Clinical and Industry News

Boston Scientific Launches Cardiovascular Patch with Low Porosity Boston Scientific Corporation announced the worldwide launch of its Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch for vascular or cardiac patch grafting. With 50% improved porosity over the Company’s existing Hemashield Finesse® Patch, the Hemashield Platinum Finesse Patch provides excellent hemostasis, or a reduced amount of bleeding after closing the incision. The patch is tapered and pre-trimmed for greater efficiency and it conforms to the host vessel for improved handling. It is designed to produce excellent results for physicians by combining a thin profile with a high degree of suture strength. The result is a patch designed for a smooth, secure closure with sutures that will remain intact, even at the edge of the patch. Pamlab, LLC Announces New Strength Foltx® Pamlab, LLC introduced a new strength Foltx® with 2mg Cyanocobalamin, 2.5mg Folacin and 25mg Pyridoxine per tablet, that will improve the safety and efficacy of the product. The new formulation of Foltx, with 2mg of vitamin B12, has been improved to meet the need for vitamin B12 deficiency and patients diagnosed with hyperhomocysteinemia (elevated homocysteine levels). The change addresses vitamin B12 deficiency as a significant health problem, particularly among the elderly. More than one million Americans over the age of 65 have or will develop pernicious anemia; and approximately 40% of elderly Americans have sub-clinical vitamin B12 deficiency. Additionally, various medical drugs and medical procedures have been identified to substantially impair vitamin B12 absorption. Because folic acid masks the symptoms of vitamin B12 deficiency, it is important for clinicians to be aware of this serious condition, which can lead to irreversible anemia and neurological disorders. The risk of vitamin B12 deficiency may be accentuated by the increasing use of folic acid and the recent fortification of U.S. grains. With its improved strength, Pamlab has formulated Foltx to manage patients with hyperhomocysteinemia who may also be at risk for vitamin B12 deficiency. InfiMed Launches New PlatinumOne Cardiac System InfiMed has introduced the newest members of their Cardiology product portfolio: the PlatinumOne Cardiac, PlatinumOne Combo and PlatinumOne EP systems. The PlatinumOne Cardiac is an in-room digital acquisition system. The system has new advanced image processing features, expanded DICOM 3.0 interface, and enhanced image quality using InfiMed’s newly designed CCD camera system. The PlatinumOne Combo system adds real-time Digital Subtraction for interventional vascular procedures as well as full cardiac functionality. The PlatinumOne EP system is designed to provide advanced imaging features and low dose pulsed fluoroscopic acquisition required for complex electrophysiology procedures. Clinical trials of the Cardiac and Combo systems were performed at Bay Area Heart Center in St. Petersburg, Florida and Scripps Green Hospital in San Diego, California. Anna Orr, Administrator at Bay Area commented, The PlatinumOne Cardiac has made a huge difference in our imaging, as well as our patient care. We are extremely impressed with the image quality and simplicity of the system. Dr. Tierstein, Director of Cardiology at Scripps Green added, Since we’ve upgraded our cath lab to a PlatinumOne Cardiac, we’ve seen dramatic improvement in image quality and our staff finds it very easy to use. It’s a great improvement over the GoldOne system! The PlatinumOne Cardiac system offers more clinically advanced features with a lower radiation dose. Some of these features include: Left Ventricular Analysis (LVA) and Quantitative Coronary Analysis (QCA) which allow results to be saved as photo files for ease of archive and review; customizable doctor preferences that allow each clinician to select their own settings for Cine/Spot/Fluoro acquisition and review; and thumbnail displays on the main screen which allow for quick identification of available images. The user interface is straightforward in design and operation, keeping user input to a minimum, and allowing for concentration on the procedure at hand. Companies Team Up to Offer Turn-key Outpatient Cardiac Cath Lab Configuration Witt Biomedical Corporation and Omega Medical Imaging Inc., have recently announced a cooperative alliance to deliver a turn-key solution for customers seeking to build their own private practice outpatient cardiac catheterization lab or cath/angio swing lab. Partnered with number one-ranked Witt Biomedical (MDBuyline Review, 6-14-04) for physiomonitoring/information systems for the cath lab, Omega and Witt will begin a new collaborative effort. Professionals considering maximizing their business potential while providing the utmost in quality outpatient care can be assisted with the many consultative, business and financing resources available from both companies through this alliance. Since 1990, Omega Medical Imaging has focused on the design, development and manufacturing of digital cardiovascular imaging systems. System reliability and consistent diagnostic performance are the hallmark characteristics of their commitment to quality. Now, with a preferred agreement with Witt Biomedical to offer Calysto Series IV, Omega Medical Imaging delivers a total cath lab configuration. Series IV is part of the Calysto for Cardiology family of products and collects physiological and information data from the cath lab procedure creating an electronic record for review, reporting and long-term archival. Additional optional modalities including Image management, ECG management, Echocardiography and Nuclear Medicine that can also be included as part of the archive and review capabilities and reported into a single cardiac record. Omega’s co-founder and CEO, Robert Lindquist said, The fundamental goal is to fill a need in the cardiology and medical imaging marketplace to provide a product fundamental in design, high quality in performance and significantly more cost-effective than systems currently available. Both Witt and Omega have long demonstrated the ability to do that effectively. Mike Wolfe, President of Witt Biomedical, added, It is a perfect business solution for any facility that is currently considering this patient care service and desires a turn-key package. The cardiology community recognizes Witt as providing intuitive, well engineered solutions with this kind of workflow management at a competitive price and we are pleased to be associated with Omega in offering our products that specifically address a rapidly growing market need. New Movable C-arm From Siemens Receives FDA Clearance The Angiography and X-ray Division of Siemens Medical Solutions has received marketing clearance from the U.S. Food and Drug Administration (FDA) for the new Axiom Artis U, a moveable, digital C-arm imaging system. The system, which offers four times more generator power than any mobile C-arm system on the market, is intended to support a wide variety of examinations including angiographic interventions, cardiac interventions and surgical procedures. In order to accommodate space limitations encountered at many facilities, the Axiom Artis U was designed with a small footprint. The system design provides the combination of a fixed generator, a high-capacity X-ray tube, and the flexibility of a movable C-arm. The technology is better able to penetrate dense tissue, and it also can provide longer fluoroscopy times without overheating. Additionally, the Axiom Artis incorporates C.A.R.E. (Combined Application to Reduce Exposure) to reduce radiation exposure for both the physician and the patient. With C.A.R.E., a specialized X-ray filtration system automatically adjusts to the density of the region of interest without using additional radiation. The Axiom Artis U can be configured with up to 30 frames per second acquisition for cardiac applications as well as subtracted imaging for body interventional and peripheral procedures. Additionally, the system provides image management capabilities to meet the needs of any information technology department for seamless integration. The flexible system configuration makes it possible to operate from within the control room or directly at the tableside. The system is equipped with syngo®, Siemens’ standard user interface for imaging equipment. Syngo helps to further optimize workflow in radiology units while using full DICOM capabilities to support clinical image data management. New Treatment Guidelines Cite ReoPro® Favorably for PCI in Acute MI Patients New guidelines issued by the American College of Cardiology and the American Heart Association are in favor of using ReoPro® (abciximab) in ST-Elevation Myocardial Infarction (STEMI) patients who undergo percutaneous coronary intervention. Abciximab, a glycoprotein IIb/IIIa inhibitor, is indicated for adjunctive use with PCI for the prevention of cardiac ischemic complications in patients undergoing this procedure. The last revision of the guidelines related to the treatment of patients with acute heart attacks was in 1999. Abciximab received the Class IIa, level of evidence B recommendation in the new guidelines, meaning that the treatment is useful/effective but may have some conflicting evidence from a clinical trial. The guidelines are in favor of starting treatment with abciximab as early as possible before primary PCI (with or without stenting) in patients with STEMI. Dosing and administration instructions for abciximab indicate that it should be administered 10-60 minutes before the start of PCI. For 10th Consecutive Year, Cleveland Clinic Heart Center Ranked Nation’s Best The Cleveland Clinic Heart Center celebrates a decade of being ranked as the nation's No. 1 cardiac care center with the release of U.S. News & World Report‘s 2004 America's Best Hospitals survey. The Cleveland Clinic has a extensive history of innovation in the treatment of heart disease. In 1956, surgeons at the Cleveland Clinic performed the worlds first stopped heart surgery, utilizing a heart-lung machine designed by Dr. Willem Kolff, who later invented the dialysis machine. In 1958, Dr. Mason Sones invented cardiac angiography, opening a new world of diagnosis and treatment of atherosclerotic disease. That same year saw the opening of the Clinic’s Constant Care Unit Heart Room, the first cardiac intensive care unit in the world. Coronary Artery Bypass Surgery, developed and refined at the Cleveland Clinic by Dr. Rene Favaloro beginning in 1968, has become the most common heart surgery in the world. In 1971, Dr. Floyd D. Loop, confirmed the superiority of the internal mammary artery over saphenous veins for coronary bypass. In 1973, Dr. Lon Castle established the section of Electrophysiology and Pacing, and Dr. Frederick Heupler developed the Ergonovine Malleate test for diagnosing coronary spasm. America’s first Department of Cardiothoracic Anesthesiology was founded by Dr. George Estafanous in 1976. The 1980’s saw remarkable achievements in cardiothoracic surgery at the Cleveland Clinic. Dr. Delos Toby Cosgrove, advances treatment of atherosclerotic and valve disease by developing mitral valve retractors, annuloplasty rings, and the cardiotomy autotransfusion system. Dr. Cosgrove has 19 medical surgical patents. In 1993, The Heart Center becomes the first hospital in the country to voluntarily release outcomes data and mortality statistics to the public, which is critical to quality improvement, cost-improvement, and patient choice. Eric Topol, MD, Chairman of Cardio-vascular Medicine, is the lead investigator for a number of pivotal research trials including GUSTO (acute MIw) and EPILOG (IIb/IIIa inhibitors). Over the last few years, Cleveland Clinic physicians and scientists have identified new cardiovascular disease risk factors and genetic markers. The Cleveland Clinic Heart Center has been a pioneer in the development of carotid artery stenting, treatment of congenital heart defects, and percutaneous valvular repair and replacement. With the new rankings, The Cleveland Clinic also continues its tradition of being recognized as one of the nation's best overall hospitals. For 2004, the hospital is ranked No. 4. In addition, the new survey ranks 16 Cleveland Clinic specialty care areas among the nation's best, with 10 of those areas ranked among the Top 10 in the United States. The ranking model used by U.S. News & World Report was devised and is conducted by the National Opinion Research Center, a social science research group at the University of Chicago. Rankings for 12 of the 17 specialties are based on a combination of factors including number of procedures performed, reputation and care-related factors, such as nursing. Rankings for five other specialties ophthalmology, pediatrics, psychiatry, rehabilitation and rheumatology are based on reputation alone. Devax Initiates First Drug-Coated Stent Clinical Trial for a Dedicated Bifurcated Coronary Stent System Devax Inc.announced the initiation of the Axxess Plus Clinical Study for the company’s Axxess Drug-Coated Stent System. The Axxess Stent System is the first bifurcated stent design to elute an anti-restenonic drug. The Axxess Plus Clinical Study is a multi-center trial to evaluate both the acute and long-term clinical utility of the Axxess Stent System for the treatment of bifurcated lesions in native coronary arteries. The first two patients in the trial were treated with the Axxess Stent System in two clinical centers in Germany. The Axxess Stent System was successfully implanted in both patients with no acute complications. Devax expects to add up to 15 international centers in the Axxess Plus Study over the next few months and complete patient enrollment by the end of 2004. All patients will receive six-month follow-up angiography to evaluate long-term outcomes. In the United States, in 2003 there were approximately 1 million percutaneous coronary interventions using about 1.5 million stents. Of these 1 million procedures, it is estimated that 15-20 percent or more involve lesions at a bifurcation. Standard stents currently used in this large patient group are not specifically designed or approved for use in bifurcations and result in restenosis rates significantly greater than those found in non-bifurcated coronary arteries, reportedly as high as 60 percent. The Devax Axxess technology is a patented, multi-component stent delivery system comprising self-expanding nitinol stents specifically engineered for the treatment of coronary and vascular bifurcation lesions. The system includes a conical stent that conforms to the bifurcation anatomy and provides full access to both side branches for additional interventional procedures. Devax has licensed the drug Biolimus A9 and a polymer coating from Occam International, an affiliate of Biosensors International. The Axxess Stent System with Biolimus A9 has successfully completed a series of pre-clinical tests. Blood Pressure Dives During Diabetics' Heart Attack People with diabetes are known to fare worse after a heart attack than people without diabetes. Now, new research suggests that this is because diabetics experience a greater drop in blood pressure when the coronary vessels are blocked during an attack. Finnish cardiologists, led by Dr. K. E. Juhani Airaksinen from the University of Turku, compared the blood pressure response in 238 non-diabetic and 32 diabetic patients during angioplasty. The investigators report that patients with diabetes developed seriously low blood pressure nearly three times as often as non-diabetic patients. Women were also more likely than men to experience low blood pressure during coronary blockage. Airaksinen said, This may increase the risk of sudden death during the early minutes of (an attack) in diabetics.

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