Industry News and Products

BIOTRONIK, Inc. Announces the First U.S. Implant of Lumax 540 Series – A Therapy for Patients Suffering From Heart Failure

BIOTRONIK, Inc., announced the first U.S. implant of the next-generation Lumax 540 Series defibrillator for treating patients with heart failure. The Lumax 540 Series was recently approved by the U.S. Food and Drug Administration. The Lumax 5 Series represents the latest devices from BIOTRONIK in its full line of patient-focused cardiac rhythm management products engineered for electrophysiologists who demand superior quality and reliability. The first U.S. implant of the new Lumax 540 Series was performed by Leon Feldman, MD, FACC, co-director of Electrophysiology and Cardiology section chief at Eisenhower Medical Center in Rancho Mirage, California. Dr. Feldman commented, “The patient presented with very complex needs: ongoing bradycardia, recurrent ventricular tachycardia, and progressive heart failure all at once. The patient will benefit from the advanced capabilities of the Lumax 5 Series defibrillator.” Heart failure is on the rise in the U.S., affecting 5 million people with 550,000 new cases each year. Fortunately, therapies are available to enhance the quality of life of a heart failure patient. “The patient already received the highest dose of beta blockers and ACE inhibitors that he could handle and was still in severe heart failure,” Dr. Feldman said. A cardiac resynchronization therapy defibrillator was the perfect solution. “I’ve had great success with previous-generation BIOTRONIK devices and have confidence in the construction of the device and lead technology. Also, I’m a big proponent of Home Monitoring® for the patient, which can remotely and rapidly detect onset of atrial fibrillation, for which this patient is at risk.” Dr. Feldman described the benefits that BIOTRONIK’s Home Monitoring® system offers him and the patient: “It will also help us with early notification of VF and VT, which allows us to modify therapy and avoid unnecessary shocks.” Lumax 540 Series exemplifies BIOTRONIK’s dedication to innovative programming solutions, painless, more accurate therapy, mobile monitoring, and unbeatable device longevity — all to help provide peace-of-mind for the patient. This individualized therapy management helps to reduce unnecessary follow-ups and prevent serious clinical events. _______________________

Transoma Medical Announces First Patient Enrollment in Clinical Study on Long-Term Cardiac Monitoring for Detection of Atrial Fibrillation after Cryptogenic Stroke

Study Utilizes Sleuth AT™ Implantable Cardiac Monitoring System to Monitor for Presence of AF after Cryptogenic Stroke Transoma Medical, Inc., manufacturer of Sleuth AT™, a wireless, automated implantable cardiac monitoring system with programmable and frequent electrocardiogram (ECG) sampling, announced the first enrollment and implant in a long-term study to monitor patients who have suffered a cryptogenic stroke (of unknown origin) to determine if atrial fibrillation (AF) is present. The implant was performed on April 10 by electrophysiologist Dr. Emile Daoud at Ohio State University Medical Center in Columbus. The company received FDA 510(k) marketing clearance for Sleuth AT, its next-generation product, on Feb. 11, 2009. “It is believed that as many as 20 percent of cryptogenic strokes are caused by asymptomatic atrial fibrillation,” said Dr. Daoud. “Due to the nature of paroxysmal atrial fibrillation, it may remain undetected by standard diagnostic methods and may be an under-recognized cause of cryptogenic stroke. With Sleuth AT, we can continuously monitor the patient for AF over a prolonged period to determine if, when and for how long AF is present.” The Long-Term Cardiac Monitoring for Detection of Atrial Fibrillation after Cryptogenic Stroke is a pilot study involving five centers in Canada and the United States. The investigators driving this clinical study are Dr. Andrew Krahn from the London Health Sciences Centre University Hospital in London, Ontario, and Dr. Daoud. The primary endpoint of the study is to determine the incidence of AF at one year from Sleuth AT implantation in patients who have had cryptogenic stroke. Sleuth AT allows physicians to program the capture of high-quality ECG strips at frequent intervals, providing a new level of insight into complex arrhythmias that are often asymptomatic and frequently changing. These captured ECG strips are automatically transferred to a 24/7 monitoring center, staffed by certified cardiac technicians, who classify and notify physicians of the presence of a wide variety of cardiac arrhythmias such as ventricular tachycardia, bradycardia, supraventricular tachycardia and atrial fibrillation. “It will be very interesting to see the results that come out of this study,” said Dr. Geoff Eubank, a neurologist at Neurological Associates, Inc. in Columbus, who frequently treats cryptogenic stroke patients and partners with Dr. Daoud for evaluation of these patients. “Monitoring and diagnostic technology up until now has been limited and sporadic in providing data. I’m hopeful that the long-term, continuous and automated nature of this system will prove more effective in delivering the information we need to effectively treat these patients and prevent future strokes.” “Having this study underway is a milestone, because AF could be the cause of a large number of cryptogenic strokes,” said Brian Brockway, Transoma Medical founder and CEO. “AF is a common cardiac arrhythmia that is challenging to manage. However, we believe Sleuth AT is a unique and superior method for monitoring AF and the effects of current and future therapies.” _______________________

ZOLL Initiates Field Corrective Action on AED Plus User-Installable Software Update Detects Battery-Aging Defect

ZOLL Medical Corpo-ration, a manufacturer of resuscitation devices and related software solutions, announced it has initiated a voluntary worldwide field corrective action on its ZOLL AED Plus® automated external defibrillator. The company has determined that some batteries do not work properly when used with AED Plus defibrillators manufactured prior to February 12, 2009 (serial numbers below X_ _ _200000). In addition, the version of the AED Plus self-test software installed in these devices does not adequately detect defective batteries. As a result of these two issues, the AED Plus defibrillator may fail to deliver defibrillation shocks during treatment of sudden cardiac arrest. The company’s investigation is not complete at this time. This corrective action applies to approximately 180,000 units. Devices installed for at least three years are at the highest risk, a population of approximately 80,000. Although this issue was identified through customer reports from non-clinical testing, there has been one clinical event reported in which a defibrillation shock was not delivered, the patient subsequently died, and an evaluation of the device found that the batteries experienced the identified problem. At this time ZOLL has reviewed all reported patient events and found up to three additional cases in which a shock was not delivered to a patient and the battery may have experienced the identified problem. The company was informed that in one of the cases the patient subsequently died. The required correction is available in the form of a software update, which can be easily downloaded from the company’s website and installed by the user. This new software, which is included in current shipments of the AED Plus, can detect this battery defect condition if it occurs within the maximum five-year standby lifetime, and alert the user to install fresh batteries. Working with its distributors, ZOLL began notifying customers with affected devices on February 12th, advising the immediate replacement of batteries on a three-year schedule until their device software can be updated. There is no need to remove devices from service pending the corrective action. More information on this corrective action, including instructions for downloading software and ordering replacement batteries is available at Customers can also call ZOLL Technical Support at 1-800-348-9011 or email “”. Although the root cause investigation is not fully complete, it appears that high internal resistance can develop in some batteries after several years in standby mode. It is possible that this can lengthen charging time beyond specified and clinically acceptable limits, resulting in the failure of the AED Plus to deliver a defibrillation shock. It is difficult to predict which batteries may develop this condition, and the affected devices’ self-test does not detect this condition. The FDA has been notified of this problem and is expected to classify it as a recall. This action does not apply to AED Plus devices manufactured after February 12, 2009 (serial numbers above X_ _ _200000), and the company does not expect any disruption in AED Plus supply or unusual backlog from this corrective action. Costs associated with notification and monitoring of customer implementation of this corrective action, and reporting compliance to appropriate regulatory authorities, will be accrued in the fiscal quarter ended March 29, 2009. _______________________

Merck & Co., Inc. and Cardiome Sign License Agreement for Vernakalant, an Investigational Drug for Treatment of Atrial Fibrillation

Merck & Co., Inc. and Cardiome Pharma Corp. announced a collaboration and license agreement for the development and commercialization of vernakalant, an investigational candidate for the treatment of atrial fibrillation. The agreement provides Merck with exclusive global rights to the oral formulation of vernakalant (vernakalant [oral]) for the maintenance of normal heart rhythm in patients with atrial fibrillation, and provides a Merck affiliate, Merck Sharp & Dohme (Switzerland) GmbH, with exclusive rights outside of the United States, Canada and Mexico to the intravenous (IV) formulation of vernakalant (vernakalant [IV]) for rapid conversion of acute atrial fibrillation to normal heart rhythm. Luciano Rossetti MD, senior vice president and franchise head, Atherosclerosis and Cardiovascular, Merck Research Laboratories, said "Vernakalant is an important addition to our broad portfolio of products and candidates that target multiple aspects of heart disease." Under terms of the agreement, Merck will pay Cardiome an initial fee of US$60 million. In addition, Cardiome is eligible to receive up to US$200 million in payments based on achievement of certain milestones associated with the development and approval of vernakalant products (including a total of US$35 million for initiation of a planned Phase III program for vernakalant [oral] and submission for regulatory approval in Europe of vernakalant [IV]), and up to US$100 million for milestones associated with approvals in other subsequent indications of both the intravenous and oral formulations. Also, Cardiome will receive tiered royalty payments on sales of any approved products and has the potential to receive up to US$340 million in milestone payments based on achievement of significant sales thresholds. Cardiome has retained an option to co-promote vernakalant (oral) with Merck through a hospital-based sales force in the United States. Merck will be responsible for all future costs associated with the development, manufacturing and commercialization of these candidates. Merck has granted Cardiome a secured, interest-bearing credit facility of up to US$100 million that Cardiome may access in tranches over several years commencing in 2010. Vernakalant (IV) is an investigational candidate being evaluated for its ability to terminate an atrial fibrillation episode and return the heart to normal rhythm. Cardiome’s co-development partner in North America, Astellas Pharma U.S., Inc., submitted a New Drug Application with the U.S. Food and Drug Administration (FDA) for KYNAPID™ (vernakalant hydrochloride) Injection in December 2006 that included results from two pivotal Phase III clinical trials. In December 2007, the Cardiovascular and Renal Drugs Advisory Committee recommended that the FDA approve vernakalant (IV) for rapid conversion of atrial fibrillation. In August 2008, the FDA issued an Approvable action letter requesting additional information. Vernakalant (oral) is being evaluated as an oral maintenance therapy for the long-term prevention of atrial fibrillation recurrence. A Phase IIb double-blind, placebo-controlled, randomized, dose-ranging clinical trial in patients at risk of recurrent atrial fibrillation showed that at the 500 mg dose, vernakalant (oral) significantly reduced the rate of atrial fibrillation relapse as compared to placebo. The effectiveness of the collaboration agreement is subject to the expiration or earlier termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, if applicable, as well as other customary closing conditions. The agreement between Cardiome and Astellas Pharma U.S., Inc. for vernakalant (IV) in the United States, Canada and Mexico is unaffected by this agreement. _______________________

Cardima Receives CE Mark Approval for its Surgical Ablation Probe with Stabilization Sheath

Surgical Ablation System Capable of Closed-Chest and Open-Chest Ablation of Left and Right Atria Cardima, Inc., a medical device company focused on the treatment of atrial fibrillation (AF) and manufacturer of the Cardima Surgical Ablation System, announced that it has received CE Mark approval for its Surgical Ablation Probe with Stabilization Sheath. All components of the Cardima Surgical Ablation System are now approved for marketing in European countries recognizing CE Mark approval. The Cardima Surgical Ablation System can be used in open-chest surgery in conjunction with other procedures, or as a thoroscopic stand-alone, closed-chest procedure. “Our discussions with European thought leaders cause us to believe there is a tremendous opportunity in Europe for the Cardima Surgical Ablation System for cardiac ablation procedures,” said Robert Cheney, Chief Executive Officer of Cardima. “Our System has patented technology that allows for creating deep, long, linear and transmural cardiac lesions. The Cardima Surgical Ablation System can be used in either closed- or open-chest procedures. Additionally, our system treats both the left and right atria, which we believe is necessary for the successful treatment of arrhythmias. He added “We will begin treating patients through a network of cardiothoracic surgeon thought-leaders and developing Centers of Excellence at key clinical sites in Europe.” The Surgical Ablation Probe with Stabilization Sheath is a microcatheter-based surgical probe powered by the company’s INTELLITEMP® radiofrequency (RF) energy management device. Together these components comprise the Cardima Surgical Ablation System. The Surgical Ablation Probe allows for creation of cardiac lesions without gaps through the use of radiofrequency and INTELLITEMP’s “controlled RF” technology. The Probe’s small, flexible design offers sole port-hole access and incorporates irrigation, suction and illumination, which aid in placement and lesion depth. The Cardima Surgical Ablation System used in a stand-alone procedure can reduce risk, as well as patient discomfort and recovery time, typically requiring only a single night hospital stay, which compares favorably to other ablation procedures. Atrial fibrillation is the most common cardiac arrhythmia and a major concern for healthcare providers worldwide. An estimated 25 million people worldwide suffer from AF, which is increasing at a compound annual growth rate of approximately 20%. AF is a leading cause of stroke, can cause congestive heart failure and adds to the morbidity of any underlying heart disease. Recent estimates are that more than 2.5 million people in the U.S. have AF, of which 1 million are symptomatic, yet do not respond well to drug therapy. The cause of AF is unknown and there is no variation by geography or ethnicity. The incidence of AF increases with age. Furthermore, about 200,000 new cases are diagnosed each year in the United States. _______________________

Type of Physician Certification Associated With Risk of Complications From Implantation of Cardioverter-Defibrillators

Patients whose implantable cardioverter-defibrillators (ICDs) are implanted by nonelectrophysiologists are at increased risk of complications and are less likely to receive a specific type of ICD when clinically indicated, according to a study in the April 22/29 issue of JAMA. Increases in the population of patients eligible for ICD therapy have led to a controversy over which physicians should implant ICDs. Currently, physicians with different training implant ICDs. The training paths range from completion of an electrophysiology fellowship accredited by the American Board of Internal Medicine to industry-sponsored training programs, according to background information in the article. “Differences in training, experience, and technique may result in differences in rates of procedural complications,” the authors write. However, it is not known whether outcomes of ICD implantation vary by physician specialty. In addition, appropriate device selection is particularly important for patients who may benefit from an ICD that also is capable of providing cardiac resynchronization therapy (CRT-D), a device that may improve survival and quality of life in patients with certain heart abnormalities. Jeptha P. Curtis, MD, of Yale University School of Medicine, New Haven, Connecticut, and colleagues analyzed data from the ICD Registry, a national procedure-based registry of ICD implantations, to assess the association of physician certification with rates of ICD procedural complications and CRT-D implantation. Cases from the ICD Registry were grouped by the certification status of the implanting physician into mutually exclusive categories: electrophysiologists, nonelectrophysiologist cardiologists, thoracic surgeons, and other specialists. Of 111,293 ICD implantations included in the analysis, the researchers found that the majority of implants were performed by electrophysiologists (70.9 percent), with about 29 percent performed by nonelectrophysiologists (nonelectrophysiologist cardiologists, 21.9 percent; thoracic surgeons, 1.7 percent; and other specialists, 5.5 percent). The rates of overall and major complications were 3.5 percent and 1.3 percent, respectively, among electrophysiologists, and 5.8 percent and 2.5 percent, respectively, among thoracic surgeons. “The mechanisms underlying the observed differences in complication rates are not clear, but they may reflect differences in training, experience, and operative technique,” the authors write. Among 35,841 patients (32.2 percent) who met criteria for CRT-D, those whose ICD was implanted by physicians other than electrophysiologists were significantly less likely to receive a CRT-D device compared with patients whose ICD was implanted by an electrophysiologist. “Given the substantial benefits associated with CRT-D both in terms of improved survival and quality of life, the decision not to implant a CRT-D device carries significant implications for patient care.” The researchers also found that the majority of ICD implantations performed by nonelectrophysiologists took place at or relatively near hospitals in which an electrophysiologist also implanted ICDs. “If confirmed, these findings may warrant a reappraisal of the need for and methods of training nonelectrophysiologists to implant ICDs,” the authors conclude. Source: JAMA 2009;301[16]:1661-1670. _______________________

University of Michigan Researchers Use SiCortex High-Productivity Computing Systems to Predict Heart Arrhythmias

Investigators are intensely striving to better understand the causes of cardiac arrhythmias using a variety of experimental and computational approaches. Now, the University of Michigan’s Center for Arrhythmia Research is using SiCortex high-productivity computing (HPC) systems to conduct pioneering research aimed at predicting and preventing fibrillation, ultimately saving lives. SiCortex computers, recognized for their energy-efficiency and small space requirements, are widely used by leading academic institutions and national laboratories around the world to facilitate important research in a variety of other areas, including engine design, aerodynamics, weather pattern mapping, ecology, astrophysics and complex signal processing, among others. “This important initiative demonstrates HPC’s far-reaching power to solve a wide array of problems, including those directly linked to medical conditions and treatments,” said Chris Stone, president and CEO of SiCortex. The University of Michigan project, led by Dr. Omer Berenfeld and funded in part by grants from the National Institutes of Health, the American Heart Association and the Heart Rhythm Society, runs mathematical modeling applications on two SiCortex systems: one that serves as the mainframe system and the other as an auxiliary development unit. The numerical simulation studies produced so far provide valuable new insight by presenting data in stunning visual displays. Historically, fibrillation was thought to be caused by random electrical disturbances in the heart. New research, however, shows that the electrical activity during fibrillation is not completely random. In fact, the seemingly chaotic disturbances are found to originate in many cases from organizing centers in the form of spiral vortices, also called rotors. The University of Michigan team will study computer simulations generated by the SiCortex systems to evaluate the many combinations of variables that can cause rotors and determine their dynamics. “We are studying the conditions of numerous variables that can interrupt the heart’s regular rhythm and lead to an arrhythmia,” said Dr. Berenfeld, assistant professor of Internal Medicine and Biomedical Engineering at the Center for Arrhythmia Research. “Through sophisticated mathematical modeling and parallel computations running on the SiCortex systems, we can reproduce the heart’s electrical activity to pinpoint more precisely where and how abnormal rhythms originate within the heart muscle. Understanding the origin is an important step in determining the underlying cause of the problem.” The computer simulations are studied together with electrical data collected from various modalities, including fluorescence imaging and electrodes threaded into the heart’s chambers. To accurately simulate and analyze the fine characteristics of voltage and motion of ions that penetrate all the way to the molecular level, the researchers needed a system with fast and efficient connectivity. The SiCortex systems were a natural choice, as they consist of processers linked together by a very fast communication fabric, making them ideally suited to run these complex simulations. “In addition to the performance considerations, the system needed to fit in a small computer room since the research lab lacks space big enough to house a large HPC system,” added Dr. Berenfeld. “As medical researchers first and HPC users second, we needed a system that we could easily configure into an existing space, plug in and start using. The SiCortex HPC systems also offered the highest performance per dollar compared to competing systems.” _______________________

Vasomedical Introduces BIOX Holter Monitoring Systems and Analysis Software

Vasomedical, Inc., a leader in the noninvasive treatment and management of cardiovascular diseases, announced that it has received FDA 510k clearance to market Vasomedical-BIOX 1305 ECG Holter Monitor and CB Series Ambulatory ECG Analysis Software. The Vasomedical-BIOX 1305 Holter Monitor is the latest addition to Vasomedical’s product line. The Model 1305, which has already received CE Marking certification to market in the EU countries, is a compact, lightweight, 3-channel ECG Holter monitor designed for monitoring a patient's cardiac rhythm for 24 to 72 hours and recording ECG on a standard SD memory card. It features a high signal sampling rate and high-resolution digital recording for comprehensive data analysis. The data recorded on the 1305 monitor is utilized in the early detection of cardiac abnormalities such as ischemia and arrhythmia. Data recorded by the Model 1305 can be quickly analyzed using the proprietary Vasomedical-BIOX CB Series Analysis Software. The CB series software provides clear, quick, and accurate recognition of QRS complexes and classification; a proprietary two-tier automatic classification process for “suspicious” waveforms; comprehensive event reports and ST-segment reports; and many other data viewing, analysis, and reporting capabilities. “As a prominent problem in the developed nations, the diagnosis of heart diseases is expensive and time consuming. Shifting some of this diagnostic workup from hospital facilities to an outpatient or doctor’s office can relieve some of the burden and expense. In this context, Holter monitoring systems can provide an invaluable service. The recorded data not only can be utilized in the early detection of cardiac abnormalities, but also in monitoring the post-treatment phase of drug therapy or EECP® therapy and in post-operative cardiac surgery,” commented Derek Enlander, MD, a director of Vasomedical. “The introduction of Vasomedical-BIOX ambulatory products is an important step towards providing comprehensive non-invasive medical devices for cardiac care. Vasomedical has selected this series of products after rigorous research and testing, which are smaller in configuration and give the patient less inconvenience during the 24 hours or more of monitoring. In addition, the reliability of the Vasomedical-BIOX Holter monitor has been shown to be high. It will be less expensive than comparable monitors presently on the market.” _______________________

University of Utah Study Shows that Novel Medical Imaging Technique May Enable Physicians to Predict Treatment Outcomes in Patients with Atrial Fibrillation

MRI-Based Method Also Gives Doctors Potential Metrics for Measuring Progress of Disease, Which Causes More Than 66,000 Deaths a Year University of Utah researchers have found that delayed-enhancement magnetic resonance imaging (DE-MRI) holds promise for predicting treatment outcomes and measuring disease progression for patients with atrial fibrillation (AF), a heart rhythm disorder that affects more than 3.5 million Americans and causes more than 66,000 deaths a year. Their latest study on a novel application of this technology for AF appears in the April 7 issue of the journal Circulation. Although DE-MRI is an established method for visualizing tissue damage in cardiac disease processes, the study assessed its use in a protocol developed to detect fibrosis in AF patients before they underwent radiofrequency (RF) ablation. In this study, the University of Utah colleagues developed a protocol using DE-CMRI to create 3-D images of the left atrium before RF ablation, which were processed and analyzed with custom software tools and computer algorithms to calculate the extent of left atrium wall injury. Patients were then assessed at least six months after the procedure, and the researchers found that only 14 percent classified as having minimal fibrosis had suffered AF recurrence compared to 75 percent recurrence for the group that had extensive scar tissue damage. “Our results indicate that DE-MRI provides a noninvasive means of assessing left atrial myocardial tissue in patients suffering from AF, and that those who do have tissue damage may be at greater risk of suffering AF recurrence after treatment with RF ablation,” said lead author Nassir F. Marrouche, MD, assistant professor of internal medicine in the University of Utah School of Medicine and director of the Atrial Fibrillation Program. “Our findings also present a disease progression model that supports the importance of early intervention.” In addition to its noninvasive nature, DE-MRI offers other advantages over commonly used invasive electroanatomic mapping studies to assess tissue health. For example, while other such diagnostic mapping studies have been associated with a high degree of spatial error, three-dimensional DE-MRI provides information on both the anatomy and the location of pathology without spatial distortion. Marrouche and his colleagues also have developed methods of processing the MRI images in order to visualize the entire volume of left atrium wall injury in 3-D. “Until now, there has not been an accurate, non-invasive way to assess left atrium scar formation, which studies show is linked to AF disease severity,” said Marrouche. “If substantiated, our DE-MRI visualization technique and analysis would provide guidance in determining appropriate candidates for AF catheter ablation as well as in identifying the heart muscle cells that need to be destroyed.” Last fall, the University of Utah Atrial Fibrillation program became the first in the world to be able to ablate using a catheter custom-made to be compatible with MRI. Next month, University Health Care will open a new multimillion dollar clinical and research lab, which will be the first in North America to provide real-time DE-MRI for treating patients with AF.