June 2004

June 2004
June 2004

Abbott Vascular Devices Launches Perclose® ProGlide Next Generation Suture-Mediated Vessel Closure System

Abbott Vascular Devices, a division of Abbott Laboratories, announced the launch of the next generation Perclose® suture-mediated vessel closure system, Perclose ProGlide, featuring polypropylene monofilament suture. The device received approval from the U.S. Food and Drug Administration (FDA) during the first quarter of 2004. Perclose closure devices are designed to close femoral artery puncture sites following diagnostic or interventional procedures.

With monofilament suture, the ProGlide knot advances to the opening in the artery, allowing a single operator to deliver a pre-tied knot to close the access site in the femoral artery following a catheterization procedure. This stitch provides rapid hemostasis and allows patients to recover comfortably by providing the ability to get out of bed in a shorter amount of time. Monofilament suture is also a preferred suture for vascular surgeons due to its high-knotted tensile strength and minimized tissue reaction.

Additional features on Perclose ProGlide include the QuickCut mechanism, which is built into the device to trim the suture after deployment, making it unnecessary to use additional sharps during the procedure. The trimmer facilitates both suture trimming and knot advancement, eliminating a potentially time-consuming step in the vessel closure procedure for many operators. ProGlide also features numbered procedure deployment steps that are printed on the device.

In addition, the FDA approved new product labeling for Perclose ProGlide that states there are no reaccess/repuncture restrictions if previous arteriotomy repairs were achieved with a Perclose suture-mediated closure device. This product labeling for Abbott Vascular Devices’ Perclose closure products allows physicians to perform repeat procedures using the same access site immediately.

Abbott Vascular Devices has also begun offering a Continuing Education Unit (CEU) course for nurses and technologists. The course, titled Building a Pathway for Better Patient Outcomes, focuses on the importance of proper access site management in catheter-based procedures and is available as either a one- or four-credit course. More information is available on this educational course by visiting www.abbottvasculardevices.com.

American Heart Association research indicates that more than 61 million Americans have cardiovascular disease, and nearly 3 million cardiac catheterizations are conducted in the United States each year.

The Perclose ProGlide 6F Suture-Mediated Closure (SMC) System is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures using 5F to 8F sheaths. The Perclose ProGlide SMC System should only be used by physicians (or other health care professionals authorized by or under the direction of such physicians) who have been trained in the use of the Perclose ProGlide SMC System, e.g., participation in the Perclose ProGlide SMC System training program or equivalent.

Witt Biomedical Delivers New ECG Management System

Witt Biomedical Corporation has received clearance to market a new ECG management software program designed and targeted at hospitals that desire to combine electrocardiograms (ECGs) with an enterprise cardiac PACS solution as well as to clinics and physician offices that desire a scalable, cost-effective ECG management solution. Witt’s Calysto for ECG Management program combines original 12-lead ECG data with clinical/image data from the cath lab, echocardiography and nuclear medicine into a single cardiac record. For those who are interested in only an electronic paperless ECG review and archival, Calysto for ECG Management can be a cost-effective solution.

Calysto ECG Management provides a non-proprietary method of obtaining original ECG patient data and interpretive statements that are imported directly from vendor neutral host ECG carts and automatically integrated with all other information within the electronic patient record. The new program allows for a solution to the retrieval and review of ECG data on a single or dual monitor workstation.

With the new Calysto for ECG Management program, the physician opens the locator window on his/her PC monitor, sets the modality filter to compile his/her patients’ ECGs, reviews the interpretive statements and clicks the confirm button, if there are no changes. The word Confirmed automatically appears in the upper right hand corner of the screen.

Dual Screen mode allows physicians simultaneous review and analysis, and a Historical Comparison viewing mode offers immediate review of current, as well as previous ECG studies. Post processing analysis features provide additional tools such as electronic calipers for performing or recalculating measurements. In printing ECGs, Calysto ECG Management provides for standard 12-lead format as well as different user configurations and final reports, delivered to the work areas where you need them. Automated Word Transcription with unlimited report templates permits report generation for those that desire a full report.

When combined with Witt’s WebDV feature, ECG Management offers anytime/anywhere access as convenient as the nearest PC. Authorized users are able to access ECGs, cardiology images, data and reports, with a standard browser and web server.

Witt’s ECG Management program is fully compatible with HIPAA security and privacy standards.

Nanobac Life Sciences Announces Positive Results of its Nanobacterial Antibody Test For Coronary Artery Disease

Simple Blood Test Shows Correlation with Coronary Artery Calcification

Nanobac Life Sciences, Inc. announced positive results from an epidemiological research study demonstrating the strong correlation between the presence of antibodies to nanobacteria and coronary artery calcification (CAC) in asymptomatic individuals.

Results showed that the Nanobac IgG test, which detects the presence of antibodies to nanobacteria, demonstrated a statistically significant correlation (p=0.017) with high CAC scores (75th percentile) in asymptomatic patients. After adjustment for the established risk factors of CAD such as gender, smoking status, hypercholesterolemia, hypertension, family history of CAD, and levels of C-Reactive Protein (CRP), the IgG test was found to be an independent predictor of CAC.

The study, entitled Nanobacterial Epidemiology, Inflammatory Markers and Coronary Artery Calcification in Asymptomatic Presumed Normal Patients, was conducted by Stephen E. Epstein, MD, Director of the Cardiovascular Research Institute, Washington Hospital Center, Washington, DC, and associate Dr. Jianhui Zhu. It was carried out in a cohort of 198 patients screened for the presence or absence of coronary calcifications using Electron Beam Computed Tomography. They were also previously analyzed for markers of coronary artery disease (CAD).

Nanobacterium sanguineum (nanobacteria) is the smallest self-replicating organism ever detected at 50 to 500 billionths of a meter, 1/1000th the size of the smallest previously known bacteria. Nanobacteria have been implicated in a variety of human diseases associated with pathological calcification.

Nanobacteria were first discovered in 1988 by a Finnish researcher, and Nanobac OY co-Founder Olavi Kajander, MD, PhD, Neva Ciftcioglu, PhD joined his team in 1991. Their research established that the blood-borne nanobacteria forms slow-growing calcified colonies in arteries and organs. Dr. Kajander participated in the current study.

Nanobac has identified two biomarkers of nanobacterial infection. These tests are being developed as the NB2 test, which is composed of the nanobacteria antigen test, and the nanobacteria IgG antibody test. The Nanobac IgG test is designed to measure the body’s immune response to the nanobacterial infection. The Company is in the final stages of development of the nanobacteria antigen test. For more information, please visit www.nanobaclabs.com.

Bypass Beats Angioplasty in Risky Patients

Seriously ill heart disease patients do better if they get bypass operations than if they have angioplasty. Patients who received the bypasses were half as likely to die within five years as those who got angioplasty, researchers report.

The sicker the patient, the more bypass surgery helped, said Dr. Sorin Brener, an assistant professor of medicine at the Cleveland Clinic Foundation in Ohio.

The findings were somewhat surprising, Brener said. Even when the angioplasty patients got stents and glycoprotein IIb/IIIa drugs, bypass surgery saved more lives.

Brener and his colleagues examined survival records for 5,161 patients who had bypass surgery and 872 who had angioplasty at the Cleveland Clinic. About half the patients in both groups had diabetes or significant left ventricular dysfunction. Overall, the survival rates looked similar at first. Then the researchers factored in individual risk characteristics such as high blood pressure, smoking and diabetes.

Mortality rates for patients who underwent surgical bypass were almost half the rate of those treated with angioplasty who had similar cardiovascular risk profiles, said Brener.

Mennen Medical Group Announces Acquisition by Nektop Ltd.

Mennen Medical Group, which includes Mennen Medical Ltd. based in Israel, Mennen Medical Corp. based in the USA and Charter Kontron Ltd. based in the UK, was purchased on April 1, 2004 by Nektop Ltd.

Mennen’s beginning goes back to 1963, developing ECG telemetry for the United States Space Agency, later to become NASA. Mennen’s cath lab was introduced in 1994.

Nektop is a part of global business group (holding company) with interests in the medical industry, distribution, real estate, retail, and media/publishing. Today, Mennen Medical produces two patient monitoring product lines. The cath lab line includes: the Horizon 9000WS and soon-to-be-released new Horizon SE system series of Hemodynamic Patient Monitoring Systems, and the Clinibase Data Management System. Mennen’s Physiological Patient Monitoring line includes: the Envoy Patient Monitor, and the Ensemble Central Station. For more information on Mennen Medical visit their website at: mennenmedical.com.

Boston Scientific Announces Results for the Peripheral Cutting Balloon Microsurgical Dilatation Device

Boston Scientific Corp. announced the results from the Cutting EDGE clinical trial for its Peripheral Cutting Balloon Device. The device uses microsurgical blades mounted on the surface of a non-compliant balloon for scoring the lesion, dilating the target lesion at lower pressures, and achieving precise dilatation.

Cutting EDGE Principal Investigator Thomas Vesely, MD, of the Washington University School of Medicine in St. Louis, MO, presented trial data at the 29th Annual Scientific Meeting of the Society of Interventional Radiology (SIR). Dr. Vesely stated that the primary objectives of the Cutting EDGE clinical trial were to compare the Peripheral Cutting Balloon Device to conventional percutaneous transluminal angioplasty (PTA) in terms of safety, efficacy and additional characteristics for the treatment of hemodialysis-related stenoses.

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