Industry News and Products

FDA Grants Marketing Approval to NaviStar® ThermoCool® Catheter for Atrial Fibrillation

First and Only Ablation Catheter Approved for Treatment of Heart Rhythm Disorder That Affects Up to 5 Million People in the U.S. Biosense Webster, Inc., a Johnson & Johnson company, announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval to the NaviStar® ThermoCool® Catheter for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (AF), when used with compatible three-dimensional electroanatomic mapping systems. On November 20, 2008, the FDA’s Circulatory System Devices Panel unanimously recommended approval of the NaviStar® ThermoCool® Catheter for AF. The NaviStar® ThermoCool® Catheter is the first and only ablation catheter in the U.S. to be approved for the treatment of this disorder, which affects an estimated 10 million people worldwide. “Today’s announcement is a milestone for electrophysiologists, physicians who specialize in heart rhythm disorders, and their patients throughout the U.S.,” said Marcia S. Yaross, PhD, Vice President, Clinical, Regulatory and Health Policy, Biosense Webster. “This landmark decision by the FDA recognizes the safety and effectiveness of NaviStar® ThermoCool® Catheter ablation for the treatment of paroxysmal AF and gives the medical community another treatment option for many patients whose often debilitating symptoms are not effectively managed through medical therapy.” Conditions of approval include a post-marketing registry and a physician education program about use of the product. The NaviStar® ThermoCool® Catheter is also approved in the U.S. for the treatment of Type 1 atrial flutter and recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction. This approval is based on results from a multicenter study comparing catheter ablation to drug therapy for the treatment of AF. In this randomized clinical trial, catheter ablation was shown to significantly outperform anti-arrhythmic drug (AAD) therapy for the treatment of drug refractory recurrent symptomatic paroxysmal AF. These data were first presented in November 2008 at the American Heart Association’s Annual Scientific Sessions. Patients receiving cardiac ablation with the NaviStar® ThermoCool® Catheter were significantly more likely to be free of recurring AF and experienced fewer serious adverse events than those receiving AAD therapy. This clinical trial was a randomized, unblinded and controlled evaluation of symptomatic, paroxysmal AF patients who were refractory to at least one AAD and had at least three episodes of AF in the six months prior to randomization. A total of 167 patients were enrolled from 19 sites throughout the world and the primary effectiveness endpoint (chronic success) was freedom from documented symptomatic AF recurrence following procedural endpoint confirmation and absent new AAD use or repeat ablation outside of protocol-defined criteria. The probability of chronic success was 62.7% for patients receiving NaviStar® ThermoCool® Catheter ablation at the end of the nine-month effectiveness evaluation period, which is significantly superior (pTransoma Medical Receives FDA Marketing Clearance for Sleuth AT Implantable Cardiac Monitoring System System Offers Advanced Trending for Long-Term Monitoring of Complex Arrhythmias Transoma Medical, manufacturer of Sleuth, the first wireless, automated implantable cardiac monitoring system, has now received FDA marketing clearance on its second-generation product, Sleuth AT™ (Advanced Trending) Cardiac Monitoring System. The Sleuth products offer physicians the ability to diagnose patients with recurrent, unexplained fainting and abnormal heart rhythms quickly with its virtually unlimited memory capacity and hands-free downloading for the patient, while minimizing paperwork and practice workload. With Sleuth AT, physicians can now choose 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 (AF). “The Transoma Sleuth AT system promises to provide an improved approach,” said Dr. Peter Kowey, Chief of Cardiology for Main Line Health, William Wikoff Smith Chair in CV Research at the Lankenau Institute in Wynnewood, Pennsylvania. “The concept of the device, without memory constraints, automatically capturing frequent ECG strips which are then over-read at the monitoring center, may address the limitations and inaccuracies of existing devices used to assess complex arrhythmias such as atrial fibrillation.” “AF is an extremely common problem for my patients and significantly increases their risk of stroke,” continued Dr. Kowey. “In fact, the need for long-term monitoring of AF patients was reinforced at the 2009 Boston AF Symposium by both surgeons and electrophysiologists. Although some therapies have been shown to control these arrhythmias, at least temporarily, until now there has not been a good way to monitor continued success. With the Sleuth AT system, physicians can be notified by the monitoring center if the patient’s AF has returned. This is important because recurrence of AF happens without symptoms as often as 50 to 70 percent of the time.” “We are pleased to announce FDA marketing clearance of the Sleuth AT system,” said Nestor Jaramillo, Transoma Medical Vice President of Sales and Marketing. “We are experiencing great success with our first clinical product which was based on more than 20 years of experience with our remote, wireless monitoring technology platform in biomedical research. In addition to providing insight into the cause of unexplained, infrequent symptoms, Sleuth AT is designed to provide physicians with timely and accurate ECG data that could allow them to monitor the efficacy of prescribed therapies.” As a complete, remote and automated system, Sleuth AT offers several advantages over other currently available implantable monitoring products. The Sleuth AT Cardiac Monitoring System includes the Implantable Loop Recorder (ILR), the Personal Diagnostic Manager (PDM), the Base Station and a 24/7 Monitoring Center operated by Medicomp: • The Implantable Cardiac Monitor is a small, thin device, about the size of a 50-cent piece (or the size of the smallest pacemakers), which continuously monitors the electrical activity of the heart, the ECG. The cardiac monitor is implanted under the skin during a brief, simple, outpatient procedure. • The Personal Diagnostic Manager (PDM) is a hand-held, multipurpose device that automatically retrieves and stores relevant ECG data from the implanted cardiac monitor, securely relays the information to the base station and then to the monitoring center. The PDM is also used by the physician to program the implanted cardiac monitor. Data are collected in three ways: -Patients who experience symptoms, such as lightheadedness, can press a button on the PDM that tells the system to store the patient’s ECG strip during the time of the symptom. -The system automatically captures and stores the ECG strip when the patient’s heart rate is above or below physician-programmed limits. -The system can be programmed to capture regular ECG strips every 4 hours, 15 minutes or 7.5 minutes. • At the third-party Monitoring Center, certified cardiac technicians review the patient’s ECG data and provide information to the physician to aid in diagnosis and ongoing treatment. Physicians can access this information via a secure Web portal, and have the reports faxed or e-mailed to them as they prefer. If the cardiac technician observes a particularly concerning arrhythmia, the patient’s physician will be contacted immediately. _____________________________

Vascular Solutions Launches Minnie Support Catheter

Bard Electrophysiology, a division of C. R. Bard, Inc., announced the launch of its new website. The website provides healthcare professionals with access to information including product and technique literature, clinical articles and patient-oriented information for the treatment of cardiac arrhythmias. Vascular Solutions, Inc. recently announced the launch of its Minnie support catheter. The new catheter is designed to provide superior guidewire support and exchange for complex interventions, with versions designed for use with 0.014”, 0.018” and 0.035” guidewires. The Minnie support catheter features a smoothly tapered distal tip to facilitate guidewire control, combined with a low crossing profile for navigating small vessels and crossing tight lesions. Its single-layer polymer design offers flexibility with exceptional tracking, while its fully embedded radiopaque markers — a unique feature that eliminates exposed metal — allow the operator to easily confirm positioning and assess lesion length. Currently available in the United States and Europe, the Minnie support catheter is packaged one unit per box. Vascular Solutions, Inc. is a leading medical device company that delivers proprietary clinical solutions for diagnosing and treating vascular conditions. The company’s rapidly growing product line consists of innovative devices across established and emerging areas of coronary and peripheral vascular medicine. _____________________________

St. Jude Medical Announces U.S. Approval of Industry’s First Connector System Designed to Simplify Implant Process for Cardiac Resynchronization Therapy Devices

St. Jude Medical, Inc. announced U.S. Food and Drug Administration (FDA) approval of the industry’s first medical device system that allows a single defibrillation lead connection between a cardiac resynchronization therapy defibrillator (CRT-D) and the wires (leads) that send electrical impulses to the heart to treat the symptoms of heart failure. The new connector system, which includes the Durata® defibrillation lead with the SJ4 connector and the Promote® CRT-D with the SJ4 connector, is expected to make the overall procedure a simpler process. In addition, the new system reduces the volume of the leads and device in the chest pocket, which could lessen the risk of lead-to-can abrasion, a known complication. The SJ4 connector system features a single connection between the CRT-D and the defibrillation lead and a single set screw. Current lead designs require three separate connections and four set screws. The St. Jude Medical SJ4 connector system was designed to meet the draft International Organization of Standardization (ISO) IS-4 standard but will not be labeled as such until the standard is published, which is expected later this year. “By simplifying the lead connection process, the physician will be able to reduce procedure time for both initial implants and future device replacements,” said Eric S. Fain, MD, president of the St. Jude Medical Cardiac Rhythm Management Division. “The SJ4 connector system also requires less lead and device volume in the body than previous designs, which could reduce the risk of lead abrasion as well as provide additional comfort to the patient.” As a requirement of the FDA approval, St. Jude Medical will conduct a post-approval study that will enroll up to 1,700 patients and follow the group for five years. The company will also be gathering data on this new connector system as part of its ongoing SCORE patient registry, designed to track long-term data on system performance for all products, including new technology. “We are pleased to be the industry leader in bringing this important new connector system to the U.S. market,” said Dr. Fain. “We look forward to working with the FDA to track the long-term benefits that we believe this technology will provide.” St. Jude Medical will begin a limited release over the coming months and expects a full release of the product later this year. St. Jude Medical will continue to offer its other standard connector systems so that physicians can select a device configuration based on their preference and the individual needs of their patient. As with previously announced leads in the Durata lead family, the Durata lead with SJ4 connector features a soft silicone tip and Optim® insulation, a hybrid insulation material that provides increased durability, along with the flexibility and handling characteristics that facilitate device implantation. The new Durata lead is the same diameter as the company’s current Durata high-voltage lead which, at 7 French, is the smallest diameter high-voltage lead on the market. Small diameter leads may be especially helpful for patients with compromised blood flow or a narrow vasculature, or patients who need CRT-D systems that require three leads to be placed in a single vessel. The design of the Durata lead is based on the Riata® lead platform, which has been proven to have excellent performance and reliability. Recent studies — which analyzed the experience of 7,498 patients and more than 680 implanting physicians at more than 370 sites — found that performance and reliability of Riata leads are excellent, with very low adverse event rates for all categories of lead-related complications, including fracture, insulation abrasion, perforation and dislodgment. The Promote CRT-D is an implantable cardiac resynchronization therapy defibrillator for the treatment of heart failure. Like its predecessor product, the Promote CRT-D with the SJ4 connector includes features designed to customize treatment to each patient’s unique needs. Built on the St. Jude Medical consolidated hardware and software “Unity” device platform, the Promote CRT-D includes the company’s advanced safety features and algorithms for better patient management. These include improved lead monitoring capabilities — including daily checks of all pacing and shock configurations — that provide added patient safety. With this system, physicians are able to monitor changes in the patient’s heart and device therapy via remote transmissions from the St. Jude Medical Merlin@home™ transmitter, and receive alerts through the Merlin.net™ Patient Care Network. The St. Jude Medical vibratory patient alert is the only notifier that gently vibrates to notify patients of critical changes in device performance instead of issuing the standard audio alert; this can be especially beneficial for people with hearing loss. Additional features inside these devices include: • QuickOpt® timing cycle optimization, a programmer-based optimization method that is proprietary to St. Jude Medical that is used with CRT-Ds and ICDs to help physicians quickly program the device's timing cycles — in about 90 seconds — to help deliver optimal therapy to patients; • DeFT Response® technology, which is designed to help devices meet the needs of patients with high or varying defibrillation thresholds, helping physicians to ensure appropriate delivery of life-saving therapy; • SenseAbility® technology, which is designed to enable physicians to program the device to more accurately sense abnormal heart rhythms, thereby protecting the patient from receiving inappropriate shocks. _____________________________

Bard Electrophysiology Announces the Launch of a New Website

Bard Electrophysiology’s new website, https://www.bardep.com, is organized around the following key areas: News & Events - features the latest information on Bard Electrophysiology’s new product launches, major congresses, satellite symposia and special promotional announcements. Products - easy-to-navigate source of information on the complete lines of diagnostic, therapeutic and recording systems products; viewers can download brochures, white-papers, technique guides and links to clinical literature. Patients/Caregivers - links to information regarding Bard Electrophysiology’s MAGELLAN clinical trial for the treatment of atrial fibrillation now underway and enrolling in the United States. “Bard Electrophysiology’s online presence will be an important resource for those who are seeking access to information about our product offerings and clinical activities in the marketplace," said Dave Hemink, Vice President and General Manager, Bard Electrophysiology. "We will increasingly use the Web as our preferred vehicle to communicate the current status of our business to the global community.” _____________________________

BIOTRONIK Announces CE Mark and First Successful Clinical Case with TRIGNUM Flux Magnetic Irrigated Gold Tip Catheter

BIOTRONIK, a leading European medical technology company focusing on vascular intervention and cardiac rhythm management, announced the CE mark and completion of the first successful cardiac ablation clinical case with the TRIGNUM Flux magnetic irrigated gold tip catheter. The launch of the TRIGNUM Flux catheter represents an important introduction of unique, new technology for the treatment of atrial fibrillation (AF). The first clinical case was successfully performed by Prof. Dr. Karl-Heinz Kuck, Director of the Cardiologic Center at the Asklepios Klinik in Hamburg, Germany. During this case, a patient who presented with a comorbidity of AF and atrial flutter was successfully mapped and ablated in both atrial chambers of the heart. The TRIGNUM Flux magnetic irrigated gold tip catheter is a highly flexible ablation device equipped with three magnets at the distal end. Its complementary flexibility combined with the computer-aided magnetic-guided Stereotaxis Niobe® System ensures a precise, stable, sensitive and reproducible catheter positioning. The safety of the device is further enhanced by the catheter’s unique irrigated gold tip electrode with high thermal conductivity. This feature prevents thrombus formation, commonly known as blood clotting, during the ablation procedure and could enable safer procedures with better outcomes. The superiority of the irrigated gold tip ablation concept was recently highlighted by Prof. Hiroshi Nakagawa, Co-Director of the Heart Rhythm Institute, University of Oklahoma Health Sciences Center, during the “Expert Meeting Berlin” on January 30, 2009. In his scientific validation, Prof. Nakagawa demonstrated that irrigated gold tip ablation reduces the incidence of thrombus formation significantly compared to conventional irrigated ablation technology. After the first successful clinical procedure, Prof. Kuck commented on the TRIGNUM Flux: “With the caution of a scientist, I can say that I am quite enthusiastic about the performance of the TRIGNUM Flux catheter. It has superior steerability and stability in different anatomical locations on the right and left side of the heart, and we have not seen any kind of blood clotting during the case. The TRIGNUM Flux combines safety and efficacy in a unique way.” "We are very excited about the commercial release of the TRIGNUM Flux magnetic irrigated gold tip catheter,” commented Marlou Janssen, Global Vice President Marketing & Sales CRM of BIOTRONIK GmbH & Co. KG. “Making the safety profile of our irrigated gold tip ablation catheters available for magnetic navigation will result in a significant increase of adoption for this breakthrough technology. More patients with complex cardiac rhythm disorders can be safely treated. AF is a clear strategic focus for BIOTRONIK with ablation being a therapy solution.” _____________________________

Baptist Hospital West Investigates Early Heart Attack Detection Device

Baptist Hospital West, a member of Mercy Health Partners, announced its first implant of the AngelMed Guardian cardiac monitor and alert system. The system is designed to reduce the time it takes patients to get to the emergency room during an impending heart attack. Shawn Baldwin, MD, with East Tennessee Heart Consultants (ETHC), performed the first implant in Tennessee, and is among the very first physicians across the United States to implant the experimental device. The AngelMed Guardian system is designed to track significant changes in the heart's electrical signal and then alert patients to seek medical attention. The objective of the ALERTS Pivotal Study is to provide an assessment of the safety and effectiveness of the AngelMed Guardian System. Evelyn Vandusen of Sevierville is the first patient in Tennessee enrolled in the ALERTS study to receive the AngelMed Guardian System. Vandusen had previous bypass surgery with occurrences of angina daily, aggravated with activity, as well as a history of congestive heart failure. Vandusen was successfully implanted with the device on December 17 by Dr. Baldwin at Baptist Hospital West’s Stokely Heart Pavilion. A second patient successfully received the device earlier this month. “This study provides an excellent opportunity for some of our patients who are at high-risk of having another heart attack,” said Malcolm Foster, MD, principal investigator for the study and interventional cardiologist with ETHC. “The device is designed to measure changes in the electrical signal of the heart and alert the patient at the earliest onset of a heart attack so that they can get treatment as soon as possible.” According to the American Heart Association, one of every five deaths in the U.S. is attributable to coronary heart disease. Further, 50% of heart attack fatalities occur within one hour of symptom onset and occur before the patient even reaches the hospital. The AngelMed Guardian System is comprised of an internal implantable device about the size of a standard pacemaker with a lead into the heart, an external telemetry device, and a programmer that aids physicians in evaluating heart signals. Baptist Hospital West is among the first medical facilities to participate in the AngelMed Guardian system trial. To participate in the ALERTS study, patients must meet various inclusion criteria. For more information on the AngelMed Guardian system or the ALERTS study protocol, contact Baptist Hospital West at (865) 218-7535. _____________________________

Anger Management: The Key to Staying Heart Healthy?

Study Provides First Evidence that Changes Brought on by Anger can Predict Future Arrhythmias New research published in the March 3 issue of the Journal of the American College of Cardiology finds that anger-induced electrical changes in the heart can predict future arrhythmias in patients with ICDs. While previous studies have demonstrated an increased incidence of SCD during times of population stress such as earthquake and war, this study provides the first evidence that changes brought on by anger and other strong emotions can predict arrhythmias and may link mental stress to SCA, which accounts for over 400,000 deaths each year. Researchers studied 62 patients with ICDs who underwent monitoring during a mental stress test. Patients who had coronary artery disease or dilated cardiomyopathy and a standard indication for ICD were recruited from the Yale Electrophysiology practice. The mental stress test, conducted in a laboratory setting shortly after ICD implantation (about 3 months), asked patients to recall a recent situation in which they were angry or aggravated. T-wave alternans (TWA) was analyzed during this test. Researchers then followed patients for a mean of 37 months to determine which had arrhythmias requiring termination by the ICD. “We know strong emotion increases sympathetic arousal,” says Rachel Lampert, MD, FACC, associate professor, Yale University School of Medicine. “In this study, we found patients with higher levels of anger-induced TWA were more likely to experience arrhythmias requiring ICD termination.” Patients with ICD-terminated arrhythmias during follow up (16%) had higher TWA induced by anger compared with those patients who did not have future arrhythmias. Even when other clinical factors that predispose patients to higher TWA levels and/or higher risk of VT/VF were controlled for (e.g., heart failure or history of arrhythmia), anger-induced TWA remained a significant predictor of arrhythmias, which led to a heightened risk of up to ten times that of other patients. The development of accurate, non-invasive risk stratification tests to identify those individuals at greatest risk for life-threatening arrhythmia is critical. The present study suggests that mental stress, namely anger, may be yet another pathway provoking arrhythmias. "What remains unclear is how this new T-wave alternans test relates to traditional exercise TWA testing,” according to Eric J. Rashba, MD, Professor of Medicine, Stony Brook University Medical Center. “It may be that combining exercise TWA tests with newer mental stress TWA tests may help clinicians better select patients likely to have arrhythmia and, in turn, benefit from a defibrillator; however, more study is needed." In contrast to exercise, mental stress doesn’t elevate one’s heart rate much, suggesting that changes seen with mental stress may be due to a direct effect of adrenaline on the heart cells. Therefore, mental stress testing could provide an alternative to atrial pacing for patients unable to exercise, according to Dr. Lampert. “More research is needed, but these data suggest that therapies focused on helping patients deal with anger and other negative emotions may help reduce arrhythmias and, therefore, sudden cardiac death in certain patients.” _____________________________

Results are Published from the Landmark ATHENA Trial with Multaq® (dronedarone) in Atrial Fibrillation

Multaq® Significantly Reduced the Risk of Cardiovascular Hospitalization or Death in AF Patients Sanofi-aventis announced that the ATHENA trial was published in the New England Journal of Medicine. The trial showed that Multaq® (dronedarone), in addition to standard therapy, significantly reduced the risk of first cardiovascular hospitalization or death by 24 percent (31.9% vs. 39.4%, p