) scans under specific conditions. When it comes to pacemaker and lead selection, one system may not be optimal for every patient. Physicians consider many different parameters that are unique to each individual patient when selecting the best combination. The approval of BIOTRONIK’s ProMRI series is the first time an entire pacemaker series, including two single chamber and two dual chamber devices, has been cleared for use in combination with MRI. In this way, physicians have the unique opportunity to select the optimal device from the Evia pacemaker series with the most advanced physiological therapy available and at the same time, give their patients access to MRI scanning. BIOTRONIK’s ProMRI portfolio includes four different Evia pacemakers and two different lengths of the Safio S pacing leads. The system was designed and approved for use with MRI under specific conditions. To gain approval, the new ProMRI Pacing Systems (Evia pacemakers with the Safio S leads) were vigorously tested in various combinations of device and lead positions and lengths, scanning time periods, and body positions in the MRI machines, all under strict regulation of the notified body. “We are very pleased to offer physicians the choice to select from a series of the most technologically advanced pacemakers — the Evia series of pacemakers — and at the same time give their patients access to MRI diagnostic procedures,” said Marlou Janssen, Vice President, Global Marketing and Sales, Cardiac Rhythm Management (CRM), BIOTRONIK. “BIOTRONIK is developing an entire CRM portfolio of MRI-compatible devices offering quality therapies to enhance patients’ safety and expand treatment options.” MRI is the gold standard for soft tissue imaging and an invaluable medical diagnostic tool for many common diseases and conditions in the area of oncology, neurology and orthopedic injuries. In 2007, there were approximately 30 million MRI scans conducted in the United States alone, and that number continues to grow.1 Until recently, the two million European patients with an implanted pacemaker were prohibited from receiving MRI scans, because the strong forces applied as part of the MRI scanning could negatively affect the pacemaker system or patients’ safety. The Evia pacemaker series combines MRI compatibility with unique innovations for advanced patient management, from the point of implant through follow-up. The small-sized pacemakers with extended longevity also provide several automatic functions to ensure a safe and convenient implantation procedure. In addition to the new platform features, Evia builds on established and proven innovations such as Closed Loop Stimulation® (CLS), which is the only rate regulation algorithm that provides appropriate heart rate response during periods of emotional stress, for improved hemodynamics and enhanced quality of life. To meet individual patients’ needs, Evia also provides two algorithms, Vp Suppression® and IRSplus®, which minimize unnecessary ventricular pacing, in order to lower patients’ risk of developing atrial fibrillation and heart failure. With a thin lead body (6.6 F), Safio S are active fixation leads with a flexible distal end, fractal coating and steroid elution to ensure optimal electrical performance and a stable fixation. BIOTRONIK Home Monitoring® allows physicians to remotely monitor their Evia patients’ clinical and device status at any time, from anywhere in the world. Importantly, physicians are alerted if there are any clinically relevant changes in their Evia patients’ condition or pacemaker status before or after the MRI procedure and have immediate access to all relevant data. In this way, physicians are able to make appropriate treatment decisions in a timely manner. 1 IMV, “Benchmark Report: MRI 2007,” IMV Medical Information Division 2008. ___________________ Advancing Age Associated With Increased Risk of Complications, Death After Implantation of Defibrillators or Pacemakers Older patients may be more likely to die in the hospital following the implantation of defibrillators or pacemakers, according to a report in the April 12 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. More than one-fifth of cardiac devices appear to be implanted in individuals age 80 and older, despite the fact that most clinical trials have not included adults in this age group. “Implantable cardiac devices have been increasingly used in primary prevention of sudden cardiac death among patients with systolic heart failure, largely on the basis of favorable results from large multicenter clinical trials,” the authors write as background information in the article. “However, it has become increasingly apparent that certain patient subgroups may not benefit from device implantation; for example, use of implantable cardiac defibrillators in patients with renal failure and in those with advanced heart failure symptoms has not been associated with a survival benefit,” the authors write. Because the average age in major clinical trials has ranged from 58 to 67 years and some have specified an upper age limit of 80 years, limited data are available on the use of these devices in older adults. Jason P. Swindle, MPH, then of Saint Louis University School of Medicine, and colleagues analyzed data from 26,887 adults who were hospitalized with a diagnosis of heart failure and underwent implantation of a defibrillator or cardiac resynchronization therapy in 2004 or 2005. The median age of all patients was 70 years. Patients aged 80 and older accounted for 17.5 percent of the procedures (4,694 patients), including 992 patients (21.1 percent) who were older than 85 years and 309 patients (6.6 percent) who were 89 years or older. In-hospital death rates increased from 0.7 percent among patients younger than 80 years to 1.2 percent among those age 80 to 85 and 2.2 percent among those older than 85 years. “We found that older patients were less likely to have a concomitant cardiac procedure or a high comorbidity score, suggesting that these patients may be, in fact, somewhat more carefully selected than the younger cohort,” the authors write. “However, older patients had slightly more complications related to the device procedure.” “Given trends in the demographics of heart failure and the costs of device therapy, additional studies are required to clarify the appropriateness of device implantation in older patients with heart failure, as well as the merits of less invasive options,” they conclude. (Arch Intern Med 2010;170[7]:631-637.) Editor’s Note: This study was supported in part by a grant from the National Institutes of Health. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. ___________________ nContact Announces First IDE Study to Research Closed Chest Convergent Ablation Procedure for Longstanding Persistent AF nContact Surgical, Inc. announced it has received the first Investigational Device Exemption (IDE) from the U.S. FDA to evaluate the safety and efficacy of a combined surgical and catheter procedure (the convergent procedure) to treat patients with longstanding persistent atrial fibrillation (AF). nContact's Numeris®-AF Guided Coagulation System with VisiTrax® will be used in combination with St. Jude Medical's Therapy™ Cool Path™ Ablation Catheter. Longstanding persistent AF has historically been the most challenging cardiac arrhythmia to treat. The majority of these patients have limited treatment options. During the convergent procedure, a cardiac surgeon and an EP work as a team to perform a closed chest epicardial ablation and endocardial catheter-based ablation procedure to treat a patient's AF. The procedure does not require chest incisions or ports and incorporates mapping and diagnostic endpoints, as measured by the EP, to determine procedure completion. The IDE study is designed to evaluate the safety and efficacy of the convergent procedure, utilizing the skills of both the EP and cardiac surgeon. The primary effectiveness endpoint from the multicenter, prospective trial is freedom from AF and freedom of all Class I and III antiarrhythmic drugs. John P. Funkhouser, President and CEO of nContact, said, "Cardiologists, EPs, and cardiac surgeons understand the difficulties in treating longstanding persistent AF patients and the associated limited outcomes. It is our hope that a convergence of surgical and electrophysiology techniques in a single procedure may provide an effective, minimally invasive, closed chest treatment option for longstanding persistent AF patients. St. Jude Medical has long been recognized as one of the premier manufacturers of medical devices that treat cardiac arrhythmias, and we are pleased to work with them in this study." ___________________ Bringing “CLARITY” on Efficacy, Safety and Efficiency of Catheter Ablation of Atrial Fibrillation Biosense Webster announces that it has obtained its first Ethics Committee approval for the CLARITY study, comparing the one-year efficacy, safety and efficiency of Carto® 3 System-guided radiofrequency ablation using the NaviStar® ThermoCool® Catheter versus fluoroscopy-guided radiofrequency ablation using the Pulmonary Vein Ablation Catheter® (PVAC®, Ablation Frontiers, Medtronic) in patients with paroxysmal atrial fibrillation (AF). This prospective, multi-center, randomized (2:1), controlled, two-arm clinical study will enroll up to 350 patients at up to 15 sites throughout Europe and Canada. The one-year efficacy results are expected to be available by Q2 2012, whereas the safety and efficiency data for both procedures will already be available by Q2 2011. “The CLARITY trial is the first randomized trial comparing the efficacy and safety of these existing ablation strategies for atrial fibrillation. Given the growing epidemics of atrial fibrillation, the results of this landmark trial will guide optimal treatment in a large patient population,” said Prof. Mattias Duytschaever, principal investigator of the CLARITY study. The hypothesis of this trial is that treatment with the NaviStar® ThermoCool® Catheter, with Carto® 3 System guidance, will provide superior efficacy and safety for the treatment of paroxysmal AF vs. the PVAC® catheter, without decreasing the efficiency of the ablation procedure, according to Marcia S. Yaross, PhD, Vice President, Worldwide Clinical, Regulatory and Health Policy, Biosense Webster. “We look forward to working with experienced PVAC® and NaviStar® ThermoCool® users in Europe and Canada to evaluate this hypothesis.” Carto® 3 System is the third generation of the Carto® electroanatomical mapping system, which brings the technology to an unprecedented level of performance. The system has been designed based on the feedback provided by several of the most prominent key opinion leaders in the atrial fibrillation treatment arena. Carto® 3 System is built on the core magnetic based Carto® proprietary technology. The Carto® 3 System brings to the physician and his/her staff: • Accurate visualization (with Carto® proprietary 3D mapping technology), which allows seeing up to 5 catheters in the anatomy with precision and clarity, while potentially minimizing fluoroscopy exposure to patients, physicians and EP lab staff • Increased mapping speed, which enables one to map as fast as moving the catheter, potentially shortening procedures and minimizing the burden to patients • Streamlined workflow allowing the physician and the lab teams to work more efficiently, saving lab resources and minimizing potential for human errors • A new User Interface designed for the EP lab, to shorten the learning curve for nurses and for other staff members • An improved connectivity for catheters, enabling better signal quality and minimizing setup errors The NaviStar® ThermoCool® Catheter, manufactured by Biosense Webster, Inc. is one of the most widely adopted catheters for the treatment of atrial fibrillation in Europe, and the only ablation catheter approved by the U.S. Food and Drug Administration for the treatment of drug refractory recurrent symptomatic paroxysmal AFib when used with Carto® Navigation Systems. According to data recently appeared in the Journal of American Medical Association, patients with atrial fibrillation who were treated with catheter ablation using the NaviStar® ThermoCool® Catheter demonstrated significantly better outcomes at one year compared to those receiving drug therapy. In addition, the patients treated with catheter ablation reported markedly fewer symptoms and substantially improved quality of life. ___________________ Vascular Solutions Launches New Gandras® Visci-G Catheter Vascular Solutions, Inc. recently launched the Gandras® Visci-G catheter for use in delivering embolic materials and radiopaque media to selected sites in visceral vascular territories. The Gandras Visci-G is a 5F, 75 cm catheter with a unique primary curve and a flexible 1 cm tip, making it useful for precise and stable placement in renal, mesenteric or abdominal catheterization procedures. The tight primary curve allows easy access of bilateral arteries through a single 5F arterial introducer, and standard microcatheters can then be delivered through the Visci-G catheter to access distal regions. Gandras is a registered trademark of Vascular Solutions, Inc. ___________________ The International Board of Heart Rhythm Examiners Receives American National Standards Institute Accreditation The International Board of Heart Rhythm Examiners (IBHRE) has received five-year accreditation from the American National Standards Institute (ANSI) under ANSI/ISO/IEC 17024 for Personnel Certification Bodies. Among just 29 other credentialing bodies in the world to receive ANSI accreditation, IBHRE received accreditation for its three certification examinations: • Certification Examination for Competency in Cardiac Rhythm Device Therapy for the Physician • Certification Examination for Competency in Cardiac Rhythm Device Therapy for the Allied Professional • Certification Examination for Competency in Cardiac Electrophysiology for the Allied Professional “IBHRE certificants are acknowledged by their peers as having acquired an extensive knowledge and understanding of cardiac rhythm device therapy and cardiac electrophysiology,” said Charles J. Love, MD, FHRS, FACC, FAHA, CCDS, President of the International Board of Heart Rhythm Examiners. “Achieving and maintaining this accreditation is part of our ongoing commitment to add value to the exam body and signify to our certificants, exam candidates and the medical community that the IBHRE certification programs adhere to the highest standards in credentialing.” ___________________ Cameron Health Commences FDA-Approved IDE Clinical Trial of the Minimally Invasive Totally Subcutaneous Implantable Defibrillator for Treatment of Sudden Cardiac Arrest Cameron Health, Inc. announced the commencement of the company's pivotal clinical trial to gain U.S. approval of its Subcutaneous Implantable Defibrillator (S-ICD®) System. The minimally invasive S-ICD System is prescribed for use in patients at risk of sudden cardiac arrest (SCA). The S-ICD System is unique in that the implantation of the system is entirely subcutaneous; no leads are in or on the heart. Additionally, there is no imaging equipment required for placement of the S-ICD System, as all of the components are positioned using anatomical landmarks. The S-ICD System received CE approval in 2009 and is commercially available in Europe. Conventional ICDs require placement of at least one lead in or on the heart. Most frequently, these leads are threaded through a vein and then placed inside the heart. These conventional transvenous leads allow for sensing of the heart’s rhythm and delivery of a lifesaving electric shock when a harmful arrhythmia is detected. The surgical placement and long-term implantation of these transvenous leads within the patient’s heart are associated with a significant proportion of the complications related to this highly effective therapy. In contrast, the Cameron Health S-ICD System resides just under the skin, potentially avoiding many of the complications associated with the conventional implant procedure. Cameron Health’s trial is a prospective, multicenter, single-arm design approved by the FDA under an investigational device exemption (IDE). The company plans to enroll up to 330 subjects at up to 35 sites globally. The study has primary clinical endpoints of arrhythmia conversion efficacy and complication free rate at 6 months for patients at risk of SCA. Jay Warren, President and CEO of Cameron Health, Inc. explains, “Our goals are to reduce or eliminate the risks that attend transvenous implants, to refine the state of the art in rhythm discrimination and to simplify implant, programming and follow up for the physician. In essence, our S-ICD System is designed to provide patients with a safe, efficacious and minimally invasive alternative to conventional ICDs.” The IDE trial will involve patients at centers in the U.S., Europe and New Zealand. The first IDE implants were performed in New Zealand by Dr. Margaret Hood at Auckland City Hospital and by Dr. Ian Crozier at Christchurch Hospital. Initial implants in the U.S. were performed by Dr. Martin Burke, Director of the Heart Rhythm Center at the University of Chicago. Commenting on the first patient to receive the S-ICD System in the U.S., Dr. Burke said, “Given the simplicity of the implantation, I can see the potential to reduce the surgical and long-term complications inherent in transvenous ICD systems.” Components of the Cameron Health S-ICD System include the SQ-RX™ Pulse Generator, Q-TRAK™ Subcutaneous Electrode, Q-GUIDE™ Electrode Insertion Tool and the Q-TECH™ Programmer. The S-ICD System is implanted subcutaneously with the electrode running parallel and slightly to the left of the sternum. While most functions are automatic, adjustments and data retrieval can be easily achieved through a highly advanced integrated programming system developed specifically for the S-ICD System. Weighing less than three pounds, the Q-TECH programmer is one of the smallest units in the industry. The lightweight, portable unit is capable of wireless communication with the SQ-RX Pulse Generator. ___________________ New Anti-Bacterial Device Helps Reduce Infections Associated with Pacemaker and Defibrillator Implantation TYRX, Inc. announced the commercial release of the AIGISRx™ Flat, an antibacterial product that helps provide protection against infections associated with implanted pacemakers and defibrillators. Like the original AIGISRx™ Envelope, AIGISRx Flat† delivers the anti-microbial agents rifampin and minocycline, which have been shown to reduce infection by organisms representing a majority of the infections reported in cardiac rhythm management device (CRMD)-related endocarditis, including “superbugs” or MRSA. AIGISRx Flat also offers the implanting physician additional flexibility in the application of these lifesaving devices. “The current AIGISRx envelope provides potent antimicrobial protection and also anchors the device to prevent device migration. However, in patients who are undergoing battery change-outs, using the AIGISRx Flat option helps minimize dissection of the pre-existing pocket,” notes Heather Bloom, MD, Assistant Professor of Medicine, Emory University School of Medicine, Director, Cardiac Electrophysiology Services, Atlanta VA Medical Center. “Since the risk of infection is much higher in change-outs, partially due to the avascular pocket preventing tissue penetration by oral antibiotics, having a drug-eluting device on the site is of critical importance.” Hospitalization for CRMD infection increased faster than rates of CRMD implants from 1996 through 2006, according to the National Hospital Discharge Survey, conducted by the Centers for Disease Control and Prevention. The disproportionate rise in CRMD-related infections carries significant public health consequences. This was further reinforced in the January 2010 guideline issued by the American Heart Association and Heart Rhythm Society which explicitly states there is a significant unmet clinical need in CRMD-related infection. Over 5 million people worldwide currently have a pacemaker or defibrillator with 500,000 people receiving a pacemaker or defibrillator each year in the United States. Following commercial release in 2008, AIGISRx has been implanted in over 8,500 patients nationwide. The company estimates that approximately 1% of all U.S. CRMD patients in 2010 will receive an AIGISRx envelope during their procedure. “We anticipate the AIGISRx products will be adopted as the standard during CRMD implants procedures,” remarked Robert White, TYRX CEO. “One of the great strengths of TYRX is the ability to leverage our current anti-bacterial technology into a wide variety of clinical applications. We are eager to help physicians and hospitals continue to address the significant unmet needs in infection control.” * Based upon preclinical in vitro and in vivo data. (Data on file at TYRX and published in PACE 2009; 32(7)898-907). † Previously referred to as AIGISRx Custom in marketing documents and website. ___________________ Boston Scientific to Immediately Resume Distribution of COGNIS® CRT-Ds and TELIGEN® ICDs in the U.S. Boston Scientific Corporation announced that it has received U.S. Food and Drug Administration (FDA) clearance for the two validated manufacturing changes affecting all of its cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs), and that it will immediately resume distribution of its COGNIS® CRT-Ds and TELIGEN® ICDs. The company is positioned to fully meet customer demand for COGNIS and TELIGEN within 24 hours. COGNIS and TELIGEN represent virtually all of the company's defibrillator implant volume in the United States. On March 15th and 16th the company submitted the two manufacturing changes to the FDA for the following CRT-D and ICD product families: COGNIS, TELIGEN, CONFIENT™, LIVIAN™, PRIZM™, RENEWAL® and VITALITY™. Solely on its own initiative, the company has conducted an internal review of manufacturing and other changes for these products, as well as the associated regulatory submissions. The review found a few additional instances where the company did not submit the appropriate documentation for validated manufacturing changes for CONFIENT, LIVIAN, PRIZM, RENEWAL and VITALITY. The company has now submitted this documentation and is working closely with the FDA to secure clearances to return CONFIENT, LIVIAN, PRIZM, RENEWAL and VITALITY — the earlier generations of the company's CRT-D and ICD products — to market as soon as possible in the United States. These products may continue to be implanted in geographies outside the United States. The company's pacemakers and other products were not affected by the ship hold and product removal actions. Geographies outside the United States were never affected — and remain unaffected — by these actions. "We are pleased that the FDA has cleared the manufacturing changes, and that we are again able to offer COGNIS and TELIGEN to U.S. patients and physicians," said Ray Elliott, President and Chief Executive Officer of Boston Scientific. "We are committed to doing the right thing every time, and we acted voluntarily, swiftly and appropriately to ensure compliance with all regulatory requirements." The company is evaluating the impact of the ship hold and product removal actions on its financial results and will provide an update with the release of its first quarter earnings. These recent actions may have a material impact on the company's previously issued guidance, including revenue, operating profit and cash flows for the first quarter and full year of 2010. ___________________ Cambridge Heart Receives FDA 510(k) Clearance for Its Microvolt T-Wave Alternans Module to Measure Risk for Sudden Cardiac Death Cambridge Heart, Inc. announced that it has received clearance from the U.S. Food and Drug Administration to begin marketing its Microvolt T-Wave Alternans (MTWA) OEM module. The MTWA OEM module is designed to work with existing cardiac stress test platforms distributed by other manufacturers. This FDA 510(k) clearance allows Cambridge Heart to begin marketing the MTWA OEM module integrated with the Q-Stress line of stress systems manufactured by Cardiac Science Corporation, Inc. The non-invasive MTWA test measures small heartbeat irregularities that indicate a patient's heightened risk for sudden cardiac arrest. In June 2009, Cambridge Heart and Cardiac Science entered into a five-year development and distribution partnership, whereby Cardiac Science will market the MTWA OEM module to its existing base of installed stress systems as an upgrade, and to new stress customers as an optional feature. Development of the MTWA OEM module was completed in early February 2010. Sales training and pre-launch activities will take place between now and an expected launch date later this year. "The development of MTWA as an add-on module for our stress systems allows us to bring new technology to our customers and extend our leadership in the stress segment," said Dave Marver, Cardiac Science President & CEO. "This initiative is consistent with our goal to help our physician customers by offering simple, cost-effective, and efficient devices that improve public health." Ali Haghighi-Mood, Cambridge Heart's President and CEO said, "We are pleased to have reached this important milestone in a relatively short period of time. Obtaining the FDA clearance is a big step as we implement our new business model that aims to market the MTWA technology via partnerships with the leading stress test manufacturers. Most immediately, the clearance allows us to focus our activities on working with Cardiac Science, training its sales force and distributors and engaging in other activities in advance of the product launch." ___________________ Endosense Launches Next Generation TactiCath® Force-Sensing Catheter Endosense, a medical technology company focused on improving the efficacy, safety and reproducibility of catheter ablation for the treatment of cardiac arrhythmias, has announced the commercial release of its next generation TactiCath force-sensing ablation catheter. Recently granted CE mark and unveiled at the DGK 2010 – German Cardiac Society meeting in Mannheim, Germany, the second generation product includes an elegantly enhanced catheter along with a feature-rich supporting system called the TactiSys™. “Endosense is committed to bringing the best force-sensing ablation catheter technology to the electrophysiology lab, and this next generation TactiCath reflects that ongoing commitment,” said Eric Le Royer, president and chief executive officer of Endosense. “This new generation was designed in response to customer feedback to create an even more valuable clinical experience with the TactiCath for the treatment of cardiac arrhythmias.” Key additions to the second generation TactiCath were based on the valuable input of early clinical adopters and are intended to optimize the utility and versatility of the catheter and the system in clinical practice. The TactiSys system, which is comprised of a graphical user interface, base station and splitter, was upgraded to include a number of features, including: • A customizable, information-rich user interface that now displays force-time integral (the calculation of force over time), a new parameter which research has shown may be a better predictor of lesion size than current alternative parameters, and • Automatically generated summary reports that document therapy delivery, including a histogram that shows physicians the forces applied throughout the catheter ablation procedure. “As a long-time user of the TactiCath, I find the next generation product to be a significantly enhanced system that delivers even greater performance and flexibility during catheter ablation procedures,” said Dipen Shah, MD, University Hospital of Geneva, Switzerland. “The new features and product enhancements make the TactiCath and TactiSys an even more compelling addition to the EP lab. They reflect a keen understanding by Endosense of our needs and a desire to continuously improve their products.” The new TactiCath and TactiSys are indicated for the treatment of atrial fibrillation (AF) and supraventricular tachycardia. The product is currently available in major markets across Europe, Latin America, Canada, the Middle East and Africa. Endosense’s TactiCath is the first and only force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. It has undergone considerable pre-clinical and clinical testing, the results of which have created a solid foundation of evidence supporting the feasibility, safety and value of contact-force sensing during catheter ablation. The TactiCath has the potential to improve the effectiveness, safety and reproducibility of catheter ablation treatment of cardiac rhythm disorders, including AF.