News from the Transcatheter Cardiovascular Therapeutics (TCT) Meeting September 21-25, 2009, San Francisco, California

Transradial Education Draws Eager Crowds at TCT Meeting

Interventional cardiologists call for growth in U.S. of wrist access procedure offering low rate of bleeding complications, earlier ambulation and greater patient comfort Transradial access for percutaneous coronary intervention was a hot topic at the Transcatheter Cardiovascular Therapeutics (TCT) meeting held September 21-25, in San Francisco, Ca. As compared to femoral access, lower bleeding complications and dramatically reduced time to ambulation are two of the most important benefits to patients receiving this procedure, as well as the hospital and healthcare system. While transradial access leads the way in many parts of the world, including Europe, Japan, China and Canada, the U.S. remains behind in its adoption of this procedure. Yet word is spreading about developments in technology that make the performance of transradial access quicker and easier. Education still remains key to overcome the initial learning curve of the procedure and physicians attending the TCT meeting were eager to learn as much as possible from experts in the field. Moderated by Drs Martial Hamon, Tift Mann and Olivier F. Bertrand, the Transradial Angiography and Intervention Seminar, held the afternoon of September 22nd, drew an overflow crowd. An evening symposium, asking “America is ready – are you?”, followed on September 24th. With nearly 400 interventionalists in attendance, transradial proponents Drs Gregg Stone, Jeffrey Popma, Sunil Rao, Craig Thompson and Jennifer Tremmel shared their experience and expertise. The symposium was supported by Terumo Medical Corporation. “Terumo has had a long-term commitment internationally to provide education and training for physicians interested in developing or improving their skills in the transradial technique,” said Gary Clifton, Senior Marketing Manager, Cardiology, Terumo Interventional Systems. “For the past several years, through the use of dedicated simulators, training seminars, physician training programs and dedicated radial products, our U.S. division has made available the tools and training necessary for the healthcare community to increase its use of the radial access as a way to improve patient outcomes. In the past year alone, Terumo has helped facilitate training for over 100 physicians throughout the U.S.” The symposium began with Dr. Stone (New York-Presbyterian Hospital, Columbia University Medical Center and The Cardiovascular Research Foundation, New York, NY), who emphasized the “patient-friendly” aspect of transradial intervention, noting some evidence of reduced major adverse cardiac event (MACE) rates. He also mentioned that TCT has been running transradial seminars for 5 years, but attendance this year at the seminars has dramatically increased. Dr. Popma (Beth Israel Deaconess Medical Center, Boston, MA) pointed out that a mere 1% of cases in the American College of Cardiology National Cardiovascular Data Registry (NCDR) database were performed using a transradial technique. Using the transradial approach only as alternative access is not ideal, said Dr. Popma. “Simply waiting until there is a contraindication to a femoral approach means you aren’t going to do as good an intervention as a transradialist,” he said. Brigham and Women’s has one of the few 600-lb weight limit tables in its cath lab, and Dr. Popma discussed a morbidly obese patient who literally walked out of the lab after an extensive intervention, a direct result of the transradial technique. He also addressed concerns about longer fluoroscopy times, which are mitigated by experience, he said. Dr. Popma concluded with a discussion on the lower reimbursements for PCI and stenting, noting that transradial access will help discharge patients earlier and is safe. Dr. Rao (Durham VA Medical Center, Durham, NC) argued that particularly in light of the COURAGE trial data, PCI needs to be made safer and more comfortable for all patients. Reducing bleeding is a “clinical priority,” particularly as transfusion is associated with a worse 30-day mortality rate. From a financial perspective, Dr. Rao noted data showing that every severe or moderate bleeding event is associated with an increased hospital cost of approximately $3,000, and the majority of bleeds are related to the access site. The reduction in bleeding seen with transradial access may work to reduce MACE and also increase survival, but more data is needed, and should be available as some clinical trials get underway. Meanwhile, “I don’t think closure devices are the answer to reducing vascular complications,” said Dr. Rao. Closure devices do save a little money, he said, noting data demonstrating a $44 reduction per patient from closure device use, but compared that to thousands of dollars saved with a transradial approach. Based on the available data, the default approach should be transradial, Dr. Rao concluded, and cited a “lack of knowledge and training” as a primary reason for its slow adoption in the U.S. Dr. Thompson (Yale University School of Medicine, New Haven, CT) spoke on patient selection for the transradial approach, sharing some tips and tricks. Most of his transradial cases are done via 6 French and he mimics the ergonomics of a transfemoral approach in his radial access, noting “for a right radial approach, we can keep the right hand by the side [of the patient]” rather than sticking it out to the side. Access should be in the ‘fleshy’ portion of the wrist (Dr. Thompson commented that often access is gained too low on the wrist), since the artery is slightly larger at this point. The new hydrophilic slipsheaths do increase patient comfort as well as make things easier overall. He recommended use of a steerable, floppy 0.035” guidewire to the aorta with the catheter, emphasizing that adequate guide support is more important in the transradial approach than with the femoral approach. You should not have pain when you are traversing the arm, he said, and this is a situation where the operator should not push, but “back off and redirect.” Balloon anchoring during PCI is also crucial for helping maintain guide catheter position. “Your learning curve will be faster than you think it is,” he concluded. Dr. Tremmel (Stanford University Medical Center, Stanford, CA) spoke on starting a successful transradial interventional program, reflecting on her first 15 months of transradial access. A strong transradial program will arise if operators meet certain fundamentals, she said, including a good reason for doing transradial access (personal motivation), training, cath lab support, equipment, and patience and perseverance. Dr. Tremmel described ways to obtain transradial training and emphasized the importance of involving and training nurses and technologists, as well as obtaining the support of colleagues and administrators. For the individual operator, “training courses are hands-on and last about a day, which surprisingly is fully adequate for providing the knowledge and comfort needed to get started,” Dr. Tremmel said. “I had a strong reason to start doing radial procedures, wanting to reduce bleeding and vascular complications in women.” For more information, visit www.invasivecardiology.com, and click on the Journal of Invasive Cardiology supplement, titled “Perspectives on Transradial PCI,” located at the top right of the home page. ______________________

Philips and Maquet to Provide Integrated Solution for Minimally Invasive and Open Surgical Procedures

At the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Royal Philips Electronics announced that it will integrate the Maquet ‘Magnus’ surgical table with Philips’ cardiovascular x-ray systems to create an efficient ‘hybrid operating room’ environment for a full range of minimally-invasive and open surgical procedures. Worldwide, there has been a shift away from open surgical procedures as hospitals increasingly move towards more same-day and minimally invasive surgery. As a result, over half of patients leave hospital on the same day as their operation[i]. Catheter-based cardiac treatments have also seen a large rise in comparison with open vascular procedures. As a result, hospitals today require rooms for minimally invasive procedures that are flexible and easily adaptable, and are able to accommodate the full range of current and future surgical technologies. The solution provided by Philips and Maquet will offer a cost-effective response to this changing healthcare landscape by optimizing workflow and simplifying the room planning and installation process. The tailored, simplified work environment will help increase the efficiency of procedures and decrease the amount of time that the patient spends in hospital. Bert van Meurs, senior vice president of Cardiovascular X-ray at Philips Healthcare, said, “By integrating Maquet’s Magnus table we can allow both minimally invasive procedures and open surgery to take place in a single space, simplifying the clinicians’ work environment.” At TCT, Philips also unveiled the ‘3D Heart Navigator’ interventional tool, which combines 3D CT images of a patients’ cardiac anatomy captured before a procedure into a single image with an overlay of the live x-ray fluoroscopy information. Clinicians attending TCT viewed a percutaneous aortic valve device implantation procedure using the 3D Heart Navigator solution that was broadcast live from Catharina Hospital, Eindhoven, the Netherlands. “The combined emergence of transcatheter valves and sophisticated interventional tools like Philips’ 3D Heart Navigator means that we’re able to have a major positive impact on the lives of a group of patients who we would’ve previously been unable to help,” commented Dr J.J. Koolen, Head of the Department of Cardiology, Catharina Hospital. “Replacing a valve in a beating heart is a very challenging procedure. By combining static 3D images with the live 2D image, we get a much better understanding of the patient’s anatomy.” The solution combining Philips’ Allura interventional X-ray solutions and Maquet’s Magnus OR table, as well as the Philips 3D Heart Navigator Tool, are scheduled for commercial release in 2010. [i] “Future of the operating room: Strategic forecast and investment blueprint,” Facility Forecast Brief supplement, The Advisory Board Company (www.advisoryboardcompany.com), 2007 ______________________

Results from Abbott’s PROSPECT Study Provide New Insight into Role of Vulnerable Plaque in Coronary Artery Disease

Abbott announced primary results from its PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) clinical trial. PROSPECT is the first prospective natural history study to evaluate the role of vulnerable plaque in unexpected heart attacks and the natural progression of coronary artery disease. Results were presented during the late-breaking clinical trials session by Gregg W. Stone, MD, professor of medicine at Columbia University Medical Center, during the 2009 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting. “We know that certain vulnerable plaques lead to sudden cardiac death, but until now, our understanding of how these plaques progress has been extremely limited,” said Dr. Stone, who is also immediate past chairman of the Cardiovascular Research Foundation, New York, and principal investigator of the PROSPECT study. “PROSPECT has provided fundamental insights into our understanding of atherosclerosis. Conventional wisdom has been that if we could identify vulnerable plaques, we would be able to determine who might be at risk for a serious cardiac event and treat them prophylactically.” Vulnerable plaques are inflamed, lipid-rich lesions that form in the walls of the arteries and usually have thin, fibrous caps. The relationship between vulnerable plaque ruptures and sudden cardiac death is well known, but until the PROSPECT study, no systematic effort had been made to prospectively understand the event rate associated with progression of vulnerable plaque. Unlike hardened plaque, vulnerable plaques are often not visible with angiography and do not actually block blood flow in coronary arteries unless their rupture results in a clot. Among the findings of the 700-patient study, researchers were able to identify the common characteristics of lesions that put patients at highest risk for future cardiac events by using virtual histology intravascular ultrasound (VH® IVUS) and standard angiography. Going forward, investigators will now have access to more than 40,000 datapoints derived from 150 variables within each of the patients, far beyond the level of assessment of previous interventional studies. “While the prognosis of patients with acute coronary syndromes undergoing successful stenting and treated with contemporary medical therapy is favorable, we are now able to identify those lesion types with a significantly increased likelihood of causing future cardiovascular events,” Stone said. The PROSPECT study recruited patients who were in need of a PCI (percutaneous coronary intervention) for acute coronary syndrome (ACS), which included unstable angina, NSTEMI or STEMI. Patients consented to collection of additional data as follow-up to their procedure, including VH IVUS imaging and standard angiography. PROSPECT collected data about characteristics of vulnerable plaque lesions that were present, but not causing symptoms at the time of the procedure. The goal was to correlate lesion characteristics, patient risk factors and biomarker measurements with subsequent heart attacks and other cardiac events, potentially paving the way for physicians to identify and treat at-risk patients before a heart attack occurs. Study Findings. In the study, approximately 20 percent of the patient population experienced a major adverse cardiac event (cardiac death, cardiac arrest or heart attack) within three years of enrollment. Half of these events can be attributed to the original “culprit” lesions (those treated with PCI) and half to previously untreated, “non-culprit” lesions of the three-vessel coronary tree. Half of the patients treated for non-culprit events exemplified the classic notion of vulnerable plaque. The event rate, particularly that attributed to vulnerable plaques specifically, was lower than expected. Further, patients who experienced “non-culprit” events in the years following PCI were more likely to present with progressive or unstable angina, and rarely with cardiac death, arrest or MI. Imaging of the lesions that did progress to events suggests that vulnerable plaque lesions with a large plaque burden and large necrotic core without a visible cap were at especially high risk for future adverse cardiovascular events. PROSPECT enrolled 700 patients from 40 clinical centers across the United States and Europe. Patient follow up continued for three years. Abbott sponsored the study and VH IVUS imaging technology was provided by Volcano Corporation. ______________________

Z-Medica QuickClot® Interventional™ Hemostatic Bandages Now Available for Use During Catheterization Procedures

Z-Medica Corporation, a medical device company developing hemostatic agents, announced the availability of the QuikClot® Interventional™ hemostatic bandage, on display at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. One of the primary applications for the new QuikClot Interventional hemostatic bandage is to control arterial and venous bleeding following cardiac catheterization or other vascular access procedures. QuikClot Interventional is a non-invasive hemostatic bandage indicated for use in the local management and control of external bleeding from vascular access sites and percutaneous catheters or tubes utilizing sheaths of up to 12 Fr. It is safe to use and proven effective for use on femoral and other arterial and venous bleeds. It contains an inert and inorganic mineral that has no known contraindications and accelerates the body’s natural hemostatic process. The product does not require any advance preparation and is double-packaged in a blister package and a foil pouch for aseptic technique. It includes a 3M® Tegaderm® adhesive bandage for easy application. QuikClot Interventional is applied in three simple steps and requires no special training. The healthcare professional removes the hemostatic pad from the packaging and places it into the sterile field using sterile technique. The hemostatic pad is then placed on the puncture site and manual pressure is applied for at least five minutes or until bleeding stops. Finally, without moving or lifting the pad, the 3M Tegaderm adhesive bandage is applied over the pad and secured to the skin, while manual compression is maintained. The QuikClot hemostatic pad may be left in place for up to 24 hours and can be removed by gently peeling away the Tegaderm bandage and removing the pad. QuikClot Interventional is currently being used in several interventional cardiology and radiology laboratories across the U.S. Recently, Z-Medica Corporation has gathered over 300 documented reports of human use of this product with an overall success rate of 98.2%, meaning that this novel device was able to achieve hemostasis in virtually all cases following arterial and venous catheterization. Z-Medica’s QuikClot® Combat Gauze™ product was chosen by the Committee on Tactical Combat Casualty Care (TCCC) as the United States Military’s sole source supplier for first-line hemostatic treatment, based on tests conducted by the Naval Medical Research Center and the U.S. Army Institute for Surgical Research. ______________________

Xience V® Superior to Taxus® in Key Safety and Efficacy Measures in SPIRIT IV Trial

At One Year, Xience V Demonstrates: - Statistical Superiority on Primary Endpoint of Target Lesion Failure, with a 38% Reduction Compared to Taxus - 74% Reduction in Stent Thrombosis Compared to Taxus - Low Event Rates across Multiple Subgroups of Complex Patients Late-breaking data from the SPIRIT IV trial demonstrated that Abbott’s Xience V® Everolimus-Eluting Coronary Stent System achieved superiority in the key safety and efficacy measures of target lesion failure (TLF) and target lesion revascularization (TLR) compared to the Taxus® Express2™ Paclitaxel-Eluting Coronary Stent System at one year. With 3,690 patients, the SPIRIT IV trial is one of the largest randomized clinical trials between two drug-eluting stents. In the trial’s primary endpoint, Xience V demonstrated a statistically significant 38% reduction in TLF compared to Taxus (4.2% for Xience V vs. 6.8% for Taxus, p-value = 0.001). TLF is defined as cardiac death, target vessel myocardial infarction, and ischemia-driven TLR (ID-TLR). The standard was established to harmonize the definition of major adverse cardiac events across various drug-eluting stent trials. Xience V also demonstrated a statistically significant 46% reduction in TLR compared to Taxus (2.5% for Xience V vs. 4.6% for Taxus, p-value = 0.001). TLR is one of the major secondary endpoints of the SPIRIT IV trial. The results were presented by Gregg W. Stone, MD, professor of medicine at Columbia University Medical Center, during the 2009 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. “Importantly, SPIRIT IV was performed without routine angiographic follow up, which may result in a tendency to treat lesions which may not be causing symptoms, and potentially impact results,” said Dr. Stone, who is also immediate past chairman of the Cardiovascular Research Foundation, New York; and principal investigator of the SPIRIT IV trial. Additional information about Xience V, including important safety information, is available online at www.xiencev.com. ______________________

Abiomed Presents Results From Two Studies: USpella and MACH II

Abiomed Inc. announced new clinical data from USpella, the first U.S. multicenter registry of Impella 2.5 patients evaluating the safety and feasibility of left ventricular support with the Impella 2.5 during high-risk percutaneous coronary intervention (PCI) and treatment of acute myocardial infarction (AMI). USpella: First U.S. Registry Data Evaluating 181 Patients From 16 Centers with IRB Approval; MACH II: Three-Year Follow Up USpella, presented at TCT 2009 by Brijeshwar Maini, MD, co-chair, cardiovascular research, interventional cardiologist, Pinnacle Health; attending cardiologist, Moffitt Heart & Vascular Group, evaluated data from 16 Impella 2.5 centers with IRB approval and over 181 patients from the more than 1,000 reported commercial Impella 2.5 cases. The registry examined both high-risk PCI and AMI patients, reporting the following results: High-risk PCI patient results in USpella • In 64% of the high-risk PCI cases, the patients had been turned down for coronary artery bypass graft surgery before treatment with Impella 2.5; • The high-risk PCI population presented with a more complex anatomy than the SYNTAX trial population (of 23), decreasing SYNTAX score from 38 to 18 after effective revascularization with Impella 2.5. • Registry results reaffirmed ejection fraction increases that were similar to PROTECT I results, with improved ejection fraction in USpella high-risk PCI patients increasing from 29 to 34, after Impella 2.5 support. • Reported overall MACE was low at 6%. • 30-day survival rate was 97%. AMI patient results in USpella • Impella was used after conventional therapies failed [88% after emergent revascularization; 88% after high-dose inotropes; 68% after intra-aortic balloon pump (IABP) therapy]. • Impella improved hemodynamics in AMI shock patients, improving cardiac index from 1.9 to 2.5 l/min/m2, increasing mean arterial pressure from 62 to 87 mmHg, and decreasing wedge pressure from 28 to 20 mmHg, as well as decreasing overall systemic vascular resistance (SVR). • After Impella 2.5 support, overall ejection fraction in AMI patients improved from 29 to 37%. • Impella successfully supported AMI refractory shock patients with 69% survival to the next therapy or on to recovery. Also, 58% of AMI shock patients and 89% of AMI patients with no shock were discharged. Maini concluded, “USpella is the largest IRB registry reported so far for Impella 2.5 that confirms prior positive study results. Impella is safe and easy to use, provides excellent support to stabilize the patients during high-risk PCI, and restores the hemodynamics in unstable conditions refractory to conventional therapies.” Three-year Follow Up of MACH II Trial Abiomed Inc. also announced new clinical data from Academic Medical Center’s (AMC) three-year follow-up results from patients in the Impella 2.5 arm of the MACH II trial, revealing improved left ventricular function, cardiac output and quality of life. The MACH II trial, evaluating safety and feasibility in STEMI, included 20 patients; ten patients were treated with three days of Impella 2.5 support; ten control patients were treated with routine standard of care. The initial four-month results, which demonstrated significant recovery of left ventricular function in Impella 2.5 patients, were published in the Journal of American College of Cardiology in 2008. The three-year follow-up results from MACH II were presented by Jose PS Henriques, MD, PhD, Academic Medical Center, University of Amsterdam, at the Abiomed customer evening symposium at TCT 2009. The results measured the three-year follow-up of 20 large anterior STEMI patients in the MACH II trial and demonstrated significant overall improvements in cardiac function as well as quality of life in the ten patients that received Impella 2.5 within the trial. All patients were measured in an IRB-approved protocol that calculated echo results, exercise testing and quality of life, and showed the following results from core laboratory analysis and strict processes: • Left ventricular ejection fraction (LVEF) in Impella 2.5 patients increased from 28% at the baseline, to 41% in the four-month analysis, to 51% at the three-year follow-up period. LVEF in the control patients increased from 40% at the baseline, to 45% after the four-month analysis to 47% at the three-year analysis. Impella 2.5 patients continued to show improvement in LVEF, demonstrating a net increase of 23 ejection fraction points while control patients only showed a net increase of 7 ejection fraction points. • Significant benefit in exercise capacity was demonstrated in Impella 2.5 patients as compared to control patients. • Impella 2.5 patients saw no effects on aortic valve function at three-year follow up. “The initial MACH II results demonstrated that Impella had sustained benefits at four months and the three-year analysis, showing a 10% increase in ejection fraction, is an even stronger indicator that this device will make a significant difference in AMI treatment,” said Henriques. “Additionally, these findings could suggest that Impella 2.5 patients who have been discharged have higher rates of recovery and lower chances of hospital re-admittance.” For additional information, please visit www.abiomed.com. ______________________

Toshiba Introduces Its Next-Generation CV-3D™ for Infinix™ Cardiovascular X-ray Systems

Reconstructs 2D X-ray Images into 3D to Improve Stent Placement Accuracy Toshiba America Medical Systems, Inc. has introduced its Next Generation CV-3D™ workstation and software package available on the Infinix-i x-ray product line. Next Generation CV-3D is an integrated reconstruction workstation and software, designed to take a 2D X-ray image and reconstruct a new, more detailed 3D image in a matter of seconds. Toshiba showcased Next Generation CV-3D at this year’s Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco. The new image provides a 3D reconstructed view of the same vessel under study. CV-3D visualization assists physicians in selecting the most appropriate stent. The latest enhancements optimize stent selection and positioning by automatically including markers in the view and providing a clear view of the stent in relationship to the vessel wall, which validates proper stent deployment. Clinicians also can increase workflow by utilizing the Infinix-i tableside controls to display the preferred CV-3D image in the examination room. ______________________

Taxus® Liberte® Stent Continues to Demonstrate Significant Improvements Over Taxus® Express® Stent in Small Vessels and Long Lesions

Boston Scientific Corporation announced comprehensive data from the TAXUS ATLAS clinical program, a series of global, prospective, single-arm trials evaluating the Taxus® Liberte® Paclitaxel-Eluting Stent System in a variety of lesions and patient groups. Three-year results from the TAXUS ATLAS Small Vessel and Long Lesion Trials continue to show significant advantages for the newer Taxus Liberte Stent when compared to the first-generation Taxus® Express® Stent. The data were presented at the 21st annual Cardiovascular Research Foundation’s (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco. The TAXUS ATLAS Small Vessel Trial was designed to evaluate the long-term safety and efficacy of the 2.25 mm diameter Taxus Liberte Atom™ Stent in small coronary vessels. The TAXUS ATLAS Long Lesion Trial was designed to assess the long-term safety and efficacy of the Taxus Liberte Long 38 mm Stent in patients with long coronary lesions. Three-year results from the TAXUS ATLAS Small Vessel Trial demonstrated a statistically significant reduction in the rate of target lesion revascularization (TLR) in small vessels treated with the Taxus Liberte Atom Stent as compared to the Taxus Express Atom Stent (10.0% vs. 22.1%, p=0.008), representing a 55% relative risk reduction. Additionally, the three-year MACE rate for the Taxus Liberte Atom Stent was 19.5% as compared to 32.4% for the Taxus Express Atom Stent (p=0.03), a relative reduction of 40%. The composite safety measure of cardiac death or myocardial infarction (MI) remained numerically lower at three years for the Taxus Liberte Atom Stent as compared to the Taxus Express Atom Stent (6.5% vs. 7.4%, p=0.79). “The Taxus ATLAS Small Vessel Trial showed a sustained and significantly reduced risk of revascularization in small vessels for the Taxus Liberte Atom Stent as compared to the Taxus Express Atom Stent out to three years,” said Mark A. Turco, M.D., Director of the Center for Cardiac and Vascular Research, Washington Adventist Hospital, and Co-Principal Investigator of the trial. “Positive three-year data from the Taxus ATLAS Long Lesion Trial showed the Taxus Liberte Long Stent significantly reduces the risk of MI and cardiac death in long lesions compared to the Taxus Express Stent, while reporting zero percent stent thrombosis. These data, combined with the previously reported reduction in nine-month late-loss, suggest that these improvements are likely the result of the thinner struts and improved stent geometry of the Taxus Liberte Stent.” In the TAXUS ATLAS Long Lesion Trial, the Taxus Liberte Long Stent demonstrated significantly improved safety outcomes when treating long lesions compared to the Taxus Express Stent. The rate of cardiac death showed a significant 78% reduction in patients treated with the Taxus Liberte Long Stent compared to the Taxus Express Stent (1.5% vs. 6.7%, p=0.03). Overall MI showed a significant 72% reduction at three years in patients receiving a single Taxus Liberte Long Stent compared to a single Taxus Express Stent (2.9% vs. 10.4%, p=0.01). This improvement was primarily driven by a significant reduction in non-Q wave MI. The Taxus Liberte Long Stent had zero stent thrombosis at three years using either the Protocol definition or the ARC definite/probable definition while the control Taxus Express Stent reported 0.8% stent thrombosis (p=0.49) using the Protocol definition and 3.9% (p=0.03) using the ARC definition. ______________________

Maquet Cardiovascular Receives FDA Clearance For Mega™ 8 Fr. 50 cc Intra-Aortic Balloon Catheter

Maquet Cardiovascular LLC announced that the United States Food and Drug Administration has cleared the company’s Mega™ 8 French (Fr) 50cc intra-aortic balloon (IAB) catheter. A 50cc IAB with a true 8 Fr shaft, the Mega has a smaller insertion point than traditional 50 cc IABs and offers additional blood volume displacement for intra-aortic balloon counterpulsation. Mega, compared to 40cc IABs, delivers 25% more blood volume displacement and provides improved unloading and augmentation.* The Mega will be available for distribution beginning in September 2009. “I recently admitted a critically ill, approximately 400-pound patient and inserted the Mega 50cc balloon,” stated George W. Christy, MD, FACC, interventional cardiologist with Advocate Christ Medical Center’s Transplant and Assist Device team in Oak Lawn, IL. “The increased augmentation we observed from Mega allowed us to stabilize the patient.” Dr. Christy believes that “the Mega gave us the needed window of time to consider further alternatives to manage this patient.” Maquet Cardiovascular recently acquired Datascope, a provider of gold-standard IABs and cardiac assist products. Since the Mega has no step down between the catheter shaft and the balloon material, it may be inserted sheathless or through an 8 Fr sheath. Because of its unique design, it can benefit patients presently using both 50cc and 40cc IABs. Additional benefits include a Durathane blow-molded balloon membrane, a full-length polyimide lumen with no gas lumen insert, and numerous safety features, such as a T-handle protector to keep the membrane tightly wrapped prior to use. “Since the Mega is indicated for patients 5’4” and taller, I would generally use it as my standard balloon moving forward,” said Dr. Christy. “It’s straightforward, easy to insert, and compatible with all the standard consoles.” ______________________

Symplicity I Trial Demonstrates Durable Blood Pressure Reduction in Hypertension Patients Treated with Symplicity® Catheter System™

Data supporting the long-term safety and effectiveness of renal sympathetic denervation (RDN) in treating patients with chronic hypertension were presented at the TCT conference, showing that patients in the Symplicity I Trial maintained a clinically significant reduction in blood pressure at one year following treatment. The Symplicity I Trial evaluated a catheter-based treatment for chronic hypertension, enrolling patients who had persistent elevated blood pressure despite taking an average of 4.7 medications. The multicenter study was conducted in Australia and Europe, using the Symplicity® Catheter System™ manufactured by Ardian, Inc. Early results from this same trial were also reported in The Lancet (April 11, 2009) and The New England Journal of Medicine (August 27, 2009). The study’s co-principal investigator, Professor Henry Krum, (Director, Center of Cardiovascular Research & Education in Therapeutics, Monash University, Melbourne, Australia) reported that the simple, 40-minute procedure safely produced a mean blood pressure reduction of -27/-17 mmHg at 12 months in the study cohort. These findings suggest that the single, catheter-based intervention may achieve a durable, clinically important reduction in blood pressure in this very difficult to treat population. Both vascular and renal safety were also carefully assessed in the study and reported. Renal vascular safety was assessed by imaging treated arteries both acutely and chronically for up to 9 months. No evidence of treatment-related abnormalities or stenoses was reported. Kidney function was assessed with serial measures of serum creatinine and calculation of glomerular filtration rate (GFR). The mean GFR in the study cohort remained stable at 12 months. Based on these results, Ardian, Inc. has initiated the Symplicity HTN-2 trial, a prospective, multicenter randomized study comparing patients treated with renal denervation to those receiving rigorous medical therapy. The trial will enroll 110 patients with blood pressure over 160 mmHg, despite taking 3 or more anti-hypertensive medications. The primary endpoint for the trial will be blood pressure reduction at 6 months. Kidney function, vascular safety and additional efficacy measures will also be assessed. Patients will be followed for 3 years. The Symplicity Catheter System delivers radiofrequency energy from within the renal artery to block conduction in the surrounding renal nerves, counteracting chronic activation of the sympathetic nervous system. The treatment is performed in the cath lab using routine interventional techniques similar to those used in renal stent procedures. The Symplicity Catheter System has received CE Mark approval in Europe but remains investigational in the United States. Visit CathLabDigest.com to learn about the Symplicity Catheter System from Dr. Krishna Rocha-Singh: https://tinyurl.com/yd9gk7u

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