Industry News and Products

Cameron Health Commences Clinical Trial of the Minimally Invasive Totally Subcutaneous Implantable Defibrillator for Treatment of Sudden Cardiac Arrest

Cameron Health, Inc. announces the first CE trial implants in Europe and New Zealand for Cameron Health’s 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 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 may be positioned using anatomical landmarks. Conventional ICDs require placement of at least one lead in or on the heart. Most frequently, these leads, constructed of thin insulated wires, 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 life-saving electric shock when a harmful arrhythmia is detected. The surgical placement and residence of these transvenous leads within the patient’s heart are associated with a significant proportion of the complications related to this well established and 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 and long-term performance. The S-ICD System is also designed for ease of placement and removal while shortening the surgical procedure time. When approved, the S-ICD System will be the first totally subcutaneous implantable defibrillator used to treat SCA. Jay Warren, President and CEO of Cameron Health, Inc., explains, “The technological advancements with the Cameron Health S-ICD System are designed to provide patients with a safe, minimally invasive alternative to conventional ICDs. Since the Cameron Health S-ICD System is placed by anatomical landmarks, there is no need for expensive imaging equipment.” Fourteen patients have received an S-ICD System as part of the CE trial, which will involve up to 55 patients at 10 centers in Europe and New Zealand. Implants performed in New Zealand were conducted by Dr. Margaret Hood at Auckland City Hospital and by Dr. Ian Crozier at Christchurch Hospital. Initial implants in Europe were under the direction of Dr. Riccardo Cappato at Policlinico San Donato Milanese Hospital in Italy and Professor Luc Jordaens at Erasmus Medical Center in the Netherlands. Commenting on the clinical trial and the first CE trial patient to receive the S-ICD System in New Zealand, Dr. Hood said, “Our initial experience with this new technology has brought positive results. The whole procedure was surgically simple. Once implanted, the S-ICD System can be programmed to automatically optimize the device parameters for monitoring the heart’s rhythm while removing some of the complexity inherent in conventional systems. Not having to wear a protective lead apron to avoid radiation exposure during the procedure was refreshing. All patients have returned to their normal routines and are doing well.” Darryl Ward, one of the first patients to receive the Cameron Health S-ICD System, remarked, “I feel fortunate that this novel technology was available to me because my previous conventional ICD lead was no longer functioning. I just like the idea of nothing needing to be inside my heart anymore.” _______________________________

Vicor Technologies Announces Receipt of 510(K) Approval to Market its PD2i Analyzer

PD2i Technology at Core of Future Platforms for Risk Stratification of Sudden Cardiac Death David H. Fater, President and CEO of Vicor Technologies, Inc., announced that Vicor Technologies received FDA 510(k) approval (K082709) to market its PD2i Analyzer, permitting immediate commercialization of the technology. Vicor Technologies, Inc. is a development-stage biotechnology company focused on the commercialization of innovative non-invasive diagnostics using its patented, proprietary PD2i algorithm for cardiovascular and trauma use. The PD2i Analyzer uses Vicor’s patented, proprietary point correlation dimension algorithm (PD2i), a deterministic, non-linear measure that analyzes ECG data to risk stratify target populations as to future life-threatening or fatal events. Specifically, the PD2i Analyzer provides physicians with insight into heart rate complexity over time. According to David Fater, “The intended use of the Vicor PD2i Analyzer is to display and analyze electrocardiographic information and to measure heart rate complexity. The clinical significance of heart rate variability, and other parameters, must be determined by the physician.” Vicor has developed a private-label PD2i Analyzer ECG with an original equipment manufacturer (OEM). During the first quarter of 2009, Vicor plans to launch the PD2i Analyzer ECG to its National Cardiac Panel of several hundred cardiologists and have it marketed for general use to other physicians by the OEM. Mr. Fater continued, “Marketing approval from the FDA represents a major step in our strategic marketing plan as the commercialization of the PD2i Analyzer paves the way for expansion of our technology platform, first through the anticipated approval of our triage diagnostic, the PD2i VS, and then for the PD2i CA for risk stratification of sudden cardiac death, both of which are currently in the regulatory process.” Vicor’s PD2i CA is an accurate, easy-to-use tool for identifying patients at high risk of sudden cardiac death (SCD) and who would benefit from an implantable cardioverter-defibrillator. With more than 500,000 deaths yearly, SCD is the leading cause of death in the United States. There is currently no technology that accurately identifies patients at risk of sudden cardiac death. The PD2i CA is the subject of the VITAL trial, a multi-site, multi-year study being conducted by the Harvard Clinical Research Institute. Vicor expects 510(k) clearance for the Cardiac Analyzer by early 2010. _______________________________

Prism Pharmaceuticals Receives FDA Approval of NEXTERONE for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia

Novel Formulation Addresses Limitations of Amiodarone IV Prism Pharmaceuticals announced that the U.S. Food & Drug Administration (FDA) has approved the new drug application (NDA) for NEXTERONE® (amiodarone HCl) Injection, a novel, patent-protected, cosolvent-free formulation of the anti-arrhythmic agent Amiodarone IV, originally marketed in the U.S. by Wyeth as Cordarone® Intravenous. NEXTERONE is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Dr. Warren D. Cooper, President and CEO of Prism, says, “We developed NEXTERONE to overcome solvent-based limitations of conventional intravenous amiodarone and to improve patient care and overall medication management in the setting of life-threatening cardiac arrhythmias.” NEXTERONE represents the first product to successfully overcome the long recognized solubility issues of amiodarone by removing the original cosolvents, polysorbate 80 and benzyl alcohol. As a result of removing these cosolvents, NEXTERONE does not have many of the product administration limitations regarding compatibility and stability with plastics and ionic infusion fluids, which are included in the labeling of conventional intravenous amiodarone. Importantly, NEXTERONE does not carry the specific warning about the risk of fatal gasping syndrome in newborn infants because it does not contain benzyl alcohol. Improving medication safety in the hospital environment is an area of significant and current attention. This agenda is being driven by entities such as The Joint Commission, which is responsible for the accreditation of hospitals, and the Institute for Safe Medication Practices. Providing injectable products, especially those for critical care use, in premixed, ready-to-use forms is a high-priority solution to minimize medication errors. Dr. Cooper continued, “While this regulatory approval is for NEXTERONE supplied in vials and a pre-filled syringe, the changes in the compatibility and stability profile of NEXTERONE, brought about by the removal of polysorbate 80 and benzyl alcohol, present the opportunity to formulate intravenous amiodarone for the first time in premixed, ready-to-use configurations.” Prism is currently implementing a full-scale manufacturing development program with the Medication Delivery business of Baxter Healthcare Corporation. Prism intends to submit a supplemental NDA for the premixed configurations, which will form the focus of the commercial launch of NEXTERONE as a complete product line. Health-System Pharmacists hold the primary management responsibility for improvements in medication safety in hospitals, and this will be a key target customer group for NEXTERONE. “We intend to commercialize NEXTERONE ourselves in the U.S. with partners that are well positioned in the hospital marketplace and will seek to license the ex-U.S. worldwide rights,” said Dr. Cooper. “As we round out the NEXTERONE product line with the premixed bag configurations, we are concurrently defining the best approach to launch the brand, drive rapid conversion and optimize the value of NEXTERONE to pharmacists, clinicians, patients and the company. I believe NEXTERONE can rapidly replace generic Amiodarone IV when it becomes available and has the potential to eventually render conventional Amiodarone IV obsolete.” The FDA approval of NEXTERONE triggers a second $10 million milestone payment from Paul Capital. This long-range financing agreement, established in September 2006, provides Prism with non-dilutive capital to enable the company to bring NEXTERONE through the period of NDA review and commercial launch. _______________________________

Gasping After Cardiac Arrest Associated with Increased Survival

Mayo Clinic Study Advises CPR for Adults who Collapse and are Gasping It may confuse bystanders who witness someone suddenly collapsing — especially when the victim is gasping for air. Because of the gasping, the first thought of a bystander may be to skip doing chest compressions and wait for the first responders. That is exactly what happens frequently and one reason so many cardiac arrest victims do not survive, according to a study in Circulation, a monthly journal published by the American Heart Association. In fact, according to the research, led by Mayo Clinic Arizona Emergency Physician Bentley J. Bobrow and colleagues from the Sarver Heart Center at the University of Arizona, that initial period of distressed breathing may provide the best chance for resuscitation and may give the cardiac arrest victim the best chance to survive. During a three-year period, researchers tracked more than 1,200 cases of witnessed out-of-hospital cardiac arrest attended by emergency medical services personnel in Arizona. Approximately one-third of the patients were gasping on paramedic arrival. The patients who gasped, compared with those who didn't, were three times more likely to survive to hospital discharge, but, more compelling, five times more likely to survive if they received bystander cardiopulmonary resuscitation (CPR). "These results suggest that the recognition and importance of gasping after cardiac arrest should be taught to bystanders and emergency personnel," says Dr. Bobrow. "There is a knowledge gap in terms of people recognizing that gasping or other labored breathing sounds should be acted on by immediately starting CPR — to delay this may mean decreasing survival for the patient." In fact, note the researchers, gasping is an indication that the brain is still alive and functioning and CPR is working. Also important, don't give up if the patient continues to gasp, warns Dr. Bobrow, who is also medical director for the Arizona Department of Health Emergency Medical Services. "Gasping is not a sign of recovery, but is a signal that resuscitation efforts are effective and should be continued to increase the chance of survival." Gasping should not be confused with "choking," according to the Arizona researchers, who say that people who exhibit choking and indicate such by pointing to their throat are actually responsive and in need of being administered the Heimlich maneuver. "Recognition of gasping and its significance in patients with primary cardiac arrest is important to successful resuscitation efforts," adds Dr. Bobrow. Out-of-hospital cardiac arrest is a common cause of death in the U.S. and is known as a major public health problem. _______________________________

Beta-Blockers in the Real World: Help for Some, but Not for ‘Stiff Hearts’

Beta-blockers can help older patients with heart failure live longer lives, but only if their condition is caused by a poorly-functioning left ventricle, say researchers at the Duke Clinical Research Institute. The finding, available online and slated to appear in the Journal of the American College of Cardiology, could lead to clarification of professional guidelines on beta-blocker drug use among older patients. Heart failure can arise from a number of underlying conditions, but they all lead to similar symptoms — fatigue, breathlessness and often, early death. Physicians divide patients into two groups, those who have weakened left ventricles, a condition known as left ventricle systolic dysfunction (LVSD), and those who have normally-functioning left ventricles, or preserved systolic function, a condition commonly known as a "stiff heart." Approximately three-quarters of patients with heart failure are over age 65 and about half of them fall into the stiff heart category. "We don't really understand the underlying pathophysiology of heart failure among patients in that latter group," says Dr. Adrian Hernandez, a cardiologist at Duke University Medical Center and the lead author of the study. "We do know, however, that patients with "stiff hearts" tend to be older women who generally have just as poor outcomes as others with compromised ventricular function." Current guidelines call for beta-blocker use in patients with weakened left ventricles, but they are silent on the use of the drugs among patients with normal left ventricles. "There is very little information about how these drugs work in patients with preserved ventricular function," says Hernandez. We wanted to conduct this study for that reason, but we also thought it was important to discover how beta-blockers work among patients in real-life settings." Professional guidelines are based upon findings from large, clinical trials. But such studies tend to include disproportionate numbers of younger, healthier patients, quite unlike those most commonly encountered in hospital or community practice settings, "so it is not entirely clear that the findings would be the same," says Hernandez. Investigators examined hospital records of 7,154 patients with heart failure in a national quality improvement registry, the OPTIMIZE-HF registry, a program designed to support better management of heart failure patients. The study population reflected the types of patients normally seen in community settings: The median age for the patients in the current study was 78 (compared to a median age of 65 among heart failure patients enrolled in clinical trials), and a significant number of the study patients had multiple health problems. All were all eligible to undergo beta-blocker therapy. Researchers divided the patients into two groups, those who had poorly pumping ventricles (LVSD) and those who had preserved ventricular function, and then merged the clinical records with Medicare data so they could track the patients as long as possible. "We found that there were significantly higher death and rehospitalization rates after one year among our study population when compared with those found among younger, healthier, study populations," says Hernandez. Investigators discovered that upon discharge from the hospital, 60 percent of the patients with weakened ventricles were prescribed beta-blockers, compared with 39 percent of the patients with stiff hearts. After adjusting for variables that could account for some of the differences between the two groups, researchers found that those with weakened ventricles who took beta-blockers experienced a 23 percent lower risk of death and an 11 percent lower rate of rehospitalization, compared with those who were not prescribed the drugs. Among patients with preserved systolic function, beta-blockers appeared to have no significant impact on lowering the risk of death or rehospitalization. Hernandez says the study is valuable because it offers new information about beta-blocker use among elderly, sicker patients with heart failure — the kind of patients physicians are likely to see in their community settings, and specifically for those with preserved systolic function. "Clinical trials can tell us if a drug works in a select population, but it's important to conduct additional studies to see if the drug works equally well in a population at large," says Hernandez. The study was funded by GlaxoSmithKline. Gregg Fonarow, from the University of California at Los Angeles, is the senior author of the study. Co-authors from the Duke Clinical Research Institute include Bradley Hammill, Christopher O'Connor, Kevin Schulman, and Lesley Curtis. _______________________________

Philips Collaborates to Develop New Clinical Tools to Aid Patients Suffering from Complex Heart Rhythm Disorders

Challenging heart rhythm disorders require electrophysiology (EP) technologies to pinpoint and ultimately fix problem areas within the heart’s electrical circuitry during an interventional procedure. As EP procedure volume increases worldwide, clinicians are requesting intuitive, advanced tools to help shorten procedure times and gain detailed visualizations for interventions. Recognizing this, Royal Philips Electronics announced an agreement with Bard Electrophysiology, a division of C. R. Bard, Inc., to co-develop new clinical tools that will be designed to help electrophysiologists meet these needs and aid patients suffering from arrhythmias. The goal of the combination of Bard’s LabSystem™ PRO EP Recording System and Philips’ EP navigator and the Allura Xper FD series is to provide electrophysiologists a faster and easier way to integrate image guidance with mapping and analysis of complex arrhythmias, while offering insights for more accurate interventional navigation. EP physicians and lab staff may also benefit from improved workflow in the EP lab due to integration and compatibility between Philips and Bard technologies. "Providing simpler and more intuitive approaches to the management of complex arrhythmias is something that fascinates me. Significant advancement in science and technology is frequently made when two seemingly dissimilar techniques are merged. The collaboration between Bard Electrophysiology and Philips is very promising, and I am looking forward to learning more about the potential for these new technologies in my practice," commented Michael V. Orlov, MD, PhD, director of the Arrhythmia Service at Caritas St. Elizabeth's Medical Center of Boston and an associate professor of Medicine at Tufts University School of Medicine. Gerard Winkels, vice president and general manager, Electrophysiology, for Philips Healthcare, said, “The collaboration with Bard Electrophysiology will allow us to bring new clinical tools to market aiming to enable our joint customers to perform EP procedures faster and more simply and allow them to provide enhanced care offerings for their patients.” Dave Hemink, vice president and general manager, Bard Electrophysiology said, “This alliance will provide us the opportunity to fundamentally impact the way that we analyze and diagnose complex arrhythmias. We recognize that current solutions are complex and time consuming. Together with Philips, we will innovate towards simpler approaches to these clinical challenges, with a focus on helping healthcare providers’ EP labs achieve greater business potential through expanded functionality and improved efficiencies.” _______________________________

Vascular Solutions Launches Convenient D-Stat® Dry Wrap Hemostatic Bandage

Vascular Solutions, Inc. recently announced the launch of its D-Stat Dry Wrap hemostatic bandage. A convenient pre-cut version of the D-Stat Dry hemostat, D-Stat Dry Wrap is designed specifically for the control of bleeding around indwelling lines. D-Stat Dry Wrap is the latest addition to Vascular Solutions’ complete line of D-Stat hemostasis products, which use the power of thrombin to control bleeding. A powerful component of the clotting cascade, thrombin cleaves fibrinogen to fibrin, enhancing the body’s own mechanism to produce a clot. D-Stat Dry Wrap contains the same thrombin activity level as the original D-Stat Dry, and comes complete with a clear adhesive bandage for continuous site monitoring after hemostasis is achieved. D-Stat Dry Wrap is currently available in the United States. 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. _______________________________

Abnormal Heart Function Associated With Reduced Capacity For Exercise

Patients with abnormal diastolic function (when the heart is relaxed and expanded) in the left ventricle of the heart have a substantially lower maximum capacity for exercise, according to a study in the January 21 issue of JAMA. Many factors, including age, female sex, body mass index and co-existing medical conditions are known to be associated with a decrease in exercise capacity. Identifying potentially reversible mechanisms underlying the decline in maximum exercise capacity could have important implications. Some research has suggested that assessing left ventricular function could be used to predict exercise capacity, according to background information in the article. Jasmine Grewal, MD, of Mayo Clinic, Rochester, Minnesota, and colleagues conducted a study to examine the relationship between left ventricular diastolic function and exercise capacity. The study included 2,867 patients undergoing exercise echocardiography (a noninvasive diagnostic procedure that uses ultrasound to study the structure and motions of the heart) with routine measurements of left ventricular systolic and diastolic function. Analyses were conducted to determine the strongest correlates of exercise capacity and the age and sex interactions of these variables with exercise capacity. The researchers found that diastolic dysfunction (impaired relaxation) was strongly and inversely associated with exercise capacity. Compared with normal function, those with resting diastolic dysfunction had substantially lower exercise capacity. Variation of left ventricular systolic function within the normal range was not associated with exercise capacity. Other independent correlates of exercise capacity were age, female sex, and body mass index greater than 30. Compared with those with normal diastolic function, patients with diastolic dysfunction had a progressive increase in the magnitude of reduction in exercise capacity with advancing age. “In identifying diastolic function parameters as strong correlates of exercise capacity, we have identified potentially modifiable and preventable factors in the development of exercise intolerance. It is well known that exercise training improves diastolic function in healthy individuals …,” the authors write. (JAMA 2009;301[3]:286-294.) _______________________________

St. Jude Medical Announces Japanese Approval of Atlas II ICD

St. Jude Medical, Inc. announced regulatory approval from the Japanese Ministry of Health, Labour and Welfare (MHLW), in addition to reimbursement approval, of its Atlas® II implantable cardioverter defibrillator (ICD). The Atlas II ICD is a powerful device that significantly enhances telemetry speed for faster communications, which results in quicker, more convenient follow-up visits for patients and physicians. The new device provides physicians and patients with therapy-enhancing benefits, including: • DeFT Response® technology, which is designed to help devices meet the needs of patients who may have high or varying thresholds for the amount of energy required to defibrillate the heart. This enables the physician to tailor device therapy for individual patients, offering them added protection in the event of a life-threatening arrhythmia. • SenseAbility® technology, which is designed to optimize sensing to help protect against inappropriate shocks. • Vibrating patient notifier, which 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. “The Atlas II DR ICD has many features that our physicians really need today. DeFT Response technology helps us to ensure appropriate defibrillation safety margins, and the SenseAbility feature provides us with more control to address sensing-related matters. The patient notifier is also very helpful, as it alerts patients by vibrating, which helps those who have difficulty hearing audible alarms,” said Takashi Kurita, MD, associate professor in the department of cardiovascular internal medicine, Kinki University, Osaka, Japan. “The Atlas II devices offer important clinical benefits due to their high-energy capability, advanced diagnostics and increased telemetry speed,” said William Phillips, president of St. Jude Medical Japan Co. Ltd. “Customized options give physicians more control and help simplify patient management through better detection, diagnosis and delivery of tailored therapy.”