Archives: 10/2011

f234tg742r54 Transcranial Magnetic Stimulation Shows Initial Promise in Alzheimers TrialIf you remember from your high school or college physics classes, there is a strong relationship between electricity and magnetism. Basic principles of electromagnetism have revolutionized the way we live; for example, knowledge that a wire carrying a current generates a magnetic field led to the development of motors and the discovery that moving a magnet through a loop of wire could produce electricity led to the creation of generators.

Deep transcranial magnetic stimulation (TMS) is a medical application of electromagnetic technology. It essentially relies on the fact that neurons communicate via chemical-electric signals; hence, like other electrical signals, neuronal communication should be able to be influenced by external magnetic fields, or pulses.

The Jerusalem-based company Brainsway has been applying deep TMS technology to potentially treat a number of clinical conditions, some of which have been previously reported here in Medgadget, such as depression, attention deficit disorder, and smoking addiction. Now, the company reports initial positive findings in a small trial of Alzheimer’s patients treated with deep TMS.

According to Brainsway’s press release:

The interim results are for 24 patients that were divided into three groups: a sham stimulation control group, a low-frequency (1 Hz) treatment group and a high-frequency (10 Hz) treatment group. Each subject received treatment over 8 weeks, and the efficacy of the treatment was evaluated both during the trial and over the course of the subsequent 8-week period.

The treatment was well-tolerated by all subjects, with no side-effects, except for one incident involving a sham control subject, which the principal investigator believes to be unrelated to the treatment.

The trial used the Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-Cog) test (the main efficacy scale used in Alzheimer’s disease clinical trials), as well as additional accepted scales of disease severity (CGI, ADL, CDR) and a quality-of-life scale (QoL Caregiver Scale) to assess the efficacy of treatment. These are the main assessment scales used to evaluate efficacy in the literature.

Analysis of ADAS-Cog results revealed a 4.2-point improvement in the high-frequency treatment group, compared with a 1.8-point improvement in the sham control group, and a 1.4-point deterioration in the scores of the low-frequency treatment group, the latter occurring mainly during the 8 weeks post treatment. In addition, in the high-frequency treatment group, severity of cognitive impairment at entry into the trial was correlated with clinical improvement (the more severe the cognitive impairment, the more the patient improved following treatment).

CDR, ADL, CGI and QoL Caregiver Scale scores indicated that high-frequency treatment halted the deterioration of the disease and even produced a moderate improvement relative to sham treatment. Similar to the ADAS-Cog test results, these scores also indicated a worsening in the condition of patients treated with low-frequency electromagnetic stimulation.

The principle investigator commented, “The interim results from the trial indicate that Deep TMS therapy for Alzheimer’s disease patients is safe and side-effect-free. Although the small sample size somewhat hampers our ability to draw any definitive conclusions concerning treatment efficacy, the results nonetheless suggest that high-frequency treatment leads to improvement on Alzheimer’s disease assessment scales, whereas low-frequency and sham treatment do not.”

Here’s a brief animation of Brainsway’s approach:

Press release: Positive Interim Results in Alzheimer’s Trial

ajrtg7111 Five Questions for CEO of Given Imaging Homi ShamirGiven Imaging is a pioneer in the field of capsular endoscopy. Its portfolio of products and patents puts the company years ahead of the competition. The company’s medical devices have now been used for over a decade the world over to diagnose a variety of upper and lower gastrointestinal diseases, in a minimally invasive, patient-friendly way.

On September 12, 2011, Homi Shamir, the CEO of Given Imaging, was ringing the closing bell at NASDAQ to celebrate the 10 year anniversary of the firm’s IPO. Now we are pleased to welcome Mr. Shamir to Medgadget, and we have a few questions for him about his firm and its future.

 

Shiv Gaglani, Medgadget:

Congratulations on a decade since the FDA approved the PillCam! In that time Given Imaging released a second generation PillCam with a wider panoramic angle, adjustable frame rate depending whether the PillCam is stationary or locomotive, and a data recorder capable of providing feedback to the PillCam during the procedure. These changes have been well-received by the GI community, with reports of enhanced diagnostic accuracy and sensitivity. What can we expect in the third generation of the PillCam?

Homi Shamir, CEO of Given Imaging:

We are always looking for ways we can continue to improve our technologies to ensure we are providing gastroenterologists with the highest quality tools to detect and diagnose gastrointestinal disorders. Currently, we are investing in and developing new products to improve GI health such as magnetically controlled PillCam capsules as well as PillCam capsules that can deliver therapeutics.

 

Medgadget:

Your primary products have focused on esophageal and small bowel imaging as well as pH monitoring with the Bravo system. Can you give us a sneak peak of any other medical areas and challenges that Given Imaging is currently working on?

Homi Shamir:dbhebpfu Five Questions for CEO of Given Imaging Homi Shamir

One of the products that we’re very excited about is PillCam COLON 2. Every year, more than 1.2 million people throughout the world are diagnosed with colon cancer. In fact, although colon cancer is one of the most preventable forms of cancer, it’s the second leading cause of cancer death as compliance for colon cancer screening remains low. PillCam COLON is designed for individuals who are not currently following colon cancer screening guidelines. We are marketing this product in Europe and a large clinical trial in the US and Israel is underway to support a filing with the FDA next year. In addition, we are investing in and developing new products to improve GI health such as magnetically controlled PillCam capsules as well as PillCam capsules that can deliver therapeutics.

 

Medgadget:

Your acquired Sierra Scientific Instruments in March of last year and in the process expanded your diagnostic capabilities. Would you please comment on any medical devices in the pipeline from that acquisition?

Homi Shamir:

Over the past year, we have focused on integrating the Sierra Scientific product line into our product offering. We have spent time in the field with physicians understanding their needs and have begun the process to tailor the offering accordingly. One of our future goals is to begin offering our products in one platform. As you may imagine space is limited in the endoscopy suite and we are working with physicians and nurses to offer not only cutting-edge medical technologies but also meet the needs of the entire gastroenterology staff.

 

Medgadget:

Does Given Imaging have any plans to couple its technology with therapeutic applications?

Homi Shamir:
We are investing in and developing new products to improve GI health such as magnetically controlled PillCam capsules as well as PillCam capsules that can deliver therapeutics. Unfortunately we can’t reveal anything more about that at this time.

 

Medgadget:

What is the largest obstacle facing widespread adoption of the PillCam by hospitals/GI specialists?

Homi Shamir:

PillCam SB has been widely adopted throughout the world and is recognized as the gold standard for imaging the small bowel. PillCam SB is available at more than 5,500 centers in 80 countries, and more than 1.5 million patients have ingested PillCam SB. In addition, 600 million individuals worldwide have reimbursed access to PillCam SB. Earlier this year, PillCam SB received FDA clearance for use in monitoring the progression of Crohn’s disease in patients. We believe that this could contribute to the future growth of this product. In June, we initiated a clinical trial for our PillCam COLON 2 product, an alternative for those who are unwilling or unable to undergo colonoscopy, which will form the basis of our planned submission to the FDA in 2012.

f00034923w New Retinal Imaging System EasyScan Does Not Require Pupil Dilatation
i-Optics from The Hague, The Netherands, developed a new retinal imaging system that uses scanning laser ophthalmoscope technology to detect early eye pathology like diabetic retinopathy. This technology provides a better contrast than regular fundus cameras and can penetrate media opacities such as cataract and corneal irregularities. Pupil dilation is not required, as the device images through pupils as small as 2 mm. The technology seems to offer lots of benefits for patients: it reduces waiting time prior to the exam and they don’t have to recover from blurred vision before driving home.

8467yrtw345 New Retinal Imaging System EasyScan Does Not Require Pupil DilatationThe device, called EasyScan, uses a narrow laser beam to scan the surface of the retina. A detector captures the reflected light and creates a real-time image on the monitor.  It supports three imaging modalities: green (532 nm), near infrared (785 nm), and those two combined.

Images can be previewed live with a freeze option on the computer screen. The system  offers  many automated features like eye steering, iris detection, and focusing. It connects to a PC or laptop via a standard USB connection which also functions as its power supply, so AC power is not required. Pictures can be stored and shared in different formats like: DCM, TIFF, TIF, JPEG, BMP. The device can easily be controlled by a joystick.

The EasyScan is touted as a fast and useful tool for rapid diagnosis of diabetic retinopathy, age-related macular degeneration, glaucoma and other retinal pathologies. The EasyScan received CE approval in Europe and is waiting for its FDA clearance now.

Press release: New retinal imager can help millions of diabetes patients

EasyScan brochure… (.pdf)

It brings us great relief knowing that the same robot that can perform complicated surgical procedures in the morning can help prepare lunch for the hungry surgeon after the operation is over.

Here’s a video from the North Bristol NHS Trust in the UK showing the da Vinci surgical robot peeling a grape:

In case you missed it, da Vinci has also been spotted making origami cranes, folding paper airplanes, playing Operation (the game!), break dancing, and just acting plain silly.

g12t5a6p Brainlab Curve Command and Control Center for Image Guided SurgeryBrainlab has launched the Curve, a command and control center for image-guided surgery. The device uses dual tracking cameras and two 27-inch touch screen “beyond HD” (1900×1200 pixels) displays to navigate and track surgical instruments and overlay their position on previously acquired CT or MRI data. In addition it features the latest Brainlab image guidance software with advanced 3D capabilities and proprietary image enrichment, which promises to bring ultra-fast image updating when tracking instruments during surgery.

However, perhaps the best reason to buy this device is that it doubles as an iPod dock, probably making it one of the most expensive that you will be able to find.

Additional new features, from the press release:

• Dual-option, beyond HD provide more space to display and efficiently organize information.
• Cameras with motorized adjustment, telescopic stand, laser pointer for unbelievable setup flexibility.
• Extended camera tracking volume multiplies setup options without compromising patient registration.
• Digital, hi-fidelity music dock for an unexpected listening experience.
• Human-factor design hub connects Curve to the outside world and rapidly integrates third party surgical devices.
• Eight multi-directional power wheels that push cables away helps rapidly maneuver Curve in and out of the OR.
Centralized ‘Home’ and ‘Start’ screens with drag-and-drop functionality, makes launching software applications and displaying contents streamlined and easy.

Curve also brings surgeons closer to colleagues, both near and far. Mobile, wireless networking lets users stream and record then push to linked workstations. Colleagues can watch, in digital HD, the live navigation stream and streaming video from integrated sources like scopes and intra-operative imaging platforms through the hospital’s ‘Brainlab OR web portal.’
Multiple data ports in the easy to access hub allow surgeons to seamlessly connect to intra-operative imaging and surgical scopes, session-share by connecting with a Digital LightBox, stream to a remote workstation, transfer patient data via PACS, and upload and share in the cloud with Quentry.

The Curve will be available first in the EU and Switzerland, FDA and Canadian clearances are pending.

Link to promo video of the Curve…

Press release: Brainlab Launches Newest Innovation in Image-Guided Surgery Technology…

Product page: Brainlab Curve…

gaew466 Siemens RAPIDPoint 500 for Point of Care Blood Gas AnalysisSiemens has released new RAPIDPoint 500 Blood Gas System for whole blood testing at the point of care with laboratory quality results.

Within 60 seconds, the device measures pH, blood gases, electrolytes, glucose, lactate and provides full CO-oximetry, including neonatal total bilirubin and total hemoglobin.

More from Siemens:

LLLE67H Siemens RAPIDPoint 500 for Point of Care Blood Gas Analysis

Equipped with fully automated calibration and quality control (QC), the RAPIDPoint 500 system is also designed to help POC professionals satisfy organizational and regulatory compliance requirements. Plus, the self-contained Automatic Quality Control (AQC) cartridge operates without manual intervention, helping reduce POC staff’s administrative tasks. An integrated bar code reader – conveniently located on the front of the system – offers a wide scanning area to accommodate patient and operator identification to ensure overall data entry integrity.

And, as with the company’s other point-of-care solutions, the RAPIDPoint 500 analyzer can be integrated with the Siemens RAPIDComm® Data Management System, offering centralized management of multiple Siemens blood gas and urine and diabetes analyzers and operators.

  • Full test menu results from a single sample in approximately 60 seconds
  • Easy-to-use, maintenance-free cartridge-based system is ideal for non-laboratory personnel
  • Proven technologies and design features maximize analyzer uptime and simplify compliance
  • Speed and flexibility to increase productivity without increasing staff workload
  • Seamless LIS/HIS integration with optional connectivity to the RAPIDComm® Data Management System

Press release: Siemens Launches New Blood Gas Analyzer to Enhance Diagnostic Testing at the Point of Care

Product page: RAPIDPoint 500

dsg1hr61 MyCalmBeat Stress Reduction Monitor Introduced
A personal heart rate monitor bundled with a software application has been launched by Brain Resource (Ultimo, New South Wales, Australia) to help users manage stress by tracking heart rate variability (HRV). yrx01cm2 MyCalmBeat Stress Reduction Monitor IntroducedAlthough not the first device to use this strategy to calm nerves, the MyCalmBeat system is “the first device to make HRV an accessible feedback mechanism by employing a second body of research linking breathing rates and HRV, making this really the first accessible method of using HRV for most people,” says Joakim Vinberg, product manager, clinical solutions at Brain Resource.

The device uses a small ear clip, which monitors an individual’s heart rate variability as the user breathes at a prescribed speed. The system calculates the optimal breathing rate where heart rate is most variable. (High HRV has been correlated with low anxiety). Apps are offered to use on desktop computers, smartphones, and online to help users train to objectively track their heart rate variability over time.

“The inspiration behind the device is a fair amount of science underlying the connection of heart-rate variability to mental and physical health outcomes, ranging from increased focus, memory, learning, and stress relaxation to improved heart outcomes,” Vinberg says. “[Although the product is] not strictly a medical device, there’s a ton of great evidence in the research realm, but not yet in the clinical realm.”

Press release: Brain Resource Launches MyCalmBeat Personal Stress Reduction Monitor at Health 2.0

Product page: MyCalmBeat

LeGoo Box Syringe 2011 LeGoo, an Innovative Gel That Stops Blood Flow During Vascular Surgery, Gains FDA ApprovalOne of the holy grails of surgery is to “get in and get out” with minimal blood loss. This is especially difficult to do in the case of vascular surgery, which often requires re-anastomosing two or more blood vessels together (e.g. in order to create a bypass or transplant an organ). Blood loss is not only detrimental to the patient, but also obscures the surgical  field – which actually can also be bad for the patient. Hence, surgeons currently use clamps and elastic loops to block blood flow through the vessel they are working on.  However, these tools can often themselves damage weak blood vessels due to their clamping pressure.

A solution in the form of a gel polymer has just been approved by the FDA. Developed by PluroMed Inc., LeGoo is a thermosensitive, reversible polymer that is liquid at room temperatures and solid at higher temperatures. (Wait, isn’t that contrary to everything you learned about phase transitions in high school? Fortunately emerging medical technologies often supersede the rules taught in intro science classes!).

According to the FDA press release:

When injected into a blood vessel, LeGoo forms a gel plug that molds to the shape of the blood vessel and stops blood flow for up to 15 minutes.

After the blood vessels are joined, the plug is expected to dissolve on its own in 15 minutes. In the event the plug needs to dissolve sooner, the surgeon can dissolve the gel plug by applying a cold pack or cold saline to the blood vessel.

In support of approval of the pre-marketing application, the FDA reviewed studies showing that LeGoo is biocompatible and non-toxic. The FDA also looked at data from a clinical trial of 110 patients undergoing bypass surgery without stopping the heart (off pump coronary artery bypass). Investigators found that LeGoo is as safe and effective as vessel loops, devices commonly used to stop blood flow during coronary bypass surgery.

LeGoo is approved for temporarily stopping blood flow in blood vessels below the neck that are 4 millimeters or less in diameter. It is contraindicated for use on vessels supplying blood to the brain.

There is a description and animation of the technology behind LeGoo on the company’s website. You can also watch the YouTube video below showing an actual application of LeGoo in surgery.

Press release: FDA approves gel to stop blood flow during blood vessel surgery

Product page: LeGoo Internal Vessel Occluder

logo23ffw es Introducing Medgadget EspañolWe at Medgadget have big ambitions. On a planet with around 1 billion people speaking Spanish, we see an opportunity to deliver the freshest and the most relevant medical tech news in Español . So if you prefer Spanish, now there’s a better way for you to read Medgadget: Medgadget.es

On this newly minted site, all of our articles are professionally translated in a timely fashion.  Medgadget.es has the same features as our home base, including RSS feeds, Facebook and Twitter integration, and everything else you can expect from the world’s leading medical technology site. So, please check it out, and spread the word around!

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Link: Medgadget.es