Archives: 11/2009

Anesthesiology / Cardiac Surgery / Critical Care / ENT / Medicine / Surgery / Thoracic Surgery

A New LED Powered Endoscope from Schölly

by Gene Ostrovsky on Nov 10, 2009 • 12:43 am

iqwer A New LED Powered Endoscope from Schölly
Schölly Fiberoptic out of Denzlingen, Germany is releasing a new video bronchoscope with CMOS “chip-in-the-tip” and bright LED technology. The device is going to be unveiled at MEDICA 2009 next week in Düsseldorf.

The controller unit is plug-and-play with easy start-up. Its compact size saves table space and the simple controls eliminate the need for lengthy training. The controller is completely silent since it does not require a cooling fan. All video settings are preprogrammed, so no complicated and time consuming set-up is necessary. A single cable leads from the controller to the ergonomic handpiece. The handpiece includes the tip deflection lever, working channel port, suction valve, and buttons for taking photos and illumination adjustment. High-powered LEDs are incorporated inside the handpiece. These LEDs eliminate the need for costly replacement bulbs.

Link: Innovative New Video Bronchoscope with DeepVu Technology …
(hat tip: German Healthcare Export Group)

Medicine / Pediatrics

GLUCOCARD Vital Blood Glucose Platform Gets US Green Light

by Gene Ostrovsky on Nov 10, 2009 • 12:34 am

vital meter GLUCOCARD Vital Blood Glucose Platform Gets US Green LightArkray out of Edina, Minnesota has received FDA clearance for the firm’s GLUCOCARD® Vital™ blood glucose testing system. The platform uses glucose oxidase strip chemistry that supposedly has less chance of false readings than many competing systems.
Features from the product page:

  • Glucose Oxidase System
  • Auto coding
  • Sleek, compact test strip bottle and meter
  • 0.5 µL sample size
  • 7 second test time
  • Highly Accurate
  • Alternate site testing
  • 250-test memory
  • Time and date stamp
  • 14 or 30-day average
  • Plasma referenced results
  • Five year warranty

    • Press release: ARKRAY, Inc. Receives FDA Clearance for New GLUCOCARD(R) Vital(TM) Blood Glucose Monitoring System …
    Product page: GLUCOCARD VITAL …

    Cardiac Surgery

    Melody Transcatheter Cardiac Valve Replacement Shows Good Results in Children

    by Gene Ostrovsky on Nov 10, 2009 • 12:16 am

    876546melo Melody Transcatheter Cardiac Valve Replacement Shows Good Results in Children
    Cardiologists from Miami Children’s Hospital, Morgan Stanley Children’s Hospital, New York, and Children’s Hospital Boston just published preliminary results from the study of Medtronic’s Melody® Transcatheter Pulmonary Valve in 34 children and young adults who were implanted with the device for dysfunctional right ventricular outflow tract conduits. The early results are promising and may help the Melody valve get approved in the US as the first transcatheter cardiac valve on the market.
    me234 Melody Transcatheter Cardiac Valve Replacement Shows Good Results in Children

    All patients underwent cardiac catheterization with the intention of implanting the artificial valve, and 30 of the 34 underwent actual implantation attempts, of which 29 were successful. Three patients (9 percent) had complications during implantation, but all survived.
    At follow-up six months later, no patient had more than mild pulmonary regurgitation. Of 24 patients who had Class II or III heart failure (mild to moderate limitation of physical activity) before the procedure, 19 had improved by at least one functional class at six months, and no patient’s function had declined.
    Eight of the 29 devices developed partial fractures during follow-up, and 3 patients required a second Melody valve (inserted inside the first one) for recurrent blockage.


    Children’s Hospital Boston press statement: Catheter-delivered Valve May Help People with Heart Defects Avoid Multiple Surgeries; Medtronic statement: Melody® Transcatheter Valve Demonstrates Encouraging Results in Study on Patients with Congenital Heart Disease…
    Abstract in Journal of the American College of Cardiology: Implantation of the Melody Transcatheter Pulmonary Valve in Patients With a Dysfunctional Right Ventricular Outflow Tract Conduit …
    Product page: Melody® Transcatheter Pulmonary Valve and Ensemble® Transcatheter Delivery System …
    Flashbacks: Medtronic’s Melody Transcatheter Pulmonary Valve on Track for Approval ; Melody Transcatheter Pulmonary Valve Still Being Tested in the US …; The Melody Valve Approved in Canada; The Melody Transcatheter Pulmonary Valve

    Cardiology

    Boston Sci’s PROMUS Element Stent Gets Go Ahead in Europe

    by Gene Ostrovsky on Nov 10, 2009 • 12:00 am

    t3423jjj Boston Scis PROMUS Element Stent Gets Go Ahead in EuropeThe EU issued approval to Boston Scientific‘s PROMUS® Element™ coronary stent based on the platinum chromium alloy.

    The platinum chromium alloy used in the PROMUS Element stent is engineered specifically for coronary stenting. This proprietary alloy offers greater radial strength and flexibility than older alloys such as the cobalt chromium alloy used in the XIENCE PRIME™ DES, and it provides enhanced visibility and reduced recoil. The innovative stent design improves deliverability and allows for more consistent lesion coverage and drug distribution. The advanced catheter delivery system further improves deliverability.
    The PROMUS Element system is being evaluated in the PLATINUM clinical trial, which completed enrollment of 1,532 patients in September at more than 140 sites worldwide. PLATINUM is a randomized, controlled, pivotal trial designed to support U.S. Food and Drug Administration (FDA) and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the PROMUS Element system.

    Here’s Boston Sci’s promo video for the PROMUS ELEMENT:


    Press release: BOSTON SCIENTIFIC ANNOUNCES EUROPEAN APPROVAL AND LAUNCH OF PLATINUM CHROMIUM PROMUS® ELEMENT™ STENT SYSTEM …
    Product page: PROMUS Element Stent …

    Nanomedicine

    Nanoparticles Able to Damage DNA Without Entering Cell

    by Gene Ostrovsky on Nov 10, 2009 • 12:00 am

    232hhh Nanoparticles Able to Damage DNA Without Entering CellA team of British researchers has shown that cobalt-chromium nanoparticles can damage the intracellular DNA without ever having to enter the cell itself. These findings may throw a new wrench into the use of nanoparticles in medicine.
    From the abstract in Nature Nanotechnology:

    Here, we show that cobalt-chromium nanoparticles (29.5 plusminus 6.3 nm in diameter) can damage human fibroblast cells across an intact cellular barrier without having to cross the barrier. The damage is mediated by a novel mechanism involving transmission of purine nucleotides (such as ATP) and intercellular signalling within the barrier through connexin gap junctions or hemichannels and pannexin channels. The outcome, which includes DNA damage without significant cell death, is different from that observed in cells subjected to direct exposure to nanoparticles. Our results suggest the importance of indirect effects when evaluating the safety of nanoparticles. The potential damage to tissues located behind cellular barriers needs to be considered when using nanoparticles for targeting diseased states.

    Abstract in Nature Nanotechnology…
    (hat tip: POPSCI)
    Image: Optical image of cobalt nanoparticles onto HOPG substrate by victorpuntes on Flickr…

    Medicine / Pediatrics

    Symphony Transdermal Continuous Glucose Monitoring System Going to Clinical Trials

    by Gene Ostrovsky on Nov 9, 2009 • 1:04 am

    kk234jj Symphony Transdermal Continuous Glucose Monitoring System Going to Clinical Trials
    Franklin, Massachusetts based Echo Therapeutics has announced the initiation of a clinical study testing the viability of the firm’s Symphony™ tCGM product. Last year we wrote about Echo’s success at pre-clinical trials of the system. MassDevice has reported that it cost the company about $60 million for the development of the system to get to this point.

    “We are extremely pleased to take this next step forward in the development work on our one piece biosensor, a critical component of Symphony, our needle-free, continuous glucose monitoring technology,” stated Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. “As we described previously, this next generation biosensor introduces new materials and a more effective geometrical construction designed to be one-piece and replaces the prior prototype two-piece biosensor used in earlier clinical trials. We believe that this biosensor will demonstrate improved performance and reliability and we look forward to confirming this in this clinical trial in Type 1 and Type 2 diabetics.”
    Echo’s pilot clinical study will enroll patients with diabetes (either Type 1 or Type 2) and will compare data obtained from its Symphony tCGM System with the “gold standard” YSI Glucose Analyzer. The study will collect approximately 900 data pairs to be used in the analyses. Reference glucose measurements will be made at 15 minute intervals for 24 hours with the study data blinded to study subjects and study personnel.

    Press release: Echo Therapeutics Initiates Clinical Study of its New One-Piece Symphony(TM) tCGM Biosensor in Type 1 and Type 2 Diabetic Patients …
    Flashback: Positive Results for Echo Therapeutics’ Noninvasive Glucometer
    Product page: Symphony tCGM System …
    (hat tip: MassDevice)

    Radiology

    Tissue Penetrating Laser Images Tumors in A New Light

    by Gene Ostrovsky on Nov 9, 2009 • 12:55 am

    lighttt Tissue Penetrating Laser Images Tumors in A New Light
    Researchers at Johns Hopkins University are developing a new diagnostic modality for identification of brain tumors. Using optical coherence tomography, a technique in which laser light is shined into tissue and analyzed how it scatters, the team hopes to differentiate tumors from healthy brain parenchyma, and that may help avoid risky biopsies. Although development of the technology has progressed significantly, animal and human trials are still in the works.
    cskku Tissue Penetrating Laser Images Tumors in A New Light

    To give doctors this detailed view of brain tissue, Kang’s device employs ultra-thin optical fiber, the material used in long-distance communication systems, to direct harmless low-powered laser light onto the area the surgeon wants to examine. When the light strikes the tissue, most of it bounces away in a scattered, incoherent manner. But using a technique called optical coherence tomography, the small portion of light that is scattered back can be collected and used to construct a high-resolution three-dimensional picture of the tissue, down to the cellular level. These images are significantly sharper than those produced by MRI or ultrasound equipment, Kang says, and should give surgeons a better look at the boundaries of a tumor and the presence of blood vessels and healthy tissue that must be preserved.
    Yet, compared to the older, widely used imaging systems, the new technology is expected to be much less expensive, perhaps less than $10,000. “It’s a very simple and cost-effective system,” Kang says.

    Full report from Johns Hopkins: New Optical Tool Could Produce ‘Virtual Biopsies’ in Brain Cancer Cases …
    More from the JHU Department of Electrical and Computer Engineering: Smart Surgical Tools Using Fiber Optic Sensor and Image …

    Cardiology / Medicine / Sports Medicine / Telemedicine

    Toumaz Sensium Digital Plaster Goes on Trial

    by Gene Ostrovsky on Nov 9, 2009 • 12:49 am

    toumazplaster Toumaz Sensium Digital Plaster Goes on Trial
    Toumaz Technology out of Abingdon, UK has announced it partnered with the Imperial College London to perform a clinical trial on the company’s “Digital Plaster” vital signs monitor. The technology, which we covered in the past (see flashbacks below), allows for continuous monitoring and wireless transmission of temperature, heart and respiratory rates to help speed up workflow and get rid of some of the cables.
    jj3423l Toumaz Sensium Digital Plaster Goes on Trial

    The focus of the trial will be to verify that the physiological data acquired by the digital plaster system within a clinical setting is equivalent to that acquired using current gold-standard monitors in use in hospitals – equipment that is often bulky, expensive and fixed, such that patient mobility is impaired. The Sensium digital plaster is wireless and unobtrusive, meaning that patients can remain ambulatory in hospital while still being monitored. This flexibility allows continuous vital sign monitoring to be extended to patients who would not normally be monitored, thereby offering the potential to increase patient safety. The Sensium digital plaster is a disposable device with a working lifetime of several days, after which the plaster is disposed of in the appropriate waste receptacle.
    The trial is being conducted in three phases, an initial phase with non-patient volunteers followed by two patient study groups: patients recovering from surgery, and patients with specific medical conditions in the general wards.
    The Sensium digital plaster is targeted for use in clinical monitoring applications such as acute care, general ward environments, tele-care, chronic disease monitoring, and in care home settings. For all these applications, disposability provides convenience, simplicity and patient comfort while ensuring infection control is maintained to the highest standards. Powered by thin batteries, body-worn Sensium-enabled monitors deliver clinical-quality data and intelligently integrate it into an electronic medical record via a network built on Toumaz’s power-optimised wireless operating and networking system, Nano Sensor Protocol (NSP).

    Press release: Toumaz Technology and Imperial College London In Landmark Clinical Trial Of Sensium
    Product page: Toumaz Sensium …
    Flashbacks: Sensium Life Pebble Wireless Vitals Monitor for Sport Training, Cardiac Health Auditing ; EU Aims to Develop Blood Glucose Prediction Device ; Sensium Chip: An Ultra Low Power Sensor Interface

    Public Health

    Ford’s Inflatable Airbags to Bring Extra Safety Up Close

    by Gene Ostrovsky on Nov 9, 2009 • 12:49 am

    fordbags Fords Inflatable Airbags to Bring Extra Safety Up Close
    Ford is going ahead with seatbelt airbags in the next generation Ford Explorer. The system uses compressed gas which, for safety, inflates the seatbelt at a slower speed than traditional airbags using chemical explosives. Apparently, Lexus is planning to release a similar system in its higher end vehicles next year.


    Press release: Ford Introduces Industry’s First Inflatable Seat Belts to Enhance Rear Seat Safety …
    (hat tip: Engadget)

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