Archives: 9/2011

0xxkdgxv Ocelot Catheter with OCT OKed in EuropeAvinger of Redwood City, CA received the CE Mark for its new Ocelot catheter for treatment of peripheral artery disease (PAD). The device features built-in optical coherence tomography (OCT) scanner near the tip of the drill.

Simultaneous navigation imaging inside the therapeutic catheter is a great combination for improved efficiency when looking for and crossing a thrombus within arteries.

qmi0e1lp Ocelot Catheter with OCT OKed in Europe

Ocelot is a groundbreaking new tool for accessing discrete regions of the peripheral vasculature while simultaneously providing OCT visualization for navigation through arteries. Using Ocelot’s Lightbox console as an adjunct to fluoroscopy, for the first time ever, medical professionals will have access to a therapeutic device that incorporates real time intravascular guidance.

Avinger recently returned from Paraguay where it is currently enrolling patients in the VISTA study. VISTA is a single­‐center, non‐randomized registry study designed to evaluate the safety and efficacy of Ocelot in patients with Peripheral Artery Disease (PAD). The Principal Investigator of this trial is Dr. Adrian Ebner of Sanitorio Italiano in Asunción, Paraguay. Dr. John Simpson of Sequoia Hospital in Redwood City, CA and Dr. John Pigott of Jobst Vascular Institute in Toledo, OH also participated in this ground-­breaking first in man registry in Paraguay.

Commercialization of Ocelot in select European countries will begin on September 23, 2011. The first three commercial cases are scheduled to be performed in Italy and Germany in late September and early October.

Press release: Avinger Receives CE Mark Approval For Its Ocelot Catheter That Incorporates Intravascular Guidance Using Optical Coherence Tomography (OCT)

gq3423200f8r745 Glassesoff: App to Combat PresbyopiaIt might seem a bit odd: an iPhone application to improve the ability people with presbyopia to see up close. But next year Ucansi, a U.S. company based in Israel, will launch their app called “Glassesoff”.

Instead of trying to improve aging eyes, this app is developed to boost visual acuity by using a proprietary method that affects the brain’s visual cortex performance. The aim is to improve the ability of reading up close and the ability to do that for a longer period of time.

Some details from Ucansi:

Gabors2 Glassesoff: App to Combat Presbyopia

Similar to computers binary code, everything captured by the human eye is translated into the equivalent of “0” and “1” by the vision system. Those “0” and “1” are translated into visual images such as Gabor patches that vary by their spatial frequency, contrast and spatial orientation and are best for stimulating the neurons in the early visual cortex of the brain.“GlassesOff™ product enhances the visual system’s image processing capabilities by using the optimal Gabor patches to stimulate the visual cortex. GlassesOff™ treatment significantly boosts the speed and quality of image processing in the brain. On average, users that train 3 times per week (each training session lasts around 15 min), complete the treatment within 3 months. Once eliminating the need for reading glasses, we recommend users to implement our maintenance training protocol, which only requires 2-3 treatment session per month.”

Their method is described by Uri Polat, co-founder of Ucansi, as “using the brain as glasses”. The app will cost about $95 and will become available early next year.

Glassesoff homepage…

nobelmedicine Reminder: Deadline Approaching for Entries in Guess a Nobel ContestThe hottest vicarious science competition in the blogosphere, Medgadget’s Guess-a-Nobel Contest, is in its final stages, and you have just a couple more days to think up of who’ll be this year’s science Nobel laureates.

This competition was designed to provide an opportunity for those not smart enough to win a Nobel to nevertheless participate and take part, however tangentially, in celebrating the world changing achievements of others.

Take a guess at DocThink…

Rules and announcement…

Art

The Goodman Cancer Research Centre at McGill University in Canada does exactly what it was named for, basic cancer research. Its scientists, though, use a unique choreographed approach when doing research, as the video below demonstrates.

Link: Goodman Cancer Research Centre…

15j2m1if Lanx Adds New Device To Their Aspen Line for L5 S1 FusionSpinal fusion is a powerful tool used for a wide range of conditions including trauma, deformity, degeneration and tumors. One of the most feared complications of it is pseudarthrosis, a fusion failure. This usually takes place because of inadequate immobilization of the spine while the fusion is maturing. The current gold standard for spinal fusion is the use of pedicle screws, however in certain cases these cannot be used, so other effective methods of spine fixation are used.

The Aspen line of spinal instrumentation products from Lanx is unique in that it utilizes the spinous processes for fixation in single level spinal fusions. These devices can be used for less invasive surgery under certain circumstances. This technique gets a little difficult towards the lumbrosacral junction, however, and this is where their new product, the Aspen Flared 5-1 device, comes into play. It is uniquely shaped to allow fixation into this area.

More from the company:

The Aspen Flared 5-1 device builds on the clinical success of the Aspen Family to provide rigid posterior fixation at the L5-S1 level, which is involved in over 40 percent of lumbar fusion cases. The device features a unique angle on each ventral plate for improved anatomic fit at L5-S1 by conforming to the sacral anatomy. The flared angle also allows the implant to securely fixate at the laminar junction of any level for anterior placement and optimal bony engagement.

Press release: Lanx, Inc. Announces Launch of Aspen™ Flared 5-1 MIS Fusion System

Product page: Aspen Spinous Process Fixation System

4twkxx91 Sony Enters the World of Medical DevicesMicronics, Inc., a developer of point of care diagnostic technologies, has just been acquired by Sony Corporation, the consumer electronics giant. At a glance, this news may come as a surprise given Sony Corporation’s status as a consumer electronics manufacturer. After all, what does the technology behind a Blu-ray disc or Playstation have in common with modern diagnostic devices? Well, as it turns out, more than you might think.

Micronics is a developer of diagnostic products with a large number of patents related to microfluidic technology. To date, they have already commercialized a nucleic acid testing device platform for infectious disease detection using disposable assay cartridges. These cartridges can be fabricated using micro-scale and nano-scale etching technology, in much the same way that data is etched onto Blu-ray or other optical storage discs. It is likely that Sony sees an opportunity to translate some of its optical disc technology and manufacturing know how into the microfluidics field.

Interestingly, this is not Sony’s first foray into the life sciences arena. In February of last year Sony acquired iCyt Mission Technology, Inc., a producer of flow cytometers (see press release). In addition, since November of last year Sony Digital Audio Disc Corporation (DADC) has announced collaborations with at least three separate life sciences companies: RainDance, Quanterix and Caliper to advance their microfluidic technology.

So, it would appear that Sony is making a serious entry into the world of medical devices. It will be interesting to see what else they might adapt from their consumer portfolio for healthcare. If we’re lucky, the Sony Stethoscope Walkman may be coming just around the corner.

Link: Micronics…

Press release: Sony acquires Micronics, Inc., US diagnostic device development venture, Acquisition to accelerate development and commercialization of Point of Care diagnostic products

j222245fvghs FDA Grants Humanitarian Device Exemption to Synapse Biomedical’s NeuRx Diaphragm Pacing System for Treatment of ALSSynapse Biomedical has been granted FDA approval to market its NeuRx Diaphragm Pacing System (DPS) for the treatment of ALS.

The device, which was granted a Humanitarian Use Device designation last year, can help ALS patients who are experiencing respiratory problems and whose phrenic nerve to the diaphragm is still intact. Following implantation, the NeuRx DPS stimulates the diaphragm to help patients breathe without a ventilator.

From the product page:

The NeuRx DPS® consists of:

  • Four PermaLoc® electrodes implanted in the diaphragm
  • A fifth electrode implanted under the skin
  • An electrode connector, which groups the five electrodes exiting the skin into a socket
  • An external pulse generator (EPG)
  • A removable cable to connect the electrode socket to the EPG

With no moving parts, noiseless operation and small size, the state-of-the-art NeuRx DPS® is engineered to help you to breathe.

The electrodes are designed using 316 Stainless Steel and other biocompatible materials with a long history of implantation. The design of the PermaLoc® electrode has been developed with anchoring technology specifically for long term implantation into the diaphragm muscle and laparoscopic delivery.

NeuRx® EPG is a stimulator box that sends electrical signals to the diaphragm, replacing the signals normally sent by your brain along your nerves. The signals cause the diaphragm to contract, which conditions and exercises the muscle. The EPG settings are adjusted by your doctor to match your natural and comfortable breathing pattern. You control the NeuRx DPS® EPG. You turn it on and off by pressing the two buttons on the front of the EPG. Because the EPG is noiseless and about the size of a TV remote, it can be easily concealed.

Press release: Synapse Biomedical Receives FDA Approval for NeuRx Diaphragm Pacing System (DPS)® to Treat Amyotrophic Lateral Sclerosis (ALS)

Product page: NeuRx Diaphragm Pacing System (DPS)®

Flashbacks: NeuRx Diaphragm Pacer Gets HUD Designation for ALS; Electric Muscle Stimulation with NeuRx Diaphragm Pacer: More Natural Breathing Without a Ventilator

7412m47e ResolutionMD Mobile for iOS Now Cleared for Clinical Use in U.S.Calgary Scientific received FDA clearance for its ResolutionMD Mobile radiological image browsing app (and underlying server system) for iPads and iPhones. Fast image access and rendering relies on servers that prepare data to be used specifically by the app.

There is also an Android version of the ResolutionMD Mobile app, but that has not received FDA clearance yet.

cex9niyj ResolutionMD Mobile for iOS Now Cleared for Clinical Use in U.S.SUPPORTED IMAGING MODALITIES
• CT
• MR
• SC
• Enhanced MR
• XA
• CR/DR
• PET
• NM
2D
• Dynamic window/level
• Viewing presets
3D
• Fully-interactive navigation
• Free volume rotation & zooming
• Dynamic volume rendering & standard preset library
MIP/MPR
• Instant access to orthogonal orientations
• Thick slab viewing (up to 50mm)
POWERFUL WORKLIST TOOLS
• Auto-generated list of recent studies
ADVANCED SEARCH FUNCTIONALITY
• DICOM query/retrieve access to PACS
ANYWHERE ACCESS
• Network: Wi-Fi and Cellular data network (3G/4G) support

Here’s a quick demo of the app running on a first generation iPad:

Press release: Calgary Scientific’s ResolutionMD™ Mobile Receives FDA Clearance for Diagnostic Image Viewing on iPhones® and iPads®

Flashback: Calgary Scientific Teams Up With Sprint to Bring ResolutionMD to the EVO 4G

todd park 2 Why Blue Button Data Is a Big Deal

Last year, the U.S. Department of Veterans Affairs launched the Blue Button Initiative in an effort to facilitate veterans’ access to their medical records, which they’d be able to share with doctors or insurers. Medicare, the Department of Defense, and the private sector have since adopted the concept. Earlier this month, the Robert Wood Johnson Foundation rolled out bluebuttondata.org, which it hopes will eventually give “all Americans” online access to their health data.

At a recent roundtable discussion with journalists, U.S. Health and Human Services (HHS) CTO Todd Park explained his thoughts on the government program and the private sector’s interest in emulating it:

Basically [Blue Button] is this really simple initiative where Medicare beneficiaries, veterans, and military health beneficiaries all have secure websites where they can log on and look at their own data. So, Medicare beneficiaries at my medicare.gov can look at their own claims data. Veterans can go into My HealtheVet and look at their own personal health record. So Blue Button is basically a blue button, literally, that we deployed on these secure portals last October. It enables you to hit the button and download a copy of your own information, which we actually didn’t think was a big deal when we launched it. But it turns out to be a really big deal because it’s actually not a commonly replicated feature [in the private sector] for a bunch of reasons.

Park explained that veterans’ appetite for the technology was much greater than initially anticipated. The Department of Veterans Affairs initially expected, that if it “knocks the ball out of the park, maybe 25,000 veterans will download a copy of their own data.” It turns out that it exceeded that expectation eight times over:

To date, with actually very little marketing, because most people don’t know this exists, over 400,000 Americans have downloaded—Medicare beneficiaries, veterans, and member of the military have downloaded a copy of their own data. [...] Here’s an interesting factoid: The number one Freedom of Information Act (FOIA) request that Medicare gets, by far, is Medicare beneficiaries asking for their own claims. So on our website, we’re looking at putting up a Blue Button that says “go get your own data! You can get it!

Park added that, after the service was launched, people from the private sector have approached HHS asking how it was possible to offer patients access to their own data.

[People asked us:] “Are you allowed under Health Insurance Portability and Accountability Act, the privacy law in healthcare, to give people their own information electronically?” We said, “Yes! That act actually encourages that.” But [that type of questioning] illustrates a lot of the confusion that is out there. So, now more and more private-sector organizations have announced that they are going to Blue Button their data, too.

So, Aetna, at a recent event, announced that it has now Blue Buttoned its personal health record for 10-million people who were covered by Aetna. United Healthcare, Walgreens, and the states of Vermont and Indiana have announced that they were going to do the same thing. PatientsLikeMe, which is a very cool patient website, has said it is going to do the same thing. And, so, it’s starting to spread.

There’s a whole new site that the Robert Wood Johnson Foundation has launched called bluebuttondata.org that explains in like four sentences what Blue Button is because it’s so easy to explain: There’s a button, write four lines of code, hit the button and download your data.

This post is the second in a series based on a meeting with Todd Park. The first is titled “Harnessing the Power of Data: Todd Park’s Vision for Rebooting U.S. Healthcare