Clinical and industry news

InfiMed Announces Release of New Cardiovascular DICOM Server InfiMed, Inc.has released a new data communication and temporary storage system named the CV Server. The CV Server integrates seamlessly into any cath lab, allowing transfer of DICOM data to any device, such as review stations or PACS systems. This is a universal system that has the ability to accept DICOM data from any device regardless of manufacturer, and then makes the data available for review. This server has the flexibility to integrate into any system, and is totally scaleable to store anywhere from hundreds to thousands of patient studies, based on customer’s requirements. The Cardiac Arrhythmia Research Institute at the University of Oklahoma Health Sciences Center is the U.S. beta site for InfiMed’s CV Server, according to Steve Belt, InfiMed’s Market Manager, Vascular Imaging. At the University of Oklahoma, the CV Server provides the ability to store cardiac images from two bi-plane EP labs, with the goal of making it convenient to review cases at any time on physicians’ workstations. Belt also noted that, The CV Server offers the benefit of having DICOM images available anywhere, at any time, a service designed to enable physicians to greatly improve productivity. When integrated with InfiMed’s GoldOne Cardiac digital acquisition system and the CV 1000 PowerStation for image review, the CV Server storage system is tailored to offer a low-cost, high-performance, scalable solution for acquisition, storage and review of cardiac studies. Cost Effective Alternative for Cath Labs Faced with continuing budget constraints, many facilities are being forced to choose between investing in their cath lab or achieving their goal of networked image and information management. The new ViewNT in-room digital processor from ComView is giving a growing number of customers the power to have both. The concept behind the ViewNT is to resolve the issues that lead facilities to consider replacing their existing lab through the use of technology. Key factors include degraded image quality, lack of internal image storage, the need for additional features, escalating maintenance cost and non DICOM image formatting. By addressing these issues directly, rather than replacing fully functional components, the ViewNT directly reduces the overall expenses of optimizing the cath lab without sacrificing quality. These savings, in addition to the construction cost savings, are providing many with the means necessary to meet their overall objectives. The ViewNT and ViewNET Image and Information System will be on display at the upcoming ACC, at ComView’s booth, # 4459. HeartStent Corporation Launches Web Site HeartStent Corporation has made available to the medical community a new website located at: https://www.heartstent.com This site is the first authoritative compilation of scientific knowledge pertaining to ventriculocoronary artery bypass (VCAB), a relatively new procedure that has shown promising results in pre-clinical trials. HeartStent Corporation pioneered and continues to refine this innovative surgical procedure. The website will also offer news and company-related information, as well as links to leading cardiac surgery and cardiology journals, associations and meetings. Kensey Nash Announces CE Mark Approval For Its TriActiv Distal Protection System Kensey Nash Corporation has received approval to apply the CE Mark to its TriActiv Balloon Protected Flush Extraction System, allowing sale of the product throughout the European Union. This final approval followed the previously announced recommendation from TUV Rheinland, a European regulatory authority. The TriActiv System is designed 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 which creates a protected space, a flush catheter which washes the graft, and an extraction system which removes the debris found in the grafts. These three features work in combination to prevent the debris found in the graft from going downstream and potentially causing a heart attack. New Guidelines for Surgery in Heart Patients Two US medical groups have issued new guidelines on performing non-cardiac operations in people with heart disease--highlighting, among other issues, the importance of delaying surgery in patients who have recently had stents placed in clogged heart arteries. According to the new guidelines, issued by the American College of Cardiology (ACC) and the American Heart Association (AHA), any non-cardiac procedures should be delayed in patients who receive stents. A minimum of 2 weeks, and ideally 4 to 6 weeks, should pass before non-heart surgery. The guidelines were released last week on both organizations' websites, www.acc.org and www.americanheart.org. The groups note that there is uncertainty regarding how much time should pass between angioplasty, in general, and non-cardiac procedures. They recommend a delay of at least one week after angioplasty to allow blood vessels to heal. The added time for stent patients is intended, in part, to allow them to complete treatment with anti-clotting drugs. The problem is that the fresh coronary stent increases the risk of developing a blood clot in the coronary artery, while the anti-clotting drugs set the patient up for the possibility of more bleeding from the surgical wound, explained Dr. Kim A. Eagle. Nurses Have Better Touch When Taking Blood Pressure Nurses cause less anxiety than doctors when taking a patient’s blood pressure, and this helps reduce white coat hypertension. Blood pressure often rises when a doctor measures it and this can lead to an incorrect diagnosis of hypertension, says Michael A. Weber, MD. The study by Brown and colleagues demonstrates that ambulatory blood pressure monitoring can identify patients who have this type of white coat hypertension and can prevent the need for costly tests to look for causes of hypertension that appear resistant to treatment. The study, conducted by Mark A. Brown, MD; Megan L. Buddle, SRN; and Allison Martin, MSc; from St. George Hospital and the University of New South Wales, Kogarah, Australia, involved 611 patients whose blood pressure exceeded 140/90 mmHg. The patients’ blood pressures were taken by both a doctor and a nurse. Of the 611 patients, 277 were not taking any medication; 216 were taking one or two medications and 118 had resistant hypertension and were taking at least three medications. The investigators found the average systolic white coat effect ranged from 16-26 mmHg across all three groups, with those taking antihypertensive medications having the greatest difference between routine doctor- or nurse-recorded systolic blood pressure and awake, ambulatory blood pressure-monitored systolic blood pressure. The magnitude of this effect was significantly lower when blood pressure was recorded by a nurse, they reported. Diastolic ˜white coat’ effect was similar. blood pressure was always lower when recorded by a nurse. FDA Clears U.S. Clinical Trial of Cook® Incorporated’s Paclitaxel-Eluting Coronary Stent to Combat Restenosis Cook® Incorporated has received conditional approval from the U.S. FDA Administration to enroll 200 patients at 20 sites in the U.S. clinical trial of its new paclitaxel-eluting coronary stent to combat restenosis. Patient enrollment in Cook’s PATENCY study, which is expected to keep Cook on track to launch its Logic PTX Drug-Eluting Coronary Stent in the U.S. in 2003, will begin immediately. In addition, FDA gave Cook approval to enroll 100 patients at 10 institutions in a randomized pilot study using its paclitaxel-eluting coronary stent to treat in-stent restenosis. CryoCath Gets FDA Approval for Modular Filing Plan for PMA Application for Freezor System (First Module Already Filed) CryoCath Technologies Inc. has announced that the U.S. FDA has approved the Company’s Premarket Approval (PMA) Modular filing plan for the Freezor Cardiac Cryoablation System. CryoCath has already filed the first of five modules, based on pre-clinical animal data. Future modules will be based on data from CryoCath’s FROSTY Pivotal Study, which is targeted to enroll 165 supraventricular tachyarrhythmia (SVT) patients using the company’s minimally invasive, catheter-based 7F Freezor Cardiac CryoAblation System. To date, more than 115 patients have been enrolled in the study. Enrollment is expected to close in the spring of 2002. The study is being conducted at 15 leading centers across North America. Improved Bulk Pack for ECG Electrodes Vermed Incorporated has improved packaging for all of its bulk pack ECG electrodes. All Vermed bulk pouches will have a resealable zip-lock opening. This feature improves storage conditions after the pouch has been opened, reducing gel dehydration and increasing the shelf life of the electrodes remaining in the opened pouch. All new bulk pouches will feature Vermed’s color-coded logo artwork for easy identification of product and product use. The quantity for all bulk products is being standardized to 600 electrodes per case. Quantum Labs Wins FDA Approval for their Powder-Free SoftSkin Aloe Vera Gel-Coated Gloves with Vitamin E No longer will laboratory technicians, personnel, chemists and those who work in laboratories have to be concerned with toxic powders or allergens which are subject to being inhaled or causing allergic skin reactions when wearing powdered latex dental examination gloves. Quantum Labs has won FDA approval for their new line of powder-free SoftSkin Aloe Vera Gel-Coated Gloves with Vitamin E. In addition, the FDA-approved SoftSkin Gloves are specially treated to remove harmful allergy causing proteins. The gloves contain less than 50 micrograms of total water extract-able protein per gram, the lowest claim allowed by the FDA. Equally important, as a result of a new exclusive manufacturing design by Quantum Labs, the powder free SoftSkin Aloe Vera Coated gloves with vitamin E offers users an emollient effect which great enhances the health of the wearer’s skin. Medical Product Manufacturing Industry Strength Continues The medical product manufacturing industry strength is continuing, with over 125 key new job openings nationwide. Almost 1 million discouraged people actually suspended their job searches in January (primarily in other industries). However, the robust growth in the number of new medical devices, instruments, equipment and supplies brought to market is constantly creating more job openings in sales, marketing, business development, regulatory, upper management and other key categories. Some of these positions continue to go unfilled weeks and months after they were initially created and announced. As a result, many medical manufacturers may now be increasingly forced to consider well-educated, good caliber candidates from outside of the traditional boundaries of the medical industry. Those candidates may often have little or no applicable medical industry experience, skills and knowledge, and will have to either learn fast on the job, or lose their new position. Cryocare Cleared for Arrhythmia Treatment Endocare Inc. has received 510(K) clearance from the FDA to market its Cryocare Surgical System for use in thoracoscopic cardiac cryosurgery to treat arrhythmia. The Cryocare Surgical System, which was cleared for the surgical treatment of arrhythmia in August 2001, uses specially designed malleable cryoprobes to create long linear lesions through the heart wall to block the aberrant electrical signals that cause the arrhythmia, according to Endocare. The new clearance allows the system to be used in a minimally invasive surgical procedure and broadens the applicability of cryosurgery as an ablation tool. Agent Delivery System to be Marketed In Europe Bacchus Vascular Inc. has received the CE Mark to market its Trellis System throughout the European Union. The system delivers physician-specified agents into the vasculature. The Trellis System is based on a vibratory pharmacomechanical platform that permits localized dissolution of infused fluids. When using the Trellis System, the treatment area is isolated to provide safe and efficacious delivery of agents while offering the potential of lower infused quantities of fluids and drugs. Dr. Andrew Bray, who has used the device several times, comments, It treats the most difficult areas, like thrombus in close proximity to a stenosis. There are no additional medications or manipulations to the patient when using the Trellis System. The Trellis System could be used in percutaneous transcatheter angioplasty and stenting, according to Bacchus Vascular. Meta-Analysis Finds Angiomax® (bivalirudin) and Other Direct Thrombin Inhibitors Are More Effective than Heparin A major meta-analysis has found that direct thrombin inhibitors such as ANGIOMAX® (bivalirudin) are associated with a significantly reduced risk of death or myocardial infarction over the indirect thrombin inhibitor heparin (p=0.001, differences persisting at 7 and 30 days). Additionally, the analysis concluded that of the direct thrombin inhibitors, only Angiomax was associated with both a reduction in ischemic events and a reduced risk of major bleeding. This overview, which was prospectively limited to randomized ACS and PCI trials involving a minimum of 200 patients, compared the outcomes of 11 trials studying six agents in 35,970 patients. In addition to looking at differences between direct thrombin inhibitors (hirudin, bivalirudin, argatroban, efegatran, and inogatran) and the indirect thrombin inhibitor heparin, the study evaluated the differences between bivalent direct thrombin inhibitors (hirudin and bivalirudin) and univalent inhibitors (argatroban, efegatran, and inogatran). Researchers noted, At the end of treatment, both hirudin and bivalirudin were associated with lower rates of myocardial infarction than was heparin, but the univalent inhibitors appeared to be associated with an increased risk of myocardial infarction. The researchers went on to state, There seem to be important differences in the risk of major bleeding among individual direct thrombin inhibitors. Hirudin is associated with an increased risk of major bleeding, particularly in acute coronary syndromes without ST elevation, for which there was an almost two-fold excess in major bleeding. By contrast, bivalirudin was associated with a 50% reduction in bleeding risk, mainly in patients undergoing percutaneous coronary intervention, but also evident in those with ST-elevation acute coronary syndromes. Integris Grove General Hospital Selects Electromed Systems Electromed Inc. announced that the Integris Grove General Hospital, a member of Oklahoma’s largest state-owned health system, has selected ComView, a subsidiary of Electromed, to take care of its in-room digital imaging needs. Working through ComView's local distributor, Radiologic Resources, the facility will be installing an upgrade solution powered by ComView’s ViewNT in-room digital system. The ViewNT provides cardiac departments with high-resolution image acquisition as well as filmless DICOM capabilities, without the delay or expense of purchasing a completely new cath lab. Intravascular Sonotherapy Trial Completes Enrollment Pharmasonics Inc. has finished enrolling patients for two clinical trials on Intravascular Sonotherapy, as a treatment for in-stent restenosis. Intravascular Sonotherapy delivers ultrasound energy through a standard percutaneous catheter to reduce cell growth in the stented vessel. The clinical trials, known as the Euro-SPAH and SWING trials, are designed to determine the long-term safety and efficacy of the Intravascular Sonotherapy procedure’s ability to reduce the incidence of restenosis in patients with de novo stents in native coronary arteries. Euro-SPAH, which enrolled 400 patients, is the pivotal trial for Europe, while SWING, which enrolled 800 patients, is one of two trials being held in the United States. The pivotal Sonotherapy trial results will be occurring around the same time as the release of the first U.S. pivotal results for drug coated stents, said Dr. Richard Kuntz, principal investigator for the SWING trial. This is good news for the interventional cardiology community because, assuming FDA approval, physicians will have more clinical and economic choices for treating patients with coronary restenotic disease. The other U.S. trial being conducted on the ultrasound-based procedure is the SPLASH trial, which is scheduled to complete enrollment this spring. It is designed to establish the long-term safety and efficacy of Sonotherapy to reduce the incidence of restenosis in patients treated for coronary in-stent restenosis. Dr. Patrick Serruys, chairman of the Euro-SPAH trial, said Sonotherapy could be used to complement the potentially more costly drug-coated stents in patients requiring more than one stent. Euro-SPAH was designed to include these patients. The timeliness of its results are ideal and I look forward to presenting them in September at the major cardiology congresses. SonoSite Introduces Hand-held Cardiac Ultrasound System Sonosite has introduced the SonoHeart Elite system, an all-digital, hand-held ultrasound system that performs complete cardiac ultrasound exams. The SonoHeart Elite system features continuous wave doppler and extended resolution harmonic imaging. The continuous wave doppler provides sensitive and accurate assessment of blood flow with a simple, intuitive user interface. The sensitivity and clear signal quality compares favorably to continuous wave doppler found on much larger ultrasound systems, according to SonoSite. Extended Resolution Harmonics provides clarity with enhanced two-dimensional image quality. According to the company, the SonoHeart Elite platform also provides higher frame rates, better signal to noise ratio and improved filtering that allow clinicians to achieve even better resolution of anatomy and pathology. New Stent, Protection Device Used on First Patient Boston Scientific’s FilterWire EX embolic protection device and Carotid Wallstent Monorail device were used on a human for the first time to begin an FDA-approved clinical trial. The FilterWire EX embolic protection device is a low-profile filter, mounted on a rapid exchange deployment system, that is designed to capture embolic debris released during a procedure to prevent it from traveling to the brain. The device is removed at the end of the procedure. The Carotid Wallstent Monorail device is a self-expanding stent mounted on a rapid exchange deployment system, designed to open the carotid artery and improve blood flow to the brain. The two devices were used to treat a patient with carotid artery disease in a clinical trial evaluating the benefits of stenting. The procedure was performed at the Arizona Heart Institute and Foundation in Phoenix. Boston Scientific recently received FDA approval to enroll as many as 775 patients in the trial, at up to 40 sites across the United States. The FilterWire EX and the Carotid Wallstent Monorail have been granted the CE Mark to market the device throughout the European Union. The device has been available in those countries for more than a year. Radiance, Endologix to Merge Endologix and Radiance Medical Systems have have agreed to merge. Under the terms of the merger agreement, Radiance, which currently owns 4 percent of Endologix, will pay the shareholders of Endologix $0.75 in cash and one share of Radiance stock for each of the 11,159,052 shares of Endologix’s remaining stock. Endologix shareholders might also receive milestone payments up to $0.50 for each share of Endologix stock. Endologix is currently selling its PowerLink AAA device in Europe, has filed for approval of the device in Japan and is conducting clinical trials on the device in the United States. The PowerLink System is an endoluminal stent graft (ELG) for the treatment of abdominal aortic aneurysms (AAAs). Many Heart Attack Patients Miss Out on Treatment One in three patients having a serious heart attack may miss out on emergency treatment to restore blood flow to the heart, according to the results of an international study. Patients over the age of 75, those without chest pain and those with a history of diabetes, congestive heart failure, heart attack or heart bypass surgery were less likely to receive reperfusion therapy, researchers say. The study included more than 9,000 patients at 94 hospitals in 14 countries. Overall, about 1,700 patients arrived at the hospital within 12 hours of having symptoms of a heart attack and had signs of a heart attack based on the results of an electrocardiogram (ECG). The use of clot-dissolving drugs alone was most common in Australia, New Zealand and Canada (67% of patients) and least common in the US (31% of patients). An angioplasty was performed on 18% of patients in the US but only 1% of those in Australia, New Zealand and Canada. The US was most likely to use a combination of the two techniques, with 19% of patients receiving this treatment. Overall, 30% of the patients did not receive any reperfusion therapy in spite of being eligible. The reason is unclear. However, doctors may be worried about the risk of treatment, especially in the very elderly, or patients may demonstrate relatively unusual symptoms, such as shortness of breath rather than chest pain. We weren’t surprised to find that cardiologists were reticent to provide reperfusion therapy to very old patients, one researcher said. Part of that reflects the fact that many clinical trials to date have excluded such patients from enrollment. Vascular Solutions Announces U.S. Launch of Two New Products Vascular Solutions, Inc.’s PMA Supplement for the Diagnostic Duett sealing device has been approved by the U.S. FDA and the company has launched the device. The 510(k) application for Vascular Solutions’ D-Stat flowable hemostat has received a favorable determination from the FDA. This regulatory clearance permits U.S. sales of the D-Stat to begin for the local management and control of bleeding from vascular access sites, and percutaneous catheters and tubes. The U.S. market launch of the D-Stat is planned for mid-February, pending the completion of initial manufacturing builds. Diagnostic Duett. The Diagnostic Duett is a new version of the original Duett sealing device that is tailored for treating diagnostic patients. The procoagulant in the Diagnostic Duett is dosed for the less-challenging diagnostic patients where substantial blood-thinning drugs are used less frequently. This results in a less expensive version of the original Duett device, which is still fully effective for the over 2.5 million diagnostic procedures that occur each year in the U.S.A The Diagnostic Duett was the subject of a 302-patient clinical study, with the results compared to the standard compression arm of the company’s seminal SEAL clinical study. The clinical results in the Diagnostic Duett study further re-enforced the positive clinical outcomes that can be obtained with the Duett approach to sealing. D-Stat. The company’s second new product, the D-Stat flowable hemostat, uses the Duett procoagulant components to create a thick, yet easily deliverable, hemostat. The D-Stat consists of the same collagen, thrombin and diluent components as the Duett sealing device, which has been proven effective in controlling bleeding from aggressive arterial puncture sites. After a simple reconstitution step, the D-Stat hemostat can be applied directly to a wide variety of bleeding surfaces using one of the three included applicator tips. The D-Stat is shelf-stable and can be prepared up to three hours before use. MRA Cheaper, Noninvasive Magnetic resonance angiography (MRA), was almost as effective as coronary angiography in looking at the results of bypass operations, reports a group led by Dr. Ernst E. van der Wall, professor of cardiology at Leiden University Medical Center. MRA uses computer technology, radio waves and high-intensity magnetic fields to get images of body tissues. It can be done without a hospital stay and at half the cost of conventional angiography. In a study of 56 blood vessel grafts in 38 patients who had undergone bypass operations, the high-resolution images were comparable to images obtained with X-ray angiography, van der Wall says. The blood vessels have a two-millimeter cross-sectional area, and we now have technological capabilities that allow sub-millimeter scanning, he continued. In most cases, the diagnostic accuracy of the MRA results, when compared to conventional angiography, was better than 80 percent. Estrogen May Hold Secret to High Blood Pressure A group of American and Swedish researchers report that mice genetically engineered to lack the beta receptors develop severe high blood pressure as they age. The study was done by a group led by Dr. Michael E. Mendelssohn, director of the Molecular Cardiology Research Institute of the New England Medical Center. His group first discovered the presence of the estrogen beta receptors in blood vessels in 1996. This is the first demonstration that there is a clear physiological function for the estrogen receptor beta, he says. That function is to regulate one or more genes that are critical for blood vessel function, Mendelssohn says. This work makes us focus our attention on what are the relevant genes that estrogen receptor beta regulates which are important to normal vascular physiology. If we can understand what the target genes are, we can develop new drugs for hypertension. In addition, he says, variations or mutations in the estrogen beta gene may [affect] blood pressure control in some people. That applies to men as well as women, Mendelssohn says, since estrogen is found in both sexes. The new study was done with male mice. However, the new research does not answer one major question for women. There is no doubt that estrogen plays a role in the vascular system. But does estrogen replacement therapy after the menopause prevent heart disease? We don't have sufficient data to answer that question, says Dr. Lori Mosca, director of preventive cardiology at the Columbia University College of Physicians and Surgeons and author of the American Heart Association position paper on estrogen and heart disease. Sudden Stress Causes Fat to Stick Around Sudden psychological stress actually delays triglycerides from leaving the bloodstream, which could put you at higher risk for heart disease. We already know that under chronic stress, like illness, cholesterol levels go up, says Ohio State University psychologist Catherine Stoney, the lead author of the study. It was thought those increases were related to behavioral changes, like not exercising or poor eating habits. But now we have documented that cholesterol goes up and goes up very quickly, faster than could be related to behavioral effects, when people are subjected to acute stressors, she adds. Acute stressors in daily life could include getting stuck in traffic and worrying you’ll be late for an appointment, or the anxiety you feel just before making a presentation at work. The study included 70 healthy, middle-age, nonsmoking men and women. The women were either pre-menopausal and post-menopausal. All participants’ levels of triglycerides were 3.2 percent per minute when they were resting. Those levels declined an average of 2.8 percent a minute during stressful activities. Some people had a bigger difference [in the decrease of triglycerides] between resting and stress sessions, and some people had very little. But, there was remarkable consistency in that everyone had a slower decrease of triglycerides [during the stressful activities], Stoney says. While at rest, the women cleared the fats out of their systems faster than the men, a finding consistent with past studies. But there was no difference between women and men in the time it took to get rid of the fat molecules during stressful situations. Similarly, there was no difference between the pre- and post-menopausal women. The body is wired to be able to provide energy needed to deal with stress. But in the distant past, the stressors were physical. The result is that the fat, instead of being burned up to meet a physically stressful situation, remains in the bloodstream. Stoney says the findings are too premature to make many specific recommendations for changing your personal habits.

NULL