Cardiology Archive

Thursday, June 25, 2009

New Xience Abbott Stent Gets EU OK


Abbott has just received the European CE Mark of approval for the firm's Xience Prime Everolimus Eluting Coronary Stent System.

From the press release:

XIENCE PRIME utilizes the same well-studied drug and proven biocompatible polymer as Abbott's market-leading XIENCE V® Everolimus Eluting Coronary Stent System. In addition, it offers a novel stent design and a modified delivery system designed for greater flexibility and improved deliverability. XIENCE PRIME uses cobalt chromium technology, which allows for very thin struts while maintaining strength to support the vessel as well as excellent visibility under X-ray during the stent implantation procedure. XIENCE PRIME is based upon the proven design of the MULTI-LINK® family of stents, which is the most widely used stent platform in the world – more than 2 million of Abbott's cobalt chromium stents have been implanted worldwide. Upon launch in Europe, XIENCE PRIME will be available in an expanded size matrix, including XIENCE PRIME SV for small vessels and XIENCE PRIME LL for long lesions.

Press release: Abbott Receives CE Mark for Company's Next-Generation XIENCE PRIME™ Drug Eluting Stent, Advancing Leadership Position

Product page: Xience V...

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Thursday, June 25, 2009

Piix Wireless Home Cardiac Monitoring to Undergo Randomized Trial


Corventis, a maker of wireless CHF monitoring devices that measure heart rate, heart rate variability, respiratory rate, fluid status and activity, and West Wireless Health Institute, a research organization promoting wireless technology use in medicine, have teamed up to conduct multi center clinical trials of the Piix device, a monitoring gadget we have profiled before.

From the press release:

Corventis' remote monitoring wireless system was approved by the FDA in February 2009, which sets up the potential for a multicenter, randomized clinical trial. The trial will be spearheaded by the West Wireless Health Institute and led by Dr. Eric J. Topol, the Institute's chief medical officer. Dr. Topol is also chief academic officer at Scripps Health and holder of the Gary and Mary West Chair of Innovative Medicine.

Participation in the pivotal randomized trial with WWHI and Corventis will be offered to the sites supported by the National Institutes of Health Clinical and Translational Science Award (CTSA) National Consortium, which consists of 38 of the most prestigious academic medical centers in the United States. The trial is designed to clinically validate remote wireless monitoring technology in proactively managing heart failure patients and reducing hospital readmissions.

Press release: West Wireless Health Institute Teams with Corventis for its First Multicenter, Randomized Clinical Trial...

Links: West Wireless Health Institute; Corventis technology...

Flashback: PiiX Monitors for Signs of Decompensated Heart Failure...

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Wednesday, June 24, 2009

Improve Your Ultrasound Skills With New SonoSite iPhone App


SonoSite has released an iPhone application, called SonoAccess™, to help clinicians improve their analytical and performance skills when using ultrasound. With the help of instructional videos and an accompanying image gallery, you can improve on your echo knowledge while on your train ride to work.

Features:

Scanning Technique Videos are designed to provide expert techniques and tips for point-of-care ultrasound applications.

Video Case Studies provide an in-depth look into specific cases that you may encounter in your practice.

Clinical Image Gallery is designed to give you a look at expert ultrasound images for anatomy recognition and as a quick comparative reference for you to compare your results to.

Quick-Start Guides are abbreviated user manuals designed to give new SonoSite users a digital roadmap of their system's controls and features to help navigate the user interface.

The Reimbursement Guides are designed to provide general coverage and payment information for diagnostic ultrasound and ultrasound-guided procedures so you have accurate coding and billing information.

The SonoAccess News Feed keeps you up-to-date on the latest SonoSite news.

Watch video here demonstrating the app...

Product page: SonoAccess™ Ultrasound iPhone App

Download link @ AppStore...

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Tuesday, June 23, 2009

Medtronic's New MRI Compatible Pacemaker Gets CE Mark

Medtronic just received European approval for the firm's Advisa DR MRI™ SureScan™ Pacing System, an implantable pacemaker that has demonstrated safety when worn while undergoing MRI scans. The Advisa has not received FDA approval and therefore is not yet available in the US.

The Advisa MRI SureScan pacing system is the most advanced pacing system from Medtronic and combines for the first time MRI SureScan with key features from Medtronic pacemakers and defibrillator systems: exclusives such as MVP® (Managed Ventricular Pacing), OptiVol® Fluid Status Monitoring, and Ventricular and Atrial Capture Management (VCM and ACM). MVP reduces right ventricular pacing by 99 percent2. In SAVE PACe, a previous trial of pacemaker patients published in The New England Journal of Medicine, use of Medtronic MVP or Search AV+ modes was proven to dramatically reduce unnecessary right ventricular pacing. This reduction was shown to reduce the development of persistent atrial fibrillation. Further, the 2008 ACC/AHA/HRS Device-Based Therapy Guidelines indicate there may be deleterious effects from even modest levels of ventricular pacing associated with alternative programming modes.

VCM and ACM are intended to automatically adjust impulses for optimal stimulation of the heart’s chambers. The device also offers enhanced diagnostics to help assist physicians in the diagnosis of irregular heart rhythms, particularly atrial tachyarrhythmia (AT) / AF. Additionally, upon commercial release, the Advisa MRI SureScan pacing system will be available for remote follow-up via the Medtronic CareLink® Network.

Press release: Medtronic Receives CE Mark for Second-Generation MRI Pacemaker...

Flashbacks: Positive Results for Medtronic's MRI-Safe Pacemaker; Developing the Next Generation of DBS Devices; Medtronic Starts Study of MRI Compatible Pacemaker; Is It Now Safe to Send a Patient With a Pacemaker for an MRI Scan?

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Friday, June 19, 2009

Voice Activated SonoSite Ultrasound System Keeps Hands Free to Perform Procedures


SonoSite just released their SonoRemote for controlling the company's M-Turbo and S Series ultrasounds during interventional procedures like joint injections or central line placements. In addition to traditional style buttons, the remote control features voice recognition and can be programmed to understand commands in any language. So now you can hold the probe in one hand and the syringe in the other, and not have to fiddle with reaching over to the unit to take snapshots or change parameters.

  • Voice or touch activated

  • Programmable to your voice and language

  • Adjust system controls from a radius of 10 meters

  • No need to break the sterile field

  • Drop-tested to 3 feet

  • Works with M-Turbo® and S Series™
  • Press release: SonoSite Begins Customer Shipments Of Ultrasound Remote Control

    Product page: SonoRemote

    Flashbacks: M-Turbo™: New Portable Ultrasound from SonoSite ; SonoSite S-ICU™ Ultrasound Tool; S-Nerve™ from SonoSite; The SonoSite® MicroMaxx™; Titan

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    Thursday, June 18, 2009

    Cappella's Sideguard Stent Gets Infusion of Capital


    Things are suddenly looking brighter for Cappella Medical Devices Ltd. (Galway, Ireland), a developer of next generation bifurcated coronary stents. The company is reporting that it has just received a significant amount of Series C investment to help advance the company's Sideguard® Generation Coronary Bifurcation Stent, a two piece device designed for percutaneous coronary interventions (PCI) at ostial and bifurcation lesions.

    The stent is composed of the following two components:

    -- side branch nitinol self-expanding drug-eluting stent, shaped to conform to the ostium, and to allow continuous drug delivery throughout the ostial zone;

    -- main vessel drug-eluting stent, designed to fit inside the vessel and at the same time to readjust the position of Sideguard ostium protection device against the main vessel wall


    More from the device info page:

  • Self-expanding nitinol stent

  • Provides optimal wall apposition and scaffolding

  • Conforms to a wide range of angles and anatomies

  • Opens & protects the side branch, eliminating wire jailing

  • “No gap” sequential T-stenting approach

  • No stent foreshortening
  • Unique balloon-catheter delivery system for nitinol stents

    Enhanced deliverability & trackability
    - Delivered over 0.14” guidewire
    - Low-profile <3.1Fr catheter
    - Single catheter design avoids wire braiding/wrapping
    Precise deployment at the ostium
    - Custom split-sheath technology
    - Eliminates stent jumping

    Video demonstrating the placement of the device:

    Product page: Sideguard® - The Next Generation Coronary Bifurcation Stent

    Press release: Cappella Inc. Secures $17.3 Million Series C Investment...

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    Wednesday, June 17, 2009

    St. Jude Medical's Cool Point Irrigation Pump Gets US OK


    The FDA has just approved St. Jude Medical's new Cool Point™ Irrigation Pump for use with SJM's open-irrigated ablation catheters for radiofrequency (RF) ablation procedures for atrial fibrillation.

    Designed to enhance physicians’ ability to perform successful atrial ablations, the new Cool Point irrigation pump was developed specifically for use with the company’s IBI-1500T9-CP cardiac ablation generator and family of Therapy™ Cool Path™ irrigated catheters.

    In addition to the intuitive setup and operation, the Cool Point Irrigation Pump provides monitoring and safety features, which are designed to give physicians more control over therapy delivery. This interface enables physicians to monitor the total volume of irrigation solution delivered through an easy-to-read display.

    The pump’s proprietary tubing includes an in-line occlusion detector, which monitors flow pressure between the pump and the catheter tip, providing an alert if flow pressure increases substantially relative to the flow rate (an indication that irrigation ports on the catheter tip may be blocked and the tip cooling may not be effective). In addition, the pump has redundant bubble detectors, each designed to detect bubbles as small as two microliters. Bubbles in the bloodstream may lead to embolism or stroke.

    Press release: St. Jude Medical Announces FDA Approval of the Cool Point Irrigation Pump...

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    Tuesday, June 16, 2009

    EU Issues OK for Minimally Invasive Subcutaneous Implantable Defibrillator


    Cameron Health out of San Clemente, California has seen its Subcutaneous Implantable Defibrillator (S-ICD®) System trialed in hospitals around the world, the results of which netted the company approval for the device across the European Union. Unlike traditional AICDs, Cameron's device does not require pacer-defibrillator leads to be placed in the heart, and therefore may overcome the various problems related to lead implantation and retention.

    Conventional ICD’s require placement of at least one lead in or on the heart. Most frequently, these leads, constructed of thin insulated wires, are threaded through a vein and then placed inside the heart. These conventional transvenous leads allow for sensing of the heart’s rhythm and delivery of a life saving electric shock when a harmful arrhythmia is detected. The surgical placement and residence of these transvenous leads within the patient’s heart are associated with a significant proportion of the complications related to this well established and highly effective therapy. In contrast, the Cameron Health S-ICD System resides just under the skin, potentially avoiding many of the complications associated with the conventional implant procedure and long term performance. The S-ICD System is also designed for ease of placement and removal while shortening the surgical procedure time. The S-ICD System is the first totally subcutaneous implantable defibrillator used to treat SCA. Market launch is scheduled to commence this summer in select geographies as Cameron Health ramps production.

    Here's a link to the presentation given at this year's Heart Rhythm Society's Annual Scientific Session: Clinical Evaluation of the Subcutaneous Implantable Defibrillator (S-ICD®) System...

    Press release: Cameron Health Announces CE Mark of the Minimally Invasive Totally Subcutaneous Implantable Defibrillator for Treatment of Sudden Cardiac Arrest...

    Link: Cameron Health homepage...

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    Friday, June 12, 2009

    St. Jude Medical Introduces New ICD-Leads Connector

    sj4c.jpgSt. Jude Medical is introducing a new connector system, called SJ4, designed to minimize the number of connections between cardiac leads and the company's AICDs. For now the new connector will be used only in Current® Plus AICD model, but our guess is that if accepted by surgeons, cardiologists and radiologists, the connector might be making its way into other company devices.

    The SJ4 connector system features a single connection between the device and the defibrillation lead, and a single set screw (used to tighten and secure the lead to the device). Previous defibrillator lead designs required three separate connections and four set screws. The reduced number of lead connections also lessens the risk of lead-to-can abrasion, a known complication that can occur in patients who have an implantable device.

    "With only a single connection and one set screw, the SJ4 connector has the potential to improve the implant procedure, may reduce the lead volume under the ICD in the chest wall and may improve patient comfort," said Cleveland Clinic's Bruce Wilkoff, M.D., who is on the company's physician lead review board and has sponsored research with St. Jude Medical, Inc. Dr. Wilkoff implanted the first Current Plus ICD with SJ4 connector on June 4, 2009. "This design is intended to reduce the risk of incorrect connections of the lead to the ICD and reduce procedure time."

    The St. Jude Medical SJ4 connector system is designed to meet the draft IS-4 standard as set forth by the International Organization of Standardization (ISO) but will not be labeled as such until the standard is finalized, which is expected later this year. St. Jude Medical began launch of the SJ4 connector system after ISO-directed interchangeability testing among multiple manufacturers was completed. This testing was deemed an important step in ensuring that these new leads, which currently meet the drafted IS-4 standard, would be compatible with future implanted devices.

    "Simplifying the lead connection process is one of many design features we have incorporated as part of our commitment to making procedures safer for patients and more efficient for physicians, from implant through follow-up," said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. "This aligns with our strategy of reducing lead risks and increasing reliability, which includes technology designed to reduce lead-to-can abrasion and sensing of far-field ventricular signals in the atrium."

    The Current Plus ICD was approved by the FDA in April 2009, along with the company's Promote(R) Plus cardiac resynchronization therapy defibrillator (CRT-D), which are compatible with the Durata(R) SJ4 defibrillation lead. As with previously announced leads in the Durata lead family, the Durata lead with SJ4 connector features a soft silicone tip and Optim(R) insulation, a hybrid insulation material that provides increased abrasion-resistance and durability, along with the flexibility and handling characteristics that facilitate device implantation.

    Press release: St. Jude Medical Announces Initial Implant of First-to-Market Connector System in the U.S.

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    Emboshield NAV6 Embolic Protection System Released by Abbott


    Abbott Laboratories has just released a new embolism protection system in its popular line of Emboshield NAV™ devices, all designed to be used in various stenting procedures.. The Emboshield NAV6™ is indicated "for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries."

    Abbott today announced the launch of the sixth-generation Emboshield NAV6™ Embolic Protection System for use in carotid artery stenting procedures. Carotid artery stenting provides a minimally invasive treatment alternative to conventional open carotid artery surgery for patients who are at high risk for surgery. Embolic protection systems are used during the stenting procedure to prevent particles of dislodged plaque from flowing to the brain, potentially causing an ischemic stroke. The Emboshield NAV6 is now available in the United States and Europe.

    Abbott’s proprietary BareWire™ technology allows for wire movement independent of the Emboshield NAV6 filter, giving physicians an increased level of control during carotid stenting procedures.

    Safety and efficacy endpoints for the Emboshield NAV6 were met in Abbott’s PROTECT clinical trial, which was designed to examine carotid artery stenting with Abbott’s Emboshield systems in patients at high risk for carotid endarterectomy (surgery). In addition to demonstrating continued improvements in outcomes for carotid stent procedures, the PROTECT study data showed a low 1.8 percent composite rate of All Stroke and Death at 30 days in 220 patients. This rate is well within American Heart Association (AHA) 30-day All Stroke and Death rate guidelines for carotid endarterectomy of 6 percent for symptomatic and 3 percent for asymptomatic patients with carotid artery disease.

    Here's an animation demonstrating the placement of the system and how the thrombus filter provides safety:

    READ MORE...


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    Tuesday, June 9, 2009

    BridgePoint Aims to Treat ChronicTotal Occlusions in Coronaries

    BridgePoint Medical, out of Plymouth, MN, has developed innovative new catheters designed to cross chronic total coronary occlusions in native arteries, and reopen myocardial blood flow through vessels that everyone has given up on. Currently undergoing clinical trials, the CrossBoss™ CTO Catheter and the Stingray™ CTO Re-Entry System are yet to receive FDA approval.

    More from BridgePoint about the devices:


    Stingray:
  • The Stingray™ CTO Re-Entry System has two components: The Stingray™ CTO Orienting Balloon Catheter and The Stingray™ CTO Re-Entry Guidewire

  • Familiar coronary balloon catheter and guidewire designs are enhanced with custom features for CTO crossing without changing routine practice

  • Flat shape of the Stingray™ CTO Orienting Balloon Catheter is intended to orient one exit port automatically toward the vessel true lumen upon low pressure inflation (4atm)

  • The Stingray™ CTO Re-Entry Guidewire's distal probe is designed for exit port selection and re-entry into the vessel true lumen

  • CrossBoss™ CTO Catheter

  • Bi-directional rotation of the proximal torque device with the FAST SPIN Technique is designed to aid in advancement of the CrossBoss™ CTO Catheter

  • A 3.0F atraumatic rounded tip is designed for passage through the CTO

  • The device is intended to cross directly through the CTO or bypass the obstruction via a subintimal path
  • Device info page: Stingray™ CTO Re-Entry System

    Video below the fold showing off the devices in greater detail:

    READ MORE...


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    World's Smallest TEE Probe Goes Multiplane


    Philips is releasing a new multiplane transesophageal echocardiography (TEE) transducer that the company touts to be the world's smallest. Developed to make cardiac imaging better in pediatric population, the probe could also be of benefit to adults with esophageal strictures and other obstructive defects. The S8-3t microTEE transducer is part of Philips' iE33 echo system offerings, and is being presented this week at the 20th annual American Society of Echocardiography (ASE) in Washington, D.C.

    Due to the larger size of previously available pediatric TEE transducers, small babies have been impossible to image during critical cardiac catheterization or surgical procedures. As a result, high-risk procedures have been done routinely on these tiny patients without transesophageal echocardiography images available to the interventionalist or surgeon.

    "The microTEE probe is a major advance in our ability to provide intra-operative cardiac imaging in newborn babies and infants,” said Dr. Girish Shirali, M.D., director of pediatric echocardiography at Medical University of South Carolina (MUSC) Children’s Hospital. “We are delighted with the image quality, and the miniaturization of the probe has already proven invaluable to our pediatric interventionalists in high-risk cath lab procedures. Finally, our smallest and sickest patients can be imaged intra-operatively just like everyone else.”

    Building on Philips’ existing 2D technology, the microTEE transducer is roughly one-third the size of previous pediatric TEE transducers, allowing physicians to ‘turn on the lights’ for the first time for their tinier patients and providing the images they need during interventional procedures. Available globally in summer 2009, the new microTEE is also entering trials for adult patients requiring TEE imaging but who have difficulty tolerating standard TEE probes.

    Press release: Philips announces world's smallest multiplane transesophageal transducer

    Product page: iE33 Echocardiography System

    Bottom image: This ventricular septal defect on a 5.4 kg infant is viewed side-by-side in 2D and color flow Doppler modes available on the Philips microTEE transducer.

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    Thursday, May 28, 2009

    FDA OK's Boston Sci's Small Coronary Drug Eluting Stent

    trialres342.jpgBoston Scientific has received FDA approval for the smallest drug eluting stent currently available, indicated for coronary vessels ≥ 2.25mm. The company plans to launch the TAXUS® Express²® Atom™ device to the US market in June.

    taxatom_mg_01_us_large.jpgMore about the stent from Boston Sci:

    Data from numerous clinical studies have shown that an estimated 10 percent of patients undergoing percutaneous coronary interventions have small vessels (<2.5 mm). Until recently, many physicians were inclined to implant bare-metal stents in these patients since they were the only approved stenting option for small vessels. Last year's launch of the TAXUS Express Atom Stent offered an alternative treatment choice for patients with small vessels who will now have the additional option of the TAXUS Liberte Atom Stent.

    The TAXUS Liberte Stent features design improvements over the Company's first-generation TAXUS Express Stent, including thinner struts to allow better stent deliverability and conformability, as well as uniform stent geometry for consistent lesion coverage and drug distribution.

    Press release: FDA Approves Boston Scientific's Next-Generation TAXUS® Liberte® Atom™ Stent System

    Product page: TAXUS® Express²® Atom™ Paclitaxel-eluting Coronary Stent System

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    ViRob, a Cavities Crawler


    At the upcoming ILSI-Biomed Israel 2009 conference (June 15-17 in Tel Aviv), researchers from the Medical Robotics Laboratory at the Israel Institute of Technology (Technion) will be showing off a microrobot called ViRob, that has only a 1millimeter diameter and can crawl through vessels and cavities, when controlled by an external magnetic field. The big idea behind the ViRob device is that it can be used to deliver pharmaceutical payloads to precise locations or pull a microcatheter through tortuous terrain.

    fdgs4534.jpgHere's what organizers of ILSI-Biomed Israel 2009 conference tell Medgadget:

    Researchers are currently examining the possibility of using ViRob as a treatment for lung cancer—the world’s deadliest cancer. ViRob could assist in targeted drug delivery to lung tumors as well as take samples from different areas within the body. In addition, a number of these micro robots could simultaneously treat a variety of metastases. Researchers also plan to install additional equipment on the robot, including cameras, miniature tongs and other miniature equipment.

    ViRob measures 1 millimeter in diameter and 14 mm in its entirety was developed in the lab of Prof. Shoham in the Medical Robotics Laboratory at the Israel Institute of Technology. The robot moves using an external electromagnetic ignition system, stimulated by an electromagnetic field with frequency and volume that do not agitate the body, enabling it to maneuver in different spaces and surfaces within diverse viscous fluids. The vibration created by the magnetic field propels the robot forward, as the tiny arms protruding from a central body grip the vessel wall. A basic prototype of the ViRob, which can move as fast as 9 mm per second, has been developed thusfar.

    Link: ILSI-Biomed Israel 2009...

    White paper from Technion...

    A few videos below the fold demonstrating the ViRob:

    READ MORE...


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    Wednesday, May 20, 2009

    Medtronic's CoreValve Transcatheter Aortic Valve Replacement System Performs Well in Trial

    gMedtronic today presented findings from a European trial testing the effectiveness of the CoreValve ReValving system, a percutaneous aortic stenosis repair device, in a subclavian approach for people who were at risk if the femoral approach would have been used. Medtronic has acquired the Irvine, California based CoreValve, Inc. in March of this year, and is now moving full steam ahead to implement this nitinol-based stent device for clinical settings.

    The data reported procedural success of 100 percent; 24-hour survival of 100 percent; and 30-day survival of 89 percent. The available 30-day analysis also demonstrated clinical improvement in heart failure symptoms with 76 percent of the patients gaining at least a one-stage NYHA class and one-third improving by at least two stages.

    Medtronic’s market-leading CoreValve system was designed to allow the implant of a replacement heart valve in patients with aortic stenosis who are at high or prohibitive surgical risk. The system enables a catheter-based implant via a peripheral blood vessel, traditionally the femoral artery. A significant subset of patients, however, have compromised peripheral arteries, which prevents the use of the femoral approach. Uniquely, the delivery system of the CoreValve device is small enough to allow an alternative approach via the subclavian artery beneath the collar bone.

    The data presented today at the PCR interventional cardiology meeting in Barcelona reported on data from 74 patients for whom subclavian access was used within the CoreValve Extended Evaluation Registry, an observational study which closed in January 2009. The average age of the patients was 81.4. Moreover, the average Logistic EuroSCORE (a measure which predicts risk of procedural mortality based upon patient status) was notably high at 28.4%.

    Press release: Medtronic's CoreValve Shows Subclavian Access Success in Patients Contraindicated for Femoral Approach

    Product page: CoreValve ReValving...

    Animation below the fold demonstrating the implantation of the CoreValve:

    READ MORE...


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    The Signos, Self Contained Handheld Ultrasound Gains FDA Approval


    While we have reported on mobile handheld ultrasounds for phones, for those of you that have not joined the iPhone/Smartphone revolution, you are now in luck. The Food and Drug Administration (FDA) has just approved the Signos device, a handheld self-contained portable ultrasound imager with a probe. The system might come in handy as a quick initial diagnostic modality for intraabdominal processes, such as ectopics, AAAs, for carotid scans in ER in patients with ongoing TIA, as well as an assistive device for central line placements. For now, the system seems to be missing a Doppler for flow studies.

    The Signos weighs half of a pound and is the size of most smartphones. It will be available with both a 3.5MHz or a 7.5MHz transducer that can be swapped. The company promotes this device for fast paced and active medical environments such as emergency departments and rural medical clinics.

    Portable and Affordable: The Signos device is the size of a PDA, weighs less than one pound and features superb image resolution. The Signos is the world's smallest and most affordable ultrasound system available today.

    Signos Is Ready When You Need It: With a sleep time of up to 14 days and the ability to power up in less than 1 second from sleep mode, the Signos brings ultrasound to your triage diagnostic care whenever and wherever you need it allowing you to visualize acute pathology on the spot.

    Increase Clinical Utility with Added Versatility and Applications: Increase the number of procedures and applications you can perform with either a 3.5MHz or a 7.5MHz transducer. Signostics makes switching from 3.5MHz to 7.5MHz frequencies simple with our easy to use screw on/off transducers.

    See More, Do More with MotionScape and SectorView Technology: Signos uses MotionScape and SectorView technology to facilitate a wide range of high resolution clinical applications, including ultrasound guidance for needle placement, AAA exams, FAST exams, bladder volumes and more.

    Image Collection: Using the included microSD card you can save up to 20,000 images on the Signos device. With the free SigViewer Software you can quickly and easily upload data and images to your computer for reports, archiving, printing or email.

    Signostics Medical has not disclosed a price point or time line for for the Signos release as of yet, but their video support for the device indicates that this is something that is very close to being ready for commercialization.

    Press release: Signostics Receives FDA Clearance for World's Smallest Ultrasound Product...

    Product page: The Signos device...; Product brochure (.pdf)...

    Signostics Medical: Signos

    Flashback : Mobile Clinical Imaging On a Smart Phone

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    Thursday, May 14, 2009

    Positive Results for Medtronic's MRI-Safe Pacemaker

    A clinical study evaluating the performance of Medtronic's EnRhythm MRI SureScan pacemaker has shown that the device is not subject to interference from magnetic resonance imaging. As the only pacemaker approved for MRI in the EU, the news may give the FDA enough guidance to also approve it as the first of its kind in the US.

    Results showed that Medtronic's investigational EnRhythm MRI SureScan pacing system still performs as intended during and after an MRI when used according to the product's labeling. The data showed no MRI-related complications, and no arrhythmias, or asystole (absence of electrical activity in the heart) during MRI scans.

    This prospective, randomized, controlled trial involved 464 individuals successfully implanted at 41 centers in the U.S., Canada, Europe and the Middle East. After successful implant of pacemaker and leads, 258 patients were randomized to MRI and 206 to no MRI (control). All patients were evaluated before and after the scan, and one week and one month after MRI scan/control visit. There was no difference in performance between the MRI group and the control group.

    Press release: Medtronic Demonstrates Positive Results on First Pacemaker Designed for Use with MRI

    Flashback: Medtronic Starts Study of MRI Compatible Pacemaker

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    Digital Subtraction Angiography on a Single Image


    Analyzing angiography sequences typically requires viewing a series of black and white images and noticing the differences the contrast medium created as it passed through the obstructions in the vessels. To help with visualization and to improve diagnosis, Siemens is releasing a new digital subtraction angiography (DSA) software, the syngo iFlow, that automates the process to produce a color image highlighting the path of the contrast medium.

    From a Siemens press statement:

    The syngo iFlow application, for example, can be used to enhance pre-procedural and post-procedural imaging of patients under treatment for leg stenosis. Flow deviations and the increased utilization of collaterals can more easily be detected prior to intervention, since anomalies more readily attract the physician's attention due to their specific colors. Following the intervention, the success of a balloon dilatation or stent implantation of a stenosis is readily visible due to the improved flow.

    In order to obtain a color image, syngo iFlow takes the time to maximum opacification of each individual pixel, starting with the injection and subsequently visualizing the distribution of the contrast medium through the vessels. These time measurements are then represented by a color allowing visualization of the complete vessel tree in one image.

    Press release: Siemens sets a new standard in subtraction angiography

    Product brochure: syngo iFlow (PDF)

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    Two Wireless Telemetry Cardiac Pacers Get EU OK


    St. Jude Medical is releasing two new cardiac pacemakers to the European market having received the CE Mark of bureaucratic approval. Both models feature wireless communication to deliver telemetry data from implant to a monitoring center.

    From the press release:

    The remote monitoring capabilities facilitated by the Accent RF and Anthem RF device product line will permit automated follow-up, and daily device safety checks with no patient action required. In addition to giving physicians fast access to device performance data, the wireless monitoring system will also allow physicians to compile a more complete patient record by easily transferring cardiac device data into electronic health records (EHRs).

    To better assist physicians in accurately diagnosing and managing patients with fast rates in the heart’s upper chambers (atria), the devices will also include a new AT/AF Alert feature. This feature is designed to notify physicians when a rapid atrial rate (atrial tachycardia/atrial fibrillation [AT/AF]) exceeds a programmed value or occurs over an extended time period. The devices also can be programmed to notify the patient of AT/AF episodes, as well as device- and lead-related issues, through a two-tone audible alert. In addition, the patient’s clinic can be informed through the home monitoring system. These features will allow the physician to more proactively manage patients’ atrial arrhythmias, such as AF, with appropriate medication or ablation.

    In addition, the Anthem RF CRT-P and Accent RF pacemaker include advanced automatic features that help to promote patient safety and efficiency for the clinician. The devices can be programmed to automatically monitor and adjust the level of electrical energy needed for stimulating the patient’s heart, in the chambers where therapy is delivered; this includes up to three chambers for cardiac resynchronization therapy. The devices do this by measuring the heart’s reaction to electrical stimulation from the device and confirming that the heart is responding to the stimulation. This AutoCapture™ Pacing System feature provides the dual benefit of added safety for the patient and increased efficiency for physicians, as vital threshold tests are performed automatically and results are available to the physician for review on-demand during follow-up via a simple device interrogation. The launch of the Accent RF and Anthem RF devices marks the first time that these automatic test results can be accessed remotely or wirelessly in a clinic for a complete pacemaker family, including a CRT-P, and single- and dual-chamber models.

    The devices are also equipped with the St. Jude Medical QuickOpt® Timing Cycle Optimization feature. QuickOpt Timing Cycle Optimization can recommend the optimal A-V (atrial-ventricular) and/or V-V (ventricular-ventricular) timing values, depending upon device model, to use in programming the devices. Optimized timing can increase the efficiency of the heart’s ability to pump blood to the body. Traditional echocardiography (echo), while considered the gold standard for optimizing devices, is expensive and time-consuming. QuickOpt Timing Cycle Optimization produces results clinically proven to be comparable with those of echo, in 90 seconds instead of the 30 to 120 minutes required for a typical echo.

    Additionally, the Accent RF pacemaker features the St. Jude Medical Ventricular Intrinsic Preference (VIP®) algorithm, with which the device monitors the heart beat-by-beat and provides pacing only when necessary. Allowing the patient’s natural heart rhythm to work on its own when possible has been shown to benefit overall heart health.

    Press release: St. Jude Medical Announces European Approval of Accent RF and Anthem RF Pacemakers Equipped With Wireless Technology

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    » Brilliance 64-slice CT Scanner by Philips (April 4, 2005)

    » Novel Device for High Blood Pressure Implanted (April 1, 2005)

    » Optical Coherence Tomography: Positive Results in Clinical Study Reported (March 31, 2005)

    » TherOx ® AO System for Hyperbaric Oxygen Delivery (March 25, 2005)

    » TriActiv ® Balloon Protected Flush Extraction System (March 22, 2005)

    » Pacemaker study sees increase in heart failure rates (March 15, 2005)

    » Acuson AcuNav 8F for Intracardiac Ultrasound Exams (March 10, 2005)

    » Vasotrac Non-Invasive Blood Pressure Monitor (March 9, 2005)

    » GE's LightSpeed VCT System (March 8, 2005)

    » Endeavor ™ Drug Eluting Stent: Positive Results Reported (March 7, 2005)

    » Biograph 64 PET/CT System (March 4, 2005)

    » DynaCT C-arm System (March 4, 2005)

    » New ultrasound technique reported (March 3, 2005)

    » GuardWire fails in international study (March 2, 2005)

    » UltraStethoscope™ (February 21, 2005)

    » CardioVision MS-2000: predicting a heart attack in the next 10 years? (February 16, 2005)

    » VentrAssist LVAS (February 9, 2005)

    » New procedure for children with LQTS (February 3, 2005)

    » Philos II DR-T from Biotronik (February 2, 2005)

    » INR@Home (January 21, 2005)

    » InSync Sentry: defibrillator and CHF monitor (January 17, 2005)

    » New Linear ™ 7.5 Fr. Intra-Aortic Balloon (January 11, 2005)

    » Signals From Deep Inside (December 28, 2004)

    » The LifeVest Conspiracy (December 28, 2004)

    » ReadMyHeart ECG (December 17, 2004)

    » Personal Health Status Monitor (December 16, 2004)

    » BioZ Dx (December 15, 2004)

    » Q-Stress® version 3.5 (December 14, 2004)

    » Endo-PAT2000 System (December 14, 2004)

    » T-Line Tensymeter (December 11, 2004)

    » iE33 by Philips (December 11, 2004)

    » Vivid i (December 11, 2004)

    » Stereotaxis (December 10, 2004)

    » Native TEQ Dynamic Technology for ACUSON Sequoia; 8V3 Transducer (December 10, 2004)

    » Toshiba Aplio xV (December 10, 2004)

    » Titan (December 9, 2004)