Clinical and Industry News

Action Products, Inc. Recognized in Imaging Study

In a newly published research poster, Action® OR overlays were found to successfully manage patient positional pain during interventional CT procedures lasting 45 minutes or longer, without impacting image quality. The poster abstract, titled, “Improving Patient Care by Managing Positional Pain During Interventional Computerized Tomography (CT) Procedures,” focused on non-pharmacological solutions for positional pain reported by patients during long procedures. Typical CT scans require patients to lie on a concave, hard surface designed for fast scanning versus patient comfort. Action overlays were selected because they are radiolucent, low-maintenance, will not bottom out, and are recognized for positive pressure management, as cited in AORN best practices and standards 2008. Christiana Care Health Systems is located in Newark, DE and is in the process of working toward magnet status. A copy of the poster is located on the Action Products website; visit www.actionproducts.com for more information. _________________________

St. Jude Medical and GE Healthcare Announce Worldwide Market Launch of Wireless Integrated FFR Solution

St. Jude Medical, Inc. and GE Healthcare announced the worldwide commercial launch of the first fully integrated wireless solution for the measurement of fractional flow reserve (FFR). The new FFR solution, seamlessly integrated into existing cath lab infrastructure, will enable physicians and cath lab staff immediate access to FFR measurement without time-consuming setup. The solution is based on the PressureWire® Aeris technology and an FFR upgrade package available for the XT and XTi system configurations of GE’s Mac-Lab® hemodynamic recording system. PressureWire Aeris was developed and marketed by Radi Medical Systems, which was acquired in December 2008 by St. Jude Medical and is now part of the company’s cardiovascular division. The Mac-Lab FFR upgrade utilizes existing cath lab infrastructure, including screens, input modules and controls, and together with the PressureWire Aeris technology forms a seamlessly integrated FFR measurement system for greatly improved cath lab workflow and ease of use. “The PressureWire Aeris system represents a true paradigm shift in our thinking about the accessibility of FFR,” said Augusto Pichard, MD, professor of medicine, cardiology, and director of cardiac cath labs, Washington Hospital Center, Washington, D.C. “The integration with our existing GE hemodynamic recording system means that traditional limitations of FFR measurements, including utilizing a standalone machine for calculation, are removed.” With all FFR results integrated into the existing physiological information archive, this new system documents the hemodynamic severity of coronary lesions, as measured by FFR, together with other procedural data and angiographic imagery, creating a more complete patient record. The Mac-Lab FFR solution is available as an upgrade path to all existing GE Mac-Lab installations worldwide, as well as new installations. Fractional flow reserve (FFR) is an index determining the functional severity of narrowings in the coronary vasculature and it is measured by PressureWire Aeris. FFR specifically identifies which individual coronary narrowing is responsible for ischemia. The landmark trial FAME (Fractional flow reserve (FFR) vs. Angiography in Multivessel Evaluation), published in the Jan. 15 issue of the New England Journal of Medicine, demonstrated a statistically significant 30 percent difference in major adverse cardiac events (MACE) such as death, myocardial infarction and repeat revascularization. The randomized, prospective, multi-center trial looked at 1,005 patients with multi-vessel coronary artery disease 12 months after receiving a stent and compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography. The FAME study, in which pressure guidewires from Radi Medical Systems were exclusively used, also showed that FFR measurement is cost-saving and does not add time to the procedure. _________________________

Healing Heart Attack Victims, One Cell at a Time

By using the amount of carbon 14 in the atmosphere from above-ground nuclear testing in the 1950s and 1960, researchers have determined that cells in the human heart develop into adulthood. But as humans age, the percentage of new heart cells decreases markedly. By age 25, renewal of heart cells gradually decrease from 1 percent turning over annually to .45 percent by the age of 75. About 50 percent of the heart cells a human is born with will regenerate during a lifetime. Myocardial damage often results in chronic heart failure because of the loss and insufficient regeneration of heart cells. But this new finding may mean that patients who have suffered myocardial damage as a result of a heart attack may have some good news. Lawrence Livermore National Laboratory scientist Bruce Buchholz, with colleagues from the Karolinska Institute, Université Claude Bernard Lyon, Lund University and Lund University Hospital, found that cells in a human heart can develop into adulthood and the age of heart cells is, on average, six years younger than the individual. Using the Laboratory’s Center for Accelerator Mass Spectrometry, Buchholz measured the amount of carbon 14 in DNA to establish the age of caridiomyocytes (cardiac muscle cells) in humans. Carbon 14 atmospheric concentration levels remained relatively stable until the Cold War, when above-ground nuclear bomb tests caused a sharp increase, or peak, which decreased slowly after the end of above-ground testing in 1963. This spike in carbon 14 in the atmosphere serves as a chronometer of the past 55 years. Because DNA is stable after a cell has gone through its last cell division, the concentration of carbon 14 in DNA serves as a date mark for when a cell was born and can be used to date cells in humans. The team determined the ages of heart cells by determining the time at which the sample’s carbon 14 concentration corresponded to the atmospheric concentration. Buchholz found that people born around or after the nuclear bomb tests corresponded to atmospheric concentrations several years after the subjects’ birth, indicating substantial postnatal DNA syntheses. “By analyzing individuals born at different times before 1955, it is possible to establish the age up to which DNA synthesis occurs, or whether it continues beyond that age,” Buchholz said. In the study, carbon 14 concentrations were elevated in subjects compared to those people born up to 22 years before the beginning of nuclear bomb tests. “DNA of myocardial cells is synthesized many years after birth, indicating that cells in the human heart do, in fact, renew into adulthood,” Buchholz said. “At the age of 50, 55 percent of the heart’s cells remain from the time around birth and 45 percent have been generated later.” Cardiac muscles have a striated appearance and their contraction in the heart propels blood from the atria and ventricles to the blood vessels of the circulatory system. The limited recovery in humans after a heart injury, such as a heart attack, demonstrates failing regeneration of heart cells. But the team concluded that the renewal of heart cells, as indicated by the mixing of carbon 14 in the DNA, suggest that the development of pharmacological strategies to stimulate this process may be a rational alternative or complement to cell transplantation strategies for heart cell replacement. The research appears in the April 3 edition of the journal Science. Founded in 1952, Lawrence Livermore National Laboratory has a mission to ensure national security and to apply science and technology to the important issues of our time. Lawrence Livermore National Laboratory is managed by Lawrence Livermore National Security, LLC, for the U.S. Department of Energy’s National Nuclear Security Administration. _________________________

Invatec Announces Strategic U.S. Distribution Agreement with Cardiovascular Systems, Inc.

Invatec has entered into a strategic distribution agreement with Cardiovascular Systems, Inc., a medical device company focused on developing and commercializing interventional treatment systems for vascular disease. Under the terms of the agreement, CSI will distribute Invatec’s FDA-cleared percutaneous transluminal angioplasty (PTA) balloon catheter product line. The CSI and Invatec sales forces will partner in selling the Amphirion Deep™ 0.014-inch PTA balloon catheter line, which is the first dedicated below-the-knee PTA catheter, as well as the Submarine Plus™ 0.018-inch PTA balloon catheter and the Admiral Xtreme™ 0.035-inch PTA balloon catheter lines. Invatec will continue to sell and market its other interventional products, such as its thrombus management catheter, the Diver CE™ and the FiberNet® embolic protection system. Invatec and CSI share a vested interest in the market of peripheral intervention technology and both are developers of solutions that treat critical limb ischemia (CLI) and other peripheral procedures. For more information, visit www.invatec.us. _________________________

FDA Approves Abiomed’s New AB Portable Driver for Patient Transport, Mobility, Ambulation

Abiomed Inc. said the FDA cleared its AB Portable driver to facilitate intra-facility patient transport, patient mobility for participation in physical and rehabilitation therapies, independent ambulation by the patient, and inter-hospital transport via aircraft or ambulance. The company said its new AB Portable driver offers a reliable cardiovascular support system, providing full bi-ventricular assist device (Bi-VAD) functionality. The new driver is designed to enhance the clinical utility of the Abiomed AB5000 Ventricle by increasing mobility and versatility without compromising performance. The device is said to be a powerful, self-contained driver to assist the sickest patients, offering hemodynamic support directly from the operating room up through the weaning process without additional computers or docking stations, which are required with current portable consoles. The AB Portable driver requires low-maintenance intervals of approximately every 5,000 hours or up to seven months of operation, which is estimated to be three times longer than existing portable consoles, the company said. “Patients on full BiVAD support for heart recovery often require mobility and transport in order to provide a comprehensive assessment for a next stage of therapy,” said Mark Anderson, MD, department of cardiothoracic surgery, Robert Wood Johnson University Hospital. “The AB Portable driver is lightweight and compact and the quietest portable Bi-VAD console on the market, yet still provides that full level of Bi-VAD support from the minute you leave the surgery suite.” The device has compact architecture that enables easy handling and transport. The driver is 25 percent smaller and 15 percent lighter than current portable consoles on the market, allowing easier independent patient ambulation, in-hospital transfer or land/air transportation, the company said. Abiomed said the device offers quiet operation with minimal disruption to the patient and their environment. The portable driver is 50 percent quieter than current portable consoles on the market, maintaining a more unobtrusive operation and providing minimal distractions for patients and caregivers. An advanced power system that offers smart battery management can operate up to 10 hours without recharging and includes an integrated battery-gauge display that offers the user real-time battery status displayed in hours and minutes. The AB Portable driver is the only U.S. approved portable console to provide this essential feature. Separate from the PMA supplement, Abiomed received conditional IDE approval from the FDA in May 2008 to conduct a U.S. patient discharge study with the AB Portable Driver at 20 hospitals for 30 patients. The VOYAGER I clinical study aims to evaluate the safety and performance of the AB Portable Driver System in combination with the AB5000 Ventricle in the outpatient environment. Of the eighteen U.S. hospital sites that have submitted for IRB review, eight hospitals have received IRB approval and are open for enrollment in the VOYAGER I trial. For more information, please visit www.abiomed.com. _________________________

Abbott Initiates U.S. Study of Absolute Pro™ Peripheral Stent System for Iliac Artery Disease

MOBILITY trial showcases endovascular treatment options Abbott announced the initiation of MOBILITY, a clinical trial studying the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in patients with iliac artery disease. The first patient was enrolled into the MOBILITY trial by John Campbell, MD, assistant professor of surgery and medicine, West Virginia University School of Medicine, Charleston Division, at the Charleston Area Medical Center in Charleston, WV. “Iliac artery occlusive disease has the potential not only to have a significant impact on a patient’s ability to carry on daily activities, but it also can be an early sign of plaque buildup in other parts of the body,” said Manish Mehta, MD, MPH, FACS, director of Endovascular Services, The Vascular Institute for Health and Disease, Albany Medical Center in Albany, N.Y., and co-principal investigator of the MOBILITY trial. “The lower extremity discomfort and fatigue with walking and exercise caused by this debilitating disease can tremendously impact a patient's overall quality of life, making it critical to find effective treatments. Data from the MOBILITY trial will be an important addition to iliac stenting research.” “As medical technology has advanced, iliac stenting has become an excellent first-line interventional treatment option for patients, as it is less invasive than surgery and has the potential to improve patient outcomes,” said Tony S. Das, MD, FACC, director, Peripheral Vascular Interventions, Cardiology Section, Presbyterian Heart Institute in Dallas, TX, and co-principal investigator of the MOBILITY trial. The MOBILITY trial is designed to study 150 patients at up to 50 centers in the United States. The primary endpoint is a composite measure of major adverse events (MAE) at nine months. MAE is defined as death due to any cause, myocardial infarction, clinically driven target lesion revascularization and limb loss (amputation only) on the treated side(s). Abbott’s Absolute Pro peripheral stent is a self-expanding nitinol stent with a flexible and conformable design that is intended to keep lesions open without introducing more metal than necessary to treat a narrowing. The peripheral stent delivery system is compatible with 0.035” (0.89 mm) guide wires. The Absolute Pro Peripheral Self-Expanding Stent is currently an investigational device in the United States for the treatment of iliac artery disease. _________________________

Court Rules that GE Healthcare Engaged in False Advertising Campaign against Bracco Diagnostics

GE Healthcare permanently enjoined; ordered to implement corrective actions and pay Bracco $11.4 million Bracco Diagnostics Inc. announced that the United States District Court in Trenton, New Jersey has ruled in favor of Bracco and against GE Healthcare in a false advertising case. The ruling validates Bracco’s position that GE Healthcare and its predecessor companies, including Amersham, engaged in a false and misleading advertising and promotional campaign in an attempt to make false claims that its x-ray contrast agent Visipaque™ was superior to Bracco’s x-ray contrast agent Isovue®. In its ruling, the Court found GE Healthcare liable for disseminating false messages in its advertising of Visipaque. The litigation is primarily related to a clinical study that was published in 2003 by the New England Journal of Medicine (the NEPHRIC study) comparing two GE Healthcare products: Visipaque and Omnipaque®. While the study only compared these two GE Healthcare products, GE Healthcare misrepresented the study in an attempt to claim that Visipaque was safer than other products that were not included in the study, including Bracco's Isovue. In addition, independent studies, Bracco studies and GE Healthcare’s own clinical research demonstrated the inappropriateness of GE Healthcare’s false claims. As a result of GE Healthcare's misconduct, the Court permanently enjoined GE Healthcare from making further false claims and ordered them to implement a number of corrective actions, including a press release and advertisements, to ensure that healthcare providers are correctly informed about the false claims. The Court also ordered GE Healthcare to pay Bracco $11.4 million in damages. Carlo Medici, President and CEO of Bracco Diagnostics, stated, “Today’s ruling highlights the importance of conducting pharmaceutical marketing in an ethically responsible manner and accurately presenting the results of clinical research to healthcare providers to ensure the best patient care. We are pleased that the Court has demanded that GE Healthcare disclose the truth to healthcare professionals, many of whom have paid a significant premium for Visipaque over many years as a result of false statements that Visipaque was superior to Isovue.” In its ruling, the Court stated the following: “Here, the Court is the fact-finder, and has found that GEH’s [GE Healthcare] conduct is in violation of the Lanham Act; accordingly, Bracco has demonstrated actual success of the merits and in turn, irreparable injury.” “Finally, it is well within the public interest for this Court to enjoin GEH from disseminating false messages regarding Visipaque.” “In connection with Bracco's claim, the Court finds that an injunction and damages for post and future corrective advertising are appropriate remedies to prevent future violations of the Lanham Act.” The Court has ordered GE Healthcare to take a series of corrective actions within 60 days, including, but not limited to: • Be permanently enjoined from making false claims about the comparative safety profile of Visipaque; • Issue a press release that would also be posted on its website on the Court's decision; • Issue corrective advertisements; • Re-train its sales and marketing staff in accordance with the Court’s decision; • When citing studies in its advertising, plainly identify which studies the findings relate to and refer to the comparator drugs by either their brand or scientific names. GE Healthcare had also filed a counterclaim against Bracco, but the Judge granted GE Healthcare no relief whatsoever. This litigation was originally filed in December 2003. The 39-day trial, taking place from May to December of 2007 and including the testimony of seven contrast agent experts, 34 other witnesses and the entry into evidence of over 1400 exhibits, was one of the most comprehensive examinations of false advertising claims in legal history. For more information, visit www.braccoimaging.com. _________________________

MSU Researcher Links Cholesterol Crystals to Cardiovascular Attacks

For the first time ever, a Michigan State University researcher has shown cholesterol crystals can disrupt plaque in a patient’s cardiovascular system, causing a heart attack or stroke. The findings by a team led by George Abela, chief of the cardiology division in MSU’s College of Human Medicine, could dramatically shift the way doctors and researchers approach cardiovascular attacks. Abela’s findings appear in the April issue of the American Journal of Cardiology. “Any time there is something completely new or unique in medical research, it is met with healthy skepticism,” said Abela, who has been working with cholesterol crystals since 2001. “But we have found something that can help dramatically change how we treat heart disease.” What Abela and his team found is that as cholesterol builds up along the wall of an artery, it crystallizes from a liquid to a solid state and then expands. “As the cholesterol crystallizes, two things can happen,” Abela said. “If it’s a big pool of cholesterol, it will expand, causing the ‘cap’ of the deposit to tear off in the arterial wall. Or the crystals, which are sharp, needle-like structures, poke their way through the cap covering the cholesterol deposit, like nails through wood.” The crystals then work their way into the bloodstream. It is the presence of this material, as well as damage to an artery, that disrupts plaque and puts the body’s natural defense mechanism — clotting — into action. Abela and his team studied coronary arteries and carotid plaques from patients who died of heart attacks. When comparing their findings against a control group, they found evidence of cholesterol crystals disrupting plaque. The breakthrough in discovering the crystals’ impact came after Abela and colleagues found a new way to preserve tissue after an autopsy, using a vacuum dry method instead of an alcohol solution. The previous method would dissolve the crystals and prevent researchers and doctors from seeing the impact. Abela also has found that cholesterol crystals released in the bloodstream during a heart attack or stroke can damage artery linings much further away from the site of the attack, leaving survivors at even greater risk. The research means health care providers now have another weapon in their arsenal against cardiovascular disease. “So far, treatments have not been focused on this process,” Abela said. “Now we have a target to attack with the various novel approaches. In the past, we’ve treated the various stages that lead to this final stage, rather than preventing or treating this final stage of the condition.” In separate research published in the March edition of medical journal Atherosclerosis, Abela and colleagues looked at the physical triggers that can cause cholesterol crystallization. They found that physical conditions such as temperature can play a role in how quickly cholesterol crystallizes and potentially causes a rupture. _________________________

Siemens Demonstrates Flash Speed, Lowest Dose at ACC 2009

Siemens Healthcare demonstrates fast speed and low dose for cardiac applications with the Somatom Definition Flash dual source computed tomography (CT) scanner at the 58th Annual Scientific Session of the American College of Cardiology (ACC) from March 29-31 in Orlando, FL. “The Somatom Definition Flash requires only a fraction of the radiation dose that systems previously required to scan even the tiniest anatomical details faster than ever before,” said Kulin Hemani, vice president, CT, Siemens Medical Solutions USA, Inc. “Scanning the thorax, including the heart, can be done in only 0.6 seconds, taking the burden of breath-holding off the patient and allowing functional imaging for body regions up to 48 cm.” Temporal resolution of 75 ms and scan speed of up to 43 cm/s make heart-scanning possible, with dose levels below 1 millisievert (mSv), whereas the average effective dose required for this purpose usually ranges from 8 mSv to 40 mSv. The patient is moved through the CT scanner more than twice as fast as with any conventional system, and at the same time, requiring a much lower radiation dose than conventional scans. In comparison, the x-ray radiation that the average person is exposed to each year from natural sources amounts to 2 mSv to 5 mSv. The dose values of the new Siemens CT scanner lie far below those of an intracardiac catheter examination, thus opening up possibilities for using CT scanners for routine cardiological examinations. A scan of the entire heart can be performed in only 250 milliseconds, which is less than half a heartbeat. In addition, it is possible for physicians to reliably display a heart with a fast pulse or an irregular heartbeat without using beta blockers, thus simplifying the workflow and yielding clinical and financial advantages. The Somatom Definition Flash is the only CT scanner on the market that enables the use of noninvasive cardiological diagnostic techniques as routine applications at the lowest possible radiation exposure levels. The second generation of Dual Energy imaging will introduce a new imaging quality. The contrast in CT scans will be increased without having to apply the higher radiation dose previously required. This is achieved via a new, selective photon shield which blocks unnecessary parts of the energy spectrum. It thereby provides improved separation of the two simultaneous scans with low and high photon energy, without causing a higher radiation exposure than would result from an individual, conventional CT examination with only one energy source. Thus, the Somatom Definition Flash can always provide a double contrast which, for the first time ever, can also be used to classify the chemical composition of tissues via a CT scan in routine daily work. Another technical development for keeping the patient’s radiation exposure as low as possible is the X-Care application. For the first time ever, this application selectively reduces the radiation exposure of dose-sensitive anatomical regions, such as the female breast. This is done by switching the x-ray tube assemblies off during the rotation phase in which the anatomical regions concerned are most directly exposed to radiation. In this way, it is possible to reduce the radiation exposure of individual anatomical regions by up to 40 percent. Furthermore, an adaptive dose shield blocks irrelevant prespiral and postspiral radiation with dynamic diaphragms, thus ensuring that only a minimum and clinically essential radiation exposure occurs. This enables an additional 25 percent reduction of the dose required for routine examinations. The Care Dose4D software, which analyzes the individual cross-sectional anatomy in real time and adapts the emitted x-ray dose accordingly, also helps to reduce radiation exposure. In addition, Siemens CT Acute Care Engine provides a complete clinical portfolio for imaging emergency patients from head to toe. Using fast, direct 3D reconstruction, images can be reviewed before the patient is off the table. For more information, visit www.siemens.com/healthcare.

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