Archives: 1/2011

89453rfj Mynx Cadence Vascular Closure Device ReleasedAccessClosure of Mountain View, CA is releasing a new version of its Mynx vascular closure device, the Mynx Cadence. When contacted by Medgadget, the company representative told us that the key differences between the Mynx Vascular Closure Device and St. Jude’s popular Angio-Seal system is in the way the femoral artery is closed and in the chemical composition of the sealant. For one, Angio-Seal has a sandwich structure, with a bioabsorbable intravascular anchor. Mynx Cadence, on the other hand, is a complete extravascular closure device. The sealant composition difference between two devices is also important, according to the company. While Angio-Seal uses collagen, a bioactive thrombogenic agent, Mynx deploys inert polyethylene glycol (PEG). And, finally, while Angio-Seal is advertised to dissolve within 60 to 90 days, Mynx is said to be entirely gone within 30 days.
Here are the design changes in the new Mynx Cadence:

Three design changes on the new Mynx Cadence device make it easier and more consistent to deploy. A definitive shuttle stop when deploying the sealant reduces the possibility of over-shuttling. Additionally, a single marker on the advancer tube removes any guesswork around sealant compression. Finally, a new sealant sleeve protects the sealant during deployment and shortens the procedure time by eliminating the need to pre-soak during device preparation. These changes result in more consistent sealant delivery every time.
The Mynx Vascular Closure Device utilizes a conformable, water‐soluble polyethylene glycol (PEG) sealant to seal the femoral artery, which dissolves within 30 days, leaving nothing behind but a healed artery.

Animation demonstrating the previous generation Mynx:


Press release: AccessClosure Announces Launch of New Mynx Cadence™ Vascular Closure Device… (.pdf)
AccessClosure …

7704uyjfgh New da Vinci Skills Simulator from Intuitive Surgical
Intuitive Surgical, maker of the da Vinci surgical robot, has developed a stand-alone simulator of the machine that can be used for training and in preparation for procedures. The da Vinci Skills Simulator feels like the real thing, but through the viewfinder you get to play around with virtual sutures and digital tissues:
cm67354 New da Vinci Skills Simulator from Intuitive Surgical

  • The straightforward set-up allows users to practice unassisted or with supervision, according to their preference.

  • Built-in metrics enable users to assess skills, receive real-time feedback and track progress.
  • Administrative tools let users structure their own curriculum to fit with other learning activities in their institution.
  • The open architecture of the system software allows for the future development and incorporation of additional practice modules.
  • Each exercise covers at least one of the following skill categories:

  • EndoWrist® Manipulation – EndoWrist instruments are designed to provide surgeons with natural dexterity and a range of motion far greater than even the human hand. These exercises are designed to help users gain familiarity with the movement of these instruments.
  • Camera and Clutching – The three-dimensional, enhanced high-definition vision of the da Vinci System offers a key clinical advantage in surgery, and these exercises help users improve camera control and learn to use the clutch effectively.
  • Fourth Arm Integration – For more advanced instrument control skills, some exercises include a fourth instrument arm that must be used. This is designed to promote instrument skill, and encourages users to think strategically about instrument placement during tasks.
  • System Settings – The surgeon console features a comprehensive set of controls for user settings. Quiz exercises on the simulator focus on basic setting topics such as icons, ergonomics and instrument scaling.
  • Needle Control and Driving – These scenarios are designed to help users develop skill when manipulating needles, including a focus on how to effectively hand off and position needles while practicing with a range of geometries.
  • Energy and Dissection – The footswitch panel enables users to perform a range of tasks such as swapping between different types of energy instruments. These exercises allow users to gain familiarity with the footswitch panel by letting them practice applying monopolar and bipolar energy while working on dissection tasks.

  • Product page: da Vinci Skills Simulator…

    ct port Port a Cath Gets CT MarksPorts or portacaths are widely used in hematology and oncology patients for easy vascular access. However, not all of them can withstand power injection of contrast media and asking patients which port they have can be an unreliable method at times. That is why Smiths Medical has launched new versions of its implantable ports with radio-opaque identifiers which can be seen on X-ray and CT scout scans. The letters C and T are embedded into the top of the port, which, the company proudly announces, prevents them from being read backwards like might happen with other manufacturers’ products. Indeed that always confused us completely! Nevertheless, this is a nice little tweak to a useful product.
    Press release: Smiths Medical Launches Implantable Ports for Easy Viewing Under CT Scans…

    62q9bp3d Viveve System for Vaginal Laxity Receives CE ApprovalViveve, from Palo Alto, CA, has received approval for a condition we never heard of before: vaginal laxity. On the other hand, of course, in this age where vaginoplasties are quickly becoming as normal as nose jobs, we should not be really surprised. The device uses radiofrequency to treat laxity of the vaginal introitus after childbirth, to improve the female sexual function. The system consists of a RF generator, a hand piece and single-use disposable tips. The procedure can be performed without anesthesia in approximately 30 minutes. According to studies cited by the company in the press release, women have reported improved feelings of vaginal tightness at several months after treatment (no words about male satisfaction though). Bingo, a new market has been created!
    Press release: Viveve obtains CE mark for gynecologic treatment of vaginal laxity… (.pdf)
    Product page: Viveve…

    mm2wa1p0 ImageSense for Digital Colposcopy FDA Approved
    STI Medical Systems, from San Diego, CA., has received FDA clearance for its ImageSense technology for colposcopy. It is an image-subtraction technique for use with the UltraSight digital colposcopy system. Acetic acid is often applied to the cervix during colposcopy after which areas that turn white are considered for biopsy. This technology enhances the visibility of the white areas.
    From the press release:

    Acetowhitening is one indicator currently used by doctors to identify areas of the cervix possibly containing disease. ImageSense is a tool for displaying areas of acetowhitening by producing a digital output depicting the color differences of the cervix before and after the application of acetic acid during a typical colposcopic exam. By digitizing and memorializing an otherwise transient effect and enabling on-demand viewing of the acetowhite process, ImageSense displays information to the doctor in ways previously not possible.
    ImageSense technology is currently in use on the Company’s UltraSightHD™ digital colposcopy system. The combined product offers a fully integrated clinical workflow solution for colposcopy that also incorporates DICOM-compatible imagery and a seamless Electronic Medical Records (EMR) interface via its onboard touch-screen user interface. ImageSense technology provides the UltraSightHD product with a unique competitive advantage over all other colposcopes in the market.

    Press release: U.S. Food and Drug Administration (FDA) clears novel ImageSense(tm) technology for use with colposcopy…
    Product page: ImageSense…

    56hsdr55 Artificial Blood Vessels Grown in Polyethylene Glycol HydrogelsResearchers from Rice University and Baylor College of Medicine have developed a method to grow blood vessels in a laboratory. The investigators used biomimetic polyethylene glycol hydrogels embedded with a growth factor called BB (PDGF-BB) to spur angiogenesis, and are now working on a way to guide the formation of vasculature for specific applications.

    As its base material, a team of researchers led by West and BCM molecular physiologist Mary Dickinson chose polyethylene glycol (PEG), a nontoxic plastic that’s widely used in medical devices and food. Building on 10 years of research in West’s lab, the scientists modified the PEG to mimic the body’s extracellular matrix — the network of proteins and polysaccharides that make up a substantial portion of most tissues.
    West, Dickinson, Rice graduate student Jennifer Saik, Rice undergraduate Emily Watkins and Rice-BCM graduate student Daniel Gould combined the modified PEG with two kinds of cells — both of which are needed for blood-vessel formation. Using light that locks the PEG polymer strands into a solid gel, they created soft hydrogels that contained living cells and growth factors. After that, they filmed the hydrogels for 72 hours. By tagging each type of cell with a different colored fluorescent marker, the team was able to watch as the cells gradually formed capillaries throughout the soft, plastic gel.
    To test these new vascular networks, the team implanted the hydrogels into the corneas of mice, where no natural vasculature exists. After injecting a dye into the mice’s bloodstream, the researchers confirmed normal blood flow in the newly grown capillaries.
    Another key advance, published by West and graduate student Joseph Hoffmann in November, involved the creation of a new technique called “two-photon lithography,” an ultrasensitive way of using light to create intricate three-dimensional patterns within the soft PEG hydrogels. West said the patterning technique allows the engineers to exert a fine level of control over where cells move and grow. In follow-up experiments, also in collaboration with the Dickinson lab at BCM, West and her team plan to use the technique to grow blood vessels in predetermined patterns.

    Time-lapse image showing how two types of cells (tagged red and green) organize themselves into a functioning capillary networks within 72 hours:


    Link @ Rice: Biomedical breakthrough: blood vessels for lab-grown tissues…
    Abstracts in Acta Biomaterialia: Covalently immobilized platelet-derived growth factor-BB promotes angiogenesis in biomimetic poly(ethylene glycol) hydrogels; Mitral valvular interstitial cell responses to substrate stiffness depend on age and anatomic region

    6m2buglc UNC Researchers One Step Closer to Synthetic BloodResearchers at the University of North Carolina-Chapel Hill have created particles that mimic red blood cells in size, shape and flexibility. Using a fabrication process called Particle Replication in Non-wetting Templates, or PRINT, 6 μm hydrogel discs are produced that can circulate through the body for 93 hours before they are excreted, compared to about 3 hours for the stiffer particles that are currently being researched. Other functions, such as oxygen transport or therapeutic drug delivery, have not been tested, but these flexible particles are a major improvement because red blood cells naturally deform in order to pass through capillaries. These new flexible hydrogel particles are also able to move through the body in a similar fashion, and are removed from the body by the spleen, the organ that typically removes red blood cells.
    An equally exciting application for these particles is for cancer treatment:

    Beyond moving closer to producing fully synthetic blood, the findings could affect approaches to treating cancer. Cancer cells are softer than healthy cells, enabling them to lodge in different places in the body, leading to the disease’s spread. Particles loaded with cancer-fighting medicines that can remain in circulation longer may open the door to more aggressive treatment approaches.


    Link @ UNC: UNC researchers inch closer to unlocking potential of synthetic blood…

    brainscanx4 New Technologies Allow for Faster Brain fMRIs
    Researchers from University of California, Berkeley, University of Minnesota, and Oxford University have developed new technology to speed up how fast neuro fMRI functions. In a study published in PLoS ONE, the researchers were able to achieve large reductions in echo planar imaging (EPI) of whole brain scan time at 3 and 7 Tesla even though the sampling rate was increased 6-fold and the peak functional sensitivity was improved by 60%:
    hdgxh4v4 New Technologies Allow for Faster Brain fMRIs

    Using echo planar imaging (EPI), fMRI vividly distinguishes oxygenated blood funneling into working areas of the brain from deoxygenated blood in less active areas.
    With EPI, a single pulse of radio waves is used to excite the hydrogen atoms, but the magnetic fields are rapidly reversed several times to elicit about 50 to 100 echoes before the atoms settle down. The multiple echoes provide a high-resolution picture of the brain.
    In 2002, Feinberg [David Feinberg, physicist and adjunct professor at UC Berkeley and president of the company Advanced MRI Technologies] proposed using a sequence of two radio pulses to obtain two times the information in the same amount of time. Dubbed simultaneous image refocusing (SIR) EPI, it has proved useful in fMRI and for 3-D imaging of neuronal axonal fiber tracks, though the improvement in scanning speed is limited because with a train of more than four times as many echoes, the signal decays and the image resolution drops.
    Another acceleration improvement, multiband excitation of several slices using multiple coil detection, was proposed in the U.K. at about the same time by David Larkman for spinal imaging. The technique was recently used for fMRI by Steen Moeller and colleagues at the University of Minnesota. This technique, too, had limitations, primarily because the multiple coils are relatively widely spaced and cannot differentiate very closely spaced images.
    In collaboration with Essa Yacoub, senior author on the paper, and Kamil Ugurbil, director of the University of Minnesota’s Center for Magnetic Resonance Research and co-leader of the Human Connectome Project, Feinberg combined these techniques to get significantly greater acceleration than either technique alone while maintaining the same image resolution.
    “With the two methods multiplexed, 10, 12 or 16 images the product of their two acceleration factors were read out in one echo train instead of one image,” Feinberg said.

    Abstract in PLoS ONE: Multiplexed Echo Planar Imaging for Sub-Second Whole Brain FMRI and Fast Diffusion Imaging
    UC Berkeley press statement: Advance makes MRI scans more than seven times faster…

    protontop Varian Proton Radiation Therapy System Gets Regulatory Clearance in U.S.Varian Medical Systems out of Palo Alto, California received FDA 510(k) clearance for its proton beam radiation therapy system. The certification means that hospitals do not need to seek individual clearances to install the Varian system.

    Proton therapy has the advantage of delivering energy to a tumor with minimal effect on healthy tissue on the way from the gun to the target, but the disadvantage is that it’s really, really expensive. Pictured above is the gantry where the patient is subjected to the beam, and below is the beam path coming from the cyclotron that can supply a number of patient treatment rooms at the same time. Further down the page is the image of the finished patient treatment room.
    varian proton beam path Varian Proton Radiation Therapy System Gets Regulatory Clearance in U.S.

    Varian’s scanning beam technology enables IMPT by modulating dose levels on a spot-by-spot basis throughout the treatment area. Irradiations from multiple angles are combined in an optimal manner to improve control of dose distributions. Scanning beam technology also eliminates the time-consuming need to manually insert separate shaping accessories for each beam angle in order to match the beam to the shape of the tumor.
    Varian’s scanning beam IMPT technology is already at work in the Rinecker Proton Therapy Center in Germany, which has now treated several hundred patients.

    varian proton table Varian Proton Radiation Therapy System Gets Regulatory Clearance in U.S.
    Press release: Varian Medical Systems Receives 510(k) Clearance for its Proton Therapy System…
    Flashback: Europe Approves Varian’s Proton Therapy System, A Cancer Zipping Cyclotron…