Vascular Surgery Archive

Monday, March 15, 2010

Rex Medical Cleaner Rotational Thrombectomy System Wins US Green Light

Rex Medical of Conshohocken, Pennsylvania won regulatory approval from the FDA to sell its Cleaner Rotational Thrombectomy System. The atherectomy system is based around a battery powered Cleaner device that rotates a tip at 4,000 RPM for drilling through arterial plaque.

  • 6Fr ergonomically designed, hand-held, battery operated drive unit
  • 6Fr introducer sheath compatibility
  • Atraumatic, effective wall contact and thrombus maceration with particulate aspiration through an introducer sheath
  • Superior trackability and steerability through tortuosity
  • Decreased procedural time and cost
  • Single use, disposable
  • Cleaner Device Specifications:

    Wire:

  • 0.035 inch diameter

  • Radiopaque tip
  • Catheter:

  • 6Fr shaft outer diameter

  • 65cm & 135cm length
  • Drive Unit:

  • Battery operated

  • 4,000 rpm
  • Press release: Rex Medical Cleaner™ Rotational Thrombectomy System Receives 510(k) Clearance ...

    Product page: Cleaner ...

    Flashbacks: Diamond Tipped 200,000 RPM Artery Drill ; Pathway Medical's Peripheral Plaque Drill Gets 510(k) Classification

    email this article to a friend      print this!      permalink to Rex Medical Cleaner  Rotational Thrombectomy System Wins US Green Light           comments and peer reviews (0)




    Monday, March 15, 2010

    Cook's NavAlign IVC Filter Placement System Gets Femoral Access Option

    At the annual scientific meeting of the Society of Interventional Radiology in Tampa Bay, Florida this week, Cook Medical is launching a version of its NavAlign inferior vena cava (IVC) filter placement system. Already on the market since the fall of 2009, the NavAlign system is now available with femoral access option to complement the jugular access model.

    From the press release:

    NavAlign, available for Cook Celect® and Günther Tulip® filters, incorporates a hemostasis valve to minimize blood loss. With an accompanying multipurpose dilator, radiopaque sizing marker bands and flushing sideports designed to decrease fluoroscopy time and contrast medium amounts, the NavAlign system is ideal for physicians using image guidance to place IVC filters to help protect patients from DVT and pulmonary embolism (PE), a life-threatening condition that can kill one out of three individuals if left untreated.

    Press release: Cook Medical Expands Next-Generation NavAlign™ System for IVC Filter Placement with Femoral Access Option ...

    email this article to a friend      print this!      permalink to Cook's NavAlign IVC Filter Placement System Gets Femoral Access Option           comments and peer reviews (0)


    Friday, March 12, 2010

    Duraspan Biomimetic Coated Hemodialysis Catheter

    r4 Vascular out of Maple Grove, Minnesota has released a new catheter for patients on long-term hemodialysis. The Duraspan catheter aims to prevent thrombus accumulation thanks to its biomimetic coating that discourages clot formation.

    A novel coating on the catheter surface mimics the glycocalyx layer found on natural endothelial tissue surfaces in vessel walls. Laboratory tests of the Duraspan™ catheter have demonstrated an 87% reduction in platelet adhesion and thrombus accumulation compared to uncoated catheters.

    R4 is committed to improving dialysis patient catheter outcomes according to r4 Vascular's President, Don Geer, "physicians have long thought that if one was able to make the catheter less recognizable as a foreign object in the body it could revolutionize catheter-based hemodialysis. Developing the catheter, r4 Vascular engineers utilized stealth coating technologies, approaching the thrombus problem by camouflaging the catheter in a biomimetic coating." The catheter is available in either a 3.5cm tip stagger or a 7cm tip stagger version, providing reduced recirculation.

    Press release: New Dialysis Catheter Reduces Thrombus Accumulation... (.pdf)

    Product page: Duraspan™ Coated Dialysis Catheter ...

    Duraspan Coated Dialysis Catheter product brochure...

    email this article to a friend      print this!      permalink to Duraspan Biomimetic Coated Hemodialysis Catheter           comments and peer reviews (0)


    Thursday, March 11, 2010

    BostonSci's Express LD Stent Now for Clearing Iliac Arteries

    The FDA has issued approval for Boston Scientific's Express LD Iliac Premounted Stent System, granting it an indication for the treatment of peripheral artery disease in iliac arteries. It is the same balloon expandable stent that has FDA indication for palliation of malignant neoplasms in the biliary tree, and already has the European CE Mark of approval for PAD in iliac procedures.

    From the product page:

    The Tandem Architecture™ design is comprised of both Micro™ and Macro™ Elements, which contribute to:

    * Flexibility
    * Conformability
    * Radial Strength
    * Radiopacity

    Precision

    * Customized balloon lengths for each stent size. Designed for minimal foreshortening and accurate placement.

    1. Balloon Inflation Lumen 2. Ergonomic Catheter Hub 3. Strain Relief 4. Catheter Shaft 5. Radiopaque Marker Bands 6. Catheter Tip 7. Stent Length 8. Distal Shaft Coated with Hydro Pass® Hydrophilic Coating for Approximately 36cm 9. Total Usable Length 10. 0.035" (0.89mm) Guidewire Lumen

    Press release: FDA Approves Boston Scientific's Express® LD Iliac Stent System ...

    Product page: Express® LD Iliac Premounted Stent System...

    email this article to a friend      print this!      permalink to BostonSci's Express LD Stent Now for Clearing Iliac Arteries           comments and peer reviews (0)


    Monday, March 8, 2010

    Olive Medical's New Disposable High Definition Endoscopy Camera


    Dr. Steven Palter of Docinthemachine was given a chance to check out a new disposable HD endoscopic video camera. The device, made by Olive Medical of Sandy, Utah, has a 1080p resolution and will cost around $300 once regulatory clearance has been obtained.

    Here's from Dr Palter's post:

    I had a chance to speak with them about the system and they claim they are using a native HD imaging sensor chip. if so, they would be the first surgical camera system to do so. All other HD systems available today do not natively sense in 1080 but rather employ post imaging processing to upscale and modify the image. Their camera unit also includes integrated still image capture software eliminating the need for yet another $10,000-$30,000 box - although with obviously less features (no video, printer, etc).

    Here are two videos, one made with a "market-leading endoscopic camera" and the other with the new disposable HD cam. Olive isn't saying which one is which, so judge for yourself:

    Docinthemachine: First Disposable Single Use HD Endocopic System-DITM Exclusive...

    Product page: Olive Single-Use HD Camera ...

    email this article to a friend      print this!      permalink to Olive Medical's New Disposable High Definition Endoscopy Camera           comments and peer reviews (0)


    Friday, March 5, 2010

    marLED Surgical Lights from KLS Martin


    By perusing through the latest stuff coming out of Germany, we found a little press release from Gebrüder Martin GmbH & Co.KG, also known as KLS Martin Group, that profiled the company's new generation of operating lights, named marLED.


    This operating room fixture runs on what the company calls "Second-Generation LEDs" and is designed to minimize formation of shadows and to deliver a cold, bright light. Furthermore, the marLED can be equipped with KLS Martin's surgiCam SD and HD camera systems, for an intraop procedure recording. The camera can be seen in the picture below.

    From marLED product page:

    In this brand-new product line, high-performance LEDs are used as a basis for effective problem solution even where surgical field illumination is difficult. By using a new overall approach in terms of design as well as lighting technology, it was possible to overcome the limits of existing solutions and set new standards regarding shadow prevention and color fidelity. The radically new optical and housing concept also makes a lasting contribution towards facilitating the surgeon's work. The innovative, modern design with its symbiosis of ergonomics and technology gives the operating room a pleasing, state-of-the-art atmosphere.

  • Maximum adaptation of the light field
  • Space-saving design creates room for movement
  • Compatibility with laminar flow systems
  • Ergonomic and perfectly easy operation with sensoTouch and sensoGrip
  • Cool light and excellent shadow compensation
  • Variable color temperature
  • Product pages: marLED; surgiCam

    Press release: The marLED Lights from KLS Martin ...

    email this article to a friend      print this!      permalink to marLED Surgical Lights from KLS Martin           comments and peer reviews (0)


    Tuesday, February 16, 2010

    GE's Vscan, World's Smallest Portable Ultrasound, Now Available Worldwide


    GE Healthcare is finally releasing the much awaited Vscan pocket sized ultrasound. Many in the industry hope that this device offers a chance for physicians to make a move from stethoscopes to portable imaging devices, bringing advanced visualization to any examination room. The unit weighs one pound and is only 3 inches (7.6 cm) wide and 5.3 inches (13.5 cm) long, offering both standard black and white imaging, as well as colored blood flow doppler. GE is touting Vscan's size and capabilities for cardiologists to transthoracically view myocardium, pericardium, and heart valves, and for primary care physicians, as well as OB, ER, and others, to scan the liver, kidney, aorta and peripheral vessels, babies in the womb, and anything else the transducer can penetrate.

    Features from the product FAQ:

  • An online portal provides Vscan users with training tools for the product and basic clinical
    applications with sections about imaging technique, anatomy and trouble shooting

  • Intuitive user interface that can be controlled using the thumb

  • Intelligent workflow enhancements

  • Battery charger station and battery life of one hour scanning - good for up to 30 patients based on
    average of 2 minutes per scan

  • Voice annotation

  • USB docking station

  • Link to a PC for organization and export of data

  • Gateway software with services tools and remote diagnostics
  • Here's our video from a GE event introducing the Vscan:

    Press release: GE Healthcare Introduces Vscan™ Pocket-sized Visualization Tool for Point-of-care Imaging

    Product page: Vscan ...

    Flashbacks: A Closer Look at GE's Vscan Pocket Ultrasound ; More Details About The New GE Vscan Ultrasound System; GE's New Ultra Small Ultrasound May Become as Ubiquitous as Stethoscope

    email this article to a friend      print this!      permalink to GE's Vscan, World's Smallest Portable Ultrasound, Now Available Worldwide           comments and peer reviews (5)


    Monday, February 8, 2010

    The Cordis Manual FAIL for their RX Nitinol Stent System

    Take a break form your day to have a quick laugh at the expense of Cordis (a J&J company) and their accidental product manual that wasn't much of, well, a manual...

    email this article to a friend      print this!      permalink to The Cordis Manual FAIL for their RX Nitinol Stent System           comments and peer reviews (0)


    Thursday, February 4, 2010

    Toshiba's Viamo Ultrasound Now Available in US


    Toshiba won FDA approval to market the Viamo portable ultrasound, a convertible touchscreen device that the company promises provides the same image quality as premium cart systems. The package comes with a wheeled pole that can carry the Viamo and additional transducers for easy exchange.

    From the product page:

    Sharing its core imaging engine and transducer technology with Aplio XG, Viamo offers high-end image quality also in situations where unlimited portability is required.

    Its full range of high-performance imaging functions lets you visualize minute tissue details and vascular structures with precision for a faster, more accurate diagnosis. Advanced imaging functions such as Pulse Subtraction THI come standard with Viamo.

    Viamo’s built-in touch screen allows for seamless workflow and an outstandingly comfortable and intuitive operation of the system. Viamo’s monitor can be rotated to enable free positioning of the screen. When fully turned and folded flat, Viamo can be operated in tablet mode solely via its touch screen. Individual key functions on Viamo’s console and touch screen are user programmable to suit your specific diagnostic requirements or personal preferences.

    A whole range of workflow automation functions is available on Viamo. One-touch QuickScan for instance helps you achieve better imaging results in less time by automatically optimizing your imaging parameters. And Viamo’s innovative SonoSet™ function alows you to carry out examinations conveniently by simply executing freely programmable protocols step by step.

    The battery-powered system is operational within just a few seconds when opened, making it instantaneously available also in critical situations.

    Press release: TOSHIBA RECEIVES FDA CLEARANCE FOR VIAMO ULTRASOUND SYSTEM...

    Product page: Viamo...

    Product brochure...

    email this article to a friend      print this!      permalink to Toshiba's Viamo Ultrasound Now Available in US           comments and peer reviews (0)


    Tuesday, January 19, 2010

    IMRIS Combination MRI Fluoroscopy Systems for Intraprocedural Multimodal Imaging


    IMRIS out of Winnipeg, Canada recently received FDA approval to market the firm's neurovascular and cardiovascular combination MRI/X-ray angiography systems. The IMRISnv and IMRIScardio systems feature MRI scanners that ride on rails attached to the ceiling and a complete fluoroscopy package that can be swung in and out of the surgical field. This combination allows clinicians to quickly evaluate the problem, perform a procedure, and then check back with the MRI to see how it went, all without moving the patient.

    IMRISNV features a wide bore 3T MRI scanner and a bi-plane angiography system completely integrated into a single suite that permits the patient to transition quickly and seamlessly between MR imaging and intervention without transporting the patient between modalities. Using IMRISNV, MR images can be taken before and during procedures to assess tissue health, and can also be used in conjunction with the fluoroscopic images during the interventional procedure. On completion of the procedure, new images can be taken to evaluate the intervention.

    IMRIScardio provides physicians with enhanced images for visualizing the cardiovascular system before, during and after an intervention. The IMRIScardio suite includes a wide bore 1.5T MRI scanner and a single-plane or biplane angiography system providing the ability to alternate between imaging modalities and immediately assess treatment.

    Link: IMRIS...

    Press release: IMRIS RECEIVES FDA CLEARANCE FOR IMRISNV AND IMRIScardio... (.pdf)

    email this article to a friend      print this!      permalink to IMRIS Combination MRI Fluoroscopy Systems for Intraprocedural Multimodal Imaging           comments and peer reviews (0)


    Wednesday, January 13, 2010

    IntroSpicio 1.2 mm Disposable CMOS Camera for Cardiovascular Angioscopy


    Earlier this week we mentioned the Video Scout, what we thought was a small video camera, at only 3mm in diameter. Now we learn of a product from Medigus of Omer, Israel that is less than half the size of the Video Scout. The IntroSpicio 120 CMOS camera has a 1.2mm diameter, but unlike the Video Scout requires external illumination to guide its path. Israel's business newspaper Globes is now reporting that Voyage Medical out of Redwood City, CA (we can't find website link) has purchased $6.5 million worth of these cameras to implement in the firm's upcoming cardiovascular angioscopes.


    From Globes [online]:

    The camera employs a CMOS sensor developed by TowerJazz Ltd., and which is manufactured at the company's Fab2 in Midgal Ha'Emek using Tower's 0.18-micron CMOS image sensor process.

    Medigus said that, in a global first, its camera will make it possible to insert a camera directly into the heart through the blood vessels, enabling Voyage Medical's proprietary endoscope to image heart tissue in real time and while performing procedures.

    Specifications from the IntroSpicio 120 brochure:

  • System Components: 1.2mm (outer-diameter) camera, head with optics plus video, processor unit

  • Image pick-up device: CMOS

  • Effective pixels: 49,280

  • Resolution: 220H x 224V

  • Video outputs: NTSC, VGA

  • System Functions: Gain, White Balance, Automatic Gain, Control, Red/Blue Enhancement, Brightness, Zoom, Freeze, Print, Save – 4 images, (additional memory – optional).

  • Power Supply: AC100-240V 50/60Hz

  • Field of View: 100°

  • Dimensions: <Camera head> Shape: circular, Outer-diameter: 1.2mm, Length: 5mm
    <Camera cable> Length: up to 3 meters
    <Video processor box> 300mm(W)x70m(H)x250mm(D)
  • More from Globes [online]...

    Product page: IntroSpicio 120...

    IntroSpicio 120 brochure... (.pdf)

    email this article to a friend      print this!      permalink to IntroSpicio 1.2 mm Disposable CMOS Camera for Cardiovascular Angioscopy           comments and peer reviews (0)


    Friday, January 8, 2010

    Rheos System for Hypertension Tested in New Clinical Trial


    Over the last few years, we've been covering the ongoing testing of a blood pressure management system from CVRx out of Minneapolis, MN. The Rheos™ Baroreflex Hypertension Therapy™ System is an implantable device that monitors the patient's blood pressure and, based on the readings, electrically stimulates the carotid baroreceptors. Located inside carotid sinuses, these baroreceptors are partially responsible for blood pressure regulation. Now a new clinical trial has been initiated to test the system's effectiveness for management of diastolic hypertension, and a Florida man is now the first person to be implanted with the Rheos to deal with this condition. The device has already received European approval, and this latest trial may earn it FDA clearance in the US.

    From St. Petersburg Times:

    In the future, as many as 1.5 million heart failure patients could become the target market for the new device, called the Rheos System, according to CVRx, the Minneapolis company that developed it. It is being assessed in clinical trials that will involve more than 500 patients.

    Physicians at TGH are familiar with implanting the Rheos System, which they used in another clinical trial for high blood pressure. That trial is further along, yielding results that researchers thought showed promise for heart failure patients.

    CVRx expects to spend tens of millions of dollars on the heart failure trial, including the cost of surgery and medical followup for patients like Cummings [Charles Cummings, first patient in the study]. Kieval [Robert Kieval, founder of CVRx] estimated the device could cost in the "tens of thousands" per patient.

    Product page: Rheos System...

    More from St. Petersburg Times: Rheos System adds heart failure trial to study of its effects on high blood pressure...

    Flashbacks: RHEOS Device for Blood Pressure Control Undergoing New Trial; Positive Results from Trial of Rheos Baroreflex Hypertension Therapy; Novel Device for High Blood Pressure Implanted

    email this article to a friend      print this!      permalink to Rheos System for Hypertension Tested in New Clinical Trial           comments and peer reviews (0)


    Wednesday, December 16, 2009

    SilverStream from Enzysurge Streams Through to FDA Approval


    A month ago we've reported that Enzysurge out of Rosh Ha'ayin, Israel was working toward getting FDA approval for its SilverStream wound therapy system. And in no time the company is already announcing regulatory clearance to sell both its prescription and over-the-counter systems in the US.

    Here are some details about the DermaStream technology:

    The patent pending DermaStream CST device provides the mechanism for EnzySurge's proprietary Continuous Streaming Therapy™ (CST). CST is a modality based on continuously streaming of fresh therapeutic solutions to the wound bed while removing exudates by vacuum assisted drainage throughout the treatment cycle. The combination of the DermaStream CSTdesign and the CST action produces negative pressure above the wound without the need for external equipment.

  • DermaStream is designed to ensure ongoing, uniform flow of fresh solutions over the entire wound bed
  • The use of therapeutic solutions allows for a broad wound management platform
  • DermaStreamCST vacuum assisted drainage continuously removes exudate and infectious material from the wound environment.
  • Gravity-induced negative pressure removes exudates including removal of loose necrotic burden
  • DermaStream CST is a disposable, single patient use device. It is designed to provide negative pressure above the wound bed without expensive external equipment.
  • Press release: EnzySurge Receives FDA Approval for SilverStream™ Innovative Wound Management Solution...

    Product page: DermaStream...

    Flashbacks: DermaStream CST for Active Wound Management; DermaStream Chronic Wound Treatment Technology

    email this article to a friend      print this!      permalink to SilverStream from Enzysurge Streams Through to FDA Approval           comments and peer reviews (0)


    Tuesday, December 15, 2009

    Pathway Medical's Peripheral Plaque Drill Gets 510(k) Classification


    Following up on last year's FDA approval, Pathway Medical Technologies out of Kirkland, Washington just received European clearance to sell the Jetstream G2 NXT coronary drill across the continent. Previously named Pathway PV, the system clears clogged blood vessels and aspirates the debris out the back.

    Jetstream G2 NXT consists of a sterile, single-use catheter and control pod and a reusable, compact console that mounts to a standard I.V. stand. The catheter has an expandable cutting tip that safely debulks and preemptively removes both hard and soft plaque, as well as calcium, thrombus and fibrotic lesions. A highly efficient aspiration port located just proximal to the cutting blades continually removes excised tissue and thrombus from the treatment site to a collection bag located on the console. A fully recessed masticating system within the aspiration port helps break aspirated material into smaller pieces before removal, providing significant benefits for the treating physician and patient while ensuring no contact with the artery walls.

    The distal portion of the catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure. Active aspiration is a safety feature that minimizes the risk of distal embolization.

    With simple set up and an ergonomic design for easy operation by trained clinicians, Jetstream G2 NXT maximizes treatment effectiveness.

    Jetstream G2 NXT offers renewed hope for non-surgical candidates and the benefits of a minimally invasive treatment option, including faster recovery and decreased systemic complications.

    Video animation of the device in action...

    Press release: Pathway Medical Technologies Receives CE Mark for the Jetstream G2 NXT...

    Product page: Jetstream G2...

    Flashback: Pathway Medical Gets FDA OK for Company's Peripheral Plaque Drill

    email this article to a friend      print this!      permalink to Pathway Medical's Peripheral Plaque Drill Gets 510(k) Classification           comments and peer reviews (0)


    Wednesday, November 25, 2009

    3D Recon Turns CT Axial Images into Volumetric Visualizations


    Medtronic has partnered with Vital Images out of Minnetonka, Minnesota to bring 3D reconstructions of CT images of abdominal and thoracic aorta, and other large vessels, to improve preoperative planning and operative outcome in patients that are undergoing for endovascular graft placements for treatment of aneurysms. Whether this partnership actually delivers clinically significant solutions, remains to be seen.

    3D Recon is a new service from Medtronic that converts two-dimensional computed tomography (CT) axial images to three-dimensional images, offering advanced visualization of the anatomy and aneurysm measurement for device sizing. This technology allows physicians to streamline pre-case planning and patient follow-up. It is cleared by the U.S. Food and Drug Administration under a 510(k) granted to Vital Images.

    Vital Images is a leading provider of advanced visualization and analysis software. Its Endovascular Stent Planning application provides real-time automated clinical information specifically for the evaluation of abdominal and thoracic aortic aneurysms. The application enables removal of bone and anatomy from the image, visualization from the aortic root through the iliac bifurcation, as well as specific measurements for procedure planning. It allows vascular surgeons and interventionalists to instantly view three dimensional anatomy pre-operatively, followed by the implanted stent graft post-operatively.

    Press release: Medtronic Introduces '3D Recon' Service to Enhance Endovascular Treatment of Aortic Aneurysms...

    Vital's Vascular Imaging Solutions...

    email this article to a friend      print this!      permalink to 3D Recon Turns CT Axial Images into Volumetric Visualizations           comments and peer reviews (0)


    Friday, November 20, 2009

    Let Draeger Polaris Be Your Guiding Light


    We are continuing to profile the latest gadgets that are being showcased at the Medica 2009 in Düsseldorf. This beautiful line of cold OR light systems, appropriately dubbed Polaris, comes from Drägerwerk AG & Co., a company better known to everyone as Dräger.

    Details from the press release:

    Compared with conventional light sources, the smaller LEDs of the Polaris system are considerably more energy-efficient than conventional light sources. An LED light source has a life span of about 30,000 hours (corresponding to about seven to ten years of service life in the operating room), while the life span of a conventional light source is about 1,000 hours (corresponding to about four months of service life in the operating room). The slight amount of lost heat from the LEDs is dispensed through the top of the housing.

    The different Polaris models are distinguished by their illuminating power. They can be used as an individual OR light or as a satellite in multiple-light systems, and can also be equipped with an integrated camera.

    This new product design received the red dot design award 2008 which, according to the Design Zentrum Nordrhein Westfalen, is based on criteria such as innovation, functionality, quality and ergonomics.

    The 108 light-emitting diodes of the Polaris (700 model) distribute light with a color temperature of 4,600 Kelvin. "Cold light" (without long-wave infrared content) is generated by means of a phosphor layer on the semiconductor and focused via an optical system. The LEDs are installed in the reflectors in pairs.

    The individual light paths form a light cylinder which has an illumination depth of about 1,100 millimeters and a variable diameter of 220 to 290 millimeters. This ensures that the light of each LED can be focused on the OR field and that several surgeons can work simultaneously on the OR field without noticeably reducing the brightness.

    Press release: Precision lighting with the new Dräger Polaris...

    Product brochure... (.pdf)

    email this article to a friend      print this!      permalink to Let Draeger Polaris Be Your Guiding Light           comments and peer reviews (0)


    Thursday, November 19, 2009

    My Lab One Portable Ultrasound from Esaote Makes Debut

    At the ongoing Medica 2009 in Düsseldorf, Esaote out of Genoa, Italy is releasing a new portable ultrasound system that features a 12 inch touch screen for manipulating settings without having to use buttons. The My Lab One can be worn on a shoulder strap and is designed for mobile applications such as ambulatory anesthesia, EMT, military and sports medicine.

    From the press release:

    The automatic rotation of the image according to the position of the system, an ergonomic probe equipped with controls, a long life battery, all add up to making this ultrasound an extraordinary innovation in the medical system arena.

    MyLab One is a “dedicated” ultrasound, which reflects perfectly today’s need for diagnostic capabilities in many different fields of application: from Radiology to Cardiology, from to Orthopaedics, Anaesthesia, Sports Medicine, etc… or in first-aid, emergency, vascular screening as well as in general practices.

    Press release: Esaote presents “My Lab One” Innovative “wearable” ultrasound scanner ARM HELD

    Product page: Esaote ultrasound...

    email this article to a friend      print this!      permalink to My Lab One Portable Ultrasound from Esaote Makes Debut           comments and peer reviews (0)


    Wednesday, November 18, 2009

    DermaStream CST for Active Wound Management


    Israel21C is reporting that EnzySurge out of Rosh Ha'ayin, Israel is expecting to begin FDA approval process for the complete DermaStream CST system. The wound healing device is designed to be placed over a wound to provide continuous cleaning and washing away of debris and extravasated fluid. Although the device itself received FDA clearance, the bio-active chemical solution that it is supposed to work with it has yet to get a green light.

    The patent pending DermaStream CST device provides the mechanism for EnzySurge's proprietary Continuous Streaming Therapy™ (CST). CST is a modality based on continuously streaming of fresh therapeutic solutions to the wound bed while removing exudates by vacuum assisted drainage throughout the treatment cycle. The combination of the DermaStream CSTdesign and the CST action produces negative pressure above the wound without the need for external equipment.

  • DermaStream is designed to ensure ongoing, uniform flow of fresh solutions over the entire wound bed

  • The use of therapeutic solutions allows for a broad wound management platform

  • DermaStreamCST vacuum assisted drainage continuously removes exudate and infectious material from the wound environment.

  • Gravity-induced negative pressure removes exudates including removal of loose necrotic burden

  • DermaStream CST is a disposable, single patient use device. It is designed to provide negative pressure above the wound bed without expensive external equipment.
  • Demo video of the DermaStream CST:

    Product page: DermaStream CST ...

    More about EnzySurge's technology from Israel21C...

    Flashback: DermaStream Chronic Wound Treatment Technology

    email this article to a friend      print this!      permalink to DermaStream CST for Active Wound Management           comments and peer reviews (0)


    Monday, November 16, 2009

    Merit Laureate Guide Wire Going to Market in US


    Merit Medical Systems out South Jordan, Utah received 510(K) clearance from the FDA for the Merit Laureate hydrophilic guide wire.

    "This product will be sold in both our cardiology and radiology sales points," Lampropoulos added. "Procedures that include drainage catheter access, dialysis catheter placement as well as difficult vascular access procedures commonly use hydrophilic guide wires."

    The Merit Laureate(TM) guide wire is fabricated from a unique core nitinol wire, covered with a urethane jacket and coated with a proprietary process that produces a slippery surface. Features of the wire, including torquability and pushability, allow passage through tortuous anatomy.

    Press release: Merit Medical Announces 510(K) Clearance for the Merit Laureate(TM) Hydrophilic Guide Wire ...

    email this article to a friend      print this!      permalink to Merit Laureate Guide Wire Going to Market in US           comments and peer reviews (0)



    More from Vascular Surgery:

    » FDA Grants Vascular Solutions Clearance for The GuideLine Catheter (November 12, 2009)

    » TRUMF's OR Table Integrated With Siemens Multi-axis Fluoroscopy Systems (October 26, 2009)

    » Lap-Pak, a Student Designed Abdominal Retractor, On Road to Market Realization (October 23, 2009)

    » ThumBlade Scalpel Safety System (October 21, 2009)

    » GE's New Ultra Small Ultrasound May Become as Ubiquitous as Stethoscope (October 21, 2009)

    » Guardian II Hemostasis Valve Gets FDA Nod (October 13, 2009)

    » Tiny Portable Ultrasound from SonoSite Gets US OK (October 5, 2009)

    » Cook's New IVC Filter Placement System Unveiled (September 23, 2009)

    » New Surgical Glue from Lifebond to Offer a Stronger, Tighter Seal (September 21, 2009)

    » Zilver PTX Drug Eluting Stent for Peripheral Artery Disease Gets European Approval (August 13, 2009)

    » Cook's TX2 Pro-Form Thoracic Endograft Gets US Green Light (July 28, 2009)

    » Large Diameter VIABAHN Endovascular Stents Approved in US (July 22, 2009)

    » First Atherectomy Performed With Spectranetics' Turbo-Tandem Device (July 17, 2009)

    » New Cerebral Oximeter from Nonin Granted US OK (July 16, 2009)

    » NanoMaxx Tiny 6 Lb. Ultrasound System Unveiled (July 7, 2009)

    » Smoother GORE VIABAHN Endoprosthesis Gets Approved in US (July 2, 2009)

    » Improve Your Ultrasound Skills With New SonoSite iPhone App (June 24, 2009)

    » Voice Activated SonoSite Ultrasound System Keeps Hands Free to Perform Procedures (June 19, 2009)

    » Cook Launches Z-TRAK PLUS Introduction System for Zenith TX2 TAA (June 12, 2009)

    » Emboshield NAV6 Embolic Protection System Released by Abbott (June 12, 2009)

    » Option IVC Filter Receives FDA Approval (June 11, 2009)

    » ViRob, a Cavities Crawler (May 28, 2009)

    » Retrievable SafeFlow IVC Filter Gets FDA Nod for Everything But Retrieval (May 21, 2009)

    » Digital Subtraction Angiography on a Single Image (May 14, 2009)

    » BrainLab's Digital Lightbox Getting an Upgrade (May 13, 2009)

    » Abbott's New PVD Offerings (May 7, 2009)

    » Magnus Operating Table from Maquet (May 4, 2009)

    » Cook's Drug-eluting Peripheral Stent Performs Well in Large Study (April 17, 2009)

    » Cardinal's Endura Scrubs for the Modern Clinician (March 19, 2009)

    » Catheter for Calcium Blocked Peripheral Vessels Gets US Green Light (March 6, 2009)

    » MRI May Replace X-Rays for Catheterizations (March 3, 2009)

    » HYPER-IMS, a Tiny Implantable Wireless Pressure Monitor (January 5, 2009)

    » Amimon's High Definition Wireless Video Goes Clinical (January 5, 2009)

    » RHEOS Device for Blood Pressure Control Undergoing New Trial (December 22, 2008)

    » WAND Vascular Introducer Gets FDA OK (December 10, 2008)

    » Zonare Shows Off Proprietary Ultrasound Technology (December 3, 2008)

    » TruSystem 7500: New OR Table from TRUMPF (November 21, 2008)

    » Talent TripleA Stent, Now with a New Delivery System (November 19, 2008)

    » Boston Scientific's Carotid Artery Stent Gets FDA OK (November 7, 2008)

    » High Flow Microcatheter from Cook Medical Goes Live (October 30, 2008)

    » PlasmaBlade Finds New Uses With New Attachments (October 29, 2008)

    » Talent Stent Graft with the New Delivery System Goes on Sale in US (October 23, 2008)

    » New Angio-Seal Evolution Goes to Market (October 17, 2008)

    » Europe Green Lights Nanofabric-based AVflo Vascular Graft (October 7, 2008)

    » LOGIQ E9: The Next Plane in Ultrasonography (September 16, 2008)

    » In the Works: A Valve for Chronic Venous Insufficiency (September 16, 2008)

    » Stereotaxis Magnetic RF Guidewire Gets FDA OK (September 9, 2008)

    » EKOS MicroSonic Accelerated Thrombolysis System (September 9, 2008)

    » Digital Lightbox Brings Minority Report to The OR (No Precognition Capabilities) (August 19, 2008)

    » CX50 Portable Ultrasound from Philips Goes On Sale (August 5, 2008)

    » A Trial of Zenith Fenestrated AAA Endovascular Graft Goes On (August 1, 2008)

    » V Series Neuro Clot Retrievers from Concentric (July 30, 2008)

    » PlasmaBlade System Gets FDA Go Ahead (July 24, 2008)

    » Pathway Medical Gets FDA OK for Company's Peripheral Plaque Drill (July 23, 2008)

    » Zenith TX2 TAA Endovascular Stent Available in US (July 14, 2008)

    » Epocrates Rx Now on iPhone (July 14, 2008)

    » Endurant Stent Graft System For Tortuous Aortas (July 10, 2008)

    » G-Wire: Visually Positioned Guidewire for Faster, Safer Procedures (June 30, 2008)

    » Artificial Mesh for Prevention of Post Operative Abdominal Wall Defects (June 17, 2008)

    » Talent Thoracic Stent Graft System Approved in US (June 6, 2008)

    » "Conditioned" Tissue-Engineered Blood Vessels Hold Promise (June 4, 2008)

    » The Third Install in the US of Aquilion ONE CT from Toshiba (May 21, 2008)

    » Demand Is High for Brilliance iCT, a 256-Slice CT from Philips (May 19, 2008)

    » CE Mark Given to AMPLATZER Vascular Plug III (May 19, 2008)

    » Novel Surgical Biomaterial Receives Regulatory Approvals (May 14, 2008)

    » Peak PlasmaBlade Wants to Be The New Bovie (May 7, 2008)

    » Gore Receives EU's CE Mark for PRECLUDE Vessel Guard (May 7, 2008)

    » VascuSeal Goes on Sale in Europe (May 6, 2008)

    » Vasovist, a Vascular MRI Contrast Agent, Meets FDA Requirements (April 25, 2008)

    » Angiotech Suspends Vascular Wrap Trial Enrollment (April 23, 2008)

    » Medtronic Defender Embolic Protection Filter Approved in EU (April 18, 2008)

    » FDA OK's Endovascular Talent Stent for AAAs (April 17, 2008)

    » Open Aortic Stapler Approved in EU (April 15, 2008)

    » NeuroFlow Cath Promises to Save Ischemic Brains (April 7, 2008)

    » Open Aortic Stapler from ES Vascular (March 28, 2008)

    » Metricath Gemini Double Balloon Catheter Showing Promise (February 19, 2008)

    » z.one ultra System (January 25, 2008)

    » ReeTrakt Surgical Retractor (January 15, 2008)

    » Endovascular Talent™ for AAAs (December 5, 2007)

    » Acuson P50 Portable Ultrasound System from Siemens (November 28, 2007)

    » AquilionONE CT from Toshiba Cleared by FDA (November 27, 2007)

    » Artis zee from Siemens (November 26, 2007)

    » New Surgical Instruments from KLS Martin Group (November 26, 2007)

    » FusionOptic™ Technology from Leica (November 16, 2007)

    » Non-Contact 3D Med Display (November 7, 2007)

    » SonoLysis™ Therapy: Stroke Treatment with Ultrasound (November 5, 2007)

    » REVA Bioresorbable Polycarbonate Stent (October 19, 2007)

    » Tissue-Engineered Blood Vessels Perform Well in a Study (October 9, 2007)

    » Sony's Versatile HD Med Monitor (October 5, 2007)

    » M-Turbo™: New Portable Ultrasound from SonoSite (October 2, 2007)

    » Peripheral Vascular Solutions from MultiGene Vascular Systems (September 28, 2007)

    » Diamond Tipped 200,000 RPM Artery Drill (September 26, 2007)

    » CT Vascular Analysis via the Internet (September 4, 2007)

    » Celect™ Vena Cava Filter (July 31, 2007)

    » ACUSON P10: An Ultrasound System That Fits in a Pocket (June 25, 2007)

    » Blood Vessels Grown from Stem Cells (June 19, 2007)

    » UniFit™ Abdominal Stent Graft (June 14, 2007)

    » ArterioVision™: The CIMT (Carotid Intima-Media Thickness) Test (June 11, 2007)

    » Force Sensor for Cerebral Aneurysm Treatment (March 16, 2007)

    » Talent™ Thoracic Stent Graft System (March 5, 2007)

    » Nanofiber-based Vascular Grafts by Nicast (February 23, 2007)

    » SafeFlo® IVC Filter (December 18, 2006)

    » Positive Results from Trial of Rheos Baroreflex Hypertension Therapy (November 16, 2006)

    » Innova IVUS Installed (October 23, 2006)

    » Carotid Stents Represent Serious Clot Risk without Downstream Filter (October 20, 2006)

    » Gelling Up Artificial Grafts (October 19, 2006)

    » MPH® Hemostatic Technology (October 3, 2006)

    » Nanocrystalline, Silver Coated, Long-Term Dialysis Catheters by Spire (September 22, 2006)

    » Live Surface, A Software for Surgeons (August 2, 2006)

    » Rebuilding Capillary Networks with Stem Cells (July 7, 2006)

    » Scan2Knit (April 19, 2006)

    » AneuRx® AAAdvantage™ (March 28, 2006)

    » Color Me Approved: StarClose Vascular Closure System from Abbott (March 17, 2006)

    » ImPressure™ Sensor (March 10, 2006)

    » Wireless C-Arms from Xograph (March 3, 2006)

    » The BioGlue® (January 25, 2006)

    » The EndoSure™ Wireless AAA Pressure Measurement System (November 11, 2005)

    » The SilverHawk™ Plaque Excision System (October 26, 2005)

    » Abbott's Stent To Treat Patients At Risk Of Stroke (September 19, 2005)

    » Gore VIABAHN® Endroprosthesis Stent: Now Approved (September 8, 2005)

    » Inflatable Stocking Therapy (August 24, 2005)

    » The LONG Arm of Medicine (May 19, 2005)

    » DVX Catheter Clot Remover (May 4, 2005)

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

    » PDAnet Lab System (March 24, 2005)

    » The BioScanIR System (March 23, 2005)

    » The Resolution System for Vascular Occlusive Disease (March 16, 2005)

    » CryoPlasty therapy: more positive results reported (February 23, 2005)

    » The CLiRpath system (January 27, 2005)

    » VNUS Closure Procedure (December 29, 2004)

    » "Helical Branch Device" (December 29, 2004)

    » Signals From Deep Inside (December 28, 2004)