Clinical and Industry News

Clinical & Industry News

Radi Medical Systems AB and GE Healthcare Announce Cooperation to Integrate FFR and PressureWire® Aeris in GE Mac-Lab® IT

Radi Medical Systems AB and GE Healthcare announced a development, marketing and sales initiative to integrate Radi Medical Systems AB wireless PressureWire® Aeris and Fractional Flow Reserve (FFR) technology into GE’s Mac-Lab® IT hemodynamic recording system. This agreement will seamlessly integrate measurement of FFR into the cath lab workflow, with all procedural results stored into existing data archives. The initiative will also provide an upgrade path for GE Mac-Lab IT customers to add this functionality to their existing systems. “Traditionally, FFR assessment required additional capital equipment and increased procedure time due to setup operations,” commented Dr. Jasvindar Singh, Associate Professor of Medicine at Washington University School of Medicine, Barnes Jewish Hospital, St. Louis, MO. “With FFR fully integrated into our GE Mac-Lab IT, I’ll be able to make the best treatment options immediately available to my patients using equipment we already have, without any installation of additional instrumentation, screens or controls. Additionally, the wireless technology of PressureWire Aeris removes cables crossing the sterile field barrier, making the entire procedure faster and easier.” The cooperation will enable the option of upgrading to wireless measurement and integrated FFR on all existing and new GE Mac-Lab IT installations. Fractional flow reserve (FFR) is an index for functional severity of coronary stenosis, measured by PressureWire Aeris. FFR is 100% specific in identifying which lesion or lesions are responsible for a patient’s ischemia, enabling the interventional cardiologist’s direction of coronary interventions and result assessment for improved treatment outcomes. ________________________________

12-Month ATLANTA Trial Data Show Sustained Benefit of Catania™ Stent in Treatment of De Novo Coronary Lesions

‘New Class’ of Stent with Polyzene®-F Surface Treatment Maximizes Endothelialization; Reduces Restenosis, Thrombogenicity, Need for Long-Term Dual Anti-platelet Therapy The ATLANTA Trial is a first-in-man (FIM), prospective, single center, non-randomized, single-arm study involving 55 patients (76 lesions) treated with the Catania™ coronary stent system with NanoThin Polyzene®-F surface modification for symptomatic ischemic heart disease due to de novo, obstructive lesions of native coronary arteries. The trial was sponsored by CeloNova BioSciences, Inc., maker of the Catania stent. Twelve-month follow-up data from the ATLANTA Trial, presented at the October 2008 TCT meeting, include zero percent thrombosis in patients discontinuing dual anti-platelet therapy after only 30 days. At 12 months, in an unusually complex FIM patient population, the results showed zero (0.0) percent stent thrombosis (Academic Research Consortium, or ARC-defined), death, myocardial infarction, stroke, or coronary artery bypass graft. Target lesion revascularization was 10.9 percent (only 3.6 percent clinically driven, 7.3 percent non-clinically driven), with a binary restenosis rate of 6.8 percent (five of 74 lesions analyzed at twelve months). Of note, all patients stopped dual anti-platelet therapy after 30 days, but continued aspirin (100 mg/d) throughout the 12-month period. The acute angiographic and procedural success rate in the ATLANTA Trial was 100%. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound (IVUS) data for all patients immediately after stent implantation and at 6-month follow up. Further analysis of 1,904 cross-sections (19,028 struts) by investigators using optimal coherence tomography at baseline and again at 6-month follow up in a subset of 15 randomly selected patients revealed complete endothelialization and 99.5 percent stent strut coverage. “Every clinician is aware of the questions and issues surrounding drug-eluting stents and the increased risk of late and very late stent thrombosis, malapposition, inflammatory or hypersensitivity reactions, as well as the economic impact of maintaining long-term dual antiplatelet therapy,” said Corrado Tamburino, MD, PhD, FESC, FSCAI, FSICI-GISE, Professor of Cardiology and Chief of the Cardiovascular Department, Ferrarotto Hospital, Catania, Italy, and lead investigator in the ATLANTA Trial. “The 12-month ATLANTA data indicate that the Catania stent with Polyzene-F is truly a new and promising class of stent. Further, the Catania stent may offer an improved safety profile as evidenced by the fact that there were no deaths, myocardial infarctions, or stent thrombosis in a significantly complex patient population. Economically, this stent has merit, because it does away with the costs associated with long-term dual antiplatelet therapy.” The rapid-exchange, cobalt-chromium Catania stent carries a CE Mark and is currently available for sale outside of the United States in 60 sizes, in lengths from 8-38mm and in diameters from 2.0-4.0mm. The Catania stent surface has a thin (35-40 nanometers) surface treatment of highly lubricious Polyzene-F, a synthesized, inorganic, biocompatible polymer that is anti-thrombotic, anti-inflammatory, bacterial-resistant, and essentially cloaks the device’s presence from the body to promote healthy endothelial cell growth without stimulating platelet activation. “We found the Catania stent to be highly deliverable, trackable, and flexible in even the most tortuous anatomy,” said Dr. Tamburino. “The Polyzene-F surface treatment endows the stent with exceptional qualities that not only create a highly lubricious system that inspires user confidence and improved pushability, but also hides the stent from the body’s defenses, which reduces platelet aggregation and the potential for thrombosis.” For more information, please visit www.celonova.com. ________________________________

Mayo Clinic Community Study of Heart Attack Survivors Finds Risk of Sudden Cardiac Death Highest Early After Attack

People who survive a heart attack face the greatest risk of dying from sudden cardiac death (SCD) during the first month after leaving the hospital, according to a long-term community study by Mayo Clinic researchers of nearly 3,000 heart attack survivors. After that first month, the risk of sudden cardiac death drops significantly — but rises again if a person experiences signs of heart failure. The research results appear in the Nov. 5 edition of Journal of the American Medical Association. This study emphasizes the need for physicians to stay in close contact with their heart attack patients, forming a partnership to recognize symptoms, says Veronique Roger, MD, MPH, a Mayo Clinic cardiologist and lead author of the study. Physicians and patients — and their family members — need to be keenly alert for the symptoms of heart failure, as described by the American Heart Association, Dr. Roger says. “There are three key findings here that can be immediately applied to heart attack patients today,” Dr. Roger says. “One is that the first month post-heart attack is the highest risk period for patients to suffer sudden cardiac death — and acute surveillance is warranted. A second is that the risk drops rapidly after the first month, but this does not mean the patient is out of danger. Surveillance is still required after the first month because our third finding shows that even though the risk drops after the first month, the onset of symptoms of heart failure at any time after the heart attack markedly increases the risk of SCD.” The study is one of the largest and longest comprehensive community studies performed by reviewing medical records. Drawing on data from the Rochester Epidemiology Project, the study analyzed the records of 2,997 men and women who had heart attacks in Olmsted County, Minn. — the county where Mayo Clinic is located — between 1979 and 2005. The patients’ average age was 67 years. Patients were followed until death or the last recorded medical exam. Investigators were able to identify out-of-hospital deaths whose primary cause was listed as coronary heart disease. This enabled them to analyze sudden cardiac death trends. Housed at Mayo Clinic, the Rochester Epidemiology Project is one of the largest long-term, integrated databases of patient records in the world. ________________________________

First Percutaneous Liver and Kidney Lesions Treated With AngioDynamics’ IRE Technology at Australia’s The Alfred Hospital

New NanoKnife™ system used to perform three cases AngioDynamics, Inc. announced that the first percutaneous uses of irreversible electroporation (IRE) technology on liver and kidney lesions were conducted at The Alfred in Melbourne, Australia. Using the NanoKnife system, Dr. Ken Thomson, Professor and Director of the Department of Radiology at The Alfred, Monash University, performed a kidney case and two liver cases between November 6th and 20th. The Alfred announced that all three cases were procedurally flawless and encountered no safety issues. In addition, The Alfred determined the first liver case initially successful, showing clear improvement after two weeks for the patient, whose lesions decreased markedly in size. The Alfred intends to conduct further patient follow-up before determining final outcomes. In addition, two patients reported no pain post-procedure and the third patient reported a small amount of pain which was transient and resolved completely overnight. NanoKnife causes cell death by impacting the cell membranes with electrical pulses in targeted tissue, sparing nearby nerves, blood vessels, lymphatic system, and other delicate structures. Targeted cells are removed by the body via blood vessels and lymphatic systems. This is different from thermal ablation modalities like cryo-ablation, microwave and radiofrequency ablation. These modalities destroy all cells and critical structures in targeted tissue, leaving destroyed material in place for years. The body can only remove it slowly and tediously by attacking from the outside since all normal pathways to remove damaged tissue have been destroyed. “Traditionally there has been a variety of methods used to destroy tumors, most of which cause damage to nearby healthy tissue. This technique does not affect the surrounding supportive tissues or nearby nerves and blood vessels.” said Dr. Thomson. “With IRE, what I believe we’re looking at is a whole new treatment modality that can be used on a wider spectrum of patients which potentially reduces risk or impact to their body. I believe the NanoKnife represents a new paradigm in radiologically guided microsurgery.” The Alfred explained that each NanoKnife procedure comprised a sequence of 90 pulses taking a total of approximately 45 seconds. Each procedure administered four to seven pulse sequences. AngioDynamics intends to file investigational device exemptions (IDE) with the Food & Drug Administration to pursue additional and more specific tissue indications. The device has been cleared for a general soft tissue ablation indication by the FDA. Irreversible Electroporation (IRE) is a surgical resection technique in which electrical fields are used to create nano-scale defects in a cell’s membrane, which causes cell death only in the targeted tissue, without destroying critical structures such as ducts, blood vessels and nerves. A research team headed by Boris Rubinsky, Distinguished Professor of Bioengineering at the University of California, Berkeley, invented the IRE technology used in the ongoing trials. The technology was exclusively licensed by the University of California to Oncobionic for commercial development. With the close of the acquisition of Oncobionic in April 2008, AngioDynamics has taken ownership of the exclusive license along with a developing portfolio of Intellectual Property in the area of IRE. Dr. Thomson has expertise in cardiovascular and interventional radiology and is a founding member of the Society of Minimally Invasive Therapy and the Interventional Radiology Society of Australasia. He has published and lectured widely on aspects of interventional radiology and his research interests are vascular stents, molecular imaging, endografts and therapeutic embolic agents. He is the past President of the Asian & Oceanian Society of Radiology. ________________________________

New Findings on the Role of Inflammation in Prevention of Coronary Heart Disease

A Statement from Elizabeth G. Nabel, MD, Director, National Heart, Lung, and Blood Institutes This year, about 450,000 Americans will die of coronary heart disease — the leading cause of death for both men and women. Although we have made great strides in preventing and treating heart disease, we continue to explore the complex mechanisms involved in cardiovascular disease, and we are eager to refine risk assessment tools and preventive strategies to reduce the incidence of heart attack and stroke. New results from three studies provide the strongest evidence to date that a simple blood test for high-sensitivity C-reactive protein (hsCRP) is a useful marker for cardiovascular disease. Importantly, a much-anticipated study demonstrates for the first time that hsCRP levels in the blood can be used to guide treatment decisions to effectively lower the risk of heart attacks, stroke, and death. Together, these studies show great promise in helping clinicians better identify and treat individuals at risk for cardiovascular disease — potentially saving millions more lives. For years, growing evidence has suggested that inflammation plays a strong role in developing cardiovascular disease, especially atherosclerosis. HsCRP is one of the most widely studied markers of inflammation in cardiovascular disease. But, whether measuring hsCRP adds any measurable value for predicting risk for cardiovascular disease independent of traditional risk factors, such as age, blood cholesterol levels, blood pressure, diabetes, and smoking has been a topic of great debate. Further, it has been uncertain whether hsCRP levels can be used to improve treatment decisions. Two studies supported by the National Heart, Lung, and Blood Institute (NHLBI) show that adding hsCRP levels to assess risk of a first heart attack or stroke in middle-aged or older adults improves accuracy over the traditional assessment tools by between 5 percent and 14 percent. The information proved to be especially valuable in reclassifying the risk of heart disease and stroke among individuals considered to be at intermediate risk (10 percent to 20 percent risk of having a heart attack within 10 years) by traditional methods. Using data from the 3006 participants in NHLBI’s Framingham Heart Offspring Study, Peter W. F. Wilson, MD, of Emory University in Atlanta and colleagues from NHLBI, Boston University, and Tufts USDA Nutrition Center in Boston found that using hsCRP levels to assess risk provided a more accurate risk assessment over traditional risk scores among people otherwise considered at intermediate risk. The researchers suggest a two-stepped approach to assessing risk — using traditional risk scores first, then adding hsCRP levels to those found to be at intermediate risk — to guide clinical decisions. These results are published online in Circulation: Cardiovascular Quality and Outcomes. In the second study, researchers used data from 10,724 men in the Physicians Health Study-II to prospectively develop the Reynolds Risk Score for Men, which adds hsCRP levels and parental history of early heart disease to traditional risk factors to assess men’s risk. The new assessment tool was significantly more accurate than traditional risk factors alone in the study population. The report, by Paul Ridker, MD, of Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues, is published online in the journal Circulation and was presented at the AHA Scientific Sessions. Previous work in the NHLBI-funded Women’s Health Study led to the development of a comparable Reynolds Risk Score for women last year. The third hsCRP study results released are from JUPITER (the Justification for Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin), an international randomized clinical trial to test the effectiveness of treating individuals with high levels of hsCRP. Dr. Ridker and his colleagues demonstrate for the first time that a strategy of treatment decisions based upon hsCRP levels in otherwise healthy individuals significantly improves outcomes. The study of 17,802 apparently healthy men and women was stopped early on March 30 after about 2 years because of the strong positive results. The researchers found that a daily dose of a commonly used statin, rosuvastatin (Crestor), reduced the risk of heart attack, stroke, and death by nearly half (44 percent) in individuals with high levels of hsCRP (2.0 mg/L or higher) but with normal or low levels of LDL (130mg/dL or lower). The treatment reduced LDL cholesterol by 50 percent and hsCRP by 37 percent. Supported by AstraZeneca, U.S., the study was presented at the AHA Scientific Sessions and appears online in the New England Journal of Medicine (November 20, 2008, print issue). These studies expand our understanding of the role of inflammation in detecting early signs of cardiovascular disease and identifying adults who are at risk for heart attack or stroke. These findings suggest that adding hsCRP levels to traditional risk factors could identify millions more adults for whom treatment with statins appears to lower the risk of heart attack. Many clinicians now offer hsCRP testing to their patients, but until now the value of hsCRP levels to treatment decisions, especially in adults with desirable cholesterol levels, was unclear. As with any medical discovery, however, broadly adopting a new approach to detect or treat a condition should first be critically tested, preferably through large-scale event-based randomized clinical trials like JUPITER, and proven to bear greater benefits than risks, including costs. As part of the NHLBI strategic plan, we have engaged an expert panel to review and update the scientific evidence regarding the assessment and management of cardiovascular risk factors. These findings will be part of the rigorous scientific review to distill the scientific evidence and generate an evidence-based, comprehensive, set of clinical guidelines for primary care practitioners to help adult patients reduce their risk for cardiovascular disease. In the meantime, however, we must not lose sight of the essential truth of what we already know to prevent heart disease: Cholesterol still counts, and we have proven ways to lower it and lessen its impact. The value of following a heart-healthy eating plan, being physically active, maintaining a healthy weight, and not smoking cannot be overestimated. And, statins can significantly reduce the risk of heart attack in those at high risk. Let us continue to use our current knowledge as well as apply new discoveries based on solid evidence to take action for the betterment of individual and public health. ________________________________

New European Guidelines on Heart Attack Management Put Emphasis on Speed of Action

Timing, emergency network, reperfusion therapy are central to new recommendations New European guidelines issued on the management of heart attack emphasize speed of action and the importance of reperfusion therapy to restore blood flow to the heart and improve survival rates. “A well-functioning regional system of care... and fast transport to the most appropriate facility is key to the success of the treatment,” state the guidelines, which have been developed by a Task Force of the European Society of Cardiology (ESC). Professor Frans Van de Werf (Leuven, Belgium), chairperson of the Task Force, describes the guidelines as “important” and says their broad uptake and adoption would make a “huge difference” to heart attack survival rates. The new guidelines cover management of ST-segment elevation acute myocardial infarction (STEMI). Around one-third of all acute coronary events are diagnosed as STEMI. Although precise numbers are missing, it is likely that 30-50 percent of victims of heart attack die before reaching the hospital, most of them in the first hours after the onset of symptoms. While this fatality rate has remained fairly constant in recent years, survival rates in hospital have markedly improved — from a rate of 75 percent in the 1960s to around 95 percent today. The introduction of coronary care units, new techniques of coronary intervention and thrombolysis have all improved in-hospital care. The principal features of the new guidelines — and the major changes since the previous edition of 2003 — relate to emergency systems and a speedy emphasis on reperfusion therapy, performed either by percutaneous coronary interventions (PCI) or thrombolysis treatment. Key to management, say the guidelines, is early diagnosis and risk assessment after “first medical contact” (FMC). • Primary PCI is the “preferred treatment” if available within two hours of FMC. • If PCI is not possible within two hours, pre- or in-hospital thrombolysis should be performed as soon as possible after FMC (and within 30 minutes at the latest). The guidelines state: “Primary PCI is defined as angioplasty and/or stenting without prior or concomitant thrombolytic therapy, and is the preferred therapeutic option when it can be performed expeditiously by an experienced team.” The shorter the delay, the better the outcome — and FMC-to-balloon should be within two hours “in all cases.” However, the guidelines add that only hospitals with an established interventional cardiology program — 24/7 — should use primary PCI. The guidelines also recommend that most patients following successful thrombolysis should be routinely referred for angiography. Professor Van de Werf concedes that not all hospitals nor all regions have the emergency networks or PCI facilities recommended in the guidelines. Indeed, current registry data suggest that around 20-30 percent of all STEMI patients in Europe still receive no reperfusion therapy. However, adherence to the guidelines, he suggests, could “dramatically” improve STEMI patient survival. The ambulance is also crucial to improving survival rates — for speedy transfer, defibrillation if needed, diagnosis by ECG, early thrombolysis therapy if needed, and early alert to the hospital. The guidelines recommend that an ambulance should be available within 15 minutes of a call and all should be equipped with 12-lead ECG. Also recommended is that the techniques of basic life support should be part of the school curriculum. An electronic copy of the guidelines is available at: http://www.escardio.org/guidelines-surveys/esc-guidelines/Pages/acs-st-segment-elevation.aspx or on request from the ESC Press Office at press@escardio.org. ________________________________

FDA Approves Boston Scientific’s Apex™ PTCA Dilatation Catheter

New Design Provides More Options for Treating Complex Lesions Boston Scientific Corporation has received approval from the U.S. Food and Drug Administration to market its Apex™ PTCA Dilatation Catheter. The Apex Catheter is a pre-dilatation balloon catheter developed specifically to address physicians’ needs in treating the most challenging atherosclerotic lesions. It is available for distribution in both Monorail® and Over-The-Wire (OTW) catheter platforms. The Apex Catheter represents the next generation of dilatation catheter technology, utilizing a new Bi-Segment™ inner shaft for improved pushability and flexibility. Additionally, it has a redesigned tip with the same low profile as the Maverick® PTCA Dilatation Catheter for turning and wire tracking. It is available in an array of balloon diameters from 1.5mm up to 5.0mm, with balloon lengths ranging from 8mm up to 40mm (for select diameters). Both the Apex Monorail and OTW catheters are available in two different 1.5mm designs — “Apex Push Catheter” and “Apex Flex Catheter.” The Apex Push Catheter is designed to enhance pushability for tight lesions, while the Apex Flex Catheter is designed to enhance trackability for tortuous arteries. “A much greater number of ‘complex’ lesions could be more readily crossed and dilated if more advanced, next-generation, catheter technology were available,” said James Hermiller, MD, Director of the Interventional Fellowship at St. Vincent Heart Center of Indiana in Indianapolis. ________________________________

FDA Approves Boston Scientific’s Carotid Artery Stent

Boston Scientific Corporation announced that the U.S. Food and Drug Administration (FDA) has approved its Carotid Wallstent® Monorail® Endoprosthesis for the treatment of patients with carotid artery disease who are at high risk for surgery. The company said it plans to launch the product immediately in the United States. The Carotid Wallstent is a self-expanding stent mounted on a rapid exchange delivery system. The stent features a closed-cell design. It is used in conjunction with the FilterWire EZ™ Embolic Protection System, which is designed to capture plaque debris released during the stenting procedure. The device features simplified filter sizing, accommodating vessel diameters between 3.5 mm and 5.5 mm. “The closed-cell design of the Carotid Wallstent Endoprosthesis is intended to provide increased scaffolding for optimal lesion coverage and a smooth inner lumen,” said Barry T. Katzen, MD, Medical Director, Baptist Cardiac and Vascular Institute, Miami. The Carotid Wallstent Endoprosthesis with the FilterWire EZ System is the only carotid artery stent system approved in the United States with an indication that includes the treatment of bilateral carotid artery disease. ________________________________

Stanley Engineered Storage Solutions Acquires Denmark-Based Scan Modul System®

Partnership Takes Healthcare Industry Presence International Stanley Engineered Storage Solutions, based in Allentown, Pa., has announced the acquisition of Scan Modul System®, a specialty healthcare storage manufacturer in Hillerod, Denmark. Scan Modul is a third-generation, 100-year-old company that produces flexible, high-quality logistical solutions for all institutions in the healthcare sector with distribution in Germany, Holland, the United Kingdom, France and Spain. With a complete product range for the storage, transport, and distribution of medical supplies and medicines, Scan Modul manufactures items including open and closed cabinets, open and covered racks, shelves, trays, and boxes, and also offers innovative software that tracks high-value medical supplies. “Scan Modul is a very well-known and respected brand in the industry,” said Jim Cannon, president of Stanley Engineered Storage Solutions. “They are the perfect complement to our North American business of Stanley InnerSpace.” Stanley InnerSpace, based in Grand Rapids, Mich., designs and manufactures storage solutions that organize supplies and improve staff efficiency in hospitals and healthcare institutions. Scan Modul will continue to operate as Scan Modul systems in Europe, and Stanley InnerSpace will continue to serve as a clinical storage solution in North America. Financial terms of the deal were not disclosed. “This acquisition has doubled the size of our healthcare storage business and provides the financial strength to move Stanley Engineered Storage Solutions forward well into the future,” Cannon added. Established in 2007, Stanley Engineered Storage Solutions oversees operations of Stanley Vidmar, based in Allentown, Pa., and Stanley InnerSpace, headquartered in Grand Rapids, Mich. Stanley Vidmar (StanleyVidmar.com) offers storage solutions to all industries, with modular space-saving systems that provide quick, safe access to parts, tools, and supplies. Stanley InnerSpace (InnerSpaceCorp.com) designs and manufactures storage and inventory management solutions that organize supplies and improve staff efficiency in hospitals and healthcare institutions. Stanley Engineered Storage Solutions is a business unit of The Stanley Works, a diversified worldwide supplier of tools and engineered solutions for professional, industrial, construction, and do-it-yourself use, and security solutions for commercial applications. ________________________________

Angel Medical Systems Announces ALERTS Pivotal Study For Implantable Cardiac Monitor & Alert System

AngelMed announced its initiation of a Phase II Pivotal US trial for the AngelMed Guardian implantable cardiac monitor and alert system. Designed to reduce time to presentation by detecting significant changes in the heart’s electrical signal and then alerting patients to seek medical attention, the AngelMed Guardian System is commercially available in Brazil and available for investigational use only in the US. AngelMed is actively seeking up to 50 clinical sites nationwide to participate in the trial. “We have worked closely with some of the world’s leading experts in heart attacks, like C. Michael Gibson, MS, MD, from Harvard University; David Holmes, MD, of the Mayo Clinic; and Mitchell Krucoff, MD of Duke University to design a study for evaluating the potential of the AngelMed Guardian System,” says Jill Schweiger, AngelMed’s Vice President of Clinical and Regulatory Affairs. “The study design is meant to test the system’s ability to alert patients of significant ST shift events in order to reduce the incidence of death and new Q-wave MI and decrease the elapse of greater than 2 hours before presentation for life-threatening thrombotic coronary occlusions, such as those caused by vulnerable plaque ruptures.” According to the American Heart Association, one of every five deaths in the U.S. is attributable to coronary heart disease. Further, fifty percent of heart-attack fatalities occur within 1 hour of symptom onset and occur before the patient even reaches the hospital. “Experimental and clinical studies have shown that most of the damage to the myocardium occurs during the first two hours after coronary occlusion,” says AngelMed’s Chief Operating Officer Jonathan Harwood. “We’ve designed the device to warn patients of this and other cardiac events hours — perhaps days — before they occur.” 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. “When someone has a heart attack, it is typically the result of a blood clot closing one of the three major coronary arteries. When this happens, there is a shift in the ST segment of the heart signal caused by the electrical difference between the portion of the heart muscle fed by the closed artery and the rest of the heart that is still receiving oxygen,” adds AngelMed’s CEO, David Fischell, PhD. “The ALERTS trial is designed to test the Guardian’s ability to detect this electrical shift in a clinical setting and then provide an early warning to patients that could potentially save their lives.” The ALERTS trial is currently underway and will be conducted in up to 50 centers across the United States. 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, go to http:// www.angel-med.com. ________________________________

Toshiba and Maquet Partnership to Offer Hybrid Solutions for Infinix-i

Toshiba America Medical Systems, Inc. is partnering with surgical table manufacturer Maquet to provide new solutions for Toshiba’s Infinix™-i product line. The partnership combines the Infinix-i systems with a complete range of Maquet table-top options, which range from general surgery to radiology- specific. The Toshiba/Maquet hybrid operating room (OR) suite is the only hybrid solution to offer interchangeable table tops, optimizing asset utilization of these specialized OR suites. Because ceiling mounted systems are typically best suited for a hybrid operating room setting, these table tops match with Toshiba’s Infinix CC-i and Infinix VC-i systems. Explains Robert Micer, director, X-ray Vascular Business Unit, Toshiba. “By having a system in an operating room that can perform multiple procedures, hospitals can ensure that hybrid suite settings are utilized for more than just surgery. They can also be used for diagnostic and interventional imaging procedures, as well as hybrid procedures that involve surgeons and interventionalists working together.” “Unlike catheterization suites, this hybrid operating suite by Toshiba and Maquet is designed specifically around the cardiac surgeon, cardiac interventionalist and cardiac surgical patient, offering new advanced access and imaging in the operating room, without having to move patients,” explained Dr. Mark E. Galantowicz, chief of cardiothoracic surgery, co-director of The Heart Center at Nationwide Children’s Hospital, and associate professor of surgery at The Ohio State University College of Medicine. Kevin Gilroy, director of business development, Maquet, Inc., comments, “Our Alphamaquet systems table solution with multiple interchangeable tops provides greater utilization of these advanced technology rooms. Various table tops can be readily exchanged to accommodate interventional and surgical procedures, making these rooms more cost effective,” added Gilroy. “The staff can attach the correct table top for the specific case they need to perform without compromising patient positioning for procedures.” ________________________________

VADs: High Cost, High Mortality in an Emerging Technology

Ventricular assist devices, or VADs are associated with high hospital costs and high rates of early death among Medicare recipients, say researchers at Duke University Medical Center. Their study, appearing in the November 26 issue of the Journal of the American Medical Association, found that only half of all patients who received a VAD were alive one year later. “This study tells us two things,” says Adrian Hernandez, MD, a cardiologist at Duke and lead author of the study. “VADs are an emerging technology and while they have been proven effective in extending life, more needs to be done before they can be more widely adopted in patients with heart failure. Also, as physicians, we need to do a better job defining the time of optimal intervention and identifying who is most likely to benefit from a VAD.” Researchers analyzed data on nearly 3,000 Medicare patients who received a VAD between 2000 and 2006, measuring hospitalization and death rates and tracking inpatient costs. Half the patients received a VAD as a primary strategy for treatment of heart failure and the other half received a VAD after cardiac surgery. Among the primary group, 55 percent of patients were discharged alive with a VAD after a median hospital stay of 30 days. By one year, 20 percent of the primary group had undergone transplant, 5 percent had the device removed, 42 percent had died and 32 percent were alive with the device. In the post-surgical group, a third were discharged alive with a device, and the median hospital stay was 10 days. At one year, a quarter of the group was alive with a VAD in place. The study is the first to examine trends in the use of assist devices after Medicare moved in 2003 to expand their use among elderly patients with certain end-stage characteristics. Lesley Curtis, PhD, a health services researcher in the Duke Clinical Research Institute and senior author of the study, says, “This is not about turning away from a promising new technology. It’s about choosing the right patient for the right device at the right time." ________________________________

Terumo Interventional Systems Launches a Complete Line of Coronary Diagnostic Catheters

Featuring two exclusive tip shapes for transradial access Terumo Interventional Systems announces the launch of Optitorque™, its new line of coronary diagnostic catheters, featuring the exclusive Tiger and Jacky tip shapes designed and cleared specifically for transradial procedures. “The Optitorque catheters, specially designed for radial approach, will help to generalize the radial technique by reducing the learning curve,” said Dr. Ramon Quesada, Medical Director of Interventional Cardiology at Miami Baptist Cardiac & Vascular Institute. With a simple clockwise or counter-clockwise rotation, the Tiger and Jacky tip shapes enable angiography of both the right coronary artery (RCA) and left (LCA) with one catheter. This eliminates the catheter exchange step and can potentially shorten procedure and fluoroscopic time. “These Optitorque catheters are valuable tools for the transradial approach. They can be used for left coronary artery, right coronary artery and left ventricle (LV). So, the need for the exchange of catheters is greatly reduced ... They are great tools and make radial cardiac catheterization easier,” said Tak Kwan, MD, FACC Associate Clinical Professor of Medicine, Senior Associate Director of Cardiac Catheterization Laboratory and Interventional Cardiology Beth Israel Medical Center. The Optitorque has double-braided stainless steel mesh middle layer for (1:1) torque control and a large lumen for high flow of contrast. For more information, customers can contact Terumo Interventional Systems by calling its Inside Sales Customer Care Team at 800-862-4143 or by visiting www.terumois.com. ________________________________

New Performance Measures Refine Tools for Improving Care of Heart Attack Patients

A new set of clinical performance measures will help physicians and hospitals give the best possible care to heart attack patients by providing up-to-date tools for gauging how closely they’re sticking to guideline recommendations and where they need to improve. Jointly developed by the American College of Cardiology and the American Heart Association, the performance measures appear in the December 9, 2008, issue of the Journal of the American College of Cardiology and the December 9, 2008, issue of Circulation. They identify some of the most important steps in helping patients return to a healthy life after surviving a heart attack — steps that sometimes are missed even by well-intentioned physicians. “We all do our best for our patients. Performance measures are extraordinarily important in helping us learn how well we are doing and in providing targets for improving quality,” said Harlan M. Krumholz, MD, chair of the writing committee that developed the heart attack performance measures and a professor of medicine at Yale University, New Haven, CT. “They guide us to areas of opportunity where we can do better — and our patients benefit from that.” The new performance measures have been endorsed by the American Academy of Family Physicians, American College of Emergency Physicians, American Association of Cardiovascular and Pulmonary Rehabilitation, Society of Hospital Medicine, and Society for Cardiovascular Angiography and Interventions. They update a previous version published in 2006. Performance measures are derived from clinical guidelines but serve a different purpose. Clinical guidelines make recommendations that physicians should consider when managing patients, and describe how strong the evidence is to support each recommendation. Performance measures distill from the guidelines key therapies that so clearly improve patient outcomes they literally define high-quality care. “A performance measure is more than a recommendation. It’s a mandate. It defines high-quality care and sets the expectation that doctors should either treat patients according to the best evidence, or explain why not,” Dr. Krumholz said. In addition, performance measures must be quantifiable, so that data can be collected in a reliable way. Performance measures also identify areas where there is likely to be room for improvement in the quality of care. Hospitals and physicians can begin using the new performance measures to benchmark the quality of heart attack care in several areas, including: • The prescription of statins before patients are discharged from the hospital. The previous performance measures were more general, calling for “lipid lowering therapy.” The new performance measures acknowledge that the evidence for benefit is primarily related to statins. • The timeliness of percutaneous coronary intervention (PCI) when the patient must be transferred from a hospital without a cardiac catheterization laboratory to a PCI-capable hospital. Previous performance measures did not track transferred heart attack patients. The new performance measures call for collecting data not only on how much time elapses from arrival at the first hospital to departure to the second hospital, but also from arrival at the first hospital to PCI at the second hospital. • Referral to a cardiac rehabilitation program. Studies have shown that cardiac rehab markedly improves survival after a heart attack, but only about one in three patients participate in such programs. The new performance measures call for hospitals to track referral to such programs. It is hoped these data may also shed light on the obstacles to referral. • Elimination of a performance measure on treatment with beta blockers within 24 hours of hospitalization for a heart attack. New scientific evidence has made the clinical decision to give or withhold beta blockers more complex, thereby making measurement difficult. • Evaluation of left ventricular systolic function, during hospitalization. This measurement is essential for subsequent decisions about care. • Several “test” performance measures that are intended for internal use by hospitals and physicians, including evaluation of blood levels of low-density-lipoprotein (LDL, or so-called “bad”) cholesterol, dosage of several types of blood-thinning medications and prescription at hospital discharge of clopidogrel. As in their previous version, the new performance measures continue to track use of aspirin therapy, both at hospital arrival and as a discharge medication; beta blocker prescription at discharge; prescription of an angiotensin-converting-enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) at discharge for patients with reduced pump function; time to delivery of clot-busting medications or PCI (in patients who are not transferred to another hospital); and counseling to stop smoking. “We have made a commitment to continually update, refine, and improve these performance measures, so that they represent the very best and most recent science,” Dr. Krumholz said. “We want to ensure that what we are measuring is meaningful and relevant and is going to make a difference for patients.”
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