CD&Ds

Siemens Healthcare< (Mountain View, California) unveiled its Acuson SC2000 volume imaging ultrasound system, which it says is the first system to acquire non-stitched, real-time full-volume 3-D images of the heart in one single heart cycle, during the 19th annual meeting of the American Society of Echocardiography (ASE; Raleigh, North Carolina) in Toronto.

Calling it "Echo in a Heartbeat," Siemens said the new technology marks "the greatest paradigm shift in ultrasound since the introduction of 2D imaging in the late 1970s." Instantaneous, non-stitched full-volume imaging comes 55 years after echocardiography pioneers Inge Edler and Hellmuth Hertz acquired the world's first cardiac ultrasound recording using Siemens technology in 1953, the company said.

Louise Kruz, senior marketing manager for echocardiography solutions at Siemens, business unit ultrasound, told Cardiovascular Devices & Drugs that Siemens had to overcome some key technical challenges to make the Acuson SC2000 stand out from the competition.

"Currently the products on the market use a 'stitched' image because they are limited by how much information and the rate at which they can acquire it they stitch shorter images together to cover the entire cardiac structure," she said. "The Acuson SC2000 can acquire at such a rate that we can cover the whole heart, a 90-degree by 90-degree imaging angle, and an acceptable frame rate at 20 or greater.

"The heart is a moving organ, so if you have to stitch something together you're kind of corrupting the clinical information," Kruz said, noting that the Acuson SC2000 offers purer information because it images one cardiac structure on the same heartbeat.

Another challenge that all other systems that do stitched imaging face, she said, is that those images often are gated by the ECG, an electrical tracing of the heart, so when the patient has an arrhythmia it makes it difficult to image. Also, patients being unable to hold their breath is a problem for clinicians using a stitched-imaging ultrasound system. With the Acuson SC2000, the patient does not have to hold their breath.

Another challenge for competing ultrasound systems, Kruz told CD&D, is those patients who are difficult to image, such as those who are obese, those who smoke, or a patient who has end-stage renal disease. This category of patients makes up about 30% of the patient population, but she said this percentage is probably is understated.

"Innovation has always been the lifeblood of Siemens, and the Acuson SC2000 volume ultrasound system is delivering on this promise," said Klaus Hambuechen, CEO, ultrasound for Siemens Medical Solutions USA. "The system has unparalleled capabilities in information rate processing that allow us to acquire a full volume of the entire heart with 90 degree pyramids. With a high-volume acquisition rate like this — in one second, every second — acquisition time is dramatically reduced, improving the overall workflow in the echocardiography suite."

Siemens says that the Acuson SC2000 system "is Siemens' premier cardiology platform that will change the way echocardiography is practiced today."

The company says that Acuson's architecture delivers vastly more information than conventional systems and is strengthened by Siemens' Coherent Volume Formation technology. Coupled with the system's high-volume acquisition rate, Coherent Volume Formation moves away from serial line-by-line acquisition towards simultaneous, multiple beams, delivering excellent image resolution, Siemens said.

The 4Z1c transducer features active cooling technology, enabling full output power within regulatory limits, according to the company. This results in improved penetration, reduced noise and high-volume acquisition rates when compared to conventional 3-D transducers. The 4Z1c is a single transducer solution for adult echo applications that provides all the modes needed: volume imaging, 2D, M-mode, color Doppler and spectral Doppler.

The Acuson system is designed to support advanced cardiovascular applications with knowledge-based workflow software using learned pattern recognition technology and an expert database of real clinical cases. This enables the system to recognize anatomical patterns and landmarks, as well as to perform automatic measurements streamlining clinical workflow.

Other features include the ability to derive reference plane images from the full-volume cardiac capture dataset and offers automated full-volume contouring for fast qualitative and quantitative analysis. Customizable, programmable, and protocol-driven workflow sequences deliver repeatability for better outcomes: greater efficiency, accuracy, consistency, and care from data acquisition to diagnosis. To further enhance efficiency, the offline workstation enables reporting, as well as complete review and processing of the acquired volumes.

According to Siemens, it has addressed the ergonomics of the system to meet and exceed today's recommended ergonomic guidelines to reduce work-related stress injuries and to accommodate the varied work environment of sonographers.

"Siemens has a reputation for going after the difficult-to-image patient," Kruz said. "We target the hard ones, not the easy ones, because everyone can do the easy patients."

Elsewhere in the product pipeline:

Abbott (Abbott Park, Illinois) reported the launch of the StarClose SE vascular closure system, a next-generation vessel closure device designed to enable fast and secure closure of the femoral artery access site following a catheterization procedure. Abbott said the StarClose SE advancements include an intuitive, numbered system, providing visual guidance and audible "clicks" for each step leading to clip deployment; immediate vessel closure with deployment of a shape-memory clip onto the surface of an artery, allowing patients to recover and be discharged sooner than with manual compression; and added device stability for the operator during clip deployment. Abbott's vascular division focuses on advancing the treatment of vascular disease.

Abiomed (Danvers, Massachusetts) received FDA 510(k) clearance for its Impella 2.5 cardiac assist device, a new tool for the cath lab that to increase blood flow to the heart muscle and vital organs. The current "gold standard" for short-term cardiac support is intra-aortic balloon pumping (IABP), with about 110,000 cases per year in the U.S. using this technology. Abiomed reported late last year that it had received FDA approval for its own IABP system, the iPulse, in 2006. The Impella 2.5 is inserted percutaneously in the cath lab via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations. Impella is cleared for use under the 510(k) for partial circulatory support for periods up to six hours. "FDA clearance of the Abiomed Impella 2.5 represents the next step in enabling heart recovery for patients in the U.S. and will likely change the standard of care in the catheterization lab," said Michael Minogue, president/CEO of Abiomed. "The device seamlessly provides immediate, minimally invasive circulatory support for critical patients." The clearance allows Abiomed to begin selling the device to the estimated 14,000 interventional cardiologists at about 1,700 heart hospitals in the U.S. "Commercial launch starts today," Minogue said in a conference call. Abiomed is charging $50,000 for a console needed to run the pumps and $20,000 for each disposable unit. The Impella is approved in more than 40 countries, including for up to seven days of support under the CE-mark in Europe.

AngioScore (Fremont, California) reported the start of enrollment in the AngioSculpt scoring balloon catheter multi-center coronary bifurcation study, or AGILITY trial. The AGILITY trial will enroll 100 patients with coronary bifurcation lesions at eight premier interventional cardiology programs in the U.S. and follow these patients for nine months. AngioScore says the AngioSculpt scoring balloon catheters represent the next generation in angioplasty catheters for both coronary and peripheral artery disease. Their nitinol elements provide circumferential scoring of plaque, leading to precise and predictable luminal enlargement across a wide range of lesion types while avoiding "geographic miss" through their unique anti-slippage properties. AngioScore makes angioplasty catheters for treatment of cardiovascular disease.

Biopure (Cambridge, Massachusetts) received positive news with publication of data in the June edition of the Journal of Trauma, termed the first Phase III trial to compare its blood substitute, HBOC-201, with natural blood, at 46 sites in the U.S., Europe and South Africa. "The majority of patients who received [Hemopure] did well," said Jonathan Jahr, MD, lead author and professor of clinical anesthesiology at the David Geffen School of Medicine at UCLA. The six-week study involved 688 patients, 18 and older, undergoing elective orthopedic surgery, requiring large amounts of blood. Patients initially received either one unit of blood, about a pint, or an equivalent one unit or 65 grams of HBOC-201, a hemoglobin-based oxygen carrier made from a bovine source. Patients could receive up to 10 units of the blood substitute during a six-day period, or for those in the study group receiving regular blood, unlimited transfusions. Subjects were evaluated daily and six weeks post-operatively. "We found that we eliminated the need for blood transfusions for 59% of the 350 patients who received the blood substitute," said Colin Mackenzie, MD, study author and professor and former director at the National Study Center for Trauma & EMS, University of Maryland School of Medicine (Baltimore). He said HBOC-201 worked best in those under 80 {with a moderate transfusion need" but that for those over 80, with more acute health issues and higher transfusion needs, HBOC-201 did not work as well as blood and many were crossed over to the blood group. Adverse events involving the cardiac and central nervous systems occurred in 21 of the older patients, due to advanced age, heart failure or possibly under-treatment, the researchers concluded. Mortality in both groups with moderate transfusion needs was just 1%. The higher transfusion need groups reported a 5% mortality rate in the blood substitute group, 3% in the group receiving regular blood, comparable, according to the researchers. Side effects among those receiving HBOC-201 — described as less serious and due to this class of product, included jaundice, elevated blood pressure and enzyme increases. These effects were temporary, Jahr said, but "should be studied in future trials." The majority of the 350 patients in the study arm received an average of five or less units of HBOC-201. The 338 patients receiving natural blood were given an average of less than 2 units.

Biotronik (Lake Oswego, Oregon) reported release of two new bipolar coronary sinus leads for use in the left ventricle for cardiac resynchronization therapy (CRT). The Corox OTW BP and Corox OTW S-BP leads offer a design that allows them to fixate in even unusual coronary vessel anatomies, which can preclude the use of other leads. They are designed for use in patients with heart failure. The Corox OTW S-BP has a threaded silicone fixation mechanism that allows the lead to attach itself in very narrow or short coronary veins. The Corox OTW BP has a progressive curve helix that expands much like a stent, enabling the lead to achieve stable fixation in a wide range of coronary veins, including very large-diameter vessels. Biotronik is a cardiovascular medical device company.

Boston Scientific (Natick, Massachusetts) received FDA approval of its Cognis cardiac resynchronization therapy defibrillator and Teligen implantable cardioverter defibrillator. The actions came a year after the FDA lifted restrictions on a unit of Boston Scientific that had prohibited the company from winning product approvals for cardiac rhythm management devices. "Boston Scientific completed the purchase of Guidant two years ago," Chas Mckhann, vice president of marketing for Boston Scientific CRM, told CD&D. "Since then, we've invested hundreds of millions of dollars into quality improvements... . We're now seeing the benefits of that effort with the fast approvals from FDA." Cognis and Teligen were built from a common platform known as Frontier, which has been Boston Scientific's single largest project investment. The company said that a major benefit of both devices is their size - much smaller than similar devices on the market, according to Boston Sci. The company did so with older and female patients in mind. The Cognis CRT-D and the Teligen ICD are 32.5 cc and 31.5 cc, respectively, and both are less than 10 mm thick. Both also have extended battery longevity over previous company devices, self-correcting software and improved programming technology. The new battery technology provides a life of six years for Cognis and seven to eight years for Teligen, both about one year longer than previously available.

Braemar, a subsidiary of Biotel (both Minneapolis), a developer of ambulatory cardiac monitoring devices, has introduced the DL900, an advanced digital Holter monitor. At 1.75 ounces, the new monitor is compact and discrete, yet provides a large liquid crystal display (LCD) and extended recording time of up to seven days, according to the company. A custom analog IC for signal acquisition is the technology platform for the advanced capabilities of the DL900. The device was showcased at the recent American College of Cardiology (Washington) conference in Chicago and the Heart Rhythm Society (Washington) conference in San Francisco. The device combines high-speed USB transfer capability with the ability to use a removable SD memory card. A programmable pacemaker detection capability provides the clinician with additional data. Braemar manufactures ambulatory cardiac monitoring and other medical devices as an OEM partner.

Cardiac Dimensions (Kirkland, Washington) said it has completed its European Carillon Mitral Annuloplasty Device European Union Study (AMADEUS). AMADEUS was a safety and performance study of the Carillon mitral contour system conducted at six centers in Germany, Poland and the Netherlands. The Carillon system is a percutaneous treatment of functional mitral regurgitation, currently under investigational use in Europe, South America, and Australia only. The Carillon combines an implantable device and delivery system. The implant consists of a shaping ribbon between distal and proximal anchors. The device is delivered percutaneously via jugular access under fluoroscopic guidance. The implant is designed to be positioned, adjusted and anchored in the coronary sinus/great cardiac vein to reshape the annulus around the mitral valve to reduce mitral regurgitation.

Cardiac Science (Bothell, Washington) said it has completed certification for its HeartCentrix ECG informatics software with the Allscripts Electronic Health Record (EHR). The connectivity between Cardiac Science said that its equipment and the EHR from Allscripts (Chicago) will help physicians streamline the diagnostic cardiology workflow in their offices, eliminate a source of data transcription errors, and provide a unified view of patient diagnostic data. With HeartCentrix ECG informatics, physicians will have immediate access to view or edit a patient's test results electronically and later retrieve the data from the Electronic Health Record. Cardiac Science makes resuscitation, rehabilitation and informatics products.

CardioDynamics (San Diego) reported the presentation of a significant independent ICG clinical study at the annual meeting of the American Society for Hypertension (New York). Study focus is the company's impedance cardiography (ICG) technology, and the BioZ noninvasive cardiac monitoring systems. Study results were reported from a 65-physician primary care and cardiology group practice and demonstrated a 102% improvement in blood pressure control rates, with control rates improving from 42% to 88%. More than 76,000 patient visits were included in the analysis. Douglas Magenheim, MD, medical director for PriMed, initially piloted use of the BioZ ICG and found that it "significantly improved" his ability to help achieve appropriate hypertension control. Based upon his experience, the group initially included BioZ ICG in the Hypertension quality process and measured whether, in fact, it would be an effective, value-added step in changing outcomes. CardioDynamics makes ICG products.

• The registry arm of a clinical study measuring the effectiveness of Cook Medical's (Spencer, Indiana) Zilver PTX drug-eluting peripheral stent (DES) in treating peripheral arterial disease (PAD) has yielded positive interim results. "Cook's registry study and randomized trial are the first to use a paclitaxel-coated stent in the treatment of arterial blockages outside the heart," said Michael Dake, MD, professor of radiology, internal medicine and surgery at the University of Virginia Health System, and the trial's principal investigator. "They are designed to evaluate the safety and effectiveness of DES technology vs. percutaneous transluminal angioplasty, and our initial findings in the registry arm give us every reason to believe that Zilver PTX has the integrity, safety and durability needed to successfully address many of the well-known limitations of angioplasty alone for management of PAD."

Cook also reported the first human use of its Zenith low-profile AAA endograft system. The Zenith Low Profile AAA Endograft System addresses those areas of concern by reducing the size of the delivery sheath to 16 Fr. This development, if proven safe and effective in an upcoming clinical trial, could open endovascular treatment of aneurysms to a new class of patients who currently have only open surgery as a treatment option due to the small diameter of their blood vessels and other anatomic issues, according to Cook. In addition, it may enable physicians to eliminate the need for a surgical cut down to access the femoral artery and allow the use of the percutaneous entry technique where a needle is inserted to allow the guidewire and delivery sheath to enter the artery with far less trauma. Cook specializes in the development and manufacturing of products for interventional medicine.

Cordis (Miami Lakes, Florida) reported the U.S. launch of the SLEEK and SAVVY long PTA balloon dilatation catheters, its percutaneous transluminal angioplasty (PTA) balloon catheters. The SLEEK balloon is one of the first .014" guidewire compatible rapid-exchange balloons fully dedicated to infrapopliteal vessels, while the SAVVY long balloon provides an .018" guidewire compatible over-the-wire alternative for both superficial femoral and infrapopliteal arteries. With balloon lengths up to 220 mm, the SLEEK and SAVVY balloons may enable physicians to treat long, diffuse lesions with fewer inflations and faster procedures compared to traditional PTA balloons, Cordis said. Cordis makes interventional vascular and gastroenterology technology.

CryoCath Technologies (Montreal) reported the introduction of Arctic Front in Hong Kong. Arctic Front, the company's lead product for the treatment of paroxysmal atrial fibrillation (PAF), is a cryoablation balloon catheter that allows physicians to isolate all four pulmonary veins in the treatment of PAF. Arctic Front is a minimally invasive bi-directional, double-ballon cryo-balloon catheter designed specifically to treat PAF. CryoCath makes cryotherapy products to treat cardiac arrhythmias.

CryoLife (Kennesaw, Georgia) reported the first implantation of its combination aortic-mitral allograft heart valve in a patient at the Cleveland Clinic. The method used to process the combination aortic-mitral human heart valve was developed by CryoLife in collaboration with the clinic. The valve was developed as a replacement option for patients with infective endocarditis involving both the aortic and mitral valves. Infective endocarditis is a condition in which the structures of the heart, particularly the heart valves, are infected. "Infections involving both the mitral and aortic valves put patients at very high risk for serious complications that can result in death," said Jose Navia, MD, a surgeon with the Heart and Vascular Institute at the Cleveland Clinic. "With the new human tissue combination aortic-mitral heart valve, we are hoping to provide an infection-resistant treatment option to offer patients." CryoLife makes implantable living human tissues for use in cardiac and vascular surgeries.

• The metrigraphics division of Dynamics Research (New York) reported the introduction of micro-induction coils designed for use in implanted medical applications and traditional biomedical devices. The micro-induction coils are equipped with radio frequency signal transmission and signal and power induction capabilities, thereby eliminating the potential harmful effects to the human body posed by battery-operated implantable medical devices. Metrigraphics' new family of coils is classified by two groups single- and multiple-layer forms. Single layer multiple-turn electroformed coils are available in round and square configurations. Multi-layer coils offer greater field density for more high-end applications. Dynamics Research specializes in the fabrication of customized micro-components and micro-circuits.

HeartWare (Framingham, Massachusetts) has received FDA approval for an Investigational Device Exemption for the HeartWare Left Ventricular Assist System (LVAS). The company said it will immediately launch its U.S. clinical trial for the LVAS for use as a bridge to cardiac transplant in patients suffering from end-stage heart failure. HeartWare makes miniaturized implantable heart pumps designed to treat patients suffering from advanced heart failure.

HoMedics (Commerce Township, Michigan) reported that its Thera-P Blood Pressure Monitors are compatible with Microsoft HealthVault, a free Web-based platform from Microsoft designed to put consumers in control of their health data. HoMedics blood pressure units, with HealthVault, incorporate features such as DK Technology, which uses a built-in microphone to listen to the body to take an accurate reading. HoMedics makes personal healthcare and wellness products.

InfraReDx (Burlington, Massachusetts) said physicians at Beaumont Hospital (Royal Oak, Michigan) have used its LipiScan coronary imaging system in a patient undergoing a cardiac catheterization. This is the first patient in whom it has been possible to assess the chemical composition of coronary artery plaques and use such information to assist in the management of coronary artery disease. The LipiScan is a catheter-based device that uses laser light to detect how much fat and other substances are contained in a plaque. The identification of the chemical composition of coronary plaques is expected to be of value to cardiologists in the selection of medical, stenting or surgical therapy for coronary lesions. InfraReDx said the device is also expected to be of value to the pharmaceutical industry as a means to assess the effect of novel anti-atherosclerotic agents on lipid core plaque burden. InfraReDx specializes in near-infrared spectroscopic technology and its application to coronary imaging.

InspireMD (Tel Aviv, Israel) reported continued positive results from the ongoing MGuard coronary stent first-in-man, multi-center trial in Germany. This study aims at establishing the safety and efficacy of MGuard coronary sent in high-risk patients with complex lesions. The study's primary end point demonstrated zero major adverse cardiac events after 30 days in 60 patients, with 100% procedural success rate. The MGuard is a bare-metal stent merged with an embolic protection device, the latter comprised of an ultra-thin polymer mesh protective sleeve, wrapped around the stent. The protective sleeve is composed of a micron-level-fiber knitted mesh, engineered in an optimal geometric configuration and designed for utmost flexibility while retaining strength characteristics of the fiber material. The sleeve is designed to expand seamlessly when the stent is deployed, without affecting the structural integrity of the stent, and to prevent plaque detachment during and post procedure. The sleeve is designed to diffuse stent pressure on the vessel wall, thereby reduce injury and lower the likelihood of restenosis. InspireMD specializes in stent platform technology.

Isotechnika (Edmonton, Alberta) said that voclosporin is positioned to enter a Phase I clinical trial as the drug used in the Cinatra drug-coated coronary stent system developed by the company's partner, Atrium Medical (Hudson, New Hampshire). The Cinatra voclosporin coated coronary stent system is made of a cobalt chromium bare metal stent mounted on a delivery balloon catheter. The stent and the balloon are coated with Atrium's Omega-3 fatty acid coating technology, using voclosporin for its anti-inflammatory properties. Isotechnika is an international biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are designed to offer advantages over other currently available treatments. Atrium makes technologies for the treatment of cardiovascular disease, hernia and adhesion prevention.

Medtronic (Minneapolis) reported FDA approval for the Talent thoracic stent graft, a device for the minimally invasive treatment of certain types of aneurysms of the descending thoracic aorta. "There are still many patients undiagnosed and in need of treatment for thoracic aortic disease," said Ronald Fairman, MD, professor of surgery and chief of vascular surgery at the University of Pennsylvania Hospital (Philadelphia). "FDA approval of the Talent Thoracic Stent Graft is an important development in physicians' abilities to treat this life-threatening condition. In my experience, this device offers a superior alternative to open surgery and will allow physicians to perform minimally-invasive thoracic aortic aneurysm repair for a broader population of patients." The Talent makes thoracic endovascular aortic repair accessible to an additional 25% of patients. It is available in a range of diameters from 22 mm to 46 mm. This size matrix offers physicians multiple options to customize devices for their patients' needs and to treat a wider range of anatomies than with the other available endografts. Medtronic's portfolio of aortic stent grafts includes the Talent abdominal and thoracic stent graft systems worldwide, the AneuRx AAAdvantage abdominal stent graft system in the U.S., and the Valiant thoracic stent graft system outside the U.S.

OmniSonics Medical Technologies (Wilmington, Massachusetts) said it has enrolled its first patient in the SONIC II registry. SONIC II is a prospective, multi-center U.S. registry study of the company's OmniWave Endovascular System in patients undergoing percutaneous mechanical thrombectomy for acute limb ischemia (ALI). The OmniWave is a minimally invasive catheter-based technology that delivers low-power, transverse ultrasonic energy to remove thrombus, which occurs in a number of conditions, including deep vein thrombosis and ALI. OmniSonics makes products for treatment of vascular disease.

OrbusNeich (Hong Kong) said that it has received approval from the Taiwan Department of Health to market the Genous Bio-engineered R stent in that country. The Genous stent is coated with an antibody to capture a patient's endothelial progenitor cells (EPCs) circulating in the bloodstream. When attracted to the inner surface of the Genous stent, EPCs have been shown to quickly form a healthy layer of endothelium that minimizes stent restenosis and provides protection against stent thrombosis. OrbusNeich makes devices to treat vascular diseases.

Perceptive Informatics, the technology subsidiary of Parexel International (both Boston), said that it has integrated its medical imaging technology with the functionality of DigiView, a specialized image management and reporting system provided by Digisonics, to offer clients expanded capabilities for cardiac function assessment in clinical studies. The system provides electronic review, analysis, reporting, and archiving of medical images related to cardiac function assessment. Cardiac function assessment is required for a broad range of therapeutic area research, including cardiology, oncology, central nervous system, and metabolism/endocrinology studies. Parexel said its technology division, Perceptive Informatics, combines clinical knowledge, quality and regulatory experience with advanced technology to decrease time to market, risk and cost associated with clinical trials.

Royal Philips Electronics (Andover, Massachusetts) reported shipments of a new version of its Xcelera multimodality cardiology image management, analysis and reporting solution. The Xcelera R2.2 offers enhanced functionality and greater workflow efficiency to approximately 3,000 Philips cardiology informatics customers around the world. Xcelera R2.2 is a centralized system that addresses efficiency and workflow challenges while helping caregivers manage the multitude of examinations and procedures their patients undergo while receiving cardiac care. Xcelera R2.2 offers support for imaging studies and data from key cardiac subspecialties including cardiac catheterization and cardiovascular ultrasound, and additionally supports nuclear cardiology, cardiac CT, cardiac MRI, and electrophysiology.

Siemens Medical Solutions USA (Malvern, Pennsylvania) has received FDA clearance for the Somatom Definition AS, an adaptive CT scanner. The Medical University of South Carolina (MUSC; Charleston) is one of the first facilities to install the scanner, adding to the Somatom Definition Dual Source MUSC installed in September 2006. The Adaptive 4-D Spiral mode of the Somatom Definition AS is able to address functional imaging (perfusion images of blood flow over time) of whole organs. This allows Siemens to offer dynamic information of up to 27 cm. In the case of a stroke, physicians can use whole-organ perfusion imaging not only for a small part of the brain, but for all of it. The Somatom Definition AS comes in multiple configurations, each of which is tailored to a hospital's workflow and clinical needs. The technology couples multiple components in a dynamic manner: a large-volume coverage area with a 200-cm scan range and up to 300 msec rotation time, 78-cm gantry bore, and the ability to add a high-capacity 660-pound patient table. "The Somatom Definition AS goes beyond slices and detector rows to addresses the overall versatility and usefulness of a CT scanner," said Joseph Schoepf, MD, associate professor of radiology and cardiology, and director of CT R&D at MUSC.

Spectranetics (Colorado Springs, Colorado) said that a new peer-reviewed study demonstrates the company's SLS II excimer laser sheath safely and effectively assists removal of pacing and defibrillator leads. The study, "Large, Single-catheter, Single-operator Experience with Transvenous Lead Extraction: Outcomes and Changing Indications," was featured in the April issue of the journal Heart Rhythm. The conclusion demonstrates safe extraction of leads successfully removed with laser assistance. The SLS II laser sheath uses use "cool" ultraviolet light to safely, effectively and efficiently ablate scar tissue that holds problematic leads in place. The technology employs a circle of fibers that emit pulses of energy travel over the cardiac lead toward the tip to dissolve scar tissue that binds the lead to the body. Once the scar tissue is dissolved, the lead can be safely removed.

St. Jude Medical (St. Paul, Minnesota) reported U.S. launch of the TigerWire steerable guidewire. The newest member of the St. Jude GuideRight family of steerable guidewires, the TigerWire is designed to enhance physicians' ability to steer through challenging peripheral arteries, the vessels that supply blood to the legs and arms. The TigerWire's tip is designed with enhanced flexibility to aid in navigation through the vessels. Its supportive design provides distinct zones of flexibility that make it easier for physicians to track and position the guidewire through challenging anatomy. The insertion of a guidewire is a first step in interventional procedures in which physicians thread catheters through the arteries to diagnose the severity of disease or deliver treatments, including devices such as stents that open blockages and restore blood flow. St. Jude Medical has five major focus areas: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation.

Valor Medical (San Diego) says it is developing Neucrylate, a device that could be introduced into the aneurysm as a liquid and, when it touches blood, turns into a solid, sponge-like material. Kerber reported early results on the use of Neucrylate at the American Society of Neuroradiology (Oak Brook, Illinois) conference in New Orleans. "The patients have had very positive results and to date the accumulated patient implant times have reached 1,400 days," Kerber said. The compound is injected into the aneurysm with a microcatheter that is inserted into the femoral artery in the groin and then passed up into the brain. This procedure takes about an hour, compared to coiling, which can take up to four hours. Neucrylate is based on the compound cyanocrylate, better known as Super Glue or Krazy Glue, which is where it gets its viscosity and why it sticks together instead of breaking away. Craig Adams, CEO of Valor, told CD&D that only so many coils can be packed into the aneurysm at a time, and if the coils shift or compress — which they do about 15% to 30% of the time, he says — then the patient is in trouble because putting more coils in is difficult at best and increases morbidity at worst. Adams said, the company's animal data has shown that tissue cells start growing through the sponge-like material. Adams said Valor will be expanding the trial sites in Europe within a few months and expects to begin trials in the U.S. later this year, pending approval of its IDE. He said the company anticipates launching Neucrylate in Europe by early 2010. Valor was formed as a Delaware C corporation in January 2007.

Vascular Insights (Madison, Connecticut) reported FDA clearance to market its ClariVein infusion catheter for infusion of physician-specified agents in the peripheral vasculature. ClariVein is a percutaneous, 2 2/3 Fr (0.035") catheter, containing a rotating wire driven by a motor, that enhances fluid dispersion in the treatment area. Vascular Insights makes devices for the minimally invasive treatment of peripheral vascular disease.

VasSol (Chicago) has launched the first available test to non-invasively quantify the volumetric blood flow rate in vessels, also skipping the potential side effects of any contrast media. NOVA (Non-invasive Optimal Vessel Analysis) incorporates interactive 3-D images that provide a fully rotatable, 360 degree view of vasculature that allows for precise identification of each vessel for volumetric blood flow calculation. NOVA allows physicians to evaluate entire vasculatures or pinpoint specific areas within a vessel that may be of concern. VasSol's first application, the NOVA Neuro system, focuses on the neurovascular region, which encompasses the head and neck. Specifically, data gathered via this software helps physicians to diagnose and treat patients who are at risk for or who have suffered from stroke and cerebral aneurysms, as well as those who suffer from neurovascular disease related to chronic medical conditions such as heart disease and diabetes. Numerous other potential applications are in the wings. "This really provides an opportunity for a physician to wait and do nothing," VasSol CEO Anthony Curcio told CD&D. "They can also determine if medical management is working or successful. Then, there is the ability to monitor patients without concern of sensitivity to gadolinium contrast or the concern of cumulative radiation or concern over an invasive procedure such as angiograms. FDA-approved via a 510(k) in 2002, NOVA has been used almost exclusively at the nearby University of Illinois-Chicago in almost 8,000 patients. Curcio said that up to 20% of those patients had a change in medical management as a result of NOVA testing. Rather than commercializing NOVA immediately, the company is just now marketing. In addition to the neurovascular applications. VasSol's has introduced NOVA Renal, a gadolinium-free procedure, which offers a safe alternative to the standard contrast-enhanced magnetic resonance angiography (MRA) and MRI scans for patients suffering from renal disease. Contrast-enhanced renal MRA/MRI has traditionally required the injection of a gadolinium-based agent which the FDA has linked to the occurrence of a potentially life-threatening disease, nephrogenic systemic fibrosis. NOVA Renal provides a comprehensive evaluation of the renal arteries without contrast or ionizing radiation. Although NOVA is a software program, the company provides it pre-loaded on a PC, which sits alongside the MR scanner with a simple plug-in to the scanner. Potential future applications include use in babies. NOVA is applicable to blood vessels throughout the body. Future modules will target hepatic, coronary and lower extremity circulation.