Clinical and Industry News

KLAS Ranks Witt Biomedical Number One for Hemodynamics and Clinical Reporting KLAS, an independent research firm specializing in monitoring and reporting performance of healthcare information technology vendors, announced that Witt Biomedical has achieved Number One status for the highly coveted KLAS Award for the market segments Hemodynamics and Clinical Reporting for October 2005. Witt’s number one ranking was published in the October 2005 KLAS Cardiology IT Report: Hemodynamics & Clinical Reporting. This report is a compilation of data gathered from websites, healthcare industry reports, and interviews with healthcare provider executives and managers, as well as interviews with vendor and consultant organizations. Performance measurements in 40 indicators, technology overviews, client win/loss and pricing provide the basis of the provider experience. "In a fragmented cardiology market, Witt has demonstrated its ability to keep customers happy. Nowhere is this more evident than in the hemodynamic monitoring market, where Witt holds a significant satisfaction advantage over competitors, stated KLAS Vice President of Operations Adam Gale. According to Witt Biomedical Vice President of Marketing and National Accounts Ruth Hurley, Our Calysto for Cardiology enterprise solution is renowned for its user-friendly and comprehensive qualities, so this distinguished recognition is truly an honor. Witt Biomedical President Mike Wolfe added, This recognition is a reflection of our loyal and growing customer base. More than 900 customers worldwide utilize our Series IV® physiomonitoring and information system for millions of procedures annually. The KLAS number one ranking for hemodynamics and cardiology reporting was announced on the heels of another distinguished honor for Witt. Frost & Sullivan’s recent analysis, U.S. Cardiology Picture Archiving & Communications Systems (PACS) Markets, selected Witt Biomedical as the recipient of the 2005 Award for Customer Service Leadership for its superior customer service and support and clear customer loyalty. Yes, our recognition may be growing these days, noted Hurley. But we’re not resting on our laurels in terms of service or technology. Now more than ever, we’re focused on delivering innovative solutions and services to meet the changing needs of the cardiology enterprise. B Vitamins to Lower Homocysteine May Prevent Strokes The B vitamin group, including folic acid, B6, and B12, reduce the amount of the amino acid homocysteine in the blood. High levels of this substance have been linked to heart disease. A previous study by the Vitamin Intervention for Stroke Prevention (VISP) group, based in Canada and the U.S., suggested that taking a combination of B9, B6 and B12 did not reduce recurrent stroke and cardiac events. However, work carried out since then suggested to the team that their initial trial included patients who were not likely to benefit from the treatment. In a new analysis, they excluded patients with low and very high B12 levels at baseline. These were likely to have B12 malabsorption or to be taking B12 supplements outside the study. Patients with significant renal impairment were also excluded as they were unlikely to respond to vitamin therapy. In the remaining 2155 patients, high-dose vitamin supplements reduced recurrent stroke, death and heart disease by 21 per cent compared with those taking low-dose vitamins. When they subdivided patients by baseline levels of vitamin B12, thus identifying those with difficulties absorbing the vitamin, the differences between the low-dose and high-dose groups became greater. The researchers suggest that given the fortification of flour with folate, the response to vitamin therapy for lowering homocysteine largely depends on B12 levels of heart patients. Higher doses of B12 could be required to reduce homocysteine, and thus to reduce stroke and heart attack. Source: Stroke Kensey Nash Announces Enrollment Completion of ASPIRE Study for New TriActiv® FX Embolic Protection System Kensey Nash Corporation announced it has completed enrollment in the ASPIRE (Angioplasty in SVGs with Post Intervention Removal of Embolic Debris) Study for the new TriActiv® FX System. ASPIRE is a multi-center, prospective registry, designed to support regulatory clearance of the TriActiv FX System in the U.S. for a saphenous vein graft (SVG) indication. The Company expects to submit a 510(k) application to the U.S. Food and Drug Administration (FDA) for the new TriActiv FX System within 90 days. The TriActiv FX System incorporates several important ease-of-use design enhancements to the TriActiv System platform. These include a new balloon inflator that simplifies catheter exchanges during the procedure, and a new flush catheter design to enhance device usage and reduce procedure time. "We were very impressed by the performance of this new device, particularly in challenging cases," commented Dr. Chris Metzger, co-Principal Investigator of the Study, about the TriActiv FX System. "I am a believer in balloon protection as the best solution for protecting the microvasculature from all potentially dangerous emboli during interventions. This new system with its innovative inflation system dramatically improves ease of use and will facilitate its adoption in our practices," he concluded. The Co-Principal Investigators of the ASPIRE Study are Drs. Christopher Metzger, Wellmont Holston Valley Medical Center, Kingsport, TN and Joseph Carrozza, Beth Israel Deaconess Medical Center, Boston, MA. Approximately 20 centers participated in the study, which enrolled over 100 patients. The TriActiv System is currently indicated to prevent heart attacks during the interventional treatment of saphenous vein grafts (SVGs) in patients who previously received coronary bypass surgery, but now have blockages in the grafts. The device incorporates three important features to address the common problem of distal embolization a protection balloon guidewire that creates a protected space, a flush catheter that washes the graft, and an automated extraction system that removes the debris found in the graft. These three features work in combination to prevent the debris found in the graft from embolizing. The TriActiv ProGuard System is a new version of the System that is being studied in the carotid anatomy. Kensey Nash Announces Commencement of Carotid Trial in Europe Using the TriActiv® ProGuard System U.S. Study to Start by the end of November Kensey Nash Corporation has commenced a trial of the new version of the TriActiv® Embolic Protection System for carotid stenting procedures in a European Pilot study. The study will support a CE Mark application, expected in 2006, for use of the TriActiv Embolic Protection System during carotid stenting procedures. The trial is utilizing the Company's newest version of the TriActiv System product line, which incorporates Local Flush and eXtraction (LFX) technology designed for use in branched arteries, such as those of the carotid blood vessels. The TriActiv ProGuard System incorporates three features designed to reduce the incidence of embolic stroke during carotid stenting procedures a balloon protection guidewire, a flush catheter, and an automated extraction system to remove debris. The system will be studied and can be used in combination with any approved stent on the marketplace. Prof. Horst Sievert, MD, CardioVascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany is serving as principal investigator for the European study. Prof. Dr. Sievert commented, "In one of my very first cases with the device, we navigated extremely tortuous anatomy and used the system to prevent significant debris from adversely impacting the patient. Embolic protection is such an essential aspect of successful carotid stenting procedures and physicians require an easy-to-use and clinically effective device. The TriActiv(R) System's combination of balloon protection, flushing and automated extraction in one device may provide a useful alternative for us and a comprehensive solution to our challenges," he concluded. Prof. Dr. Sievert performed two of his initial three cases in front of a live audience at the world’s largest congress dedicated to carotid stenting, his 5th International Course on Carotid Angioplasty and other Cerebrovascular Interventions (ICCA) in Germany, which highlighted new technologies and methods used in carotid stenting. The U.S. Food and Drug Administration (FDA) has approved KNC’s IDE submission to commence a similar feasibility study in the U.S. The carotid study in the U.S. is scheduled to start in November 2005. The TriActiv System is currently indicated to prevent heart attacks during the treatment of saphenous vein grafts (SVGs) in patients who previously received coronary bypass surgery, but now have blockages in the grafts. The TriActiv FX System, the second generation of the TriActiv System, is commercialized in Europe and has been studied in the 100-patient ASPIRE Study registry to support clearance in the U.S. Evalve Announces Intiation of Trial of Percutaneous Alternative to Open-Heart Mitral Valve Surgery Evalve, Inc. announced the successful initiation of the study Endovascular Valve Edge-to-Edge REpair STudy (EVEREST) II, a randomized, multi-center study designed to demonstrate the safety and efficacy of its MitraClip percutaneous valve repair system for patients with mitral regurgitation (MR). EVEREST II will compare the MitraClip technique to standard surgical mitral valve repair or replacement in patients with functional or degenerative MR. Approximately 30 medical centers across North America will be participating in the study. To qualify for the EVEREST II trial, patients must have moderate to severe or severe mitral regurgitation and be experiencing symptoms; or, lacking these symptoms, they must have a weakened left ventricle. The Phase II study is being conducted under a United States Food and Drug Administration (FDA) approved Investigational Device Exemption. Positive long-term follow-up results from the company’s initial clinical study, EVEREST I, were also presented at the TCT. The EVEREST I feasibility study has enrolled 47 patients with moderately severe or severe mitral regurgitation who were experiencing symptoms or had a weakened left ventricle. Only four percent of the 47 patients enrolled experienced a significant adverse event at 30 days. The first 27 patients treated have reached one-year follow-up. Ninety-three percent of those patients who experienced a significant reduction in MR at one month following treatment have maintained that improvement at one year. While all patients required surgery prior to the MitraClip procedure, 75 percent of those who received a clip remain free from surgery. The MitraClip demonstrated it could reduce MR severity from moderate-severe or severe to moderate or lower. Importantly, the MR reduction achieved at 30 days is maintained at one year in 93% of patients and 74% of all patients treated have avoided open heart surgery. This is a very exciting study because the only option currently available for patients with moderate to severe MR is open-heart surgery, said EVEREST principal investigator Ted Feldman, MD, director of the cardiac catheterization lab at Evanston Hospital in Evanston, IL. These initial results are very encouraging in that not only did we observe a reduction in MR at six months, but the durability of the repair has held up in those patients who have completed 12-month follow up. Early-Phase Data Show Prasugrel Demonstrates More Consistent Platelet Inhibition Compared to Clopidogrel Eli Lilly and Company and Sankyo Co., Ltd. announced data results at the TCT from three early-phase, cross-over studies demonstrating that all subjects responded to prasugrel, an investigational antiplatelet agent, while 22 to 43 percent of the same subjects did not respond to clopidogrel (Plavix®), as measured by objectively defined parameters for inhibition of platelet aggregation. Prasugrel is an investigational antiplatelet agent designed to prevent platelet activation and aggregation by blocking adenosine diphosphate receptors on the platelet surface. Eli Lilly and Sankyo Co., Ltd. are developing prasugrel as a potential treatment for patients who have suffered a heart attack or unstable angina. Recent studies suggest that a relationship may exist between a poor platelet response to antiplatelet agents in individual patients and poor clinical outcomes, which manifest as major adverse cardiovascular events, including heart attacks. The pooled analysis, Clopidogrel Nonresponders: A Comparison With Prasugrel (CS-747, LY640315), a Novel Thienopyridine P2Y12 Receptor Antagonist, is based on the results of three, single-center, two-way cross-over clinical pharmacology studies. One hundred and twelve healthy volunteers aged 18-65 years old were randomized to receive either a 60 mg loading dose of prasugrel or the approved 300 mg loading dose of clopidogrel in a 2-way cross-over design. Adenosine diphosphate (ADP) was used to induce platelet aggregation in samples of subjects’ blood. Inhibition of platelet aggregation (IPA) and the change in maximum platelet aggregation (MPA) from baseline were evaluated at both 4-5 and 24 hours after the medication was administered. Nonresponders were objectively defined as subjects achieving less than 25 percent IPA or a difference of less than 20 percent in MPA in response to 5 µM adenosine diphosphate (ADP), and less than 20 percent IPA or a difference of less than 15 percent in MPA in response to 20 µM ADP. These thresholds represent levels of platelet inhibition that are more consistent with a placebo than that of an active antiplatelet agent. All subjects responded effectively to a loading dose of prasugrel 60 mg. However, when the same subjects were administered 300 mg of clopidogrel, 22 percent were nonresponders based on IPA in response to 5 µM ADP (p<.001 and="" percent="" were="" nonresponders="" based="" on="" ipa="" in="" response="" to="" adp="" a="" phase="" iii="" clinical="" study="" with="" prasugrel="" triton-timi="" is="" underway.="" this="" head-to-head="" will="" compare="" the="" effects="" of="" clopidogrel="" up="" patients="" acute="" coronary="" syndrome="" who="" suffer="" heart="" attack="" or="" have="" unstable="" angina="" are="" undergo="" pci.="" primary="" focus="" two="" agents="" ability="" prevent="" stroke="" death="" secondary="" look="" at="" impact="" bleeding="" hospitalization="" for="" recurrent="" ischemia="" need="" urgent="" target="" revascularization.="" it="" anticipated="" that="" triton="" timi-38="" should="" be="" completed="" early="" regulatory="" submissions="" follow="" second="" half="">CoreValve’s ReValving System Used Instead of Open-Heart Surgery to Non-Surgically Implant a New Aortic Bioprosthesis Over the Diseased Heart Valve CoreValve announced that its second-generation, proprietary aortic heart valve was implanted successfully in a high-risk patient using CoreValve’s percutaneous ReValving System during the opening session at the TCT. Eberhard Grube, MD, chief of cardiology at The Heart Center, Siegburg, Germany, and a consulting professor of medicine at Stanford University, and Jean-Claude Laborde, MD, an interventional cardiologist at Clinique Pasteur in Toulouse, France, performed the ReValving procedure in the cath lab at The Heart Center. As a result, their patient was able to avoid open-heart surgery to treat a defective aortic heart valve. CoreValve’s proprietary delivery system for percutaneous heart valve replacement is based on a catheter-and-self-expanding-frame approach on a beating heart, thus avoiding open-heart surgery. The CoreValve procedure with the proprietary CoreValve Percutaneous ReValving System can be performed in a cardiac cath lab just like angioplasty and stenting, resulting in less trauma to the patient and substantial cost-savings to the healthcare system. The live ReValving procedure at TCT used CoreValve’s own proprietary porcine pericardium aortic heart valve, delivered via CoreValve’s small 21-French-sized catheter, and required less than 15 minutes to be implanted. Siemens Unveils Computed Tomography System: Dual Source CT Siemens Medical Solutions has unveiled the world’s first dual source computed tomography (CT) system, the Somatom Definition, which is faster than every beating heart and capable of imaging full cardiac detail with as much as 50 percent less radiation exposure compared to traditional CT scans. The Somatom Definition is faster than any existing CT technology. This dual source CT system uses two X-ray sources and two detectors at the same time, compared to all other CT systems that use only one source and detector. With 0.33 seconds per rotation, electrocardiogram- (ECG) synchronized imaging can be performed with 83-millisecond temporal resolution, independent of the heart rate, resulting in motion-free cardiac images. Featuring a 31-inch (78-cm) bore opening and a 79-inch (200-cm) scan range, the Somatom Definition increases patient comfort and access, allowing clinicians to image more of the body in less time. It is equipped with z-Sharp Technology, the Straton® X-ray tube and Care solutions. The first Somatom Definition was installed at the University of Erlangen (Germany) in October 2005 and is being used for technical and clinical research as well as regular patient care. Siemens’ newest CT system provides valuable clinical information for patients presenting in our department with acute chest pain and suspicion of coronary artery disease, said Dr. Stephan Achenbach, associate professor of Cardiology, University of Erlangen. The first U.S. installations will take place in early 2006 and will include Mayo Clinic, Rochester, MN; Cleveland Clinic Foundation, OH; William Beaumont Hospital, Royal Oak, MI; and New York University Medical Center.

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