Thursday, May 8, 2008
GE Healthcare Unveils New 3.0T Signa MR750 System
GE Healthcare is introducing a new 3.0 Tesla magnetic resonance scanner, the latest addition to its Signa family of MRI systems, a machine called Signa® MR750 3.0T. The device, newly approved by the FDA, has just been unveiled at the International Society of Magnetic Resonance in Medicine in Toronto, May 3-9.
The Signa MR750 features a newly designed RF Transmit system maximizing performance with a 17 percent gain in scanning efficiency. In addition, the system includes the GE-exclusive Optical RF Technology that adds up to 27 percent higher signal-to-noise ratio (SNR) over conventional, non-optical MR receivers by reducing electrical noise and increasing signal detection.When combined with GE’s use of high-density surface coils, the optical receive chain is a critical path for ensuring clear signal reception and data analysis. To ensure that the high-density approach will always be maintained, the Signa MR750 3.0T architecture is scalable to 128 channels of simultaneous data acquisition.
Revolutionizing imaging capabilities with new parallel imaging technique
In efforts to improve full-body imaging on 3.0T MR, GE Healthcare’s Signa MR750 features a newly developed parallel imaging technique entitled ARC™, Auto Calibrating Reconstruction for Cartesian imaging. In addition to reducing specific absorption rate (SAR), the ARC technique also improves body imaging by allowing:
Auto-calibration that helps avoid collecting external sensitivity map;
Less sensitive to field-of-view (FOV) positioning with a tight FOV;
Clinically practical reconstruction times for continuous scanning; and
Workflow simplification that can be seamlessly integrated into sequences without the need for separate calibration scans. As a result of this new imaging technique, the MR 750 also features new operational efficient advanced applications, including:
LAVA-IDEAL™
LAVA-IDEAL is a dual-echo acquisition technique that raises the bar on existing sequences to provide consistent, detailed, three-dimensional abdominal images in one breath-hold. By allowing the user to select the output image types-- in-phase, opposed-phase, water and fat-- LAVA-IDEAL has the ability to produce four image contrasts with only one scan. With this new 3.0T application, clinicians can now conduct a complete liver exam in 15 minutes.“LAVA-IDEAL is a robust sequence that offers ‘fat only’ and ‘water only’ images in addition to excellent in-phase and opposed-phase images in a single breath-hold. This sequence has quickly become a routine part of all our abdominal sequence protocols at 3.0T,” said Dr. Elmar Merkle, professor of Radiology, Head of Body Magnetic Resonance Imaging and Medical Director of the Center for Advanced Magnetic Resonance Development at Duke University.
VIBRANT-IDEAL™
VIBRANT-IDEAL is a new application that allows for fat-free breast imaging with high spatio-temporal resolution. This application catches the shortest in- and out-of phase echoes to keep scan times comparable to single echo acquisitions even though twice the amount of data is collected.VIBRANT-IDEAL optimizes acquisition with a high signal-to-noise ratio (SNR ) for acquiring high quality water and fat images. This capability lets the user prescribe thinner slices for high spatial resolution imaging.
PROPELLER 2.0™
PROPELLER 2.0 enables strong performance in all neuro imaging planes with the implementation of the No Phase Wrap (NPW) technique. NPW allows virtually ghost-artifact-free, motion-immune scans in sagittal, coronal, axial and oblique planes. Since this technique effectively deals with the aliasing artifact, PROPELLER 2.0 is now more robust performing small field-of-view (FOV) scans.
Driven by customer demands for improved clinical capabilities, the Signa MR750 has been designed around clinical workflow needs with a strong focus on improving productivity, With that in mind, the system also includes operational efficiencies such as the newly designed detachable patient table and the first ever in-room operator console.In addition, The Signa MR750 features automated acquisition based on the concept of touch and go protocols. The aspect of the system allows for more focused attention on the patient and consistent protocols and processing across operating technicians.
Product page: Signa MR750...
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Wednesday, May 7, 2008
Boston Scientific ALTREA Pacemaker EU Approved
Boston Scientific just received approval from the EU to market the company's newest family of pacemakers.
The following features are listed in the press release:
ALTRUA is Boston Scientific's most advanced pacemaker and delivers enhanced therapies while maintaining its small size and battery longevity. It is the first Boston Scientific-branded pacemaker to treat bradycardia, a condition in which the heart beats too slowly -- usually less than 60 beats per minute -- depriving the body of sufficient oxygen.Multiple Atrial Ventricular (AV) Delay programming options: These options are designed to reduce unnecessary right ventricular (RV) pacing, without dropping ventricular beats, a key distinction from other competitive RV pacing algorithms. The ALTRUA 50 and 60 series also include an enhanced AV search hysteresis feature, now with an extendable AV delay out to 400 milliseconds, providing physicians with additional flexibility to tailor device programming for unique patient needs. Minute Ventilation (MV) Blended Sensor: This proprietary technology treats a condition called Chronotropic Incompetence, which is the inability of the heart to regulate its rate appropriately in response to physical activity and emotional stress. Boston Scientific's MV Blended sensor is the only sensor that has been shown to restore Chronotropic Competence. Ventricular Rate Regulation (VRR): This feature helps physicians manage patients with frequent atrial arrythmias. Automatic Capture: This capability is designed to offer automatic, safe and accurate ventricular pulse management. The device checks every heart beat 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.
News release: Boston Scientific Announces European Approval and Market Launch of New Family of Advanced Pacemakers
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HYDROCHALARONE MRI Contrast Agent Does Well in Early Study
HYDROCHALARONE™ nanomaterial is a next generation contrast agent, under development by Roanoke, Virginia based firm Luna Innovations, that has just been successfully demonstrated as an effective MRI image enhancer in the mouse model. HYDROCHALARONE is based on the company's proprietary TRIMETASPHERE® molecular cage construct (second picture below), a molecule formed by up to 80 carbon atoms, that is capable of encapsulating a variety of metals (Scandium, Lutetium, Holmium, Gadolinium) inside its cage.
From the press statement by Luna Innovations:
The new class of molecules discovered by Luna is called HYDROCHALARONE(TM) ( hi-dro-kal-a-rone )-- Hydro, meaning water, combined with Chalaro, the Greek word for relax. The level of relaxivity is the characteristic of molecules that provides the image enhancement. "The high relaxivity in Hydrochalarone means fewer molecules are needed to obtain a better quality image," said Robert Lenk, President of Luna's nanoWorks division. "Our studies demonstrate that our proprietary nanomaterials do not release gadolinium under conditions which are found in the human body. Our imaging studies in mice have shown Hydrochalarone improves image quality up to 30 minutes after injection at a dose 20 times lower than that used with current agents."
"Achieving high magnetic resonance relaxivity with a small, biologically inert, chemical moiety that can be derivatized for targeted tissue delivery, cell tracking, or inclusion as part of a nanoparticle drug delivery vehicle is a Holy Grail within the fast evolving field of biomarker development," said Dr. Joseph Ackerman renowned MRI researcher and Chemistry Department Chairman at Washington University in St. Louis. "The design and production of Hydrochalarones by scientists at Luna nanoWorks may herald such an advance."
Luna's HYDROCHALARONE(TM) was selected for preclinical studies and a collaboration with National Cancer Institute's Nanotechnology Characterization Laboratory (NCL). "We hope within 12 months the NCL will provide us a complete preclinical package which will contribute to an Investigational New Drug application," said Lenk. "The end goal of Luna's product development effort with the Hydrochalarone is using it as a fundamental building block that will generate a portfolio of novel imaging agents targeted to reveal diagnostic information specific for a variety of different diseases, such as cancer tumors, sites of inflammation and plaque related to coronary artery diseases, as announced in our previous press release."
Product page: Luna's HYDROCHALARONE...
Press release: Luna Innovations Successfully Demonstrates MRI Contrast Agent...
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Tuesday, May 6, 2008
Sentinelle Vanguard Breast MR Auxiliary Table
Sentinelle Medical Inc., a Toronto, Ontario firm, is reporting that its president Mr. Cameron Piron was just recognized as Best Young Innovator by the Ontario Ministry of Research and Innovation. Putting aside the whole twisted idea of "Ministry of Research and Innovation", we ventured to check out the product of Sentinelle Medical. It turns out that the product, called Sentinelle Vanguard Breast MR Auxiliary Table®, is a pretty clever device. Designed to work in tandem with GE Healtcare's Signa® HDx 1.5T MRI system, the table features an eight channel coil array that enhances imaging of the breast, while the configuration of the table makes percutaneous biopsies (and other interventions) more tolerable for the clinician and the patient, thanks to an open design that offers easy accessibility to all quadrants of the breast.
More about the system:
Variable Coil Geometry® of the 8 channel array allows the position of the coils to be customized for every patient. Vanguard® coils can be moved medially and laterally, as well as posteriorally towards the axilla and chest wall providing improvements to image quality unavailable on traditional tabletop coilsThe unique coil geometry improves overall signal to noise ratio which can result in higher resolution images. Higher resolution images provide more detailed information and may promote earlier detection of lesions. This can, in turn, result in better management of disease and treatment...
Complete and open medial and lateral access provided by the Vanguard® design allows interventions to all quadrants of the breast. The system employs adjustable interventional grids which can be moved medially and laterally as well as towards the axilla and chest wall, providing access to lesions in the inner upper and outer upper quadrants of the breast. Use of a removable sternum support and support plate improves access to lesions near the chest wall in medial approaches.
The Vanguard® works in combination with several biopsy devices and localization needles...
A Significant amount of effort has been put into the design and padding of the patient support. Increased patient clearance in the bore means that more patients can be comfortably positioned with arms by their side. This improves comfort for the patient and reduces motion during the exam. The ‘wings’ of the system not only provide support for this positioning but also protect the patient from the magnet.
The padding used is made of visco-elastic foam providing improved comfort especially in common pressure areas such as the diaphragm and sternum. All padding is adjustable, allowing customized cushioning for every patient. The foam is covered in surgical grade material allowing for easy clean up.
The Sentinelle Vanguard Breast MR Auxiliary Table® is a comprehensive system. All features, including storage drawers, tray tables, biopsy grids, padding, safety rails, movable sternum supports, and integrated lighting are designed to work together for improved workflow. The Vanguard® is the only dedicated, detachable table design available for Breast MR.
The Vanguard’s® unique detachable table design allows patient preparation prior to and after both imaging and intervention to be performed outside the MR suite. Used in conjunction with the standard Signa™ detachable table, this results in significant savings in per-patient magnet use time. Experience with Vanguard® has shown an average efficiency increase of 10-25 minutes per patient.
Product page: Sentinelle Vanguard Breast MR Auxiliary Table...
(hat tip: Boomer Babe)
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Friday, April 25, 2008
Vasovist, a Vascular MRI Contrast Agent, Meets FDA Requirements
Epix Pharmaceuticals Inc., an Israeli firm that has developed Vasovist (gadofosveset trisodium), a novel MRI contrast agent, has announced that its product "has achieved positive results from the blinded, independent re-read of images of its novel blood pool magnetic resonance angiographic (MRA) agent, Vasovist. In the re-read of images obtained from previous phase 3 studies, EPIX met all pre-specified endpoints prospectively agreed to with the U.S. Food and Drug Administration (FDA). EPIX plans to resubmit a New Drug Application (NDA) to the FDA for Vasovist in mid-2008. Vasovist is currently approved for marketing in 33 countries." And that includes the European Union, where the device (as it is classified) has been marketed (in collaboration with Schering AG) since 2005.
Here's how the agent is described:
Vasovist® is an injectable intravascular contrast agent discovered internally at EPIX and is designed to provide improved imaging of the vascular system using magnetic resonance angiography (MRA). EPIX's initial target indication for Vasovist is for use in MRA imaging of peripheral vascular disease, providing a breakthrough in the physician's ability to visualize the human vascular system and improve disease diagnosis and treatment.Vasovist reversibly binds to the human blood protein albumin, allowing imaging of the blood vessels for approximately an hour after administration. With a single injection, Vasovist enables clear three-dimensional images of arteries and veins throughout the body. Vasovist may make it possible for physicians to detect vascular disease earlier and less invasively than with X-ray angiography, and provide an improved evaluation of potential therapeutic options including percutaneous intervention and vascular surgery.
Press release: EPIX Pharmaceuticals Announces Positive Results From Re-Read of Vasovist(R) Phase 3 Images...
Product page: Vasovist...
More from Globes: Epix imaging device meets FDA requirements...
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Friday, April 18, 2008
Medtronic Defender Embolic Protection Filter Approved in EU
This device, newly approved for the European market, is designed to get rid of nasty emboli that can occur during a variety of stenting procedures:
Made of braided nitinol (a “memory metal” that resumes its original shape upon deployment), the Defender embolic protection filter has a low profile and a peel-away delivery sheath that enables physicians to maneuver the device easily across lesions to the desired location. When opened, the filter acts as a basket, allowing sufficient blood flow while simultaneously trapping dangerous embolic debris that may become dislodged during the stenting procedure. Without this protection, embolic debris can flow into other portions of blood vessels – and, in the case of patients with carotid artery disease, this can lead to a stroke, one of the world’s leading causes of death and long-term disability...The Defender filter has a 2.2 French (0.029 inch) crossing profile and an extendable 0.014 inch stainless steel core wire that is designed for both flexibility and support. Also, the device’s mesh filter basket design allows the filter to fit snugly against vessel walls, even in eccentrically shaped vessels. This reduces the risk of embolization by preventing particles from migrating through gaps and into the blood stream. Another key feature of the device is its steerability and guidewire-like torque response, which measures the number of revolutions needed to turn the tip 180 degrees within the sheath. Bench testing shows the Defender filter to have improved torque response.
“Torque response is a key attribute for a filter, and Defender performed very well, with a 1-to-1 torque response between the proximal and distal tip of the wire,” said Dr. Dierk Scheinert, director of the Park-Hospital Leipzig and head of the Department of Angiology at the University of Leipzig Heart Center. “We were impressed with the trackability of the system. One of the cases had a long lesion (2 cm) to cross, and the filter went through without any issue.”
Press release: Medtronic Announces CE Mark and European Launch of New 'Defender' Embolic Protection Filter ...
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Thursday, April 17, 2008
New MRI Approach for Lung Imaging
Traditional MRI systems used in hospitals are tuned to the resonant frequency of water, and so are designed to visualize "wet" organs. The cost comes when MRI is used in imaging the lungs which are full of air, leading to low quality images. To address this, Massachusetts researchers from the Harvard-Smithsonian Center for Astrophysics and the Martinos Center for Biomedical Imaging have developed an open access, low magnetic field MRI that focuses on inhaled helium.
From the MIT Technology Review:
Lung function is dependent on the orientation of the body, but it hasn't been possible to study this before because conventional MRI would require patients to lie on their backs. (PET can be used to look at some aspects of the physiology of the lungs but it gives limited information.) Asthma symptoms can be exacerbated when patients lie down, for example. The Harvard system "allows imaging with the patient in any orientation, something no one has ever been able to do," says Bastiaan Driehuys, an assistant professor at the Center for In Vivo Microscopy at Duke University.The open MRI system may also make it possible to monitor the lung function of newborns in intensive care without taking them out of their incubators. The researchers have filed a provisional patent for this application.
Unlike conventional MRI, which images the protons in water molecules, the Harvard MRI system monitors magnetically polarized helium gas inhaled by subjects. Conventional MRI requires a magnet about 150 times stronger than that in the Harvard system to magnetically align protons inside the body. But the helium used in the Harvard system is magnetically aligned before the patient inhales it, making it possible to use a very weak magnet inside the scanner.
More at the MIT Tech Review...
Project page: Open-Access, Low Magnetic Field MRI for Humans
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Wednesday, April 9, 2008
Philips HD7
Philips is introducing in the United States its new general purpose, modestly priced ultrasound system, the Philips HD7:
The system provides grayscale and color Doppler imaging with simple one button optimization, as well as Tissue Harmonic Imaging. In addition, the HD7 features a wide array of transducers, an adjustable flat panel LCD monitor, proven system architecture, and advanced imaging, measurement and quantification technologies.The Philips HD7 system addresses basic scanning needs while adding new technology and design advances that help improve image quality. Developed with clinicians in mind, the ergonomic, easy-to-use system can meet the demands for high-volume use in cardiovascular, OB/GYN, anesthesiology, oncology, electrophysiology, stress echo, pediatric, orthopedic, urologic, emergency and other applications.
Like all Philips ultrasound systems, the HD7 has a broadband digital beamformer to capture and preserve more tissue information than conventional narrowband systems and its wide dynamic range and digital focal tuning provide exceptional sensitivity and detail resolution. Features such as iSCAN one button image optimization, multiple transducer ports, DICOM connectivity, and easy data recording to CD or USB, position the HD7 well against other modestly priced ultrasound systems. In addition, optional off-line QLAB quantification software capability allows clinicians to perform post-examination image review and analysis on a PC. Further enhancing the system’s usability is a Study Guide on disk that quickly equips clinicians to use the advanced features of the HD7.
The system can accommodate a range of Philips' transducers for all kinds of clinical applications.
Product page: HD7 Ultrasound System...
Press release: Philips HD7 ultrasound system now commercially available in the United States...
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Monday, April 7, 2008
NeuroFlow Cath Promises to Save Ischemic Brains
CoAxia, Inc. of Maple Grove, MN, is a firm developing an aortic device designed to restrict blood flow in the descending aorta, in the hope of diverting blood flow from the lower extremities to the brain via the cerebral collaterals, in patients with acute ongoing stroke. 
According to the latest reports from the company, "CoAxia's ongoing SENTIS clinical trial has now passed 125 patients with participation from over 50 major stroke centers in North America and Europe. Analysis of interim safety data suggests that treatment with CoAxia's NeuroFlo(TM) catheter is well tolerated with a very low rate of the complications normally associated with stroke patients. In addition, the FDA has recently approved an expansion in the scope of the trial to now treat patients up to 14 hours after symptom onset."
Here's what we know about the company's NeuroFlo catheter:
The CoAxia technology is a potential alternative or complement to these clot-focused techniques. The brain has an extensive, interconnected collateral vascular network. Already somewhat active following an ischemic stroke, collateral pathways are capable of further increasing the delivery of oxygenated blood to the stroke’s ischemic penumbra. The ability to salvage that penumbra and minimize the eventual size of the infarct may lead to improved neurological recovery.CoAxia has developed the NeuroFlo™ catheter as a device for augmenting the blood flow to the brain, and in particular to increase blood flow in the collateral blood vessels to augment perfusion in the ischemic penumbra. NeuroFlo partially restricts blood flow in the descending aorta, diverting blood flow from the lower extremities to the cerebral collaterals. The NeuroFlo catheter itself is a unique, dual-balloon endovascular device. It is inserted through the femoral (leg) artery into the descending aorta and has independently inflatable balloons located immediately above and below the renal (kidney) arteries. The balloons are sequentially inflated to produce occlusions of approximately 70%. The balloons are left inflated for 45 minutes and are then removed and treatment is complete.
This concept was first tested through animal experimentation which demonstrated that partial aortic occlusion could be accomplished without significant side effects, cerebral perfusion could be rapidly and significantly increased, and the size of a resulting infarct could be reduced. In April 2002, the first clinical studies began in humans to demonstrate the safety of the procedure. The images shown on this page (click to enlarge) are taken with a variety of techniques from patients treated with the NeuroFlo catheter.
In 29 stroke patients treated during CoAxia’s feasibility studies 61% of patients improved by more than 3 NIHSS points during the NeuroFlo procedure and 62% had an improvement of 3 NIHSS points at 24 hours. The significance of this improvement is reinforced by the fact that the average time to treatment in these patients was 7.5 hours after the symptom onset - well beyond the 3 Hour treatment window of the FDA-approved intravenous tPA. These feasibility results provided the basis for CoAxia’s current SENTIS pivotal trial, and its recent SafeFlo24 feasibility study (see ongoing clinical trials).
NeuroFlo, as the first device designed to utilize the brain’s own collateral, blood vessels, has a number of potentially important benefits. First, it does not involve intracranial access, instead requiring only a simple aortic placement – a procedure performed at thousands of hospitals throughout the world. In addition, since the therapy does not attempt to remove or disturb the clot, it may be less likely to cause hemorrhage – a common complication of other acute stroke treatments. In fact, current treatments are generally not attempted beyond 3-6 hours post stroke for this reason. NeuroFlo has been evaluated up to 12 hours beyond onset and could become a viable treatment alternative for the hundreds of thousands of patients that are too late to treat with current options.
Product page: NeuroFlo™ catheter...
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Friday, April 4, 2008
FDA Grants Approval to First (?) Digital Mammograph With Computer Aided Detection
iCAD Inc. has announced that the FDA approved the integration of its SecondLook Digital tumor detection system with Fuji's FCRm tomograph. iCAD claims it is the first implementation of computer aided detection technology on top of a digital mammography system, although Medgadget covered Siemens' announcement of iCAD's integration into its systems two years ago. (Update below)
From the product brochure:
The unique SecondLook algorithms detect up to 72% of actionable missed cancers an average of 15 months earlier than screening mammography alone. Potential cancers are identified using patented artificial intelligence and pattern recognition technology to analyze images and identify patterns. Sophisticated mathematical analysis identifies and marks suspicious areas without obscuring the underlying image, enabling faster, more accurate reading.SecondLook Digital provides the most powerful and flexible DICOM connectivity solutions – enhancing digital workflow and enabling seamless integration with acquisition systems, review workstations, and PACS from
leading vendors. Flexible integration options enable CAD results to be viewed on workstations or sent to a plain paper printer. Priority queuing of studies improves clinical efficiency and efficacy by enabling the most
urgent or important studies to be analyzed with CAD first. SecondLook Digital performs CAD analysis on an image in an average of up to just 30 seconds, maximizing throughput and preventing bottlenecks.
Press release: iCAD receives FDA Approval for its SecondLook Digital for use with Fuji's Digital Mammography System
Product page: SecondLook Digital
Update: In an email, a representative from iCAD corrects our initial confusion: "The write-up questions the statement in iCAD's release about this being the first application of CAD "with digital mammography"..you are correct to point out that this is not the first application of CAD with DM. However, this refers to the first application of CAD with Computed radiography, a version of digital mammography that is more cost-effective than previous DM systems."
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Wednesday, April 2, 2008
FDA OK's Distribution of Dominion Vi 3D Fluoroscopy Scanner for Trial
Imaging3, a medical device company out of Burbank, California, has received FDA approval to begin distributing the Dominion Vi Scanner to evaluate its effectiveness in the clinical environment. The system, a high-resolution photo-fluoroscopy device that produces three-dimensional medical diagnostic images reconstructions in real- time, is touted by the company as a safer alternative to CT scanning because of its lower radiation doses.
From the company page about the purpose of the device:
A diagnostic medical imaging device built with Imaging3 Technology can perform several functions and can replace or supplement a number of exiting devices, resulting in considerable cost savings for hospitals and healthcare centers. These functions include:Perform real time, 3D medical imaging Emulate a CT scanner (at a fraction of the capital cost) Perform standard fluoroscopy Cross over to other modalities such as mammography and digital radiography The Company's management believes that this multi-function capability will be especially attractive in foreign markets, where the cost of a CT scanner is beyond the means of most hospitals and healthcare centers.
Press release: Imaging3 Receives FDA Approval to Distribute the Dominion Vi Scanner Under FDA (IDE) Regulations
Product page: Dominion Technology
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Monday, March 31, 2008
TruePoint PET-CT Scanner from Siemens
Siemens is reporting that their first tomograph with so-called HD-PET technology, a PET-CT unit called Biograph 40 TruePoint, has been installed at the UT Southwestern Medical Center in Dallas.
System features, taken from the product brochure and product website:
TruePoint PET-CT completely integrates the functional sensitivity of PET with the rich anatomical detail of diagnostic multislice CT. Exclusive technologies, such as the award winning Patient Handling System (PHS), HI-REZ, LSO, Pico-3D, True C, and SureView, offer superb image quality for improved diagnostic confidence. With Biograph's leading-edge technology, you can be more confident in your ability to detect changes in molecular activity even before anatomical changes become visible.TruePoint PET-CT helps you to reveal primary tumors, detect metastases, quantify uptake, and reduce false positives. Whether you're working in oncology, cardiology, or neurology, you need the most complete set of information possible in order to make a truly accurate diagnosis. Only TruePoint PET-CT reveals the tiniest abnormalities in the clearest detail.
HD-PET providing a new level of PET performance
LSO crystals for faster scans
HI-REZ offering unsurpassed resolution
TrueX providing uniform PET resolution and 2x improvement in signal-to-noise ratio
TrueV providing the longest axial field of view
TrueC offering model-based scatter correction calculated independently for every patient and bed position
UFC detectors providing stunning CT image quality
SureView ensuring maximum image quality at any speed
CARE Dose4D for real-time dose modulation
z-Sharp for the highest spatial resolution available
Press release: Siemens Installs First High-Definition PET-CT
Product page: Biograph TruePoint PET-CT
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Debris Aspiration During Heart Attack Improves Cardiac Blood Flow, Chances of Survival
The latest news from the ongoing meeting of the American College of Cardiology in Chicago is that using the Export® Aspiration Catheter from Medtronic before stenting, in patients with ongoing acute myocardial infarction (AMI), can "significantly improve blood flow and survival rates compared to conventional treatment with percutaneous coronary intervention (PCI) alone." The study, led by Felix Zijlstra, MD, PhD from University Medical Center Groningen, Netherlands, recruited 1,071 patients who were randomly assigned to PCI supported by the Export aspiration catheter (535 pts) or to PCI using conventional techniques (536 pts).
From the joint statement by the Society for Cardiovascular Angiography and Interventions and the American College of Cardiology:
To assess the quality of myocardial perfusion, the researchers documented myocardial blush grade. A myocardial blush grade of 0 or 1 indicates that little or no x-ray dye has reached from the surface artery into the heart muscle, a sign that the microcirculation is blocked. A myocardial blush grade of 3 indicates that x-ray dye has reached deep into the heart muscle, a sign of good blood flow through the microcirculation. A myocardial blush grade of 2 falls in between. Analysis of the elevated ST-segment on the electrocardiogram -- specifically, its return to a normal baseline -- was also used to gauge the quality of blood flow to the heart muscle.During angiography, researchers observed a blush grade of 0 or 1 in 17 percent of patients treated with the aid of the aspiration catheter and in 26 percent of patients treated with conventional PCI (p less than 0.001). At 30 days, clinical outcomes were strongly related to the degree of myocardial reperfusion. The rate of death in patients with a myocardial blush grade of 0/1, 2 and 3 was 5.2 percent, 2.9 percent and 1.0 percent, respectively (p equals 0.003). The combined rates of repeat heart attack, repeat procedure in the target artery and death in patients with a myocardial blush grade of 0/1, 2 and 3 were 14.1 percent, 8.8 percent and 4.2 percent, respectively (p less than 0.001).
At one-year follow-up, mortality was significantly lower in patients treated with the aspiration catheter (p equals 0.04), as was a combination of death and heart attack. A similar, highly significant relationship was observed between myocardial blush grade and death, or a combination of death and repeat heart attack (p equals 0.001).
The study team concluded that the degree of blood perfusion into the heart muscle helps to predict the patient's clinical condition, and that aspiration of debris from the treated artery during PCI can reduce the risk of death and repeat heart attack, even one year later.
Device That Clears Debris From Artery Aids Blood Flow in PCI... (.pdf)
Product page: Export® XT Aspiration Catheter...
Medtronic press release: Heart Attack Patients Benefit from Thrombus Aspiration Prior to Stenting, Study Shows...
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SIRTeX to Trial Radiation Spheres for Liver Cancer
Australian company SIRTeX has received FDA approval to begin trials of their injectable, beta radiating microspheres thought to directly target intrahepatic tumor sites.
From the product brochure:
SIR-Spheres microspheres consist of biocompatible microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Yttrium-90 is a high-energy pure betaemitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. The half-life is 64.1 hours. In therapeutic use, requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days. The average number of particles implanted is 30 – 60 x 106. SIR-Spheres microspheres are a permanent implant.SIR-Spheres microspheres are implanted into a hepatic tumor by injection into either the common hepatic artery or the right or left hepatic artery via the chemotherapy catheter port. The SIRSpheres microspheres distribute non-uniformly in the liver, primarily due to the unique physiological characteristics of the hepatic arterial flow, the tumor to normal liver ratio of the tissue vascularity, and the size of the tumor. The tumor usually gets higher density per unit distribution of SIR-Spheres microspheres than the normal liver. The density of SIR-Spheres microspheres in the tumor can be as high as 5 to 6 times of the normal liver tissue. Once SIR-Spheres microspheres are implanted into the liver, they are not metabolized or excreted and they stay permanently in the liver.
Each device is for single patient use.
Press release: Sirtex receives US FDA approval for FAST clinical trial (.pdf)
Product page: Product Package Insert (PDF)
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Wednesday, March 26, 2008
UC Davis Develops First Combined PET/MRI Tomograph
Scientists at UC Davis overcame difficult technical problems and succeeded in building the world's first combined PET/MRI scanner. The two imaging modalities are naturally complementary, as MRI provides information about tissue structure while PET is a functional modality that informs about biological processes.
Combining the two types of scan in a single machine is difficult because the two systems interfere with each other. MRI scanners rely on very strong, very smooth magnetic fields that can easily be disturbed by metallic objects inside the scanner. At the same time, those magnetic fields can seriously affect the detectors and electronics needed for PET scanning. There is also a limited amount of space within the scanner in which to fit everything together, Cherry [Simon Cherry, professor and chair of biomedical engineering at UC Davis -ed.] noted.Scanners that combine computer-assisted tomography (CAT) and PET scans are already available, but CAT scans provide less structural detail than MRI scans, especially of soft tissue, Cherry said. They also give the patient a dose of radiation from X-rays.
The photomultiplier tubes used in conventional PET machines are very sensitive to magnetic fields. So the researchers used a new technology -- the silicon avalanche photodiode detector -- in their machine. They were able to show that the scanner could acquire accurate PET and MRI images at the same time from test objects and mice.
Press release: MRI/PET Scanner Combo
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Wednesday, March 19, 2008
Stentys, Maker of Bifurcated Self-Expanding Coronary Stents, Gets Financed
Stentys, a Paris, France-based developer of bifurcated cardiac stents, has completed an $18 million 'Series B' round of venture financing led by a UK venture firm Scottish Equity Partners. The company hopes that its "world's first next-generation dedicated stent" for treatment of blocked coronary artery bifurcations will become a standard therapeutic option in cath labs across the world.
More about the technology:
A coronary stenosis can be treated fairly efficaciously with a stent, a small metal spring-like tube that opens up the artery.However treatment of artery bifurcations, which represent one coronary intervention in five, is ineffective : one patient in four suffers from restenosis (recurrence of the narrowing) and must undergo a second intervention, too often a by-pass surgery.
The Stentys stent is as simple to use as a conventional stent and is designed to offer superior clinical results thanks to a full opening and excellent scaffolding of the side branch.
The Stentys provisional strategy (treating the main vessel without compromising the side branch) is a prudent approach, in line with the consensus on bifurcations. If the side branch requires stenting, a standard DES can be placed without excessive gap or overlap.
Stentys stent is covered by a highly haemocompatible polymer used in dialysis devices, and a drug with a proven efficacy against restenosis.
The self expanding properties of the platform ensures complete strut coverage after a few weeks.
Stentys - Easy Bifurcation Stenting...
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Monday, March 17, 2008
Impella Percutaneous VAD to be Studied for Acute MI Patients
The FDA today gave approval to Abiomed to proceed with a clinical study of the Impella® 2.5 Circulatory Support System for patients with acute myocardial infarction (AMI). (2.5 refers to the ability of the device to augment the cardiac output by 2.5 liters per minute.) We've been following Impella, a ventricular assist device designed for percutaneous placement in the catheterization lab, for at least four years now, ever since it was designed and manufactured by Impella CardioSystems AG of Germany.
From today's announcement:
The AMI shock study will determine the safety and effectiveness of the Impella 2.5 as a left ventricular assist device for heart attack patients as compared to optimal medical management with an Intra-Aortic Balloon Pump (IABP). According to a recent American Heart Association report, approximately 865,000 AMI patients are treated annually in the U.S. The study is approved under category B2 status and the trial sites are eligible for full reimbursement from the Centers for Medicare and Medicaid Services (CMS).The randomized study, at up to 150 hospitals, is comprised of two arms; those patients that receive the Impella 2.5 for up to five days as a left ventricular assist device (VAD) and patients that receive IABP therapy. The study will compare 192 Impella 2.5 patients to 192 IABP patients relative to a composite end point comparing safety and efficacy. The primary endpoint will be a composite endpoint of major events assessed at 30 days post-PCI. These major events include but are not limited to: death, acute renal failure, and need for a major cardiovascular operation. The secondary endpoint will be a composite of cardiac function such as ejection fraction, requirement for inotropic support and cardiac power output. Following Institutional Review Board (IRB) approval at each participating hospital and requisite training, the Company plans to ship Impella 2.5 disposables and Impella consoles to enrolled sites.
Check out the product brochure below:
Press release: Abiomed Receives Conditional FDA Approval for Impella 2.5 Study for Acute Myocardial Infarction (AMI) Patients...
Product page: Impella 2.5...
Flashbacks: impella® recover LV ; Impella Recover Devices Approved in Germany for Reimbursement