Proteus Biomedical (Redwood City, California) certainly is not the only company looking at how to improve the measurement of cardiac performance in heart failure patients. But, according to Andrew Thompson, CEO and co-founder of Proteus, "everybody else" has come up with a new lead and/or a new procedure."
"We don't want to invent a new therapy," Thompson told Cardiovascular Devices & Drugs. Proteus says it is more interested in using its cardiac electronic tomography (CET) and multi-sensor lead system to make existing therapies safer, more effective and higher-value, he said.
CET is an operator-independent modality developed by Proteus. The first product application, in the field of heart failure, is intended to improve outcomes by "objectively assessing the relative hemodynamic effect of lead placement sites during and after CRT device implantation, and by quantitatively tracking a range of standard cardiac synchrony and performance measures over time," the company said.
The technology is designed to be integrated into any existing cardiac rhythm management system, without requiring additional complex pressure sensors or invasive procedures, Proteus said.
The technique works by tracking the 3D displacement of cardiac regions using standard CRT systems that have been modified to incorporate Proteus sensing technology and software. The procedure takes a few minutes and can be performed on patients at rest or on a treadmill, the company said.
A CRT device implantation procedure runs upwards of $60,000 about $30,000 for the device and roughly $30,000 for the procedure "and it doesn't work about half the time," Thompson said. "That's a problem."
Earlier this month, Proteus reported the start of its Resynchronization using Electric Tomography to Improve Myocardial Efficiency (RETIME) 2.0 study, designed to assess the performance of its CET technology in heart failure patients undergoing implantation of a CRT device. The point of this study, Thompson said, is "to show that the technology that we've now tested very extensively in animals and a previous feasibility study in humans does what we say it does."
According to the Proteus, data from pre-clinical studies and from its RETIME 1.0 study demonstrated that CET quantifies important aspects of cardiac performance using an automated, operator-independent technique that yields results comparable to Tissue Doppler Imaging (TDI).
The company said the RETIME 2.0 study will evaluate the system's ability to provide "immediate, actionable physiologic feedback" to determine optimal pacing sites in individual patients by correlating CET data with left ventricular pressure catheter readings, the current gold standard for measuring hemodynamic performance.
The three-site study will enroll from 30 to 50 patients and should be finished by the end of the year, Thompson said. Participating sites include The Ohio State University (Columbus), with William Abraham, MD, and Ayesha Hasan, MD, serving as co-investigators; the University of Southern California (Los Angeles), with Ray Matthews, MD, and Michael Cao, MD, as co-investigators; and Cardiocentro Ticino (Lugano, Switzerland), with Angelo Auricchio, MD, as investigator.
Abraham, professor of internal medicine and director of the division of cardiovascular medicine at OSU, said, "Cardiac electric tomography offers potential value in improving the efficacy of CRT as well as polypharmacy by providing objective, longitudinal measures of cardiac performance such as contractility, synchrony, and output."
By integrating in-body computer, sensor and communications technologies into existing device and drug therapies, Proteus is "pioneering" a space the company terms intelligent medicine, Thompson said. He compared the technology to the computer in a car that runs every aspect of the vehicle, yet is completely invisible to the driver, to describe how the company can build sensors and computers into existing devices and connect to a mobile computing platform for patients and their physicians can monitor how well their heart is working.
Elsewhere in the product pipeline:
• Abbott Vascular (Santa Clara, California) , a business of Abbott (Abbott Park, Illinois), reported launch of the StarClose SE vascular closure system, a next-generation vessel closure device engineered to enable fast, safe 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 Vascular also reported a study published in the Journal of the American Medical Association reported that the Xience V everolimus-eluting coronary stent system from, used in patients with coronary artery disease, resulted in a 50% reduction in vessel renarrowing (in-segment late loss) at eight months, non-inferior rates of target vessel failure at nine months, and a 42% reduction in major adverse cardiac events (MACE) at one year compared to the Taxus paclitaxel-eluting coronary stent system. The SPIRIT III study is designed to evaluate the safety/efficacy of the Xience V stent system compared to the Taxus system from Boston Scientific (Natick, Massachusetts). "SPIRIT III is the first large-scale clinical trial to show that patients have a lower risk of experiencing a heart attack, cardiac death or re-treatment when treated with a new stent, Xience V, compared to the most widely used drug-eluting stent, Taxus," said Gregg Stone, MD, of Columbia University Medical Center (New York), principal investigator of the SPIRIT III clinical trial. "With a significant reduction in angiographic in-segment late loss, non-inferiority in target vessel failure and a clinical advantage in the composite rate of MACE compared to Taxus, Xience V represents an important advance in improving the lives of patients with coronary artery disease," Stone said.
• Advantage Medical (Solana Beach, California) reported FDA clearance of a new safety engineered short-term peripheral intra-venous catheter. The VantageCath is designed to reduce exposure to blood-borne pathogens during the placement of the catheter. The company said existing safety-engineered peripheral IVs have mechanisms to protect a contaminated needle but do not usually address the problem of blood leaking out of an open hub. The VantageCath uses a closed-hub system that eliminates the need to tamponade above the site while connecting tubing or saline lock. The VantageCath comes with built-in, needle-free access to avoid needlestick injuries. The company says it can immediately be used to deliver push meds, connect to an extension tubing or standard IV or pump tubing. Push-button retraction shields the used needle. Advantage specializes in disposable medical products.
• AngioScore (Fremont, California) reported FDA clearance for its AngioSculpt Percutaneous Transluminal Angioplasty (PTA) catheter for balloon dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The catheter is not labeled for use in the coronary or neuro vasculature. Thomas Trotter, president/CEO of AngioScore told CD&D that the clearance opens opportunities in the "largest and fastest-growing segments" of the U.S. peripheral artery disease (PAD) market, including the superficial femoral artery (SFA) and stenoses involving hemodialysis of synthetic or native arteriovenous (A/V) fistulae. He noted that in 2007 an estimated 275,000 SFA and 300,000 A/V fistula procedures were performed in the U.S. The An-gioSculpt is comprised of a semi-compliant angioplasty balloon surrounded by a scoring element, intended to work in tandem with the balloon to deliver a scoring effect to the target lesion upon balloon inflation. As the balloon inflates, the radial forces are concentrated along the surfaces of the nitinol-scoring element, which results in luminal expansion that is, according to AngioScore, "precise, predictable, and controlled." The PTA catheter received initial 510(k) clearance for the treatment of infra-popliteal PAD in late 2005. In January 2007, AngioScore's companion product, the An-gioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) scoring balloon catheter, received PMA approval from for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion. Then, this past January, AngioScore obtained import approval for the AngioSculpt in Japan for the interventional treatment of coronary artery disease (CAD).
• ATS Medical (Minneapolis) reported the first North American commercial implant of the ATS 3f Aortic Bioprosthesis. ATS says the bioprosthesis uses design concepts intended to preserve native aortic root geometry and function. Through this approach, the prosthesis more closely mimics native valve function providing excellent hemodynamic performance that may contribute to improvements in key determinants of cardiovascular performance such as coronary blood flow and left ventricular mass regression. ATS makes cardiac surgery products and services.
• Biopure (Cambridge, Massachusetts) said that the results from its Phase II coronary revascularization trial have been published in the peer-reviewed EuroIntervention Journal. The paper is titled "Proof-of-concept trial to evaluate haemoglobin based oxygen therapeutics in elective percutaneous coronary revascularization. Rationale, protocol design, and haemodynamic results." The COR-0002 trial is a single-blind, open-label, single-center, cross-over pilot study where subjects underwent coronary balloon occlusion, with and without oxygenated HBOC-201. The primary objective of the study was to test the hypothesis that intracoronary infusion of HBOC-201 during brief, total coronary artery occlusion would preserve left ventricular function. The primary endpoints in COR-0002 were left ventricular diastolic relaxation indices as assessed by left ventricular pressure-volume loops and ST segment changes as assessed via electrocardiograms. The study concluded that HBOC-201 was indeed capable of preserving left ventricular function, likely through maintenance of myocardial oxygenation. Biopure makes pharmaceuticals called oxygen therapeutics.
• Boston Scientific (Natick, Massachusetts) reported the FDA approval of its Altrua family of pacemakers, following on the heals of winning the CE mark. The company says the Altrua is its most advanced pacemaker, delivering enhanced therapy with small size and battery longevity. It is the first Boston Sci-branded pacemaker to treat bradycardia — a condition when the heart beats too slowly, usually less than 60 beats per minute. "FDA approval of [our] Altrua family of pacemakers — especially following the European approval of ALTRUA we announced yesterday — further demonstrates the significant progress we have made rebuilding our CRM organization and reinvigorating our product pipeline," said Fred Colen, executive VP, operations and technology. The company cited a number of Altrua features: Multiple Atrial Ventricular (AV) Delay programming options, options designed to reduce unnecessary right ventricular (RV) pacing, without dropping ventricular beats; Minute Ventilation (MV) Blended Sensor, treating a condition called chronotropic incompetence, the inability of the heart to regulate its rate appropriately in response to physical activity and emotional stress; Ventricular Rate Regulation (VRR), which helps physicians manage patients with frequent atrial arrythmias; Automatic Capture, designed to offer automatic and accurate ventricular pulse management. The device checks every heartbeat to see if the lower chambers of the heart contract in response to the delivered pulse. If no contraction is detected, a backup pace with more energy is delivered.
Boston Scientific also reported the launch of its FilterWire EZ embolic protection system in a new 2.25 mm to 3.5 mm size, designed to contain and remove embolic material that may be dislodged during an interventional saphenous vein graft (SVG) procedure. Otherwise, embolic material may travel into the microvasculature where it could pose an increased risk for a heart attack. The FilterWire is a low-profile embolic protection device that has been clinically proven to capture and remove embolic material, leading to reduced complications during balloon angioplasty and stenting procedures in SVGs SVG disease occurs in patients who have previously had coronary artery bypass graft surgery in which a vessel harvested from the patient's leg is surgically attached to the arteries of the heart. Blood is redirected through the surgically attached SVG, bypassing the blocked artery and increasing blood flow to the heart. "Recently revised treatment guidelines by the American College of Cardiology (Washington) have recommended the use of embolic protection devices when treating patients with SVG disease," said Hank Kucheman, senior VP and group president, cardiovascular for Boston Scientific. "Until now, a filter-based solution smaller than 3.0 mm was not available for SVGs, which meant a significant patient population went underserved. By introducing this smaller size, Boston Scientific now makes it possible for physicians to meet this standard of care in a broader range of SVG vessels."
• CardioDynamics (San Diego) reported the presentation of a significant independent ICG clinical study at the meeting of the American Society for Hypertension (New York) in New Orleans. The study's focus is on 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. 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.
• CardioTech International (Wilmington, Massachusetts) reported receiving approvals to add a second medical center for the clinical trial of CardioPass, the company's synthetic coronary bypass graft, an alternative for patients who have undergone repeat procedures or have insufficient native vessels for bypass. Repeat surgeries account for up to 20% of all bypass procedures. CardioPass is made from ChronoFlex, the company's biodurable medical-grade polymer and engineered to be pulsatile, biostable, torque-resistant and suturable. Once implanted, the graft's polymer construction allows it to incorporate the patient's own cells and tissue, so that the inner surface mimics the normal environment for blood contact. ChronoFlex has been formulated to be flexible, enabling CardioPass to pulse like a human vein would as it carries blood to the heart. CardioTech makes polymer materials and manufactures other therapeutic and diagnostic products.
• Cordis (Miami Lakes, Florida) reported U.S. launch of the SLEEK and SAVVY Long PTA Balloon Dilatation Catheters, calling them its "most advanced percutaneous transluminal angioplasty" (PTA) balloon catheters. The company said that the SLEEK Balloon is one of the first .014" guidewire compatible rapid-exchange (Rx) balloons fully dedicated to infrapopliteal vessels, while the SAVVY Long Balloon provides an .018" guidewire compatible over-the-wire (OTW) alternative for both superficial femoral and infrapopliteal arteries. With balloon lengths up to 220 mm, the longest available for superficial femoral and infrapopliteal use, the SLEEK and SAVVY Long Balloons "may enable physicians to treat long, diffuse lesions with fewer inflations and faster procedures compared to traditional PTA balloons. Cordis is a business unit of Johnson & Johnson (New Brunswick, New Jersey).
• Corgenix Medical (Denver, Colorado) reported FDA clearance for its IgG Anti-AtherOx test kit, a laboratory test that uses the company's AtherOx technology to detect antibodies in individuals with important autoimmune diseases. AtherOx technology uses oxidized low-density-lipoprotein (oxLDL) complexed with the plasma protein B2GPI. Although oxLDL has been implicated in cardiovascular disease, determination of oxLDL/B2GPI complexes, rather than oxLDL alone, may be a more physiologic and accurate way of assessing the risk of progressive atherosclerotic cardiovascular disease in individuals with systemic lupus erythematosus and lupus-like disorders, according to Corgenix. The IgG test kit indication is used for the detection of IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with B2-glycoprotein I (B2GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). Corgenix makes diagnostic kits for vascular diseases, immunology disorders and bone and joint disorders.
• GE Healthcare (Waukesha, Wisconsin), makers of imaging and dose reduction technologies, reported FDA clearance of the LightSpeed CT750 HD, which they billed as the "world's first high-definition CT scanner." GE engineers discovered that, by changing the molecular structure of real garnets, they could develop a scintillator capable of delivering images 100 times faster, with up to 33% greater detail through the body and up to 47% greater detail in the heart. They had unlocked the secret of the GE gemstone detector, which the company boasts as the fastest primary speed in the CT industry. Gemstone spectral imaging uses up to 2496 views per rotation (a 2.5x increase) to deliver improved spatial resolution and improved image quality across the entire field of view. Dual energy fast kV switching registers energies at least 165 times faster than Dual Source CT at a .33s rotating speed. It offers 128 slices of unique data per rotation and 101 user selectable energy levels for viewing.
• HeartWare (Sydney, Australia) reported initial results from an international clinical trial of the HeartWare Left Ventricular Assist System (LVAS). The data show a six-month survival rate of 91% among the first 23 patients implanted with its LVAS. The study noted that one of the key features of the pump is its small size, allowing it to be implanted in the chest, thereby avoiding the abdominal surgery generally required to implant competing devices.
• InfraReDx (Burlington, Massachusetts) reported FDA clearance for its catheter-based LipiScan coronary imaging system. The LipiScan device uses near-infrared spectroscopy to identify lipid core containing plaques of interest in the coronary arteries in patients already undergoing cardiac catheterization. Such plaques, which cannot be detected by tests such as a treadmill exams or coronary angiography, are suspected as the cause of most sudden cardiac deaths and non-fatal heart attacks. Near-infrared (NIR) spectroscopy is used to measure the chemical composition of unknown substances. The LipiScan system uses optical technology to deliver and retrieve NIR light from coronary plaques. The light reflected back at different wavelengths is analyzed to detect the chemical composition of the coronary plaques. At the completion of the catheter pullback, the LipiScan console instantly displays the scan results on a "chemogram," a digital color-coded map of the location and intensity of lipid core containing plaques of interest in the artery. "We understand the great potential of interventional cardiology and anticipate that this novel tool will assist physicians with the complex decisions they face in the management of patients with coronary artery disease," said James Muller, MD, cardiologist, president/CEO and co-founder of InfraReDx.
• InspireMD (Tel Aviv, Israel) reported positive results from the ongoing MGuard coronary stent first-in-man, multi-center trial in Germany to look at the safety/efficacy of the MGuard coronary sent to treat complex lesions. The study's primary endpoint demonstrated no major adverse cardiac events after 30 days in 60 patients, with 100% procedural success. 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 a geometric configuration and designed for flexibility while retaining strength characteristics of the fiber material. The sleeve expands seamlessly when the stent is deployed, without affecting the structural integrity of the stent, and to prevent plaque detachment. 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 technology.
• Maquet Cardiovascular (San Jose, California) reported launch of the Heartstring III proximal seal system for coronary artery bypass surgery procedures, the latest version of Maquet's proximal seal technology for coronary artery bypass grafting (CABG) without use of a partial occlusion clamp during beating-heart surgery. The Heartstring III features an improved seal loader and delivery device. Once deployed, it maintains a low compliant profile for optimal hemostasis at the anastomotic site. With the device, surgeons can perform either distal or proximal grafts first and can choose grafts of varying lengths, hooded grafts, and angled take-offs. Maquent, a division of Maquent Medical Systems, makes solutions for less-invasive endoscopic vessel harvesting, off- and on-pump CABG surgery and vascular grafts.
• nContact Surgical (Morrisville, North Carolina) reported interim results from a study of atrial fibrillation, saying that the data demonstrated that a port access, paracardioscopic Ex-Maze procedure produced favorable outcomes and allowed patients to discontinue antiarrhythmic drugs. Epicardial lesions to complete the bi-atrial pattern were created in all patients by coagulating cardiac tissue using the nContact's VisiTrax device. nContact makes products for the coagulation of cardiac tissue.
• Spectranetics (Colorado Springs, Colorado) reported on a study demonstrating, it said, that its excimer laser sheath safely/effectively assists removal of pacing and defibrillator leads. The study, "Large, Single-catheter, Single-operator Experience with Transvenous Lead Extraction: Outcomes and Changing Indications," featured in the April issue of HeartRhythm — the journal of the Heart Rhythm Society (Chicago) and Cardiac Electrophysiology Society — offers a seven-year retrospective analysis of data from 498 lead extraction procedures involving 975 leads. The conclusion demonstrates safe extraction of leads removed with laser assistance. The company noted increased efforts to encourage physicians to consider lead removal vs. lead abandonment, with new technologies in the market. The Spectranetics Laser Sheath (SLS II) uses "cool" ultraviolet light to ablate scar tissue that holds problematic leads in place. A circle of fibers that emit pulses of energy travel over the cardiac lead towards 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. Spectranetics' Lead Locking Device (LLD) technology can also be used to assist removal by creating secure traction during procedures that may or may not require laser assistance. The retrospective study at Brigham and Women's Hospital (Boston) examined indications, outcomes and complications associated with transvenous lead extraction. and showed a success rate of more than 97% with two major complications (out of 4998 procedures, a rate of 0.4%) but no deaths. The article notes that "the rate of complications from abandoned leads reported in one study was as low as 5.5%, which still is higher than the complication rate from extraction." Spectranetics says that it manufactures the only excimer laser approved in the U.S., Europe and Japan for use in minimally invasive cardiovascular procedures via photo-ablation of multiple lesion types into tiny particles absorbed into the blood stream.
• St. Jude Medical (St. Paul, Minnesota) reported U.S. launch of the TigerWire steerable guidewire. The newest member of the St. Jude Medical 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.
The company reported FDA clearance and CE-mark approval of the Strada carotid guiding sheath, a flexible tube through which physicians can deliver balloon catheters, stents and other tools to open blockages in the carotid arteries. The Strada is designed specifically to provide easier and faster access to challenging carotid anatomy. The Strada is engineered with five distinct transition zones to provide flexibility on the far, or distal, end of the sheath, and support on the near, or proximal, end of the sheath. Its construction provides excellent kink resistance for added confidence in navigating challenging anatomy. The Strada is available in 80 cm and 90 cm working lengths.
St. Jude also reported the initial enrollments into a new clinical trial designed to better identify which patients could benefit from implantable cardioverter defibrillator (ICD) therapy for the prevention of sudden cardiac arrest (SCA). St. Jude said that the Defibrillators To Reduce Risk by Magnetic Resonance Imaging Evaluation (DETERMINE) study, coordinated by researchers at Northwestern University (Evanston, Illinois) and sponsored by St. Jude, is the first study to look at patients who already have had a myocardial infarction but whose hearts are less damaged, to determine if ICD therapy will prolong their lives. DETERMINE will study patients who have had a heart attack but have not yet had a sudden cardiac arrest, in an effort to identify patients at highest risk. The DETERMINE trial is designed to investigate these issues by looking at patients for whom: the amount of damage caused by a heart attack as measured by the percentage of resulting scar tissue (or "infarct mass") is equal to or greater than 10%, and the ejection fraction is greater than 35%.
• Sunshine Heart (Sydney, Australia) is seeking to initiate an Investigational Device Exemption feasibility trial for its C-Pulse device, a non-blood contacting heart therapy for patients with moderate to severe heart failure. The company in late April reported passing a five-year milestone on the durability testing of the device last. Sunshine has six clinical trial sites planned. C-Pulse uses a standard pacemaker lead, a single soft percutaneous line and an external pneumatic battery-operated driver. The driver unit, which resembles a Walkman or portable CD player, is worn outside of the body along the hip and linked by an air tube to the cuff. The cuff is secured around the ascending aorta. Implantation is performed through a simple surgery on a beating heart, without the need for heart-lung bypass or any incisions to the heart or great vessels. A balloon found in the cuff is inflated and deflated in time with the heart rhythm to improve blood supply to the body and to the heart muscle itself, as well as serving to reduce the workload of the heart. A sensing lead conveys the heart's electrical signals to the driver unit. As a result, the balloon in the cuff inflates and deflates with the heart's rhythm creating a counterpulsation action. This counterpulsation action forces the blood out of the ascending aorta and assists the heart in pumping blood more efficiently. Sunshine Heart partnered with Polymer Technology Group (PTG; Berkeley California), a biomaterials company, which supplied the company with BioSpan for the balloon, a segmented polyether urethane that is used in the majority of clinical ventricular assist devices and artificial heart cases worldwide. It also used Bionate, a thermoplastic polycarbonate urethane (TPU) for the tubing of the device. C-Pulse doesn't yet have the CE mark.
• SunTech Medical (Morrisville, North Carolina) reported the launch of the Advantage hemodialysis monitoring OEM non-invasive blood pressure (OEM NIBP) technology, designed for monitoring blood pressure during hemodialysis. The company said it sought to address concerns about the accuracy of automated blood pressure measurements of hemo-dialysis patients. It investigated an oscillometric blood pressure technology for end-stage renal disease (ESRD) patients during hemodialysis. Current validation protocols and guidelines do not require blood pressure monitors to be validated on specific patient populations. Consequently, most are validated on readily available healthy volunteers. Efforts were made to focus not only on ESRD patients, but also in the environment for which the technology was intended by performing the evaluation during dialysis. SunTech makes non-invasive BP monitoring products.
• SynCardia Systems (Boston) reported the introduction of the prototype of its new four-pound Companion II Driver, the next step in its Companion Driver System series. The Companion Drive System is docked into the Companion Hospital Cart for use in the operating room and intensive care unit. Once the CardioWest artificial heart patient is stable, the Drive Unit is designed to be re-docked into the Companion Discharge Caddy for mobility around the hospital and recovery at home. SynCardia makes the CardioWest temporary total artificial heart.
• Terumo Heart (Ann Arbor, Michigan) made a presentation titled "Long-Term Circulatory Support with the DuraHeart Mag-Lev Centrifugal LVAS for Advanced Heart Failure Patients Eligible for Transplantation: European Experience" at the recent meeting of the International Society for Heart & Lung Transplantation (Addison, Texas) meeting. The presentation concluded that Terumo's DuraHeart LVAS provides safe and reliable long-term circulatory support with improved survival. The DuraHeart is a circulatory support device intended to provide cardiac support for patients who are at risk of death due to end-stage left ventricular failure. Terumo Heart specializes in heart failure devices.
• Volcano (San Diego) reported its participation in Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN (SATURN) trial. SATURN is a 104-week, parallel-group, multicenter, double-blind, Phase IIIb intravascular ultrasound (IVUS) imaging study of about 1,300 patients at 170 centers worldwide. This marks the first major pharmaceutical trial allowing physicians to use the Volcano Revolution45 MHz IVUS Imaging catheter as part of the protocol, the company said. The study, by AstraZeneca (London), is designed to measure the impact of Crestor (rosuvastatin) 40 mg and atorvastatin (Lipitor) 80 mg on the progression of atherosclerosis in high-risk patients, comparing the effects of these two statins on the ability to decrease progression or induce regression of atherosclerosis following two years of treatment in patients with coronary artery disease. Under this protocol, physicians enrolling patients may select the Volcano Revolution IVUS catheters as their IVUS catheter of choice. Volcano's IVUS product line includes ultrasound consoles that can be integrated directly into cath lab instrumentation. Volcano's IVUS poroduct features single-use, phased-array and rotational IVUS imaging catheters and functionality options such as VH tissue characterization and ChromaFlo Internal DICOM networking.
• W.L. Gore & Associates (Flagstaff, Arizona) reported FDA approval to conduct the Gore REDUCE clinical study for its Gore Helex Septal Occluder to be used in patent foramen ovale (PFO) closure to prevent recurrent stroke. Gore said that the device is the first of its kind to use ePTFE, a biocompatible material that allows progressive tissue in-growth, to help seal the defect and designed to be soft and flexible, conforming to the anatomy of the heart while bridging and covering the defect to stop the shunting of blood between the atria, a key difference, it said, from other PFO devices. "The device is catheter-based [and] unfolds on the side of the defect," a Gore spokesperson told CD&D. "[T]he way it wraps around the defect is reminiscent of a DNA helix —hence its name." The company in September received FDA approval for the device for a separate application, treatment of atrial deptal defects (ASD), congenitaldefects that often involve young children. Patients in the study will be divided into two treatment arms, anti-platelet medical management alone or device closure of the PFO with anti-platelet management. Endpoints include freedom from recurrent ischemic stroke, transient ischemic attack (TIA), or death due to stroke at 24 months follow-up.