Vascular Surgery Archive

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...

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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...

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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)

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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)

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    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

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    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

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    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

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    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...

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    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)

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    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...

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    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

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    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 ...

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    Thursday, November 12, 2009

    FDA Grants Vascular Solutions Clearance for The GuideLine Catheter


    US FDA has given 510(k) regulatory clearance to Vascular Solutions Inc., a Minneapolis, Minnesota firm, to market the GuideLiner™ catheter. The device, designed to provide a coaxial guide extension and rapid exchange for coronary or peripheral interventions, comes in 6F, 7F, 8F (Freedom Fries) sizes and is delivered through standard guide catheters, hence it allows physicians to use "standard length guidewires, balloons or stents through an existing hemostatic valve," according to the company.

    From the press release:

    The GuideLiner is a unique coaxial “mother and child” guide extension with rapid exchange convenience that provides back-up support and selective deep intubation in challenging coronary interventions. The GuideLiner catheter will be available in 6, 7 and 8 French sizes as part of Vascular Solutions’ specialty catheter product line. CE mark clearance of the GuideLiner was received and European sales and clinical uses commenced in October, with the U.S. launch of the GuideLiner catheter expected to commence in November through Vascular Solutions’ direct sales force.

    Dr. Douglas Fraser, an Interventional cardiologist with Manchester Heart Centre in Manchester, United Kingdom, commented on his initial clinical experience with the GuideLiner: “Deep intubation of the Guideliner catheter within a soft 6F guide provides better backup support and is less traumatic than using stiff 7F and 8F guides that were previously required in complex disease. Furthermore, the soft and very flexible tip will often cross tortuous disease where a stent gets stuck, enabling delivery of stents and other equipment directly to the target lesion. The GuideLiner is as easy to insert as a standard rapid exchange balloon catheter and has quickly become a routine part of my angioplasty practice.”

    Dr. Colm Hanratty, an interventional cardiologist at Belfast City Hospital in Belfast, Ireland, commented on one of his initial clinical uses of the GudieLiner: “In this patient, despite modification of the diseased segment and subsequent pre-dilatation, we could not track a 3.0 mm stent across the lesion due to significant friction in the proximal vessel. We then passed a 6F GuideLiner into the vessel and by removing the proximal resistance we could then deliver the 3.0 mm stent, followed by a 4.0 mm stent and post-dilatation with a 4.0 mm balloon. Deep intubation with the Guideliner facilitated delivery, allowed us to optimize stent apposition and also improved visualization of the vessel due to selective cannulation.”

    Press release (.pdf)...

    Product brochure: GuideLiner Catheter...

    Product page: GuideLiner Catheter ...

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    Monday, October 26, 2009

    TRUMF's OR Table Integrated With Siemens Multi-axis Fluoroscopy Systems


    Siemens has just announced that it has integrated the TruSystem 7500 OR table from TRUMPF (Puchheim, Germany) with its Artis zee and Artis zeego fluoroscopy scanners. The TruSystem 7500 adjusts to just about any position imaginable and is transparent to x-rays, and so can be used in almost any surgical or invasive radiological procedure. TruSystem 7500 OR table is illustrated above, and Artis zeego multi-axis interventional fluoroscope is shown in the picture below.

    The Trumpf OR table has been designed especially for this integration and is equipped with a onepiece carbon tabletop, which can be replaced by a segmented universal tabletop. The table column enables the two tops to be exchanged easily. The carbon tabletop is transparent to X-rays and thus ensures that there will be no disruptive artifacts in the images. It is suitable for interventional procedures and minimally invasive surgery. The integration of the OR table with the Siemens angiography systems also make fast rotations and 3-D imaging possible with the surgical C-arm. The modular design of the segmented tabletop enables extremely flexible positioning of the patient, particularly important in orthopedics and neuro surgery. Complicated positions, such as the chest side position, can be achieved quickly with great precision as well as comfort for the patient and staff.

    Along with the integrated Trumpf OR table, Siemens continues to offer its Artis tables for the entire Artis zee series, which are available in three designs: as a standard table, a table with Trendelenburg tilting and one with Trendelenburg and lateral tilting.

    Press release: Siemens integrates Trumpf's OR table in its Artis zeego and Artis zee ceiling angiography systems...

    Product pages: TruSystem 7500, Artis zee, Artis zeego

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    Friday, October 23, 2009

    Lap-Pak, a Student Designed Abdominal Retractor, On Road to Market Realization


    A device developed by clinicians and students at Johns Hopkins University to move bowels out of the way in laparotomies has been licensed to Seguro Surgical, a Columbia, Maryland company. The Lap-Pak is see-through and flexible, giving you ability to quickly displace the guts without all the towels and sponges and external retractors.

    The primary goal for Lap-Pak is to reduce bowel packing time by 50%. Use of Lap-pak during laparotomies ensures interoperability with retractors, facilitates monitoring of bowels, and maintains tissue temperature and hydration.

    The Lap-Pak device is a one-piece device constructed from a soft and flexible material that is easy to position. It contains a stable body support that evenly distributes pressure. Side and bottom flaps contour against the abdominal walls to prevent movement and allow for varied cavity sizes. The dual top flaps shield the bowels while maintaining visibility of the intestines as well as internal temperature and moisture. The product will be offered in three sizes designed to fit over 80% of adults.


    Press release: Seguro Acquires Worldwide Rights to Johns Hopkins Abdominal Surgery Device...

    Product page: Lap-pak...

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    Wednesday, October 21, 2009

    ThumBlade Scalpel Safety System


    Here's an interesting new take on improving the safety for scrub techs, nurses and surgeons. ThumBlade™ scalpel system from Precision Medical Devices Inc. (Marlboro, NJ) is a no contact, disposable safety sheath that covers blades, and allows activation of the scalpel with just one hand. So no more sharps and no more mosquito use to mount a blade.

    Medgadget has obtained the following details about the device:

    Featuring patent pending innovative thumb activation independent mechanisms, PMD’s ThumBlade™ safety scalpels enable one-handed activation smoothly and safely by right or left handed practitioners with no contact with the exposed blade. This activation affords an easy, natural opening motion while keeping the other fingers out of the way. The safety sheath is made from high quality ABS composite with a completely flat and smooth top, providing a stable platform for better control during the procedure. The extra sharp blades are stainless steel, pre-sterilized, and disposable after single use. The blade sheaths and packaging are color coded by size for easy counting and safe use. The stainless steel handles are pre-sterilized for first use and can be re-sterilized and re-used. These handles, available in both #3 and #4 fitments, are premium length and back-weighted for the grip and feel practitioners prefer.


    Product page: ThumBlade™ safety scalpel system...

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    GE's New Ultra Small Ultrasound May Become as Ubiquitous as Stethoscope


    Yesterday at the Web 2.0 Summit in San Francisco, GE showed off their new handheld ultrasound device. The Vscan looks like a cross between an iPod and a cell phone, making it possibly the world's smallest ultrasound. Later today we'll be attending GE's healthymagination technology showcase in New York where further details and specs will hopefully become available.

    For critical care clinicians, Vscan can offer an immediate look beyond patient vital signs with the potential to identify critical issues, like fluid around the heart, which could be a sign of congestive heart failure. And for cardiologists, Vscan provides a dependable visual evaluation of how well the heart is pumping at a glance, so they can treat patients more efficiently.

    More from GE...

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    Tuesday, October 13, 2009

    Guardian II Hemostasis Valve Gets FDA Nod


    The FDA has granted approval to the Guardian II™ Hemostasis Valve produced by Zerusa, a Galway, Ireland firm. The valve, designed for easy movement of catheters and other interventional angio devices while providing hemostasis, has already been approved in Europe. The device will now be distributed in the US by Vascular Solutions out of Minneapolis, MN.

    Features from the product page:

    Unique Seal Technology

  • Provides a cleaner procedural field protecting physicians, staff and patients by reducing the amount of blood in the field.

  • Allows separation of guidewires and other devices during complex procedures.
  • Click-open and Click-close Design

  • Allows single handed operation

  • Unique proximal cap is easily depressed for both opening and closing the lumen.

  • Distinctive wide “bulls eye” opening in the proximal cap allows for easy insertion of devices along with the ability to separate multiple guidewires and other devices during complex cases.
  • Ergonomic Design

  • Practical design allows the Guardian to fit comfortably in a physician’s hand.

  • Subtle finger tabs have been added for improved handling characteristics.

  • Actual device length 92mm.
  • 8 French Lumen

  • Allows multiple or large therapeutic devices to be inserted during procedures.
  • Secure Device Lock

  • Rotating lock-nut has been designed to provide an additional mechanism for securing device position. Lock-nut functions similar to a tuohy borst™ style valve.
  • Here's a demo animation showing how one operates the device...

    Press release: Vascular Solutions and Zerusa Limited Announce FDA Market Clearance for the Next Generation Guardian II Hemostasis Valve...

    Product page: Guardian II™...

    Guardian II™ brochure...

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    Monday, October 5, 2009

    Tiny Portable Ultrasound from SonoSite Gets US OK

    sonomax.jpg
    SonoSite (Bothell, Washington) just announced that the company received FDA approval to market the firm's tiny NanoMaxx ultrasound system throughout the United States. Weighing in at only 6 pounds (2.7 kilo) and with a battery life of 2 operational hours, the system is truly portable for busy clinics, ambulances, emergency rooms, and elsewhere that ultrasound is needed.

    sono34343.jpg

    The new ultra portable and one button design of the NanoMaxx system makes high quality ultrasound available to a much broader range of clinicians. The system incorporates SonoSite’s advanced proprietary imaging algorithms, including SonoMB™ and SonoAdapt™ to deliver superior image quality in a lightweight, rugged form factor.

    With a touch screen that responds easily to the tap of a finger, and one button optimization, clinicians can readily acquire high resolution images to increase clinical productivity at the point-of-care. A system boot-up time of less than 20 seconds and long battery life further enhance workflow when using the NanoMaxx system.

    At introduction, the NanoMaxx tool is available with a complement of five transducers to support a wide range of examinations and procedures including thoracic assessment for pathology, vascular access, needle aspirations and injections, as well as abdominal, cardiac, nerve, OB/Gyn, musculoskeletal, small parts and vascular scanning.

    For convenience and flexibility, the system can be wall mounted, placed on an exam table with kickstand attached, or used from a highly maneuverable stand. Physicians can easily carry the NanoMaxx tool from room-to-room, to a satellite office, to the operating room or to a field site for immediate use.

    The NanoMaxx system’s highly integrated architecture and ruggedized design, including the industry’s first elastomeric bumper for extra durability, plus magnesium outer shell, allows it to be used in the most demanding and austere environments. Proving its reliability, the NanoMaxx system and its transducers successfully passed SonoSite’s standard three foot durability drop test.

    In addition, to further reduce the risk of infection, the NanoMaxx system’s fluid-resistant user interface makes the system easy to clean and disinfect, helping to address the growing concern over infection control in the medical community.

    Press release: SonoSite Announces FDA Clearance for Its New Nanomaxx Ultrasound Tool

    Product page: NanoMaxx

    Flashback: NanoMaxx Tiny 6 Lb. Ultrasound System Unveiled

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    More from Vascular Surgery:

    » 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)