Posts Tagged ‘cryolipolysis-equipment’

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BattleView Infrared Vascular Trans-illuminator

BattleView Infrared Vascular Trans-illuminator

Let’s just say that you’re a medic out there “in the field” in the middle of the night, with bad guys all over the surrounding hill tops, and they just shot one of your buddies.  You managed to move the injured soldier to a safer location, and are attempting to setup an IV, but you certainly don’t want to turn on the flashlight with enemy snipers scanning every inch of the landscape.BattleView-Infrared-closeup

That’s where the BattleView Infrared Vascular Trans-illuminator may be of help, as it shines infrared light through the body part where you’re trying to set the IV, illuminating the internal anatomy for your night vision goggles to see as bright as day.

From the product page:

The device incorporates four encapsulated IR LED’s that bond with the iron in the venous blood travelling back to the heart, effectively fluorescing the veins.  This makes target veins extremely easy to spot, allowing IV’s to be inserted as if under normal lighting conditions.

BattleView © has a fantastic power to size ratio, capable of shining right through several inches of tissue.  It can be used on the upper appendages to locate commonly targeted veins (Cephalic and Dorsal Venous) in the hand and wrist.  It can even reveal the veins in the medial part of the lower arm (Median Anti-Brachial and Cephalic).  In areas of higher muscular density, BattleView © can be rotated to the same side as the infiltration site to trans-illuminate the superficial target veins.  The same can be done on the lower appendages when targeting common structures like the Saphenous Vein.

BattleView © is one of the most innovative products developed for the tactical medicine community.  Its lightweight foam and neoprene construction make it easily packable in a medic’s kit and it deploys in seconds.  Simply run the patient’s appendage through the shock cord retaining band with the foam pad against the skin and click the on/off button.  BattleView © is powered by a single 3-volt CR123A lithium battery.  The LED’s operate in the near-infrared spectrum.  So, while they mainly produce IR light visible only through night vision goggles, they also emit a faint red glow that is visible to the naked eye.  The red glow can only be seen from a few feet away and is used for checking power status without NVG aid.  The IR emission is very strong, allowing BattleView © to be used as an IR Beacon or area light as well.  In addition, the unit also produces heat when powered on.  The heat lets it be used as a thermal beacon.  Because the device produces heat, though; users should take caution in leaving it on a patient for too long.

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Analogic Launches Three New BK Medical Ultrasound Systems With Innovative Quantum Technology

Analogic Launches Three New BK Medical Ultrasound Systems With Innovative Quantum Technology

Analogic has announced the worldwide launch of three new ultrasound systems from its subsidiary BK Medical, the Pro Focus UltraView 800, the Flex Focus 800, and the Flex Focus 500.analogic-new-devices

All three models sport the company’s “Quantum Technology” that provides high resolution visualization of the tissues.

Quantum Technology offers image quality enhancements including improved contrast resolution, as well as new gray scale maps and new image pre-sets, making it easier and quicker to obtain the highest quality images. In addition, the new technology includes a unique Vector Flow Imaging (VFI) mode*, enabling angle independent visualization of blood flow, and an advanced color Doppler mode, enabling superb spatial resolution. Key benefits also include advanced harmonic imaging when imaging all patient types, even the extremely difficult-to-image patient.

Compatible with all of BK Medical’s transducers, the fully featured, premium performance systems are ideally suited for surgery, including robotic-assisted surgery, general imaging and high-end urology imaging. The UltraView 800 system also has contrast imaging capabilities**, and both the UltraView 800 and Flex Focus 800 systems have a HistoScanning*** ready option. The Flex Focus 500 is the mid-range system in the BK Medical family incorporating Quantum Technology. This portable system is powerful and well suited for a busy practice utilizing ultrasound for urology and general imaging needs. All of the new systems also have VFI* as an option.

BOSTON, Feb. 7, 2012 (GLOBE NEWSWIRE) — Analogic Corporation (Nasdaq:ALOG), enabling the world’s medical imaging and aviation security technology, today announced the worldwide launch of three BK Medical ultrasound systems, the Pro Focus™ UltraView 800, the Flex Focus™ 800, and the Flex Focus 500, each incorporating the groundbreaking Quantum™ technology. Significant new features and advancements from the Quantum Technology improve the practice of medicine by providing clinicians a faster and easier way to maximize ultrasound performance in urology, surgery, general imaging and anesthesiology.

“The three new ultrasound systems with Quantum Technology are our most significant and innovative product announcements to date, underscoring our pioneering innovation in ultrasound for over thirty years,” said Lars Shaw, vice president of global marketing at Analogic. “The superb imaging performance and dramatic increase in 2D and color Doppler capabilities, coupled with the productivity enhancements built into the new Quantum Technology, are examples of Analogic’s continuing promise to provide leading-edge ultrasound systems.”

Quantum Technology offers image quality enhancements including improved contrast resolution, as well as new gray scale maps and new image pre-sets, making it easier and quicker to obtain the highest quality images. In addition, the new technology includes a unique Vector Flow Imaging (VFI) mode*, enabling angle independent visualization of blood flow, and an advanced color Doppler mode, enabling superb spatial resolution. Key benefits also include advanced harmonic imaging when imaging all patient types, even the extremely difficult-to-image patient.

Analogic’s three new ultrasound systems complement BK Medical’s extensive product portfolio. The UltraView 800 and Flex Focus 800 are premium performance, highly efficient new systems that incorporate Quantum Technology. Compatible with all of BK Medical’s transducers, the fully featured, premium performance systems are ideally suited for surgery, including robotic-assisted surgery, general imaging and high-end urology imaging. The UltraView 800 system also has contrast imaging capabilities**, and both the UltraView 800 and Flex Focus 800 systems have a HistoScanning*** ready option. The Flex Focus 500 is the mid-range system in the BK Medical family incorporating Quantum Technology. This portable system is powerful and well suited for a busy practice utilizing ultrasound for urology and general imaging needs. All of the new systems also have VFI* as an option. The full BK Medical product portfolio includes the Flex Focus 200, 200 Surgery, 400 Anesthesia, 700, and the Pro Focus UltraView.

Analogic’s worldwide launch began in Copenhagen, Denmark, continued to Dubai, United Arab Emirates, and concluded in Las Vegas, Nevada.

Analogic Corporation recently received the coveted 2011 Frost & Sullivan North American Product Differentiation Excellence of the Year Award in the Surgical Ultrasound Market for its BK Medical ultrasound solutions.

About Analogic and the BK Medical brand

Analogic (Nasdaq:ALOG) provides leading-edge healthcare and security technology solutions to advance the practice of medicine and save lives. Analogic’s ultrasound group designs and manufactures ultrasound systems and specialized transducers that are sold directly to medical practitioners under the BK Medical brand. For over 30 years, our market-leading BK Medical branded ultrasound solutions have been used to improve the practice of medicine in procedure-driven markets such as urology, surgery and anesthesia. BK Medical’s products, including our award-winning Flex Focus family of systems and unique transducer designs, offer advanced imaging capabilities that enable real-time image guidance in an easy-to-use, portable platform.

Source:http://www.analogic.com/646971/news-and-events-press-releases-detail.htm

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Medtronic Announces 510(k) Clearance for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer for Spine Surgery

Medtronic Announces 510(k) Clearance for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer for Spine Surgery

Medtronic received FDA 510(k) clearance to market its Aquamantys SBS 5.0 Sheathed Bipolar Sealer for sealing soft tissue and epidural veins during spinal surgery.

The device delivers RF energy for cauterization and saline to keep the area clean and clear for easy access around sensitive tissue.

From the press release:

The SBS 5.0 Sheathed Bipolar Sealer gives spine surgeons the ability to optimize speed and continuity in surgical cases by providing hemostatic sealing capabilities for both incised soft tissue (e.g., cut muscle) and epidural veins with a single device. Like other devices in the Aquamantys line, the SBS 5.0 uses Transcollation® technology, a combination of radiofrequency energy and saline that has been shown to reduce blood loss and improve visualization when used during spine procedures. Reductions in blood loss during surgery have been linked to reduced blood transfusion rates and decreased surgical time.

“The SBS 5.0 is a great combination tool that will allow surgeons to treat cut muscle planes as well as compress and treat epidural veins with a single device,” said Dr. Paul Santiago, a surgeon at Washington University School of Medicine. “This will be particularly useful in cases like 1-2 level TLIFs/PLIFs in which you want the ability to address both of these needs but the economics can make using multiple devices difficult.”

MINNEAPOLIS – January 23, 2012 – Medtronic, Inc. (NYSE: MDT) announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for the Aquamantys® SBS 5.0 Sheathed Bipolar Sealer, a new addition to the spine portfolio of the company’s Advanced Energy business.

The SBS 5.0 Sheathed Bipolar Sealer gives spine surgeons the ability to optimize speed and continuity in surgical cases by providing hemostatic sealing capabilities for both incised soft tissue (e.g., cut muscle) and epidural veins with a single device. Like other devices in the Aquamantys line, the SBS 5.0 uses Transcollation® technology, a combination of radiofrequency energy and saline that has been shown to reduce blood loss and improve visualization when used during spine procedures. Reductions in blood loss during surgery have been linked to reduced blood transfusion rates and decreased surgical time.

“The SBS 5.0 is a great combination tool that will allow surgeons to treat cut muscle planes as well as compress and treat epidural veins with a single device,” said Dr. Paul Santiago, a surgeon at Washington University School of Medicine. “This will be particularly useful in cases like 1-2 level TLIFs/PLIFs in which you want the ability to address both of these needs but the economics can make using multiple devices difficult.”

“We are excited to offer surgeons this new addition to our ever-growing spine portfolio of advanced energy products,” said Mark Fletcher, President of the Surgical Technologies business at Medtronic, Inc. “The SBS 5.0 utilizes the effectiveness of our patented Transcollation technology in preventing and stopping bleeding during surgery, and it will deliver considerable value to surgeons, patients, and hospitals alike.”

Source:http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1327328898338&lang=en_US

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DuoFertility Decodes Messages Between Armpit, Ovaries

DuoFertility Decodes Messages Between Armpit, Ovaries

Cambridge Temperature Concepts Ltd. received 510(k) approval for their DuoFertility ovulation Monitor. The DuoFertility monitor has been featured previously onMedgadget and comprises a wearable sensor and reader unit for measuring ovulation patterns. The sensor is worn under the armpit and measures subtle changes in basal body temperature which is indicative of ovulation. The reader wirelessly receives the sensor data and predicts when you are most likely to become pregnant up to six days in advance. A number of additional parameters can also be entered into the reader unit to improve the prediction quality. The recorded data can be visualized by connecting the reader unit to a PC, as shown in the video below.

The DuoFertility has been commercially available in Europe since 2009 and was the subject of aresearch paper published last year which demonstrated its efficacy in some couples eligible for IVF.

From the product website:

The study followed the first 500 couples using DuoFertility from launch in 2009, including 242 who qualified for IVF/ICSI treatment, of whom 90 had previously had the procedure. The one-year clinical pregnancy rate for those who qualified for IVF was 39%, which is higher than either the UK or EU clinical pregnancy rates for a cycle of IVF (26% and 28% respectively), whilst the corresponding rate for those who had already been through a cycle of IVF/ICSI was 28%.

The study included couples with unexplained infertility, as well as those with mild to moderate male and female factor infertility. This accounts for approximately 80% of all infertile couples, and half of all IVF patients.

At the Future Health Mission 2011 in San Francisco last week, we were offered a chance to check out some of the latest and most promising medtech startups from the United Kingdom, who came for a tour of Silicon Valley.
Here’s one technology that impressed us a lot. DuoFertility is an ovulation pattern temperature monitor from Cambridge Temperature Concepts Ltd. The DuoFertility technology wasprofiled by us back in 2008 when it was in prototype stage. Now it is a fully developed device that has an auxiliary temperature monitoring patch and a receptacle that downloads temperature data from the patch and sends it to a service center. The idea is to use the temperature variations of a woman to extrapolate the best day(s) for her to conceive. According to the company’s CEO and founder Dr Shamus Husheer, the device is already selling quite well in emergent markets such as Middle East and Asia, and is on its way to wider use in Europe. And, of course, the company is hoping to obtain US FDA approval sometime in the near future.

The system is based on a sophisticated version of the body basal temperature (BBT?) measurement method (the small upward shift in basal body temperature which is associated with ovulation). The system identifies when you are most likely to get pregnant, up to six days in advance. This gives you plenty of time to plan intercourse for the best time of the month.
Temperature measurements are made automatically up to 20,000 times per day by the DuoFertility sensor. In addition, personal fertility related data you provide such as menstruation? dates, ovulation pain, etc are also added into the fertility analysis to give you the most accurate predictions possible.

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MAKE YOUR OWN CANCER DIAGNOSTIC TEST

MAKE YOUR OWN CANCER DIAGNOSTIC TEST

Ever wanted to create your own cancer diagnostic test? Stanford Medicine magazine has profiled the work of Purvesh Khatri and Atul Butte who have developed a method to easily create cancer biomarker spotting tests. They use publicly available data from National Center for Biotechnology Information’s GEO database of gene expression of cancer tumors, a bit of statistics and data filtering, and outsourcing of an ELISA test to develop the diagnostic capabilities.

Now, if you’re really motivated, you can develop your own cancer diagnostic test and all the steps for doing that are readily explained to get you started.

So it takes years of hard work and serious cash to create one of these “simple” tests, right? Not anymore.

“All you really need is a computer browser and Excel,” says computer scientist Purvesh Khatri, PhD, who, working with Atul Butte, MD, PhD, associate professor of systems medicine in pediatrics, identified telltale chemicals (aka biomarkers) for three types of cancer all in the span of one year.cancer-test-at-home

How was this possible? By analyzing some of the vast amount of genetic information from tumor cell samples that has been amassed over the past decade in free, publicly accessible databases, and by outsourcing the lab work.

“We say ‘outsource everything except the genius,’” says Butte. “You come up with the question and the target, and let everyone else do the work.”

As Khatri walked me through the discovery process, I learned there’s a little more to it than that. Some work and cash is involved, not to mention high-school level biology. And basic statistics will be a big help. But with those tools, skills and about five days’ work, plus $4,000 to confirm through blood tests, you’re on your way.

Go to an online repository that offers gene expression data from cancer tumors. We’ll use the National Center for Biotechnology Information’s GEO database for our example.

At GEO, enter a type of cancer in the DataSets window, surround it with quotation marks — for instance, “pancreatic cancer” — and click “go.” That pulls up a list of experiments. You’ll want to download the data from five to 10 of these; the more data, the better. Here’s what to look for: experiments with mRNA results (not miRNA or SNPs) with lots of samples, including some from non-tumor cells. To download, click on the record number, and in the new window click on “Series Matrix Files.” You’ll get a file that you can open in Microsoft Excel or other spreadsheet program. Do this for each experiment.

Next you’ll look for mRNA sequences that are produced at high levels in tumor cells but not in ordinary ones. This is the part where some knowledge of statistics is helpful: You’ll need to run a T test for each experiment. Luckily, Stanford professor Rob Tibshirani, PhD, developed SAM, a free Excel plug-in that makes it easy. So download SAM, open Excel and click on the SAM ribbon. Choose “two class unpaired” as the response type, select “unlogged” (if any of the values are in hundreds or thousands) or “logged” (if they’re not) and click OK for a chart of the results. Set the delta value that corresponds to 5 percent false discovery rate, click “list significant genes” and then you’ll see them: Genes that are over-expressed in tumors compared with normal samples will be red. These are the ones to choose from. Pick those with the highest fold change (greater than 2 is best) and the lowest false discovery rate.

Now check whether each of the finalists is over-expressed in tumor tissue in the majority of the experiments. Rule out those that appear in just a few. Those that remain are your contenders for the diagnostic test.

The idea behind most diagnostic tests is simple: Identify a telltale chemical and look for it in a blood sample. The PSA test for prostate cancer is the best-known cancer diagnostic, but diagnostics exist for other cancers too — ovarian and colorectal to name a few. And while the tests are not infallible, they can help find hard-to-detect, early stage cancers and monitor treatment.

Source: http://medgadget.com/2011/12/step-by-step-guide-to-making-your-own-cancer-diagnostic-test.html,http://stanmed.stanford.edu/2011fall/article6.html

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Surfing the flow of brain waves to help employees pay attention

Surfing the flow of brain waves to help employees pay attention

Canada’s The Globe and Mail is reporting that workers at Ontario’s Pickering and Darlington nuclear power plants have been testing a new device that detects brain waves through skin contact on the arm.  The hope is to have the ability to detect when workers are losing concentration, a critical issue when dealing with nuclear fission.

It’s not clear how the device manages to gather enough signal so far away from the brain, butFreer Logic, the Skyland, North Carolina company that developed the Body Wave device does not plan on introducing the technology for clinical use.  Nevertheless, the promise of EEG monitoring away from the scalp is intriguing and we hope to see this technology develop further.Mental Acuity of Nuclear Plant Workers

Five years ago, Mr. Templeton was in charge of OPG’s [Ontario Power Generation] operator training program when he heard that a kind of neurofeedback technology being used for children with attention-deficit disorder was also being used by NASA to measure astronauts’ level of concentration.

“If its original intent was to help astronauts and test pilots,” he says, “why not nuclear operators?”

The technology is the brainchild of Peter Freer, a North Carolina elementary-school teacher frustrated by stymied efforts to help students with ADD. It took 11 years and three jobs for him to scrape together enough cash to create a prototype for an educational program called PlayAttention. Mr. Freer was testing the technology on the U.S. bobsled team, with the same focus-boosting aim, when Mr. Templeton cold-called him. Could Mr. Freer whip up something like that for nuclear-plant operators?

Mr. Freer called back the next day. What ensued was years of back-and-forth on how, exactly, the device could be adapted to suit OPG.

Mr. Templeton wanted something as unintrusive as possible – normally, electroencephalograms are gathered through wires suctioned to the scalp, which can get in the way in a simulated nuclear control room. The result is a device called BodyWave. It weighs about 170 grams, can be strapped anywhere on the body and is eminently portable.

Nine months after meltdowns at Japan’s Fukushima Daiichi facility, there’s still heightened global wariness of nuclear power.

And in an age of splintered attention spans, says Rob Templeton, Ontario Power Generation’s lead auditor for operations, the imperative of teaching concentration is greater than ever.

“There’s talk of a cultural attention deficit, where we’ve got so many sensory inputs, we’ve got so much bombardment that takes place, it affects people’s ability to pay attention,” he says. “How do you pay attention? It’s never been a tangible, achievable thing – it’s just been something that we’ve said. And now we’ve come to a new point.”

Five years ago, Mr. Templeton was in charge of OPG’s operator training program when he heard that a kind of neurofeedback technology being used for children with attention-deficit disorder was also being used by NASA to measure astronauts’ level of concentration.

“If its original intent was to help astronauts and test pilots,” he says, “why not nuclear operators?”

The technology is the brainchild of Peter Freer, a North Carolina elementary-school teacher frustrated by stymied efforts to help students with ADD. It took 11 years and three jobs for him to scrape together enough cash to create a prototype for an educational program called PlayAttention. Mr. Freer was testing the technology on the U.S. bobsled team, with the same focus-boosting aim, when Mr. Templeton cold-called him. Could Mr. Freer whip up something like that for nuclear-plant operators?

Mr. Freer called back the next day. What ensued was years of back-and-forth on how, exactly, the device could be adapted to suit OPG.

Mr. Templeton wanted something as unintrusive as possible – normally, electroencephalograms are gathered through wires suctioned to the scalp, which can get in the way in a simulated nuclear control room. The result is a device called BodyWave. It weighs about 170 grams, can be strapped anywhere on the body and is eminently portable.

About 100 employees at the Pickering and Darlington nuclear plants, east of Toronto, have tested the device over the past year. People were skeptical at first, Mr. Templeton says, but “then they try it, and … it’s like, ‘Wow. This is really neat.’ ”

But it’s early days yet. OPG is rolling it out with the next class of trainee field operators in February.

In a large control room replete with buttons and flashing lights, the potential for attention problems doesn’t stem from boredom, Mr. Templeton says, but hyperarousal.

“There’s too much going on for their brain to deal with, cognitively. It divides their attention and it can impact their performance,” Mr. Templeton says. “We don’t pass people if they can’t perform in that type of environment. The downside for us is, we really need to be able to train and qualify enough people to do the job.”

Whether BodyWave works – that is, whether it actually improves employee focus and performance and, in turn, lowers a plant’s rate of human error – remains to be seen.

“We’re kind of marching ahead of the band here. We have to convince people this is viable … and to show that in the context of its cost, it’s effective.”

The program has cost OPG $50,000 to roll out, out of what the utility reports is a total $50-million training budget.

Some neurologists, however, think Mr. Freer’s claims are too good to be true.

“It sounds like science fiction. It doesn’t make any sense,” says Claude Alain, a scientist at Baycrest Rotman Research Institute. “The farther away you are [from the head], you will pick up a lot of interference. … I have a hard time imagining how it would work.”

Mr. Freer is not surprised by the skepticism. He insists his method works. “The method has to allow one to gather enough signal to make sense of it. … It’s like looking for a needle in the haystack. When you have a bunch of needles, you can filter out the hay.”

While he may do a peer-reviewed study, he says a clinical trial wouldn’t work: “It’s not a clinical device.”

Meanwhile, Mr. Freer has big plans. He says he’s already in talks with other nuclear plants, although he won’t say who. NASCAR started checking it out last year. Mr. Freer just returned from a trip to a West Coast conference selling the technology to lawyers.

It can be a weird pitch to make – teaching an essential skill about which few people think twice.

“We think attention is innate, that we’re born with it,” Mr. Freer says. “And the fact is, we’re all born with the capacity to attend. … But attention is also taught. And, unfortunately, we don’t do that.”

Source:http://medgadget.com/2011/12/arm-worn-device-monitors-mental-acuity-of-nuclear-plant-workers.html,http://www.theglobeandmail.com/news/technology/science/surfing-the-flow-of-brain-waves-to-help-employees-pay-attention/article2242244/?from=sec431

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Zeo Launches Mobile Sleep System

Zeo Launches Mobile Sleep System

Sleep tracking company Zeo has announced today that they’ll soon be selling a mobile version of their product, compatible with both iOS and Android.  The company previously only offered what amounted to a base-station clock with a sleep monitoring  headband. Together they tracked your sleep patterns, including Light, Deep, and REM, but in the process the data got a bit trapped in their clock. To upload sleep data to the web for easier analysis, users had to pull an SD card out of the clock, plug it to a computer, and complete the upload. This step presented a pretty high barrier to learning about your personal sleep.Sleep Tracking

The mobile version solves this by eliminating the intermediary to your sleep metrics. By porting the data directly to your phone, users will be able to see richer charts and easier to understand summary metrics on how well they are sleeping, as well as have access to the full suite of Zeo’s “Sleep Management” tools.

 With 64 million Americans facing sleep issues every night and an
additional 49 million Americans experiencing problems at least a few
nights a week,(1) the need for a good night's sleep as part of optimum
health and wellness has become almost epidemic. The new Zeo Sleep Manager
is the only consumer system that tracks all sleep phases and offers
science-based solutions to everyday sleep issues that affect health,
aging, mental acuity, energy level, stress level and physical performance.

    Zeo CTO and Co-Founder Ben Rubin speaks to the complete health triad of
exercise, diet and sleep as keys to overall wellness. "For too long, a
good night's sleep has been the missing link to optimum health for
millions of people. Zeo's new mobile sleep management system uses
smartphones to show consumers how they really sleep, wherever they go,
and then illustrates how to take control of and harness sleep's awesome
and restorative power."

    Zeo Sleep Manager is the only consumer sleep tracking system with
scientifically-proven accuracy that measures actual sleep phases,
including Light, Deep and REM sleep, providing a complete and accurate
picture of users' sleep. Zeo uses a comfortable and highly accurate
wireless headband equipped with SoftWave(TM) sensor technology to track
these sleep phases and provide a nightly ZQ score, a customized sleep
quality score. The new Zeo Sleep Manager Mobile system sends sleep data
directly to users' smartphones, which then sync automatically to their
online Zeo accounts, so they can easily access online analytical tools
and customized expert guidance to help them improve their sleep.
Source:http://medgadget.com/2011/09/zeo-brings-sleep-tracking-to-your-phone.htmlhttp://www.reuters.com/article/2011/09/26/idUS124933+26-Sep-2011+MW20110926,

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Microsulis Medical’s ablation device used in first microwave assisted robotic liver resection

Microsulis Medical’s ablation device used in first microwave assisted robotic liver resection

Microsulis Medical is reporting that its Acculis microwave thermal ablation system has been successfully integrated with the da Vinci robotic surgical system and used to perform a minimally invasive hepatectomy.

The Acculis Accu2i pMTA applicator delivers microwave energy at 2.45 GHz while pumping cooling fluid through the applicator needle to keep the device within operating temperatures.acculis-accu2i-applicator

Some details about the procedure:

The patient, a 60-year-old female, presented with a liver lesion measuring 3.5cm. Dr Legaspi used the da Vinci’s state-of-the-art robotic technology to operate through tiny incisions in the patient’s abdomen. Using intra-operative ultrasound and direct visual guidance he located the target coagulation zones and used the da Vinci system to place the Accu2i pMTA along the line he intended to cut in order to minimise blood loss. In total he conducted six 120 watt, two minute burns.

Dr Legaspi then proceeded to cut out the lesion with minimal blood loss while carrying out three further two minute burns at 180 watts. At the end of the operation the removed tissue measured approximately 5.5cm, providing an excellent margin, and the collection canister was empty, with only trace amounts of blood in the suction tubing. In total, the patient was in theatre for two and half hours.

Microsulis is a medical device developer specialising in minimally invasive microwave technology for the coagulation, or destruction, of soft tissue. Clinicians have successfully used the company’s devices to coagulate tissue in the liver, lung, kidney and bone.
The recent hepatectomy involving the da Vinci Surgical System and Accu2i pMTA was carried out by Dr Adrian Legaspi, MD, at Mount Sinai Medical Center, Florida.
The patient, a 60-year-old female, presented with a liver lesion measuring 3.5cm. Dr Legaspi used the da Vinci’s state-of-the-art robotic technology to operate through tiny incisions in the patient’s abdomen. Using intra-operative ultrasound and direct visual guidance he located the target coagulation zones and used the da Vinci system to place the Accu2i pMTA along the line he intended to cut in order to minimise blood loss. In total he conducted six 120 watt, two minute burns.
Dr Legaspi then proceeded to cut out the lesion with minimal blood loss while carrying out three further two minute burns at 180 watts. At the end of the operation the removed tissue measured approximately 5.5cm, providing an excellent margin, and the collection canister was empty, with only trace amounts of blood in the suction tubing. In total, the patient was in theatre for two and half hours.
After the case Dr Legaspi said: “I feel that the capability of pre-coagulation with microwave ablation for robotic surgery is going to help reduce operative time and improve patient outcomes.”
Stuart McIntyre, Chief Executive of Microsulis Medical Ltd, said: “We are delighted that the versatility of the Accu2i pMTA applicator has been highlighted as part of this technologically advanced, minimally invasive procedure.”
The Accu2i pMTA applicator – part of the Acculis Microwave Tissue Ablation (MTA) system – is the most powerful soft tissue ablation product available, combining extreme ease of use with the widest range of clinical applications. It is a single high power, high frequency 2.45GHz, saline-cooled needle that is between three to 10 times faster than other devices. It can coagulate tissue masses of up to 5.6cm in size in just six minutes.
Mount Sinai Medical Center is the largest private independent teaching hospital in South Florida and has used Microsulis Medical’s Acculis MTA system since April 2011.
Dr Legaspi is working on a full write up of this liver resection case for publication in the near future.
Microsulis’ microwave tissue ablation devices have been used in more than 100 hospitals world-wide.

Source:http://medgadget.com/2011/12/microsulis-microwave-thermal-ablation-system-now-used-in-robotic-liver-resection.html,http://www.microsulis.com/content.php?page=news&i=72.

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Gene therapy achieves early success against hereditary bleeding disorder

Gene therapy achieves early success against hereditary bleeding disorder

Hemophilia is a rare blood-clotting disease famously known for afflicting the royal families throughout Europe. One type, Hemophilia B, also called Christmas disease after Stephen Christmas, the first patient described with it, is caused by a defect in the eponymous gene on the X chromosome that leads to less than 1 percent of normal expression of Factor IX (FIX), an important blood clotting factor. Hence patients, who are usually male because they only have one X chromosome, require regular intravenous transfusions of Factor IX to prevent internal bleeding, or hemorrhage. These injections cost an individual patient about $300,000 a year, which may add up to around $20 million over a lifetime.

That may soon change due to a “landmark” study published this weekend in the New England Journal of Medicine. An international research team led by scientists at the University College London successfully used gene therapy (adeno-associated viral vectors) to replace the defective or missing copy of the FIX gene in a small cohort of patients, prompting the New York Times to write that Hemophilia B may be “the first well-known disease to appear treatable by gene therapy, a technique with a 20-year record of almost unbroken failure.” The viral vector used by the team inserted the replacement gene into the liver cells of the hemophiliac patients, carefully avoiding the chromosomes to reduce the risk of inducing cancerous mutations, and induced physiologically relevant expression of the coagulation factor up to 22 months post-therapy. As the authors summarize in NEJM:hemophilia-B-gene-therapy

The development and widespread use of clotting factor concentrates for the treatment of hemophilia in the early 1970s dramatically improved the life expectancy for patients with the disease. Subsequent development of recombinant clotting factor concentrates has improved their safety profile, but there remains a strong interest in treatment strategies that would eliminate the need for long-term intravenous infusions and that would be available to the hemophilia population throughout the world. This study documents a critical step toward that goal and shows that sustained therapeutic expression of a transferred factor IX gene can be achieved in humans. The increase in FIX levels in our study participants was roughly dose-dependent, with the high dose of the vector scAAV2/8-LP1-hFIX (2×1012 vg per kilogram) mediating peak expression at 8 to 12% of normal levels. After peripheral-vein administration of scAAV2/8-LP1-hFIXco, four of the six participants were able to stop using prophylaxis with FIX concentrate without having spontaneous hemorrhage, even when they undertook activities that had provoked bleeding in the past. For the other two participants, the interval between prophylactic FIX concentrate injections was extended, but prophylaxis was not completely discontinued…

In summary, we have found that a single peripheral-vein infusion of our scAAV2/8-LP1-hFIXco vector consistently leads to long-term expression of the FIX transgene at therapeutic levels, without acute or long-lasting toxicity in patients with severe hemophilia B. Immune-mediated, AAV-capsid–induced elevations in aminotransferase levels remain a concern, but our data suggest that this process may be controlled by a short course of glucocorticoids, without loss of transgene expression. Follow-up of larger numbers of patients for longer periods of time is necessary to fully define the benefits and risks and to optimize dosing. However, this gene-therapy approach, even with the associated risk of transient hepatic dysfunction, has the potential to convert the severe bleeding phenotype into a mild form of the disease or to reverse it entirely.

Study of gene therapy developed at UCL and St. Jude Children’s Research Hospital offers first proof adults with haemophilia B benefit from treatment, reducing need for injections with clotting factor to prevent bleeds.

Symptoms improved significantly in adults with the bleeding disorder haemophilia B following a single treatment with gene therapy developed by researchers at St. Jude Children’s Research Hospital in Memphis, US and demonstrated to be safe in a clinical trial conducted by UCL.

The findings of the six-person study mark the first proof that gene therapy can reduce disabling, painful bleeding episodes in patients with the inherited blood disorder. Results of the Phase I study appear online ahead of print today in the New England Journal of Medicine. The research is also scheduled to be presented on 11 December at the 53rd annual meeting of the American Society of Hematology in San Diego, US.

Four study participants stopped receiving protein injections to prevent bleeding episodes after undergoing the therapy and have not suffered spontaneous bleeding. Several have also participated in marathons and other activities that would have been difficult prior to gene therapy. The study participants were all treated at the Royal Free Hospital in London under the care of Professor Edward Tuddenham, a pioneer in the field of blood coagulation and a study co-author.

“The first patient has been followed for the longest time, and his levels have remained at 2% for more than 18 months. These results are highly encouraging and support continued research. More patients are scheduled to be enrolled in future trials scheduled to begin later this year,” Davidoff said.

One of the participants who received the highest dose of the vector underwent successful, short-term steroid treatment after his liver enzymes rose slightly after the vector infusion. The rise signalled mild liver damage. The volunteer remained otherwise healthy, his Factor IX levels remain above pre-infusion levels and his liver enzymes have returned to normal. Liver enzymes also rose slightly, but remained in the normal range, for the other participant who received the highest dose of the vector. The participant also received a short course of steroids.

Researchers believe an immune response targeting the vector triggered the elevated enzyme levels. A similar response was reported in earlier gene therapy trials conducted by other investigators using a different vector.

The vector used in this study was produced at the Good Manufacturing Practices (GMP) facility on the St. Jude campus. The GMP operates under government-approved manufacturing guidelines and produces highly specialized medicines, vaccines and other products that pharmaceutical companies are reluctant to pursue. The vector can also now be produced in a similar facility at UCL.

The research was funded in part by The Katharine Dormandy Trust, Medical Research Council, Wellcome Trust, NHS Blood and Transplant and the UCLH/UCL National Institute for Health Research Biomedical Research Centre, all in the UK. In the US, the research was funded by the National Institutes of Health, the Assisi Foundation of Memphis and ALSAC.

Source: http://www.ucl.ac.uk/news/news-articles/1112/111209-haemophilia-gene-therapy-study,http://medgadget.com/2011/12/hope-for-hemophiliacs-gene-therapy-stops-the-bleeding.html

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neuroinflammation in retinal degeneration

neuroinflammation in retinal degeneration

A collaboration of researchers from Wayne State University, the Mayo Clinic and Johns Hopkins Medicine has discovered a potential new treatment for macular degeneration and retinitis pigmentosa. The investigators managed to attach steroids to dendrimers nanoparticles and showed that the drugs only targeted the activated microglia, the damage-causing cells associated with neuroinflammation. The researchers published their article online in the journal Biomaterials.eye-close-up

Age-related macular degeneration and retinitis pigmentosa are leading causes of blindness worldwide. Neuroinflammation plays a big role in both diseases. Activated microglia release substances that damage certain cells in the retina, which eventually can lead to vision loss.

Because steroids have neuroprotective and anti-inflammatory properties, the researchers tried to deliver them precisely to the right target. Therefore they used polyamidoamine dendrimers as drug delivery vehicles, which are about 3-10 nm in size. The activated microglia in the degenerating retina turned out to eat the dendrimers selectively and retain them for at least a month. The drug is slowly released from the dendrimer, offering neuroprotection to the retina.

Source:http://medgadget.com/2011/12/nanoparticles-to-deliver-steroids-to-the-retina.html

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