Archives: 10/2008

Radiology / Surgery

Sentinelle Vanguard Breast MR Auxiliary Table Gets European OK

by Gene Ostrovsky on Oct 15, 2008 • 12:53 am

4534van1 Sentinelle Vanguard Breast MR Auxiliary Table Gets European OK
Back in May, we reported about the Sentinelle Vanguard Breast MR Auxiliary Table®, a product of Sentinelle Medical Inc. from Toronto, O’Canada.
4534van2 Sentinelle Vanguard Breast MR Auxiliary Table Gets European OK
Here’s what we said about the device back then:

Designed to work in tandem with GE Healtcare’s Signa® HDx 1.5T MRI system, the table features an eight channel coil array that enhances imaging of the breast, while the configuration of the table makes percutaneous biopsies (and other interventions) more tolerable for the clinician and the patient, thanks to an open design that offers easy accessibility to all quadrants of the breast.

The latest news from the company is that its line of devices, that now also features a new table for Siemens Avanto® and Espree® MRI machines, has been cleared by the European regulators with the CE Mark of approval.
More details in this press release (.pdf)…
Sentinelle Medical’s products…
Flashback: Sentinelle Vanguard Breast MR Auxiliary Table

Surgery

Cook Medical’s Biodesign Hernia Graft

by Gene Ostrovsky on Oct 15, 2008 • 12:22 am

cook%20hernia Cook Medicals Biodesign Hernia Graft
Cook Medical is releasing its new hernia repair graft made out of the company’s proprietary Biodesign™ material that’s strong and resistant to infection.
From a press release obtained by Medgadget:

Cook’s Biodesign product line establishes a new category in tissue repair that combines the best attributes of synthetic mesh and biologic grafts while reducing disadvantages of those materials including erosion and infection. Based on the breakthrough technology that has made the original Surgisis material from Cook an advanced tissue repair solution, the newly enhanced Biodesign base material now offers surgeons better handling characteristics, long-term strength and faster tissue remodelling, thereby delivering better surgical outcomes
and an improved quality of life for patients.
Using this technology, Cook is introducing the Biodesign™ Hernia Graft, designed to meet the challenges of complex hernias.
Suited for use in contaminated surgical fields, Cook’s enhanced Biodesign Hernia Graft is quilted for reliable handling and perforated to ensure adequate drainage. Serving as a full-strength scaffold, the graft signals surrounding tissue to promote rapid and complete remodelling that, over time, becomes strong, vascularized tissue.

Product brochure: Biodesign Surgisis Hernia Graft (PDF)

Cardiology

Boston Sci Adds Another Player to Rapidly Growing Stent Market

by Gene Ostrovsky on Oct 15, 2008 • 12:14 am

taxlib cellpattern Boston Sci Adds Another Player to Rapidly Growing Stent MarketBoston Scientific received FDA approval to market the company’s paclitaxel eluting coronary stent, the TAXUS Liberté. Boston Sci believes that the physical shape of the stent provides better coverage and results in a more consistent deployment of the embedded drug.
From the product page:

The TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System is engineered specifically for consistent drug elution and impressive performance. Enhanced deliverability features allow access to the target lesion, because first you have to get there.
* Uniform stent geometry promotes even and consistent neointimal coverage
* Thin struts and enhanced stent delivery system improve deliverability
* Proven performance of paclitaxel supported by the rigor of theTAXUS clinical program
Unique Uniform Cell Geometry
* Supports even drug delivery and distribution
* Provides uniform vessel coverage for arterial support
* Reduces gaps in drug concentration loaded on the stent

And the obligatory stent placement animation:


Press release: Boston Scientific Announces FDA Approval of Second-Generation TAXUS® Liberte® Drug-Eluting Stent
Product page: TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System

Cardiology / Radiology

Abbott Reports Positive Data from Study of Its Bioabsorbable Drug Eluting Stent

by Gene Ostrovsky on Oct 14, 2008 • 2:24 pm

54734bax4 Abbott Reports Positive Data from Study of Its Bioabsorbable Drug Eluting StentAt the ongoing Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC, Abbott has just presented new results from two-year data from 30 patients in its ABSORB clinical trial. The company says its bioabsorbable drug eluting stent “successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similar to unstented arteries.”
More details from Abbott’s press statement:

ABSORB Clinical Trial Results
Two-year data from the first 30 patients enrolled in the ABSORB clinical trial demonstrated a low (3.6 percent, n=28) MACE rate, which was consistent with results at one year (3.4 percent, n=29) and before six-months (3.3 percent, n=30). One patient had a minor heart attack due to lack of blood supply at six-months, another was electively lost to follow up at one year, and one patient died from a non-cardiac cause at two years. A zero percent stent thrombosis rate persisted for all patients across all time points in the ABSORB trial. Potential restoration of unstented artery movement to coronary blood vessels after the bioabsorbable stent was absorbed was revealed at two years with the drugs acetylcholine and nitroglycerin used in nine patients, showing vasodilation in the previously stented area, and methergine used in seven patients, showing vasoconstriction in the previously stented area.
About the ABSORB Clinical Trial
The ABSORB trial is a prospective, non-randomized (open label) study designed to enroll up to 110 patients in Belgium, Denmark, France, New Zealand, Poland and the Netherlands. Key endpoints of the study include assessments of safety – MACE (defined as any event that resulted in re-treatment of the treated artery, heart attack or cardiac death) and stent thrombosis (blood clot formation) rates – at 30, 180 and 270 days, with additional annual follow-up for up to five years, as well as an assessment of the acute performance of the bioabsorbable drug eluting stent. Other key endpoints of the study include successful deployment of the bioabsorbable drug eluting stent, follow-up measurements assessed by angiography, intravascular ultrasound (IVUS), and state-of-the-art imaging modalities at 180 days and two years.

The company has also released the following video that takes a look at the stent technology:


Press release…
Flashbacks: Bioabsorbable Stents: So Far So Good ; Evaluation of Bioabsorbable Drug Eluting Coronary Stent Underway; Dissolvable Heart Stents

Critical Care / Emergency Medicine / Military Medicine

MedEx 1000: ICU in a Suitcase!

by Stephen Sheehan on Oct 14, 2008 • 2:01 pm

54674pot MedEx 1000: ICU in a Suitcase!
Do you remember when a cellphone came in a small suitcase? If you don’t, your parents surely will! Well, the FDA has just approved an “ICU in a suitcase”. Containing an integrated ventilator with CO2&O2 monitoring, ECG, invasive pressure monitoring, non-invasive blood pressure monitoring, low and high rate infusion pumps with a fluid warmer… But that’s not all. It also measures temperature, pulse rate and blood oxygen saturation, and it has…

… data storage and transmission system, unified control-and-display unit, and hot-swappable batteries. Additional medical devices can be added using the Auxiliary Device Port and be controlled and displayed through the MedEx 1000. A USB Port provides connectivity to an external printer, and allows for a connection of a USB flash drive to off-load (download) logged data. An Ethernet Port allows for Local Area Network (LAN) connectivity. The unit can accept external sources of both electrical power and oxygen

And it all weighs less than 40 lbs.
It is no wonder the FDA took less than 60 days to approve this device’s application request. Further quoting the press release from Integrated Medical Systems, Inc. (IMS):

…the company’s new modular integrated architecture will serve as a basis for an entire product family of scalable, customizable integrated solutions, and includes the first centralized control – as well as the first remote control – of multiple medical, data and utility capabilities. Just like systems integration transformed the automotive, aerospace and computer industries, the company is at the forefront of transforming healthcare through systems integration. We believe this innovative system addresses a large unmet clinical need to support continuous patient care,” said Adam Seiver, MD, PhD, Adjunct Clinical Associate Professor of Surgery Medical School, Stanford, former Director of Surgical Critical Care at Stanford Medical Center, and a member of company’s Board of Advisors.

Initial deliveries of the MedEx 1000 are expected in the first quarter of 2009. IMS expects to have a CE Mark by fall 2008, permitting marketing and sales in Europe.
Product page: MedEx 1000…
Press release: Integrated Medical Systems Receives FDA Clearance for World’s First ‘Suitcase’ Intensive Care Unit…

Genetics / in the news...

Stem Cells From Skin Cells…Phew!

by Stephen Sheehan on Oct 14, 2008 • 1:16 pm

SkinCell Stem Cells From Skin Cells...Phew!It was only Friday when we lamented that “…testicles could be a new source for viable non-embryonic stem cells” which took us to “…testicular biopsies” and, well, there must be another way. Thankfully science moves at a break-neck pace and we at Medgadget are happy to have tracked down this advancement so quickly.
From Reuters:

In the past year, several teams of scientists have reported finding a handful of genes that can transform ordinary skin cells into iPS cells, which look and act like embryonic stem cells.
To get these genes into the cells, they have had to use retroviruses, which integrate their own genetic material into the cells they infect. This can be dangerous and can cause tumors and perhaps other effects.
Last month U.S. researchers did the same thing using a harmless virus called an adenovirus, but the method was not efficient. And last week, Shinya Yamanaka of Kyoto University in Japan, who discovered iPS cells in mice, used a loop of genetic material called a plasmid to reformat the cells.
Huangfu tried treating the cells first with valproic acid. After she did this, it only took two of the four usual genes to reprogram the cells into iPS cells, she reported.
This is good because the other two genes usually needed can promote cancer.
The Melton team used retroviruses to carry the two genes in but suggest they might not be necessary.
Huangfu said the valproic acid unraveled the chromatin — the physical structure of the chromosomes — making it possible to get in and alter the DNA more easily.

More from Reuters…
Press release: Chemical found to simplify production of stem cells; Harvard team hopes technique cuts tumor risk
Friday’s Medgadget article: Testicles May Be New Source of Stem Cells

Neurological Surgery

Bion Implantable Nerve Stimulator for Chronic Headache

by Justin Barad on Oct 14, 2008 • 1:34 am

bion amf Bion Implantable Nerve Stimulator for Chronic HeadacheHeadaches are upsettingly stubborn, and can be a difficult symptom to treat chronically. Nerve stimulator therapy has become an increasingly popular studied and used avenue for headache treatment. A new cross-over study out of UCSF and the National Hospital for Neurology and Neurosurgery in London demonstrates the effectiveness of BION® Microstimulator device, a product of Boston Scientific (first reported by us back in 2005). The company says that the BION® Microstimulator is the world’s smallest implantable neuromodulator at approximately 28 mm in length and 3 mm in diameter. It is CE marked in Europe for urinary urge incontinence.
Anyways, back to the head. From the University of California press release:

The device, called a bion, is a rechargeable battery-powered electrode, similar in size to a matchstick. When implanted near the occipital nerve in the back of the neck, it alleviates pain by generating pulses that the nerve receives. The bion can be turned on or off via an external wireless remote control. Previous versions of the bion have been used in pain management for osteoarthritis and in the treatment of dislocated joints for patients recovering from stroke.
The study measured the effectiveness of nerve stimulation in six patients aged 37 to 64 with hemicrania continua, a rare headache disorder defined by the International Headache Society as a form of chronic daily headache in which patients have 15 days or more of headache per month.
…Researchers found that within a range of six to 21 months after implantation of the bion, five of the six patients reported sufficient benefit to recommend the device to other patients with hemicrania continua. Similar results were reported in 2007 by two other research teams studying patients with chronic cluster headaches.
At long-term follow-up, four of the six patients reported substantial pain improvement at a level of 80 to 95 percent, one patient saw a 30 percent improvement, and one patient reported that his pain worsened by 20 percent

Read the press release here…
Abstract: Treatment of hemicrania continua by occipital nerve stimulation with a bion device: long-term follow-up of a crossover study Lancet Neurology 2008; 7:1001-1012
Flashback: First ‘Bionic’ Electrode Implanted in UK
Headaches and neuromodulators flashbacks: A similar device and TMS, PFOs,and trephination.

Pathology

Ikonisys Focuses on Cervical Cancer, Metastatic Cells, and Its Future

by Gene Ostrovsky on Oct 14, 2008 • 12:57 am

63455wr1 Ikonisys Focuses on Cervical Cancer, Metastatic Cells, and Its FutureIkonisys out of New Haven, Connecticut is a company making great strides in the digital pathology business. The company’s main product is Ikoniscope Digital Microscope, a “fully automated slide handling, complete slide scanning and real-time image capture and analysis” device (shown below). Medgadget spoke to Petros Tsipouras, MD, the company’s Chairman, and to Paul C. White, President of Ikonisys. They are quite excited about the direction the company is taking and its prospects. For example, Ikonisys recently introduced a cervical cancer test called oncoFISH® cervical, designed to predict chances of low grade squamous intraepithelial lesions (LSIL) progressing into a full blown cervical CA. FISH stands for fluorescence in situ hybridization, and the test, or rather the Ikoniscope, automatically looks at the acquisition of specific chromosomal aneuploidies (within the 3q26 region) in cytological specimens revealing LSIL. The machine has a 175 slide load that can be automatically analyzed by Ikoniscope.
In other developments from the company, we learned that Ikonisys will report today that its technology has been validated in a new clinical trial. Conducted by the Weatherall Institute of Molecular Medicine at Oxford University and published in this month’s British Journal of Cancer, the study by Dr. Walter Bodmer, et. al. has shown that the company’s CellOptics® platform and the Ikoniscope® digital microscope offer a viable method for quick detection of circulating tumor cells in the blood.
More about company’s technology:
ikoniscope Ikonisys Focuses on Cervical Cancer, Metastatic Cells, and Its Future

The CellOptics® platform is the foundation for the highly accurate, automated diagnostic tests we offer and represents the fusion of cell and molecular biology, microscopy imaging, artificial intelligence and informatics. Ikonisys realized that none of these technologies could, by itself, satisfy the requirements for completely automated cell based diagnostics, and therefore created the CellOptics platform.
CellOptics provides the tools and protocols to create seamless, highly integrated procedures for automated and unattended cell based diagnostic products, representing a welcome new approach for a discipline that has traditionally required long training and tedious work by laboratory scientists, physicians and technologists.
At the heart of the CellOptics platform sits the Ikoniscope®/IkoniLAN® digital microscope system, which supports a broad spectrum of cell based diagnostic applications. Its exceptional sensitivity and speed make it particularly well suited for rare cell detection with dramatic implications for disease diagnosis, disease monitoring and therapy. Other elements of the CellOptics platform are proprietary processes and technologies including: cell enrichment techniques, staining techniques, specialized slides, antibodies and FISH probes.

Ikonisys…
Ikoniscope Digital Microscopy System…
Press release: Ikonisys Introduces Rare-Cell Test Designed To Determine Early Progression To Cervical Cancer…

in the news...

First Complete Blueprint of Embryo of Vertebrate Created

by Gene Ostrovsky on Oct 10, 2008 • 1:40 pm

4565em1 First Complete Blueprint of Embryo of Vertebrate CreatedAt the European Molecular Biology Laboratory scientists have tracked and recorded all cells in an embryo of a zebrafish during its first 24 hours of development. The observation led to a first complete model of an embryo of a vertebrate.

The data was reconstructed into a three-dimensional, digital representation of the embryo. The study, published in the current online issue of Science, grants many new insights into embryonic development. Movies of the digital embryo and the underlying database of millions of cell positions, divisions and tracks will be made publicly available to provide a novel resource for research and scientific training.
To get from one cell to a complex organism, cells have to divide, travel around the body and arrange intricate shapes and specialised tissues. The best way to understand these dynamic processes is to look at what happens in the first few hours of life in every part of an embryo. While this is possible with invertebrates with a few hundred cells, like worms for example, it has so far been impossible to achieve for vertebrates.
“Imagine following all inhabitants of a town over the course of one day using a telescope in space. This comes close to tracking the 10 thousands of cells that make up a vertebrate embryo — only that the cells move in three dimensions,” says Philipp Keller. Together with Annette Schmidt he carried out the research in the labs of Jochen Wittbrodt and Ernst Stelzer at EMBL.
Two newly developed technologies were key to the scientists’ interdisciplinary approach to tracking a living zebrafish embryo from the single cell stage to 20,000 cells: a Digital Scanned Laser Light Sheet Microscope that scans a living organism with a sheet of light along many different directions so that the computer can assemble a complete 3D image, and a large-scale computing pipeline operated at the Karlsruhe Institute of Technology.
Zebrafish is a widely used model organism that shares many features with higher vertebrates. Taking more than 400,000 images per embryo, the interdisciplinary team generated terabytes of data on cell positions, movements and divisions that were reassembled into a digital 3D representation of the complete developing embryo.

Here’s a time lapse video of two developing embryos:


Press release: Digital zebrafish embryo provides the first complete developmental blueprint of a vertebrate
Videos from the research project…
Abstract in Science…

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