Clinical and Industry News

Kerberos Completes First Clinical Cases with New Peripheral Rinspiration® System Kerberos Proximal Solutions, Inc. has successfully completed its first series of cases with the new Peripheral Rinspiration® Catheter System. The Peripheral Rinspiration System is designed to remove thrombi and emboli from the peripheral vasculature. In the cases just completed, the Peripheral Rinspiration Catheter was used during endovascular procedures to restore or improve blood flow in patients experiencing acute or chronic lower limb occlusions. Physicians found Rinspiration to be especially effective when used pre- and post-intervention with balloon angioplasty, stent placement, and/or atherectomy. Dr. Bernard Reen III, FACC of Presbyterian Hospital in Charlotte, North Carolina, was among those to use the Peripheral Rinspiration System to reestablish flow in a patient case with an occluded Superficial Femoral Artery (SFA). According to Dr. Reen, I was able to remove a significant amount of clot prior to performing an atherectomy. Post procedure I again used Rinspiration to retrieve still more debris. Rinspiration proved to be an excellent choice in clearing the vessel of potential debris both pre- and post-treatment. Rinspiration® allows physicians to enter a vessel to use therapeutic solutions to simultaneously rinse and aspirate embolic debris and thrombus out to the vessel wall. This combined action effectively helps prevent debris from potentially moving downstream and putting patients at risk of peripheral occlusions within the microvasculature. Dr. Barry Weinstock, Florida Hospital-Orlando in Orlando, Florida has performed several cases using the Peripheral Rinspiration System in occluded lower limb vessels. The device is extremely easy to use. It has repeatedly surprised me by removing an extensive amount of debris from vessels that appear angiographically ‘normal,’ even post-stenting, said Dr. Weinstock. Preliminary use of the product suggests that Rinspiration may be valuable in elective procedures for rinsing and aspirating chronic thrombus, or ‘cleaning up’ after an interventional treatment device has been applied, such as PTA, stent placement, or atherectomy. Up to 30 million people in the United States are afflicted with peripheral vascular disease (PVD). Kerberos will showcase the Peripheral Rinspiration System at major interventional meetings throughout 2006. Low-Profile Skyway Support Catheters Launched Vascular Solutions, Inc. recently launched the Skyway support catheters for wire support and exchange in complex interventions. The Skyway OTW and RX support catheters are intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and coronary vasculature by facilitating placement and exchange of guidewires and other interventional devices. The Skyway OTW also may be used to subselectively infuse/deliver therapeutic agents. The Skyway catheters provide 1.9F ultra low-profile wire support for easy lesion entry and crossing with a hydrophilic coating on the distal 20 cm to glide through tortuous anatomy. The Skyway RX catheter features a rapid exchange design that allows delivery over an in-place 180 cm guidewire for wire support. The Skyway RX’s wire exchange simplicity allows exchange of the guidewire without wire extension. The Skyway catheters are available in both the United States and international markets. FDA Approves First U.S. Study of Stent Placement To Treat Arterial Blockages Below the Knee Study to Evaluate Xpert Self-Expanding Stent System from Abbott Vascular Inc. The first U.S. multicenter, prospective clinical trial to investigate the use of minimally invasive stent placement to treat severe peripheral arterial disease (PAD) below the knee, has been cleared by the Food and Drug Administration (FDA), which approved an investigational device exemption (IDE) filed by the study’s sponsors. The study, sponsored by VIVA Physicians, Inc. (VPI) and supported by a restricted educational grant from Abbott Laboratories, will be the first in the U.S. to evaluate the Xpert expandable nitinol stent in the blood vessels below the knee. The Xpert, which is manufactured by Abbott Vascular Inc., is cleared in the U.S. to treat blockages in the biliary ducts that carry digestive enzymes from the liver. VPI submitted its IDE application to study the stent’s use in the popliteal and tibial arteries below the knee to the FDA on Feb. 7. The Xpert stent is particularly appropriate for this trial because it is the only self-expanding stent that comes in a variety of sizes small enough to treat the blood vessels below the knee, said James Joye, DO, principal investigator for the XCELL trial. Dr. Joye’s center, El Camino Hospital in Mountain View, CA, will be among the sites participating in the study. "The study is also important because it is one of only a very few independent, physician-sponsored efforts. VPI set the protocol, applied for the IDE and is responsible for data collection, evaluation and reporting. The primary endpoint of the study is avoidance of major amputation at 12-months follow-up after treatment, he said. It is estimated that 25 million people suffer from blockages in the arteries of the lower leg. Those with advanced disease may be poor candidates for surgery and have few treatment options. Many are at high risk of losing a limb, Dr. Joye said. This is an important trial to expand patient treatment options, increase physician awareness and take an important step forward in preventing amputation. The study is expected to enroll 140 patients at 10 centers, according to Dr. Joye. In addition to El Camino Hospital, other centers are participating in the study, and their principal investigators include: UCLA Medical Center, Los Angeles; Thomas McNamara, MD St. John’s Hospital/Memorial Medical Center, Springfield, Ill.; Nilesh Goswami, MD Midwest Cardiovascular Research Foundation, Davenport, Iowa; Eric Dippel, MD Ochsner Clinic Foundation, New Orleans; Christopher White, MD Washington University, St. Louis, Mo.; Patrick Geraghty, MD Riverside Methodist Hospital, Columbus, Ohio; Charles Botti, MD CAMC Memorial, Charleston, W. Va.; Mark Bates, MD University of Virginia, Charlottesville, Va.; John Angle, MD Presbyterian Hospital of Dallas; Tony Das, MD VPI is a multi-disciplinary group of independent physicians who are nationally known experts in the diagnosis and management of all peripheral vascular diseases, and who joined together to advance education in vascular medicine and support research and innovative treatment options. In 2002, the group of 10 specialists in vascular medicine, vascular surgery, interventional cardiology and interventional radiology, organized VIVA: The National Education Course for Endovascular Interventions, an annual educational symposium held in Las Vegas that provides a highly interactive, "turf neutral" educational forum. The XCELL study is VPI's first clinical trial and meets the group's goal of sponsoring and executing trials that will support standards of practice. VPI also is involved in developing objective performance criteria for limb salvage and interventions for lower extremity peripheral arterial disease, and is investigating strategies to deal with in-stent restenosis and acute stroke intervention. Study presented at American Heart Association Holds Key to Vascular Health: Cardiovascular and diabetic patients to benefit A study recently presented at the American Heart Association’s 7th Annual Conference on Arteriosclerosis, Thrombosis and Vascular Biology held in Denver, Colorado has demonstrated that a new form of folate is effective in improving endothelial function, a measure of vascular health. Patients taking the new folate in combination with vitamin B12 and B6, demonstrated a 136% improvement in ability of the blood vessels to promote blood flow. This exciting study shows tremendous promise for millions of cardiac and Type 2 diabetic patients. James V. Talano, MD, the senior author and principal investigator of the study conducted at the Cleveland Clinic and NCH Healthcare System, commented, It has long been believed that endothelial dysfunction is the beginning of atherosclerosis. This clearly has huge implications for both cardiac and vascular patients. Endothelial dysfunction is now also believed to be an indicator for poor circulation and impaired wound healing. This study indicates that several patient types, such as those with diabetes, who are characterized by endothelial dysfunction and are known to suffer from vascular impairment, can benefit from treatment with high doses of this new folate therapy. The new oral folate, L-methylfolate, is a significant improvement over folic acid, the more common form of folate found in over-the-counter supplements. L-methylfolate is the body’s biologically active form of folate (i.e. the form that the body can readily use). This is a major benefit for those individuals who suffer from certain metabolic or genetic disorders related to the metabolism of folic acid (metabolism which allows folic acid to be converted to the active form, L-methylfolate). Dr. Talano, who is currently the Director of Cardiology of the SWICFT Institute in Naples, Florida and was previously the Director of Cardiology at the Cleveland Clinic, Florida, as well as Chief of the Cardiology Center of Excellence at Tulane University School of Medicine, added, Approximately 45% of the general population suffers from the disorder that may inhibit their ability to convert folic acid to the active form. L-methylfolate is the active form, and therefore overcomes the problem of conversion for millions of people. This enables L-methylfolate to work more efficiently and thoroughly than the folic acid that a vast number of Americans have been taking. The positive implications for physicians treating cardiovascular and diabetic patients are based upon certain basic facts: Nitric oxide, the body’s natural vasodilator, is necessary for maintaining proper vascular health of blood vessels. Studies have shown that L-methylfolate increases the production of nitric oxide. Pain in the extremities (neuropathy) and poor wound healing in the legs and feet (lower extremity ulceration) are two of the most common debilitating symptoms of Type II diabetics. It is widely accepted that both of these symptoms are associated with endothelial dysfunction. This dysfunction inhibits the production of nitric oxide, the body’s most powerful vasodilator, and leads to inadequate circulation. This leads to poor cardiovascular health and also to neuropathy and poor wound healing. This current study showed that high doses of L-methylfolate, with or without vitamins B6 and B12, improve the levels of nitric oxide and improve endothelial function. Michael Kazimir, MD, of the SWICFT Institute, also a clinical investigator for this study, received the 2nd Place Irving Page Research Award at the Conference for his contribution to the study. Talano concluded, While improvement of endothelial function can have many cardiovascular benefits, it now also has benefits for the millions of individuals who suffer from Type 2 diabetes and its complications. This has been shown in my own practice, and has been confirmed by many other practitioners. Data from Largest Independent U.S. Drug-Eluting Stent Registry Shows Excellent Outcomes for Taxus® stent system in Diabetics Boston Scientific’s Taxus stent system used in more complex lesions than J&J’s Cypher Boston Scientific Corporation welcomed results from the independent, multi-center STENT registry, the largest prospective, comparative real world drug-eluting stent study ever reported. An analysis of data on diabetic patients revealed numerically favorable outcomes for the Taxus Express2 paclitaxel-eluting stent (PES) system compared to Johnson & Johnson’s Cypher® sirolimus-eluting stent (SES) system in reducing mortality rates and overall major adverse cardiovascular events (MACE). The STENT (Strategic Transcatheter Evaluation of New Therapies) registry included follow-up on 5,566 patients at eight coronary centers in the United States who received either a Taxus stent system or a Cypher stent system, including 1,680 diabetic patients, nearly 500 of whom were insulin-treated diabetics. The new information included nine-month outcomes for all diabetic patients and nine-month death rates in insulin-treated patients. Among the study’s diabetic patients, the Taxus patients generally had more complex lesions than Cypher patients as evidenced by a slightly higher American College of Cardiology risk score, smaller vessels and longer lesions. Despite the higher complexity of the Taxus patients, the Taxus stent system demonstrated excellent outcomes in MACE when compared to the Cypher stent system in diabetic patients overall (6.8 percent versus 7.1 percent). In addition, the rate of death was lower for Taxus (1.9 percent for Taxus versus 3.4 percent for Cypher) without reaching statistical significance. Both groups presented excellent target vessel revascularization (TVR) and sub-acute thrombosis (SAT) rates. Among the non-insulin treated subset, the investigators did not observe any significant differences in MACE between the Taxus and Cypher groups. Updated data presented by Thomas Stuckey, MD, at EuroPCR included more detail on the breakdown of cardiac and non-cardiac death rates in insulin-treated patients. Among insulin-treated patients, the overall rate of death also trended lower in the Taxus group (2.1 percent for Taxus [n=5] versus 5.7 percent for Cypher [n=15]). The rate of cardiac death was 1.3 percent for Taxus (n=3) and 3.0 percent for Cypher (n=8), whereas the rate of non-cardiac death was 0.9 percent for Taxus (n=2) and 2.7 percent for Cypher (n=7). Although none of the differences reached statistical significance, the investigators did note that the insulin-treated subgroup demonstrated a trend favoring PES such as Taxus over SES such as Cypher for late MACE, and that further studies need to be conducted to confirm these results. The latest analysis of this head-to-head study reinforces the benefits of TAXUS stents in complex lesions, said Dr. Stuckey. Positive outcomes like these give physicians great confidence in the performance of these devices. Joint Commission Announces 2007 National Patient Safety Goals for Laboratories The Joint Commission on Accreditation of Healthcare Organizations announced the 2007 National Patient Safety Goals and related Requirements that will apply specifically to accredited laboratories. There are no additions to this fifth annual issuance of Laboratory National Patient Safety Goals, which were recently approved by the Joint Commission’s Board of Commissioners. The development and annual updating of the National Patient Safety Goals and Requirements continue to be overseen by an expert panel that includes widely recognized patient safety experts, as well as nurses, physicians, pharmacists, risk managers and other professionals who have hands-on experience in addressing patient safety issues in laboratories and other health care settings. Each year, the Sentinel Event Advisory Group works with the Joint Commission to undertake a systematic review of the literature and available databases to identify candidate new Goals and Requirements. Following a solicitation of input from practitioners, provider organizations, purchasers, consumer groups, and other parties of interest, the Advisory Group determines the highest priority Goals and Requirements and makes its recommendations to the Joint Commission. The 2007 Laboratory National Patient Safety Goals are: Improve the accuracy of patient identification. Use at least two patient identifiers when providing care, treatment or services. Prior to the start of any invasive procedure, conduct a final verification process, such as a time out, to confirm the correct patient, procedure and site, using active not passive communication techniques. Improve the effectiveness of communication among caregivers. For verbal or telephone orders or for telephonic reporting of critical test results, verify the complete order or test result by having the person receiving the information record and read-back the complete order or test result. Standardize a list of abbreviations, acronyms, symbols, and dose designations that are not to be used throughout the organization. Measure and assess, and if appropriate, take action to improve the timeliness of reporting, and the timeliness of receipt by the responsible licensed caregiver, of critical test results and values. Implement a standardized approach to hand off communications, including an opportunity to ask and respond to questions. Reduce the risk of health care-associated infections. Comply with current Centers for Disease Control and Prevention (CDC) hand hygiene guidelines. Manage as sentinel events all identified cases of unanticipated death or major permanent loss of function associated with a health care-associated infection. Encourage patients’ active involvement in their own care as a patient safety strategy. Define and communicate the means for patients and their families to report concerns about safety and encourage them to do so. The full text of the 2007 Goals and Requirements is posted on the Joint Commission website, www.jointcommission.org. Compliance with the Requirements or alternatives judged by the Advisory Group to be acceptable is a condition of continuing accreditation for Joint Commission-accredited laboratories. Mennen Medical Announces the Acquisition of MTRE Mennen Medical, a provider of cardiac catheterization and electrophysiology systems as well as patient monitoring and clinical data information solutions, announces the acquisition of MTRE (Medical Thermo-Regulation Expertise) Company. MTRE focuses on the field of cooling therapy for post cardiac arrest and head trauma victims in intensive care units. The leading product of the company is CritiCool. The company's products are installed in more than 200 hospitals and over 15 countries worldwide. The company was established in 1998. We welcome MTRE to the Mennen Medical family, said Ran Nimrod, Chairman of Mennen Medical Group. MTRE allows Mennen Medical access to the rapidly growing field of therapeutic hypothermia of post cardiac arrest and head trauma patients. Thus, it will enable Mennen Medical to extend its product offering to its strategic market segments “ the cardiology, the intensive care and the theatre departments in the hospitals.

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