Industry News and Products

Physio-Control Receives FDA 510(K) Clearance for LIFEPAK® 20e Defibrillator/Monitor

Physio-Control, Inc., a wholly-owned subsidiary of Medtronic, Inc., announced that it has received clearance by the U.S. Food and Drug Administration (FDA) to market the LIFEPAK 20e defibrillator/monitor within the United States. The 20e is an enhancement of the LIFEPAK 20 defibrillator/monitor, which has become the standard of care in many hospitals worldwide since its introduction in 2002. It offers all the capabilities of the LIFEPAK 20 device, along with a more powerful lithium-ion battery that doubles ECG monitoring time and the run time of other parameters such as noninvasive pacing and pulse oximetry, a noninvasive way to monitor the oxygenation of a patient’s hemoglobin. Additionally, a new on-screen “fuel gauge” displays the real-time status of available battery capacity so clinicians can monitor remaining use time. The 20e also was developed to be easily transported, helping hospitals meet The Joint Commission standard for having resuscitation services readily available in all facility areas. Physio-Control is currently under a consent decree with the FDA, which restricts the amount of products that can be delivered to customers until certain improvements in the company’s quality system have been completed. However, the company is permitted to manufacture and ship a limited selection of product under certain conditions to meet the critical needs of emergency response customers. Hospital staff should call their local Physio-Control representative to learn more about the specific conditions under which Physio-Control can deliver LIFEPAK 20 and LIFEPAK 20e products to U.S. hospital customers. _____________________________

WaveMark Announces the Availability of WaveMark CIMS 2008

Application Upgrade Provides Better Patient Safety, Product Tracking and System Integration Features to the Healthcare Supply Chain WaveMark, Inc., a provider of real-time inventory management solutions for high value medical products, introduced a new version of its WaveMark CIMS product. Focusing on patient safety, integration with other hospital information systems and high value inventory controls, WaveMark CIMS Fall 2008 brings a new level of visibility and simplicity to healthcare inventory management. “Over the past year, we’ve added numerous features, functions and reporting capabilities to our WaveMark CIMS product aimed at helping our customers improve the way they manage their high value and critical supply items,” said John Wass, CEO, WaveMark. “Our new version contains several important capabilities aimed at improving patient safety, as well as streamlining the inventory management process. This is one in a series of new product upgrades that we will bring to market, which will continually be focused on perfecting the management of medical inventory while concurrently improving the quality of patient care.” WaveMark CIMS Fall 2008 contains three major enhancements that help hospital customers concentrate on patient safety while reducing overall operational costs. Each of these new features will be automatically provided to new and existing WaveMark CIMS subscribers at no additional cost. The FDA recall module pushes critical device recall information to customers via WaveMark’s secure Web-based reports, including the exact current location of those products. By pushing this time-sensitive information to users, WaveMark further accelerates the tracking and timely removal of these devices, thereby improving patient safety while also streamlining clinical workflow. In developing the new version of WaveMark CIMS Fall 2008 product, WaveMark proactively established relationships and developed integrations with recognized materials management systems, billing systems and clinical documentation systems in an effort to streamline administrative workflow for clinical staff. As a result, the second enhancement provides customers with automatic connectivity of their critical information. By creating a direct link to billing and materials management systems, WaveMark CIMS users can achieve a truly automated requisition process, resulting in less time and greater accuracy in ordering and billing processes, helping to reduce discrepancies and streamline workflow. The third major feature, inventory valuation and consignment reconciliation, provides hospitals with a direct line to cost savings. With consignment par tracking, hospital labs now have the ability to compare consigned product par levels against actual on-hand amounts and usage patterns for that product in real-time. WaveMark delivers an easier way to compare and evaluate the availability of consigned devices and provides a more streamlined interaction with suppliers, resulting in the optimization of consigned par levels. WaveMark CIMS uses RFID cabinets and Point of Service readers to collect information that enables real-time inventory management. By eliminating the manual process of tracking inventory and providing automatic recommendations for replenishing critical supplies, WaveMark CIMS ensures nurses and technicians are able to focus more of their time on other areas of importance — their patients. With WaveMark CIMS, hospitals enjoy optimized inventory levels, better management of product expirations and recalls, and improved charge capture. WaveMark’s subscription service model makes this solution accessible to hospitals of any size without the constraint of a capital approval process. _____________________________

Endosense Launches TOCCATA Clinical Study

Endosense, a medical technology company focused on enabling the broad adoption of catheter ablation for the treatment of cardiac rhythm disorders, has launched the TOCCATA (TOuCh+ for CATheter Ablation) clinical study to evaluate the safety of the TactiCath™ system, with enrollment gaining momentum. TOCCATA is a 70-patient European multi-center safety study. Constructed to gain the CE mark for the treatment of atrial arrhythmias, secondary endpoints were designed to evaluate the value of force-sensing in successfully impacting outcomes of the ablation procedure. The start of this clinical trial marks the first use of the TactiCath force-sensing catheter in patients. Ten patients have been treated so far by different investigators, including Endosense European Scientific Advisors Professor Karl-Heinz Kuck, MD at St. Georg Hospital in Hamburg, Germany; Professor Dipen Shah, MD at the University Hospital of Geneva, Switzerland; and Professor Nadir Saoudi, MD at the Princess Grace Hospital in Monaco. The patients treated to date have had different arrhythmia pathologies, including atrial fibrillation. “The first TOCCATA patients had their arrhythmia successfully treated at acute follow-up. The physicians’ experiences have shown the tremendous potential of force-sensing to the clinical practice, and we’re hopeful that the results will reinforce our initial findings,” said Pr. Kuck, the principal investigator of TOCCATA. With TactiCath, physicians can be assured they are using the optimal contact force for the appropriate lesion creation in a catheter ablation procedure. “Electrophysiologists have had to estimate — and frequently guess — the level of force required, as too little may render the procedure ineffective and too much may induce serious complications,” said Pr. Shah. “The TactiCath has the potential to solve that.” Pr. Shah was a key driver in the pre-clinical evaluation and validation of the product. “The momentum we’re experiencing in the TOCCATA trial is very exciting,” said Eric Le Royer, President and Chief Executive Officer, Endosense. “The support and contributions of our Scientific Advisors have assisted us successfully through preclinical evaluations.” Endosense’s Scientific Advisory Board includes worldwide experts in the treatment of cardiac arrhythmias. In addition to Prs. Kuck, Saoudi, and Shah, other members include: Warren Jackman, MD, University of Oklahoma Health Sciences Center; Hiroshi Nakagawa, MD, PhD, University of Oklahoma Health Sciences Center; Andrea Natale, MD, Texas Cardiac Arrhythmias Institute; and Vivek Reddy, MD, University of Miami Hospital. _____________________________

TyRx Launches AIGISRX™ ICD to Reduce Surgical Site Infections Associated with Implantable Cardioverter Defibrillators

TyRx, Inc. announced the launch of the AIGISRX™ ICD, an anti-bacterial envelope developed to help stabilize the implanted device and which also contains anti-microbial agents that help provide protection against surgical site infections (SSI) associated with implantable cardioverter defibrillators (ICDs). The launch of AIGISRX ICD extends TyRx's AIGISRX CRMD (cardiac rhythm management device) platform to the implantable cardioverter defibrillator market. The AIGISRX CRMD platform also includes AIGISRX PM, the company's anti-bacterial coated mesh designed specifically for implanted pacemakers. TyRx received FDA 510(k) clearance of AIGISRX CRMD in January 2008. Since May 2008, the AIGISRX PM has been implanted in excess of 600 patients nationwide. During a CRMD implantation procedure, the physician inserts the pacemaker or ICD into the AIGISRX anti-bacterial envelope and positions the device normally within the surgically created pocket. Once implanted, AIGISRX provides an adjunct to general antibiotic therapy by eluting the antimicrobial agents rifampin and minocycline and serves to stabilize the implanted pacemaker or defibrillator. "The launch of AIGISRX ICD offers a unique and potentially groundbreaking solution for protecting an extremely vulnerable patient population, while allowing hospitals to reduce the incidence and cost of treating surgical site infections related to ICD implantation," said Bill Edelman, CEO of TyRx, Inc. “AIGISRX offers a solution that may meet the thresholds of high cost, high volume and reasonably preventable hospital-acquired conditions through the application of evidence-based guidelines selection criteria set by CMS. In the August 19, 2008 Federal Registry, CMS stated, "we agree...that surgical site infection following certain cardiac device procedures is a strong HAC (hospital-acquired condition) candidate. The condition is high cost and high volume, triggers a higher-paying MS-DRG, and may be considered reasonably preventable through the application of evidence-based guidelines...we expect to propose surgical site infection following certain cardiac device future candidate HACs." The Center for Disease Control and Prevention (CDC) estimates that approximately two million patients contract nosocomial infections annually, with 50% being associated with indwelling devices. In testimony before Congress, The Leap Frog Group pointed to the fact that "hospital-acquired infections (HAI) add over $15,000 to a patient's hospital bill, amounting to over $30 billion a year wasted on avoidable costs." "The envelope provides antibiotic protection for about ten days after the procedure. It also helps to stabilize the device in the body. The device will also make it easier for future device replacement," stated Dr. Ali Massumi, Director of the Center for Cardiac Arrhythmias and Electrophysiology at St. Luke's and Clinical Professor of Medicine at Houston's Baylor College of Medicine. "These high-risk patients are more prone to infection. Obviously, we want to provide our patients with every advantage to prevent this complication." Dr. Massumi performed the first in-man procedure using AIGISRX PM on May 12, 2008. _____________________________

Warfarin Significantly Underused in the Treatment of Patients with Atrial Fibrillation

New research reveals that warfarin therapy is significantly underused in patients being treated for atrial fibrillation (AF) in the United States. The new study published in the October edition of the HeartRhythm Journal, the official journal of the Heart Rhythm Society, concludes that not only is warfarin not prescribed as often as it could be, in many cases when warfarin is administered, it is not used at optimal therapeutic levels. Untreated, AF and atrial flutter can lead to stroke and arterial thromboembolism. Warfarin is the most common treatment, but can also cause bleeding. The new study, led by Dimitri Bennett, MD, and Alexander Walker, MD, documents how frequently and how effectively anticoagulants are used in patients with AF or atrial flutter in the U.S. Bennett and Walker examined health insurance claims and laboratory results from a population of more than 10 million U.S. patients to quantify the association of AF outcomes with treatment, patient characteristics and the International Normalized Ratio (INR) — a laboratory measurement of warfarin efficacy. Among 116,969 patients over the age of 40 with an insurance claim for AF or atrial flutter between 1999 and 2005, warfarin was prescribed to 45 percent of the patient population, and 48 percent had no insurance claim for an anticoagulant or antiplatelet agent. Of the 45 percent of patients who received warfarin therapy, records showed that, as expected, INR levels outside of the accepted therapeutic range increased the risk of stroke, arterial thromboembolism and intracranial hemorrhage: • Subtherapeutic, or low INR levels, more than doubled the incidence of stroke and arterial thromboembolism; • Supratherapeutic, or high INR levels, doubled the incidence of intracranial hemorrhage. As a result, only 19 percent of patients spent all or most of their time within the therapeutic INR range. Most of the out-of-range time was spent with a low INR, indicating insufficient doses of warfarin. “It appears that many doctors prescribe warfarin at a lower dose than required, or simply not at all,” stated author Alexander Walker, MD, World Health Information Science Consultants in Wellesley, Massachusetts. “It is important that we address this problem because, unfortunately, it is the misuse of warfarin that can put patients at a higher risk of stroke, bleeding and other medical complications.” More than two million people in the United States have AF, making it a very common heart rhythm disorder. In addition to the associated risks of stroke and arterial thromboembolism, AF can lead to other heart rhythm problems, chronic fatigue and congestive heart failure. When used properly, there are a number of effective treatments, including warfarin therapy, to control AF and/or reduce the risk that it will cause serious health problems. “When used at an optimal level, warfarin is very effective, but warfarin can be a difficult drug to manage. We will begin to see more and more alternatives to warfarin developed for the treatment of AF,” states Walker. _____________________________

LifeWatch Services Inc. Launches Next-Generation LifeStar ACT III Platinum

Card Guard AG, the parent company of LifeWatch Corp., announced that LifeWatch has launched its next-generation LifeStar ACT III Platinum (ACT III) monitor in the United States. This advanced monitoring device, cleared by the FDA in June 2008, provides enhanced heart arrhythmia detection through its 3-channel ECG functionality and ST deviation analysis that can measure ischemic changes. The ACT III monitor automatically detects and sends heart rhythm abnormalities to a 24/7 LifeWatch monitoring call center. This call center is staffed by certified cardiac technicians who interpret the data and initiate physician notification based on pre-determined criteria. The ACT III monitor, which requires only minimal patient intervention, significantly improves patient compliance and increases diagnostic yield. The ACT III monitor offers broader functionality with its high-performance multi-channel Ambulatory Cardiac Telemetry in a simple-to-use system. With up to 21 days of real-time ECG monitoring and the provision of ST deviation analysis, the ACT III provides more sensitive and specific data for initial or early detection of arrhythmia in patients that have limited or atypical symptoms. The device has six hours of memory in the sensor and a flash memory of up to 21 days of data on the ACT cell phone monitor. This ensures that no valuable data is lost if a patient is disconnected from the cellular phone. The sophisticated algorithm and advanced wireless and web-based technologies of ACT III enhances data collection, analysis, transmission and reporting, and can be utilized in standard and alternative patient monitoring programs, such as specialized atrial fibrillation (AF) patient care and congestive heart failure (CHF) programs. “In my opinion, real-time outpatient cardiac monitoring using this new and unique 3-channel configuration will extend physicians’ management of patient conditions, which have been traditionally monitored in an inpatient setting. Disease state management requires more accurate diagnostic tools such as the ACT III to allow for early detection of a worsening condition in patients that are minimally symptomatic,” according to Dr. Harry A. Kopelman, Director of the Cardiac Electrophysiology Laboratory at the Fuqua Heart Center & the Piedmont Heart Institute. Dr. Kopelman is a highly esteemed electrophysiologist who also serves as the Chairman of the LifeWatch Medical Advisory Board. Forty-five percent of the top U.S. cardiac centers (US News and World Report), utilize the LifeStar ACT System in their monitoring programs, while over 20 key cardiac institutions have enrolled their AF catheter and surgical ablation patients in the first-to-market LifeWatch AF Patient Care Program. This unique program provides objective post-operative arrhythmia analysis that dramatically improves a physician’s ability to assess the clinical outcomes from these complex procedures. _____________________________

Lessening Medication for Prevention of Atrial Fibrillation Does Not Reduce Side Effects, Appears to Worsen Outcomes

Reducing how often a patient receives amiodarone, a medication used for suppressing atrial fibrillation but which causes side effects, did not decrease the overall amount of amiodarone-related and heart disease-related side effects, but did increase the rate of atrial fibrillation recurrence and the risk of death from all causes and cardiovascular hospitalizations, according to a study in the October 15 issue of JAMA. The adverse events caused by amiodarone are mostly associated with high daily dosages and long-term therapy, according to background information in the article. Sheba Ahmed, MD, of the University of Groningen, Netherlands, and colleagues conducted a study to compare the effects of episodic vs. continuous amiodarone treatment on major events related to amiodarone use and to determine if episodic treatment could effectively suppress atrial fibrillation. The trial included 209 patients with recurrent atrial fibrillation who were randomly assigned to receive either episodic or continuous amiodarone treatment. Episodic amiodarone treatment was discontinued after a month of sinus rhythm and reinitiated if atrial fibrillation relapsed. In the continuous treatment group, amiodarone was maintained throughout. After a median follow-up of 2.1 years, 51 (48 percent) of the patients in the episodic vs. 64 (62 percent) in the continuous treatment group had sinus rhythm. The researchers found that in the episodic group, more atrial fibrillation recurrences occurred (80 percent) than in the continuous treatment group (54 percent). The incidence of the primary outcome for the study — any amiodarone or underlying heart disease-related major event — was 35 percent in the episodic vs. 33 percent in the continuous treatment group. There were differences in the incidence of amiodarone major events (19 percent, episodic vs. 24 percent, continuous) and underlying heart disease-related major events (16 percent, episodic vs. 9 percent, continuous), although these differences did not reach statistical significance. All-cause deaths and cardiovascular hospitalizations were higher among those receiving episodic treatment (53 percent vs. 34 percent). “Considering the above, episodic amiodarone treatment cannot be advocated for most patients with persistent atrial fibrillation,” the authors write. “This study shows that episodic amiodarone treatment — in contrast to our expectations — has no clinical advantage over continuous treatment because it did not lower morbidity in patients with persistent atrial fibrillation over two years of follow-up.” Source: JAMA 2008;300[15]:1784-1792. _____________________________

eCardio Launches the eVolutionSM

Extended Cardiac Monitoring System Provides Instant and Accurate Patient Information Through Automated Data Transmissions eCardio Diagnostics, LLC announced the launch of the eVolutionSM, a single-component cardiac monitoring system that provides instant andaccurate patient information through automated data transmissions. "The eVolutionSM is the next leap forward in extended daily monitoring," noted Robert Jordan, Executive Vice President for eCardio. "The simple configuration offers patients a more convenient remote monitoring option while continuing to provide physicians with real-time information about the cardiac health of their patients." The eVolutionSM automatically detects and records cardiac rhythm events and transmits the data to the eLab, eCardio's 24-hour state-of-the-art monitoring center. The device provides continuous computerized monitoring by means of a microprocessor running an exclusive auto-detecting algorithm. This technology delivers real-time data analysis, allowing physicians to discover both symptomatic and asymptomatic arrhythmias with speed and precision. In addition, the eVolutionSM offers: • A single-component system, eliminating the cumbersome monitor, modem and base station associated with traditional ambulatory cardiac telemetry systems; • Flexibility for physicians to remotely program the device while being worn by the patient; • Customized parameters to more effectively monitor changing patient conditions or specific patient requirements; and • Convenience for patients with minimal interruptions to the patient's daily routine. "Diagnosis and monitoring of cardiac arrhythmias is a complicated and challenging process, and timing plays a crucial part," commented Nadim Nasir Jr., MD, FACC, Director of Clinical Electrophysiology Services and Medical Director of the Cardiac Electrophysiology Lab at Methodist DeBakey Heart Center. "The eVolution's instant detection and transmission features deliver immediate reports with minimal artifact, which allows me to make more precise treatment decisions for my patients." The eVolutionSM also enhances patient compliance by simplifying the set-up and the extended monitoring process. As with all of eCardio's arrhythmia monitoring products, the eVolutionSM monitors are complimentary to enrolled physicians, and monitoring services provided by eCardio are covered by commercial insurance and Medicare. eCardio will offer hands-on demonstrations of the eVolutionSM at the upcoming American Heart Association's Annual Scientific Sessions, November 9-11, 2008 in New Orleans.