Clinical and Industry News: Part 1

Datascope Interventional Announces the Launch of Safeguard 12 cm and the X-Site® Suture-mediated Vascular Closure Device Safeguard is now available in two sizes, 12 cm and 24 cm. Safeguard is a versatile access site management device that can be used anywhere pressure is required. Safeguard’s hands-free pressure simplifies management of access sites. It reduces demands on the staff and maximizes valuable resources. Safeguard does not require manual compression or ancillary equipment to deliver consistent hands-free pressure. Safeguard delivers adjustable, active pressure, anywhere pressure and time are required to maintain hemostasis. Introducing X-Site ^®, the newest innovation from Datascope Interventional. X-Site delivers secure and safe arterial closure following percutaneous catheterization procedures. X-Site was proven safe and effective in a randomized, prospective multi-center clinical trial including highly anti-coagulated interventional patients on GPIIb/IIIa inhibitors. X-Site provides definitive closure without mechanical feet or anchors that can cause intra-arterial trauma and patient discomfort. X-Site’s low profile design and suture delivery system allows immediate confirmation of suture placement prior to device removal. Doctor Cuts Wall Street Ties to Avoid Potential Conflict A Cleveland Clinic researcher has stopped working as a paid consultant for a Wall Street fund and has broken ties to many drug companies to avoid any potential conflicts of interest. Fortune magazine reported in December that Dr. Eric Topol, a critic of the arthritis drug Vioxx, was a paid consultant to a hedge fund that was betting against shares of Merck & Co., the drug’s maker. Topol said he didn’t know Great Point Partners’ Biomedical Value fund was short selling Merck and that he had no financial interest in the fund. He has since not only resigned from his role as consultant to the fund, but has left consultant positions with numerous other drug, diagnostics and medical device companies, including Eli Lilly. Topol said it’s important for him in his role as the clinic’s chief academic officer to avoid even the perception of a conflict of interest. Dealing with the conflicts is tricky. The best way is not to have any, he said. Doctors at the prestigious clinic and elsewhere increasingly face similar conflicts now that more medical research is being funded by private industry, said Mildred Cho, associate director of Stanford University’s Center for Biomedical Ethics. She said she respects Topol’s decision. I think it’s an appropriate response for someone like him as a clinical researcher, also as a person in a leadership position at a clinical research institution, Cho said. Dr. Catherine D. DeAngelis, editor in chief of the Journal of the American Medical Association, said physicians need to take back their profession by refusing to take money from for-profit companies. She advised Topol to sever his paid consultant positions. There’s only one way out: give it all up, she said. I really hope that other physicians and scientists look at him and say, ‘That’s what I should do.’ The clinic does not have a policy that prevents doctors from being paid for their consulting work. It is developing a policy advising doctors not to have relationships with investment firms. Another new policy will educate physicians about potential conflicts and ways of avoiding them. We don’t want to stifle researchers from doing good work. We have to do a better job of managing those conflicts, clinic spokeswoman Eileen Sheil said. Topol said that when physicians work with private companies it often leads to new drugs or technology that helps patients. He still plans to work with drug and medical device companies, but will not receive payment. At least one Cleveland Clinic doctor, cardiologist Steven Nissen, donates money he receives from for-profit companies to charity a heart health fund run by the American College of Cardiology. My own view is that ethics is a very personal matter and that every physician who is involved in research needs to make their own mind up, he said. This is a situation where I try to lead by example. Mennen Medical Receives FDA 510K for Horizon Angio Mennen Medical has received FDA clearance to market its Horizon Angio patient monitoring and documentation system to the interventional cardiology and radiology market. Horizon Angio is a computerized medical device that analyzes a full range of patient physiological parameters during interventional peripheral arterial analysis procedures, while performing a complete spectrum of monitoring functions. Specifically designed for the interventional cardiologist and radiologist, the system provides a cost-effective, efficient and convenient method to document and monitor all peripheral angiography procedures. Making the Horizon Angio a stand-out in the industry, its measurement and documentation capabilities include a full set of peripheral diagrams with visual stenosis depiction. These include head, neck, leg and arm right and left sides, carotid, trunk and renal diagrams. Statistical reporting, custom physician reports, ADT interfacing, HL7 and XML data exports are just a few of the extra tools available. Flowmedica Announces New Physician-Sponsored Study of its Benephit Infusion System in Patients with Renal Insufficiency Study to Focus on Benefits of Intra-Renal Drug Delivery FlowMedica, Inc., a medical device company developing intravascular systems for treating renal dysfunction related to cardiovascular diseases, announced Scripps Clinic’s initiation of a physician-directed clinical study of its FlowMedica Benephit Infusion System in patients with compromised kidney function who are undergoing coronary procedures. The Benephit Infusion System is a proprietary catheter-based infusion system for targeted renal therapy. The physician-sponsored, multi-center, randomized, placebo-controlled study is being coordinated by Scripps Clinic, La Jolla, Calif., under the direction of principal investigator Paul Teirstein, MD, director of interventional cardiology at Scripps Clinic. Eight to 10 centers will participate, enrolling 64 diabetic patients with compromised kidney function. These patients are at high risk of developing radiocontrast nephropathy (RCN). It is estimated that about half a million patients in the U.S. each year have known risk factors for this life-threatening condition. The study will evaluate the ability of the Benephit Infusion System to deliver fenoldopam selectively to the kidneys to preserve renal function as measured by serum creatinine levels. Although fenoldopam can increase blood flow to the kidneys and improve kidney function, its systemic use to prevent RCN is limited, since doses high enough to be effective are associated with hypotension. The study is designed to assess the effectiveness of escalating doses of fenoldopam delivered intra-renally by the Benephit System. This study builds on the success of an initial trial of the Benephit System in patients at a lesser risk for developing RCN, said Dr. Teirstein. In this case we will be evaluating high-risk patients to confirm that targeted intra-renal drug delivery can maximize the beneficial kidney effects of drugs while minimizing systemic side effects. According to a previous study conducted at Scripps Clinic and St. Joseph’s Medical Center in Stockton, Calif., the intra-renal delivery of fenoldopam via the Benephit Infusion System improved kidney function significantly; the intravenous administration of fenoldopam at the same dose improved kidney function only minimally. The study also showed that systemic drug levels were significantly less following intra-renal delivery of fenoldopam vs. intravenous treatment, leading to less blood pressure reduction. The results were reported in September 2004 at the Cardiovascular Research Foundation’s (CRF) Transcatheter Cardiovascular Therapeutics (TCT 2004). The FlowMedica Benephit Infusion System is a proprietary, selective infusion catheter system capable of delivering therapeutic agents directly to the renal arteries through a dedicated infusion catheter while enabling concurrent cardiovascular procedures through a single-vessel access site. The system consists of a proprietary Bifurcated Infusion Catheter and a unique Introducer Sheath. In January 2004, the system received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the infusion of physician-specified agents to the renal arteries. Philips Introduces the HD11 Ultrasound System Designed to Give Hospitals and Clinics Advanced Features on a Restricted Budget Royal Philips Electronics has introduced the first ultrasound system to provide ultrasound departments serving a diverse patient population and on a restricted budget with advanced high definition imaging and features in their price range. The Philips HD11 system offers many advanced features and multiple scanning configurations to support the broad needs of an end-referring institution. The improved diagnostic capabilities of the HD11 system result in improved diagnostic confidence for the physician, greater peace of mind for the patient, and potentially reduced medical costs, in part by reducing or eliminating the need for more expensive or invasive tests. Among its many standard features, the HD11 ultrasound system includes real-time SonoCT compound imaging with XRES technology; broadband beamforming; 3D, 4D and STIC imaging; Stress Echo; panoramic and contrast imaging; and full networking capabilities. In addition, the system features automation to improve workflow and reduce variability between exams, and the choice of more than 20 transducers for a wide variety of scanning needs. The HD11 allows us to scan across the full spectrum of exams from high-resolution breast imaging to deep abdominal-and do it well, said Heidi Clark, director of diagnostic imaging at the Derry Imaging Center in Derry, N.H. We often have to schedule different systems for different exam types. We found the HD11 gives us one system with great imaging that we can use for all our ultrasound exams. The core of the HD11 system is its high-definition imaging. Its digital broadband beamformer with beam steering capabilities and signal processing techniques, including Philips exclusive SonoCT real-time compound imaging with XRES technology, provide enhanced edges and margins for more sharply defined structures, reduced noise and speckle, and visibility and contrast resolution of even the smallest structures. The HD11 system also provides Philips iSCAN Intelligent Optimization technology to replace numerous fine-tuning steps on the control panel. Using one button, the system automatically samples digital data and adjusts multiple parameters to improve the image quality and help provide image consistency between exams. The ability to quickly scan for a variety of conditions is essential to meeting the imaging needs of a diverse imaging department. The HD11 platform empowers imaging departments to customize their system to their clinical environment and have up to five transducers connected at one time to increase efficiency and workflow. Optional features include Stress Echo, 4D, panoramic and contrast imaging, and STIC (Spatio-Temporal Imaging Correlation) imaging, which allows the perinatologist or obstetrician to view and assess fetal heart function in 3D. In addition, clinicians can customize their HD11 with specialized application requirements for breast, transesophageal, pediatric, vascular, musculoskeletal and more. More information on the Philips HD11 ultrasound system is available at: www.medical.philips.com/HD11 COX-2 Inhibitors Associated with Blood Pressure Elevation An analysis of 19 randomized controlled trials involving COX-2 inhibitors (selective cyclooxygenase-2 inhibitors) suggests that these agents raise blood pressure more than either conventional nonsteroidal anti-inflammatory drugs (NSAIDs) or placebo, according to a JAMA study. NSAIDs, among the most widely prescribed drugs for pain relief, are associated with gastrointestinal side effects. As a result there has been a significant preference to prescribe COX-2 inhibitors over conventional NSAIDs, even when patients do not meet specified criteria for treatment, according to background information in the article. Some COX-2 inhibitors have been associated with an increased risk of cardiovascular events. Tai-Juan Aw, MBBS, FRACP, Monash University, Melbourne, Australia, and colleagues, analyzed data from all 19 randomized controlled trials of COX-2 inhibitors published before May 2004, with a total of 45,451 participants for whom blood pressure data were available. The meta-analysis was designed to compare the relative risk of developing hypertension and of clinically important blood pressure elevation in study participants treated with COX-2 inhibitors versus those treated with NSAIDs or placebo. COX-2 inhibitors were associated with a blood pressure elevation compared with NSAIDs and placebos, the authors found. These blood pressure elevations may be clinically significant in relation to increased cardiovascular risk. The authors also saw differences between the COX-2 inhibitors. Rofecoxib appears to confer a greater risk of developing hypertension and clinically important elevations in both systolic and diastolic blood pressure compared with celecoxib, they stated. While COX-2 inhibitors have been considered to be a welcome therapeutic option for arthritis, the authors concluded, their potential (and differential) effect on blood pressure elevation requires caution in their use and warrants further investigation. Clinicians need to weigh the risks of improved gastrointestinal safety versus potential hazards of developing elevated blood pressure when considering the use of these agents, especially in the elderly population. Maxell Unveils New DVD-R Media for Medical Market New DVD media for imaging, compliance and archival applications Maxell Corporation of America announced new DVD media designed specifically for the medical market. Maxell’s new medical-grade media incorporates the Maxpro Hardcoat technology to produce DVD-R media that delivers data protection with up to twice the archival shelf life. Maxell Medical DVD-R is HIPAA- and DICOM-compliant, and with its scratch, dust and smudge resistance and extended archival life, is ideal for critical medical images, patient records, backup and fixed content storage. Maxell Medical DVD-R’s hardcoat top layer offers increased data longevity and protection for twice the archival and storage lifespan. Compared to conventional DVDs, Maxell Medical DVD-R is: 40 times more scratch-resistant 20 times more dust-resistant 20 percent more light-resistant Smudge- and fingerprint-repellent Maxell Medical DVD-R will have a capacity of 700 MB and will be able to store up to 700 X-rays or 550 high-resolution images. Maxell’s 700 MB, 8X speed Medical DVD-R media will be available in March as a single disc in a jewel case and in 50-pack spindles with printable white surfaces for either thermal or inkjet printers. St. Jude Medical Announces Agreement to Acquire Velocimed St. Jude Medical, Inc. announced it has signed a definitive agreement to acquire the business of Velocimed, LLC, a privately-owned company located in Maple Grove, Minnesota. Velocimed develops and manufactures specialty interventional cardiology devices. The first additional contingent payment contemplated under the agreement would be paid in March 2007. St. Jude Medical anticipates this acquisition will close in the second quarter of 2005. Velocimed was founded in 2001 to develop, manufacture and market specialty interventional cardiology devices. Velocimed has developed three product platforms: the Premere patent foramen ovale (PFO) closure system; the Proxis proximal embolic protection device; and the Venture guidewire control catheter for accessing difficult anatomy and crossing chronic total occlusions in interventional catheterization procedures. Velocimed’s shareholders include Warburg Pincus and the Vertical Group. Paul R. Buckman, president of the Company’s Cardiology Division, noted, In July 2004, St. Jude Medical announced the formation of the Cardiology Division. With this transaction, St. Jude Medical gains immediate access to three product platforms that serve growing segments of the interventional cardiology market and that we are particularly interested in bringing to our customers. The Premere PFO closure system already is approved in Europe. Efforts to initiate a U.S. clinical study of the Premere system under an investigational device exemption (IDE) are underway. The Proxis device has CE Mark approval for SVG use in Europe and is currently being evaluated in the United States in a clinical study under an approved IDE granted by the FDA. The Venture wire placement catheter has CE Mark approval in Europe and is ready for market release in the U.S. AEHA Releases 1st National Shape Guidelines The Association for Eradication of Heart Attack (AEHA) has released the 1st National SHAPE (Screening for Heart Attack Prevention and Education) Guideline, which addresses the practice of cardiovascular screening in the asymptomatic population. The National SHAPE Guideline recommends that all men age 45 and older and all women age 55 and older periodically undergo a comprehensive vascular health assessment to gauge their individual risk of a near-term heart attack. It is the search for the vulnerable patient that remains the focus of the SHAPE guideline. The guideline can be reviewed in more detail by reading the SHAPE Task Force Report at www.VP.org or www.AEHA.org. Unless previous risk factor assessment has revealed a very-low-risk state, all men aged 45 and older and women aged 55 and older are encouraged to undergo screening for subclinical atherosclerosis to determine their risk of heart attack. Individuals with negative tests for atherosclerosis if they have established risk factors are treated according to existing guidelines. All should be offered EHAC education, focusing on early warning signs and reducing delay time in seeking medical assistance after the onset of symptoms. In individuals with positive tests for subclinical atherosclerosis, the severity of atherosclerosis determines the intensity of treatment. The importance of life-style modifications is stressed, and all individuals and their closest relatives are offered EHAC education. Reassessment of the disease is recommended within 5 years unless otherwise indicated. Diabetes counts as a cardiovascular risk factor when no atherosclerosis is detected. If, however, subclinical atherosclerosis is present, diabetes is always considered a high-risk state and treated aggressively. An ankle-brachial index (ABI) 50% stenosis. Comparing to recommended tests, optional tests have less accuracy, higher cost, poorer reproducibility, inadequate availability, or insufficient evidence for uplifting ROC curve in the setting they are optionally suggested. Simpler Blood Thinning Medication Found As Effective as Commonly Used Therapies For Preventing Recurrent Blood Clots and Preventing Stroke A medication that could simplify anticoagulation therapy, ximelagatran, was found to be as effective as other common therapies for preventing stroke and recurrent blood clots, according to studies in JAMA. Ximelagatran is currently approved for use in some European countries but it has not been approved in the United States because of concerns about adverse effects. In the first study, Jean-Noel Fiessinger, MD, of Hospital European Georges Pompidou, Paris, and colleagues conducted a study of patients with deep vein thrombosis to determine the efficacy and safety of oral ximelagatran compared to standard treatment with the anticoagulants enoxaparin and warfarin. Current therapy for patients with acute venous thromboembolism consists of 5 to 7 days of the anticoagulant heparin overlapped with and followed by long-term, oral anticoagulation with a therapy such as warfarin. Heparin must be given parenterally (by injection, usually through the veins) and administration requires considerable health care resources. Warfarin is given orally, but has an unpredictable dose response, interacts with many drugs, and can be affected by changes in diet; thus, continued coagulation monitoring and dose adjustment are necessary. Ximelagatran is administered orally and is rapidly absorbed and quickly converted to its active form. The trial (Thrombin Inhibitor in Venous Thromboembolism [THRIVE] Treatment Study) included 2,489 patients with deep vein thrombosis. The study was conducted at 279 centers in 28 countries from September 2000 through December 2002. Patients were randomized to receive 6 months of treatment with either oral ximelagatran, twice daily, or subcutaneous enoxaparin, twice daily for 5 to 20 days followed by warfarin. The researchers found that the primary efficacy end point of recurrent venous thromboembolism occurred in 26 and 24 patients in the ximelagatran and enoxaparin/warfarin groups, respectively, corresponding to estimated cumulative risks of 2.1 percent and 2.0 percent. The absolute difference between ximelagatran and enoxaparin/warfarin was 0.2 percent. This met the prespecified criterion for non-inferiority. The cumulative risk of major bleeding at 6 months in the ximelagatran-treated patients was 1.3 percent compared with 2.2 percent for those receiving enoxaparin/warfarin. All-cause death was not significantly different between the 2 groups. A total of 9.6 percent of patients in the ximelagatran group had alanine aminotransferase levels (a measurement in the blood used as an indicator of possible liver damage or disease) increase to greater than 3 times the upper limit of normal, vs. 2.0 percent in the enoxaparin/warfarin group. Analysis of locally reported adverse events showed a higher rate of serious coronary events with ximelagatran (10/1,240 patients) compared with enoxaparin/warfarin (1/1,249 patients). In conclusion, for the initial and prolonged treatment of deep vein thrombosis, direct thrombin inhibition with oral ximelagatran, 36 mg. twice daily, was as effective as enoxaparin/warfarin, without the need for coagulation monitoring or dose adjustment. The mechanism and clinical importance of the increased liver enzyme levels in ximelagatran-treated patients requires further evaluation. Prospective assessment of coronary events in future studies is warranted, the researchers note. Patients With Cancer Have Highly Increased Risk for Blood Clots Patients with cancer have a 7-fold increased risk for venous thrombosis, according to a study in JAMA. Studies that identify patients at highest risk of thrombosis are scarce. It is unclear what risks are for various types and stages of cancer. Jeanet W. Blom, MD, of the Leiden University Medical Center, Leiden, the Netherlands, and colleagues conducted a study to identify individuals with cancer with an increased thrombotic risk, evaluated different tumor sites, the presence of distant metastases, and carrier status of gene mutations. The study (Multiple Environmental and Genetic Assessment [MEGA]) included 3,220 patients, aged 18 to 70 years, with a first deep venous thrombosis of the leg or pulmonary embolism (blood clot in the lungs), between March 1, 1999, and May 31, 2002, at 6 anticoagulation clinics in the Netherlands. There were 2,131 control participants (partners of the patients). Both groups reported via a questionnaire on acquired risk factors for venous thrombosis. Three months after discontinuation of the anticoagulant therapy, all patients and controls were interviewed, a blood sample was taken, and DNA was isolated to ascertain the gene mutations, factor V Leiden and prothrombin 20210A, both linked to thrombosis. The researchers found that the overall risk of venous thrombosis was increased 7-fold in patients with a malignancy vs. persons without malignancy. Patients with hematological malignancies had a 28-fold increased risk of venous thrombosis, followed by those with lung cancer and gastrointestinal cancer. The risk of venous thrombosis was highest in the first few months after the diagnosis of malignancy (53 times greater risk). Patients with cancer with distant metastases had a higher risk vs. patients without distant metastases (20 times greater risk). Carriers of the factor V Leiden mutation who also had cancer had a 12-fold increased risk vs. individuals without cancer and factor V Leiden. Similar results were indirectly calculated for the prothrombin 20210A mutation in patients with cancer. Assuming a baseline risk of 1 to 4 patients with venous thrombosis per 1,000 per year, a 5 percent prevalence of factor V Leiden and a 2 percent prevalence of the prothrombin 20210A mutation, among 10,000 patients with cancer, we would expect 8 to 34 patients with venous thrombosis due to factor V Leiden or the prothrombin 20210A mutation. Screening for factor V Leiden and the prothrombin 20210A mutation and subsequent prophylactic anticoagulant therapy with an effectivity of 80 percent would prevent annually 7 to 27 venous thrombotic events per 10,000 patients with cancer screened (numbers needed to screen: 700-2,700), which does not make screening a useful strategy. Rather than screening for factor V Leiden or the prothrombin 20210A mutation, it may be more cost-effective to consider prophylactic anticoagulant therapy for patients with cancer who have an increased risk to develop venous thrombosis, the researchers conclude.

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