Clinical and Industry News

Vascular Solutions introduces the SmartNeedle^® Vascular Access System Vascular Solutions, Inc. recently acquired the SmartNeedle^® Vascular Access system. The SmartNeedle system consists of a hand-held monitor and one-time use needles designed to provide auditory ultrasound guided access to arteries and veins during catheterization procedures. The SmartNeedle monitor is a re-usable, hand-held device that transmits a continuous wave Doppler signal, providing continuous auditory feedback to help locate and access the artery or vein quickly and with confidence. If desired, the monitor can be covered with a disposable sterile bag for use in the sterile field. Sterile, single-use SmartNeedles range from 18G to 24G, with bare tip and sheathed IV options. Bare-tipped needles are available in 18G, 20G and 22G sizes, and consist of a detachable Doppler probe that is housed within the lumen of a standard sized introducer needle. IV sheathed needles, used when attempting to access a vessel with the intent of leaving a small catheter in place, are available in 20G, 22G, 24G and 26G sizes. Acquired by Vascular Solutions from Escalon Medical in May 2010, the SmartNeedle system was formerly known as the pdAccess Doppler guided needle access system. Moving forward, Vascular Solutions will use solely the name SmartNeedle. SmartNeedle products are available in the United States and Europe. For more information, visit www. vascularsolutions.com.

Atrium and Kaneka Launch Xpress-Way^™ RX Extraction Catheter in the U.S.

Atrium Medical Corporation and Kaneka Corporation are proud to announce the introduction of the Xpress-Way^™ RX Extraction Catheter. Xpress-Way RX recently received FDA 510k clearance and is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The Xpress-Way RX manual extraction catheter is manufactured by Kaneka Corporation (Osaka, Japan) and Atrium Medical Corporation (Hudson, NH) is the exclusive distributor of the Xpress-Way RX in the U.S. The Xpress-Way RX Extraction Catheter is an ultra low-profile manual aspiration system designed for the removal of fresh, soft emboli, and thrombi in both coronary and peripheral vessels. Xpress-Way RX incorporates a removable stylet and has been designed with enhanced pushability, anti-kinking, trackability, and crossability. Outside the United States, the Xpress-Way RX is marketed as the Thrombuster II (Kaneka Corporation, Osaka, Japan). For more information, please visit Atrium’s website at www.atriummed.com.

Some Heart Attack Rates Declining and Survival Improving

Coronary syndromes vary in severity, ranging from unstable angina, non-ST segment elevation myocardial infarction (NSTEMI), to ST-segment elevation myocardial infarction (STEMI), the most severe diagnosis. Little data exist about changing trends in acute myocardial infarction and whether death rates are increasing or decreasing. In a study published in the January 2011 issue of The American Journal of Medicine, investigators found that STEMI rates decreased and one-year post-discharge death rates decreased in both NSTEMI and STEMI patients. “The results of this study demonstrate recent decreases in the magnitude of STEMI, slight increases in the incidence rates of NSTEMI, and decreases in long-term mortality in patients with STEMI and NSTEMI,” commented lead investigator, David D. McManus, MD, FACC, Departments of Quantitative Health Sciences and Medicine, Division of Cardiovascular Medicine, University of Massachusetts Medical School, Worcester. “Our findings suggest that acute myocardial infarction prevention and treatment efforts have resulted in favorable decreases in the frequency of STEMI and death rates from the major types of acute myocardial infarction.” Using data from the Worcester Heart Attack Study, an ongoing population-based investigation examining long-term trends in the incidence rates, in-hospital, and post-discharge case fatality rates (CFRs) of greater Worcester, Massachusetts, researchers examined the medical records of 5,383 patients hospitalized for either STEMI or NSTEMI between 1997 and 2005 at 11 greater Worcester medical centers. Trained physicians and nurses abstracted demographic and clinical data, including the patient’s age, sex, and, medical history (including previous MI events). Information about the use of important cardiac medications, coronary angiography, percutaneous coronary interventions (PCI), and coronary artery bypass graft surgery was also collected. Any records of various clinical complications during hospitalization were noted. Survival status after hospital discharge was determined through a review of medical records and search of death certificates. Some form of follow up after hospital discharge was obtained for more than 99% of discharged patients. The incidence rates per 100,000 population of STEMI decreased from 121 to 77 between 1997 and 2005. A significant increase in the NSTEMI incidence rates occurred in 2001, after which point NSTEMI incidence rates decreased. Overall, there was a slight increase in the incidence rates of NSTEMI between 1997 and 2005. There were notable differences in treatment utilization trends. A greater increase in the hospital use of beta-blockers was noted among patients with NSTEMI, whereas a greater increase in the use of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, cardiac catheterization, and PCI was noted in patients with STEMI. Encouraging declines in 1-year death rates were observed for patients with STEMI or NSTEMI. The odds of dying during the first year after hospital discharge decreased steadily among patients with STEMI between 1997 and 2005. By 2005, the odds of dying within 1 year after discharge was 50% lower among STEMI patients in comparison with those admitted in 1997; a non-significant and inconsistent trend toward lower odds of dying within 1 year of hospitalization was noted among patients with NSTEMI. Dr. McManus stated, “Mortality from NSTEMI remained significantly higher than STEMI at both 30 days and 1 year. The higher long-term death rates observed in patients discharged after NSTEMI may have resulted from the fact that patients with NSTEMI were in general older and had a greater burden of cardiovascular co-morbidities. Under-utilization of effective cardiac medications and PCI, as well as greater delays in the time to receipt of PCI in patients with NSTEMI, may also have contributed to differences in the post-discharge death rates observed in these patients.” He continued, “Increased attention needs to be directed to secondary prevention practices in the hospital and post-discharge management of patients hospitalized with NSTEMI because the proportion of NSTEMI patients receiving effective cardiac therapies lags behind those with STEMI.” Source: McManus DD, Gore J, Yarzebski J, et al. Recent trends in the incidence, treatment, and outcomes of patients with STEMI and NSTEMI. Am J Med 2011 Jan;124(1):40-47.

New Heart Attack Warning Sign Uncovered

A protein fragment has been identified that when detected in the blood can be a predictor of heart attack. Published in the January 11 issue of the Journal of the American College of Cardiology, researchers found heart attack patients had elevated levels of the protein fragment known as Caspase-3 p17 in their blood. “We’ve discovered a new biomarker for heart attack, and showed that apoptosis, or a particular kind of cell death, is a cause of heart muscle damage,” says Dr. Bruce Liang, director of the Pat and Jim Calhoun Cardiology Center at the University of Connecticut Health Center. “The ability to see a heart attack coming with a simple blood test and to develop new therapies to block apoptosis would enable us to get a head start on treatment and preserve crucial heart muscle and cardiac function.” “This test can work in patients but has not met regulatory requirements for clinical application in patients suspected of having a heart attack,” Liang says. “If it is successfully applied one day, it would mean another way to diagnose heart attack and the possible development of new treatments.” Source: Agosto M, Azrin M, Singh K, et al. Serum Caspase-3 p17 fragment is elevated in patients with ST-segment elevation myocardial infarction. A novel observation. J Am Coll Cardiol 2011 Jan 11;57(2):220-221.

Vascular Solutions Introduces the SuperCross^™ Microcatheter

Vascular Solutions, Inc. announces the immediate availability of the SuperCross^™ microcatheter. The SuperCross offers crossability, flexibility, and exceptional guidewire support during coronary and peripheral catheterization procedures. The SuperCross is 0.014” guidewire compatible and is available in 130cm or 150cm lengths. The distal 40cm has a hydrophilic coating, reducing friction during deployment, and the catheter tapers to 1.8F at the distal tip, for navigating small, tortuous vessels and crossing tight lesions. A full length stainless steel braid provides flexibility, pushability, and kink resistance. The SuperCross’ internal PTFE liner provides superb guidewire movement and the tapered inner lumen a smooth transition during wire delivery for optimal guidewire control. The fully embedded gold marker band on the distal tip delivers brilliant radiopacity, enabling precise device placement. The SuperCross is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature, and it may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents. The sterile, single-use SuperCross microcatheter is available in the United States and Europe. For more information, visit vascularsolutions.com.

Corindus Vascular Robotics Announces FDA Conditional Approval for Pivotal Study to Evaluate Robotic-Assisted Placement of Coronary Guidewires and Stent/Balloon Catheters

Corindus Vascular Robotics, a developer of precision vascular robotics, announced it has been granted Food and Drug Administration (FDA) conditional Investigational Device Exemption (IDE) approval to evaluate the safety and effectiveness of its CorPath® 200 System in delivering and manipulating coronary guidewires and stent/balloon systems in percutaneous coronary interventions (PCI) procedures. With this approval, Corindus is authorized to begin its pivotal trial, CorPath PRECISE (Percutaneous Robotic-Enhanced Coronary Intervention Study). The trial is a prospective, single-arm, multi-center, study, which will initially enroll 154 patients. The CorPath 200 System allows for controlled robotic-assisted placement of coronary guidewires and stent/balloon catheters from an ergonomically optimized interventional cockpit. The lead-lined cockpit protects the operator from radiation exposure. The comfortable seated position in front of the “slaved” monitors provides enhanced visualization of the angiography screen while reducing fatigue and minimizes head, neck and back strain. While the clinical endpoint of the trial is the ability to treat the patient without the incidence of major adverse cardiovascular events (MACE), the trial will be closely monitoring the radiation exposure of interventional cardiologist. “Improving precision of PCI procedures and the ergonomic conditions of the cath lab will ultimately improve patient procedures,” said Joseph P. Carrozza, Jr., MD, co-principal investigator and Chief of Cardiovascular Medicine at St. Elizabeth’s Medical Center in Boston. “The CorPath System allows interventional cardiologists to operate in a comfortable environment, completely focused on the patient’s physiology. The ergonomically optimized cockpit enhances visualization, while minimizing fatigue, radiation exposure and other occupational hazards, such as back strain.” The first procedures in the trial are targeted for early 2011. More information is available at www.corindus.com. NOTE: The CorPath 200 System is an investigational device and limited by federal law to investigational use only.