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.

Cutting EDGE, a prospective, randomized, multi-center clinical trial, enrolled 340 patients* with stenosed or thrombosed hemodialysis grafts at 27 U.S. sites. 173 patients were randomized to the Peripheral Cutting Balloon Device; 167 were randomized to conventional angioplasty. For the combined treatment groups, the mean reference vessel diameter (RVD) was 6.5 mm with a mean 1.6 cm target lesion (TL) length. TLs were focal and non-angulated.

The study’s primary endpoint was TL primary patency through 6 months. The TL primary patency for the Peripheral Cutting Balloon Device group was 47.9 percent and for the PTA group 40.5 percent (p value=0.373).

TL primary patency at six months was comparable for the Peripheral Cutting Balloon Device compared to PTA, said Dr. Vesely. However, thrombosed grafts had a larger absolute difference (43.1% for Peripheral Cutting Balloon, 32.0% for PTA, p value=0.150), suggesting that there may be a greater benefit to patients with thrombosed dialysis grafts.

Through its mechanism of action, the Peripheral Cutting Balloon Device is able to dilate lesions at significantly lower mean pressures than conventional angioplasty. Additionally, there may be less pain associated with use of the device. At the time of the procedure, subjects were asked if they experienced any pain at the access site during balloon inflation. More subjects (67.6%) reported no pain among those treated with the Peripheral Cutting Balloon Device than among those treated with conventional angioplasty (56.3 percent, p value = 0.034).** For those subjects that reported pain, the severity of the pain reported was less in subjects treated with the Peripheral Cutting Balloon Device (p value = 0.003).

Data from this trial were used to support the Company’s 510(k) submission to the U.S. Food and Drug Administration to market the Peripheral Cutting Balloon device for percutaneous transluminal angioplasty of obstructive lesions of synthetic arteriovenous dialysis fistulae.

*Mean age, 62 years; 42% men; 58% African-American; 33% Caucasian; 9% Other; 195 had stenosed grafts; 145 had thrombosed grafts.

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Mr. Sheridan, 95, remained active in the catheter industry until age 90 and was a leading philanthropist to hospitals and medical schools. Mr. Sheridan founded or helped found four major medical catheter companies: United States Catheter and Instrument (now CR Bard), Sheridan Catheter and Instrument Corp., National Catheter Corp., and Sheridan Catheter. He held more than 50 medical instrument patents.

Forbes Magazine dubbed Mr. Sheridan Catheter King in 1988. David Sheridan is a throwback to an earlier age when a man without a formal education could tinker and invent his way to a fortune, as Edison or Ford did, Forbes said. Sheridan became a major force in development of the medical catheter. He pioneered processes to make catheters from extruded plastic cheaply enough to be disposable, which helps prevent infection.

Forbes quoted Mr. Sheridan as saying: I always figure that if it can be done, I can do it, and if I can’t do it, it can’t be done.

David Sheridan was born on July 10, 1908, in Brooklyn, the second of six sons of Adolf and Anna Sockolof, who immigrated to the United States from Russia. He changed his name from Sockolof to Sheridan in 1939. Mr. Sheridan attended school until 8th grade when he went to work with his father and brothers in the hardwood flooring business.

In 1939, Sheridan invested $35,000 from his hardwood flooring business in United States Catheter and Instrument Corporation, which he founded with Norman Jeckel.

In 1953, he founded his second company, Sheridan Catheter and Instrument Corp., in Argyle, and began to invent a variety of medical catheters.

In 1959, Sheridan Catheter and Instrument Corp. was sold to Brunswick Corp. (later Sherwood Medical). In 1967, Mr. Sheridan founded a third company, National Catheter Corp. (NCC). NCC was sold to Mallinckrodt, Inc., in 1974, and Mr. Sheridan continued his association with them until 1979.

Mr. Sheridan was 73 when he co-founded his last firm, Sheridan Catheter Corp. (SCC), again in Argyle, in 1982, with his son Ross and Isaac S. (Ike) Jackson, a co-inventor and associate.

Mr. Sheridan’s companies provided nearly 1,000 jobs to generations of women and men in Argyle and created an industry that grew to include six major medical instrument manufacturers employing 3,300 people.

Mr. Sheridan pioneered a plastic endotracheal tube used routinely in surgery. At 84, he was honored by the American Society of Anesthesiology as a pioneer and innovator in the field for developing the first cardiac catheters and the Saratoga Sump Drain and Salem Stomach Sump Drain.

Clinical Images Released from 64-Slice CT Scanner

Siemens Medical Solutions released clinical images acquired using a 64-slice computed tomography (CT) system (below). The images were acquired at the Friedrich-Alexander University Erlangen-Nuremberg, Germany. Developed by Siemens, the Somatom Sensation 64 can visualize small intracranial, pulmonary, mesenteric and peripheral vessels in less than ten seconds.

Cleared for the US market in April, the Somatom Sensation 64 provides 64-slice sub-millimeter imaging per rotation and gantry rotation time at 0.37 seconds. It is designed for cardiac, neurology and body imaging applications with a spatial resolution of 0.4 mm.

Acquisition of 64 slices per rotation is possible through the new Straton® x-ray tube’s Double z-Sampling technology, and new Siemens proprietary detector technology. Double z-Sampling allows two focal points in the anode by precise deflection of the electron beam, oscillating almost 5000 times per second, within the x-ray tube. This generates two overlapping beams to pass the scan field. The double readout of the detector produces 64 slice projections at down to half the thickness of a detector slice, thus increasing spatial resolution.

After completing a comprehensive testing phase at leading clinical institutions in the United States, Europe and Asia, the system will be commercially available in fall 2004.

Possis Medical’s Rapid Exchange Catheter Receives U.S. Coronary Labeling

Possis Medical, Inc. has received approval from the U.S. FDA to market the rapid exchange version of the XMI® Rheolytic Thrombectomy Catheter for coronary indications. The XMI-RX had previously been labeled for peripheral arterial use, and the new FDA approval came in response to the Company’s PMA supplement.

The Company also announced it has received CE mark approval, allowing coronary marketing of the product in the European community. Possis launched the new, CE-marked product at the Paris Course on Revascularization (PCR) in May.

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