GI Archive

Tuesday, March 9, 2010

Third Eye Retroscope Gives Docs a Better View of The Colon

The Third Eye Retroscope from Avantis Medical Systems (Sunnyvale, CA) is getting some good reviews in two studies just published in Gastrointestinal Endoscopy. The device works in conjunction with a standard colonoscope to look behind, kind of like a rear view mirror in a car. And as designed, this device is proving valuable in spotting polyps that would otherwise have gone unnoticed.

From an Avantis Medical press release:

The first study was led by Dr. Jerome D. Waye, Clinical Professor of Medicine at Mount Sinai School of Medicine, New York, NY. Titled “A Retrograde-Viewing Device Improves Detection of Adenomas in the Colon: A Prospective Efficacy Evaluation,” the study involved 14 investigators and 249 patients at 8 medical centers in the U.S.1 The investigators found that the Third Eye improved detection and removal of polyps by 13.2% compared to the colonoscope alone. For adenomas, the polyps that are most likely to become cancers over time, the additional detection rate with the Third Eye was 11.0% for lesions of all sizes. For medium-size adenomas (at least 6 mm in diameter), the additional detection rate with the Third Eye was 25.0%, and for large adenomas (at least 10 mm), they found 33.3% more with the Third Eye. Thus, the Third Eye not only allowed for identification of more polyps, but its greatest yield was in the detection of larger adenomas, which are further along in the progression to cancer.
The second study was led by Dr. Daniel C. DeMarco, Director of Endoscopy at Baylor University Medical Center, Dallas, TX. Titled “Impact of Experience with a Retrograde-Viewing Device on Adenoma Detection Rates and Withdrawal Times during Colonoscopy: the Third Eye Retroscope Study Group,” the study involved 298 patients at 9 U.S. sites, and was conducted by 17 investigators who had not previously used the device.2

Overall, beginning with the very first time they used the device, the Third Eye allowed the investigators to find 16.0% more adenomas in addition to those they were able to find with the colonoscope alone. However, after each investigator had gained some experience with the device by performing 15 procedures, their average additional adenoma detection rate with the Third Eye compared to the colonoscope alone was 25.0%. Again considering their overall results from start to finish, the endoscopists found a higher proportion of larger pre-cancerous adenomas that were hidden from the colonoscope by folds, including 24.3% more adenomas at least 6 mm in diameter and 19.0% more adenomas at least 10 mm.

Relevant articles in Gastrointestinal Endoscopy: Adenoma detection and retroscopy; Impact of experience with a retrograde-viewing device on adenoma detection rates and withdrawal times during colonoscopy: the Third Eye Retroscope study group

Product page: Third Eye® Retroscope®

Flashbacks: Third Eye Retroscope Wins FDA OK ; It's a Retrospectroscope... It's a Rectospectroscope...No It's Retroscope!

Device demo video and more after the fold:

Thursday, March 4, 2010

Hercules 3 Stage Esophageal Balloon Now On Sale Worldwide

Cook Medical is reporting that it has received FDA's 510(k) clearance and EU's CE Mark of approval to market the Hercules 3 Stage Esophageal Balloon. The device is indicated for treatment of GI strictures in patients with cancer, s/p XRT, etc.

More details from the press release:

The Hercules 3 Stage Esophageal Balloon is made with proprietary P.E.T. FLEX™ technology, a new material that optimally combines the high tensile strength and flexibility necessary for a strong balloon that inflates accurately to three distinct and increasing diameters. Already available as a non-wire guided balloon, Hercules has been used by clinicians to successfully treat benign and malignant strictures in the esophagus. With the addition of the wire-guided version, Cook now offers a Hercules Balloon option for the entire GI tract including the pylorus, duodenum and colon.

The preloaded wire-guided Hercules dilator facilitates the navigation of narrowed passageways. With the strongest radial strength of any dilator on the market, Hercules holds its shape during dilation and inflates to three distinct and increasing diameters, reducing the need for multiple dilation procedures. Two radiopaque bands on the balloon aid in accurate fluoroscopic positioning, and glow-in-the-dark labels and unique packaging enhance ease of use.

Features from the product page:

Rapid balloon deflation is achieved with the Express Evacuation Catheter and patent-pending Rapid Deflation Sleeve™ (Based on using a 60cc Syringe)

Kink-resistant Nitinol catheter provides maneuverability

Flexible atraumatic tip for smooth access through especially tight strictures

Excellent through-the-balloon visualization permits view of dilation progress

Glow-in-the-dark size and inflation information on packaging and catheter tags for easy identification

Pre-lubricated balloon facilitates removal from the accessory channel

Product page: Hercules 3 Stage Balloon Dilator ...

Press release: Cook Medical's Hercules 3 Stage Esophageal Balloon, Used to Treat Gastrointestinal Strictures, Now Available in U.S., Australia, Canada and Europe ...

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Thursday, February 4, 2010

ReShape Inflatable Gastric Balloon Going on Trial as Weight Loss Option

Here's the latest report from the obesity epidemic front. The Orange County Register is reporting that clinical trials are soon to begin on the intragastric balloon developed by ReShape Medical out of San Clemente, CA. The device, already approved in Europe, is inserted endoscopically using the ReShape delivery system into the stomach and then inflated with normal saline, effectively reducing the capacity and will of the patient to intake and digest food. Unlike gastric banding, the procedure is done on an outpatient basis and the device can be easily removed at a later time.

From the product page:

The delivery system is a long insertion catheter with the deflated balloons attached to the end. The balloons are inserted through the mouth, and filled with saline once it is placed in the stomach. The ReShape intragastric balloon is designed to fit comfortably in the stomach while maximally filling the stomach area.
The ReShape intragastric balloon is comprised of two balloons attached to each other by a flexible tube. Each balloon has independent channels so that unintentional leaks or deflation in one balloon are designed not to impact the other balloon. The device is used in conjunction with diet and exercise.

OC Register: Doctors to study stomach balloon for weight loss...

Product page: ReShape intragastric balloon...

Flashbacks: EndoBarrier, an Internal Condom, Gets Positive Results in Diabetic Clinical Trial ; EndoBarrier Bypasses Gastric Bypass for Obesity, Diabetes Treatment

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Friday, January 8, 2010

Cook's Zilver Biliary Stent Compares Favorably to Boston Sci's Wallstent

Cook Medical is touting a recent study that compares the effectiveness of the firm's Zilver Biliary Stent to the most commonly used device, the Wallstent from Boston Scientific. Essentially, the conclusion of the international multi-center study, published in Gastrointestinal Endoscopy, is that the two stents have very similar performance (patency) characteristics, both exhibiting stent occlusions in the low 20% of cases. (The Zilver stent in a smaller 6mm diameter was found to exhibit a higher, 39.1%, rate of occlusion, hence that arm of the study was closed earlier than anticipated.)

The MOZART study included a total of 241 patients in nine centers in the U.S., Canada and Europe who presented with malignant biliary obstructions – a complication associated with several forms of cancers – in which the bile ducts of the liver become blocked by tumors. Biliary obstructions or strictures impair liver function and cause a range of symptoms including abdominal pain, nausea, vomiting, fever and fatigue. The blocked ducts can be opened using stents inserted endoscopically that expand upon deployment. Plastic stents are cheaper than metal for this purpose, but data suggest that plastic stents occlude more readily when compared to SEMS, necessitating repeat procedures. In fact, SEMS have proved more robust and cost-effective in many clinical settings.

According to the MOZART study, the 6-mm SEMS demonstrated a higher occlusion rate than the 10-mm SEMSs; therefore, the study agreed to close this arm to further patient entry and continue to follow the exiting enrolled patients. The remaining 10-mm SEMS patients revealed equal patency among SEMS.

The two biliary stents in the MOZART study differ significantly in design, materials and mechanism of expansion, but achieved equal patency by several measures: for both, fewer than a quarter became occluded after placement over the life of the study. Treating physicians, who had more experience with Boston Scientific's stent, reported the ease of positioning of the Zilver during the study.

Cook Medical's Zilver Biliary Stent is the first stent of its kind made of flexible laser-cut nitinol tubing. Nitinol, which is inherently kink-resistant, allows Zilver to conform to the ductal wall while providing reliable patency. Through the interlocking design construction, Zilver's stent ends are atraumatic, potentially reducing the risk of ulceration or perforation. Its non-foreshortening design gives precise accuracy in placement; potentially reducing instances of migration and the need for repeat procedures. Additionally, four gold radiopaque markers at each end of the stent provide greater fluoroscopic visualization and exacting placement.

Benefits and Offerings of the Zilver 635:

Zilver 635 has the markets only 6 FR introducer, the optimal platform for hilar and bifurcation stenting;

Utilizes Cook's proprietary Flexor coil-reinforced introducer technology: a truly unique material that has excellent pushability and flexibility while providing a distinct advantage in stent placement due to its kink resistance;

The only system in the world that allows two stents to be placed simultaneously through a standard 4.2-mm channel duodendoscope, thereby increasing procedural efficiency;

Includes a shelf-less tip design to ensure smooth withdrawal of the introducer through the deployed stent.

Press release: First and Only International Study of its Kind Shakes up Metal Biliary Stent Market...

Product page: Zilver 635...

Abstract in Gastrointestinal Endoscopy: Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial

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Wednesday, December 23, 2009

EndoBarrier Bypasses Gastric Bypass for Obesity, Diabetes Treatment

The European Union has issued the CE mark of approval to GI Dynamics of Lexington, MA for its EndoBarrier device as a treatment option for obesity and type 2 diabetes. The device, which is implanted endoscopically via the mouth, essentially creates a chamber in the stomach and effectively limits the amount of food a patient can digest. The device is not intended for permanent placement and the approval stipulates its use for a six month therapeutic period.

Press release: GI Dynamics Receives European CE Mark Approval for the EndoBarrier Gastrointestinal Liner System for the Treatment of Type 2 Diabetes and Obesity...

Flashback: EndoBarrier May Be Helpful in Patients With Type II Diabetes; EndoBarrier, an Internal Condom, Gets Positive Results in Diabetic Clinical Trial; Eat Away, Just Don't Digest

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Monday, December 14, 2009

Let's Smell Your H. pylori! BreathID Racks Up New Positive Trial on Road to FDA Approval

Globes [online], Israel's business newspaper, is reporting that Exalenz out of Modiin, Israel has completed a clinical trial testing its BreathID system for detection of Helicobacter pylori bacteria in patients' breath. According to the company, the trial involved 167 patients and the system was 99.2% accurate when compared to isotope ratio mass spectrometry (IRMS). Exalenz is hoping this will help it obtain FDA regulatory approval to market the device in the U.S.

Some details about how the system works:

BreathID uses a clinically proven, sophisticated laser-like light source to pinpoint real-time changes in 13C/12C isotope ratios at an accuracy level of single parts per million. It is a paradigm change in the way liver and GI disorders are assessed and managed. Covered by more than 60 patents and patent applications worldwide, the BreathID system is one of the most versatile and advanced diagnostic platforms for hepatologists and gastroenterologists in today`s medical environment.
BreathID® is a proven, breath-testing system that incorporates a number of proprietary core technologies - such as Microstream®, MCS™ (Molecular Correlation Spectroscopy), CRT™ (Continuous Real Time) and online analysis algorithms that are protected by a series of patents and patent applications.

The BreathID combination of advanced technologies allows for automatic, continuous and real-time breath sampling and analysis. This ensures highly accurate results and the shortest possible test duration. Moreover, the system is portable so that tests can be conducted in any clinical setting.

BreathID Technology Process:

Here are a couple videos explaining the BreathID system and demonstrating its use:

Product page: BreathID System...

Globes [online]: Exalenz reports trial success for breath test bacteria detector...

Original Hebrew press release...

Flashbacks: BreathID for Simple Liver Disease Identification Gets FDA's Trial OK; BreathID Sniffs Success, Eyes FDA Approval; BreathID for Simple Liver Disease Identification Gets FDA's Trial OK

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Tuesday, November 24, 2009

New PillCam Colon 2 May Be Viable Alternative to Colonoscopies

Given Imaging out of Yoqneam, Israel is releasing a new version of PillCam Colon, an endoscopic capsule designed for imaging of the large intestine. The PillCam COLON 2 has recently received European approval and was just unveiled at the Gastro 2009 Conference in London, England.

From the press release:

The Company also announced that independent investigators presented results of a 98-patient feasibility study. The investigators concluded that PillCam COLON 2 is a safe and effective method to visualize the colon and detect colonic polyps. An article discussing the study has been accepted for the December 2009 edition of the journal Endoscopy.
Results of the study comparing PillCam COLON 2 to colonoscopy, showed a sensitivity of 89 percent and a specificity of 76 percent in detecting polyps greater than or equal to 6 mm and a sensitivity of 88 percent and a specificity of 89 percent in detecting polyps greater than or equal to 10 mm. Conducted by clinicians at five hospitals in Israel, the study evaluated the performance of PillCam COLON 2 in 98 patients who had risks or warning symptoms of colon pathology. Like Given Imaging's other PillCam capsules, PillCam COLON 2 does not require the use of sedation, intubation or air insufflation during the procedure, offering physicians and patients a convenient way to visualize the colon.

Features:

Bi-directional communication between PillCam Colon 2 and the DataRecorder enables tracking of the capsule's motion in the GI tract so that the image capture rate can be adjusted to maximize colon tissue coverage.

Adaptive Frame Rate adjusts the image capture rate from four frames per second to 35 frames per second, enabling creation of a smooth, continuous video.

Polyp Size Estimation is a new research tool that allows clinicians to estimate the size of polyps.

Superior Imaging Compared to COLON 1

Advanced optics for enhanced image quality and polyp detection.

172 degrees field of view from each imager offers a near 360 degrees view of the colon.

It should also be mentioned that last year FDA has rejected Given Imaging's 510(k) application to market the original PillCam COLON in the United States, citing a "not substantially equivalent" applicability of the device.

Press release: Given Imaging Launches Next-Generation PillCam(R) COLON 2 at GASTRO 2009 Conference...

Product page: PillCam COLON...

Flashbacks: PillCam Colon; FDA Rejects PillCam Colon

(hat tip: Globes Online)

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Monday, November 23, 2009

Boston Scientific Gets CE Mark and FDA Clearance for Covered Esophageal Stent

Boston Scientific has announced that its WallFlex® Fully Covered Esophageal Stent received 510(k) clearance from the FDA as well as EU's CE Mark of approval. The stent is designed for esophageal strictures caused by cancer of the esophagus. The use of stents can re-open a blocked esophagus, allowing patients to consume solids and liquids once again.

IR Micro-Endoscope to See Underneath Epithelium

University of Florida Researcher Huikai Xie is working on an endoscopic imaging technique using a tiny infrared scanning technology that, when placed near the surface of a tissue, moves rapidly back and forth to not only provide high resolution images of epithelial tissue, but also peer immediately underneath it.

Xie and his team have already published forty papers on the research and recently founded WiOptix, Inc. to try and commercialize the technology. His vision is not only to augment and/or supplement a traditional endoscope, but to merge the technology with cutting tools for surgical use, so that "when surgeons begin cutting, they know exactly what's in front of them."

From the University of Florida press release:

Xie's endoscopes replace the cameras with infrared scanners smaller than pencil erasers. The heart of his scanner is a microelectromechanical system, or MEMS, device: A tiny motorized MEMS mirror that pivots back and forth to reflect a highly focused infrared beam.
By itself, the beam only strikes a period-sized dot of tissue. But the MEMS mirror allows it to move methodically back and forth, scanning a fingernail-sized piece of tissue row by row, like a lawnmower moving across a yard. The resulting image is high resolution: Xie said his scanners have achieved resolution of 10 microns, or 10 millionths of a meter, in laboratory tests. That's more than 10 times higher resolution than the only other non-camera-based endoscopes on the market, which use ultrasound technology, he said. The high-resolution image also includes depth information, so the risky biopsy can be more specific to avoid randomness, or even completely avoided.

Computers process the return signal from the endoscopes, transforming it into a three-dimensional image of the surface tissue and the tissue beneath. One scanner even produces a 360-degree-image of all the tissue surrounding the endoscope. Doctors or other trained observers can then search the image for abnormalities or suspicious growth patterns.

Press release: Engineer designs micro-endoscope to seek out early signs of cancer...

WiOptix technology page...

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Tuesday, November 17, 2009

EndoBarrier May Be Helpful in Patients With Type II Diabetes

Clinical researchers from Hospital Dipreca in Santiago, Chile, Gastro Obeso Center in São Paulo, Brazil, Carolinas Medical Center in Charlotte, North Carolina, and the Billings Clinic in Billings, Montana conducted a multi-center study of the EndoBarrier gastrointestinal liner from GI Dynamics (Lexington, Massachusetts) on patients with type II diabetes. The trial demonstrated overall positive results, and Dr. Robert Jasmer from UCSF reviewed the findings of the study at MedPageToday.

A snippet:

In a small pilot study, fasting plasma glucose levels for patients who received the duodenal-jejunal bypass liner (EndoBarrier) fell 55 mg/dL, while levels among those who had a sham procedure rose 42 mg/dL (P≤0.05), according to Christopher Sorli, MD, of the Billings Clinic in Billings, Mont., and colleagues.
But differences in this measure of glycemic control did not remain significant after the 24 weeks of the study were completed. Also, the study was scheduled to run for 52 weeks but too many patients had to have the device removed because of pain or anchor migration before that time.

Read on at MedPage Today: Intestinal Sleeve May Improve Glycemic Control

Press release: GI Dynamics' EndoBarrier™ Gastrointestinal Liner Demonstrates Safety and Efficacy in Pre-surgical Weight Loss ...

Abstract in Diabetes Technology & Therapeutics: Pilot Clinical Study of an Endoscopic, Removable Duodenal-Jejunal Bypass Liner for the Treatment of Type 2 Diabetes

Link: EndoBarrier Technology...

Flashbacks: EndoBarrier, an Internal Condom, Gets Positive Results in Diabetic Clinical Trial ; Eat Away, Just Don't Digest

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Tuesday, November 10, 2009

SmartPill Receives Expanded Indication in US

The FDA has given the go ahead to SmartPill (Buffalo, NY) to market version 2 of the firm's device for evaluation of constipation. The device measures temperature and pH as it moves through the GI tract, and provides temporal-spacial analysis of its voyage. The system was already approved for analysis of suspected delayed gastric emptying (gastroparesis).

The SmartPill GI Monitoring System, version 2.0, allows physicians to measure pH, pressure and temperature throughout the entire gastrointestinal (GI) tract, providing whole gut and regional gut (gastric, small bowel and colonic) transit times, a pH profile of the entire GI tract and GI tract pressure patterns. SmartPill's ability to differentiate slow (abnormal) transit from normal transit, while providing regional transit times for both the upper and lower GI tract, is an important assessment for physicians when evaluating GI motility disorders and guiding appropriate therapy.

The SmartPill GI Monitoring System features the SmartPill Capsule, a wireless, ingestible medical device about the size of a large vitamin pill. The patient ingests the single-use SmartPill Capsule in the doctor's office and then returns to their daily activities. As the Capsule travels through the GI tract, data is wirelessly transmitted to the SmartPill Data Receiver. The SmartPill Data Receiver is later returned to the physician's office where the data is downloaded to a computer providing gastric, small bowel, large bowel, and whole gut transit times.

Press release: SmartPill Announces 510(k) Release for Evaluation of Constipation ...

Product page: SmartPill GI Monitoring System ...

Flashbacks: FDA "Green Light" for Sale of SmartPill ; Fastastic Voyage: Smart Pill to Expand Testing

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Monday, October 19, 2009

Maderi Tries to Solve a Tricky Marketing Challenge

Mederi Therapeutics out of Greenwich, Connecticut offers an radiofrequency therapy system designed to treat fecal incontinence. Not surprisingly, this is a topic that patients rarely bring up due to embarrassment, and the consequence is an untreated condition that can severely impact the quality of life. MassDevice spoke to William Rutan, CEO of Mederi, about the challenges of operating in such a market and what the company learned from the marketing efforts of pharmaceutical firms selling erectile dysfunction drugs.

A snippet from the interview:

MassDevice: Tell us about the procedure. It's a minimally invasive device?
Will Rutan: I don't know what the classification is for minimally invasive, but I would say it's a class below that. The product goes through an existing opening, the anus, and the whole procedure takes place within two inches of the anus. It's under direct visualization by the doctor. It's a one-time treatment that takes 45 minutes, either under general anesthetic or conscious, but it's a same-day procedure and the patient can return to normal activity within 24 to 48 hours. There's generally no post-operative discomfort and any discomfort can be handled with aspirin or Tylenol.

Read on at MassDevice...

Link: Mederi Secca procedure...

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Tuesday, October 13, 2009

Swallowable Robot Carefully Crawls Through The GI

The BBC is reporting on a wirelessly controlled "spider pill" being developed somewhere in Italy. The device supposedly has eight legs and reportedly can crawl through intestines. With an attached video camera, the device might actually become a diagnostic modality for imaging the intestinal tract. The big question is whether it is more unpleasant to have a colonoscope defile you or a robotic gerbil crawl through the insides.

Link @ BBC...

(hat tip: Engadget)

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Wednesday, October 7, 2009

Boston Sci Wins Biliary Stent Approval by FDA

Boston Scientific just announced FDA approval of the WallFlex Biliary RX fully and partially covered stents "for the palliative treatment of malignant bile duct strictures." The device has already been approved in Europe and now it will be available on both continents.

The WallFlex Biliary RX Stent is designed to offer the benefits of prior-generation stents, such as the industry-leading WALLSTENT(®) Endoprosthesis, while incorporating new features to accommodate a range of anatomical and clinical requirements. Based on extensive research and physician feedback, the WallFlex Biliary RX Stent employs a platinum-cored Nitinol construction designed to deliver on three critical components: radial force, flexibility and radiopacity. The Platinol™ Wire provides greater flexibility - 30 percent more than the WALLSTENT Endoprosthesis - to help the stent conform within tortuous anatomies. The enhanced full-length radiopacity offered by the Platinol Wire and the reconstrainable delivery system are designed to allow for more precise stent placement, while the radial force of the WallFlex Biliary RX Stent is designed to maintain patency and resist migration....
TheWallFlex Biliary RX Stents also feature a closed-cell construction designed to resist tissue ingrowth(2), looped ends intended to reduce the risk of tissue trauma, and flared ends to help reduce the risk of stent migration. The proprietary, durable silastic polymer (Permalume(®)) covering of the fully and partially covered stents is designed to reduce the potential for tumor ingrowth. In addition, the WallFlex Biliary RX Stent incorporates an integrated retrieval loop for removal during the initial stent placement procedure, which can be used in the event of incorrect placement.

Preliminary results from Dr. Petersen's study were reported at United European Gastroenterology Week (UEGW) in 2008. Results showed that the fully covered WallFlex Biliary RX Stent yielded technically successful placement, low rates of re-intervention (two percent) and recurrent biliary obstruction, and minimal occurrence of migration (two percent) and complications. With 98 percent of patients meeting the primary endpoint of clinical palliation of the biliary obstruction until completion of follow-up, study results suggest that the fully covered WallFlex Biliary RX Stent may successfully palliate most patients with malignant distal biliary obstructions.

Also presented at UEGW were preliminary data on a 70-patient WallFlex Biliary RX partially covered stent study led by Primary Investigator Guido Costamagna, M.D., Head of Digestive Endoscopy at Universita Cattolica del Sacro Cuore in Rome. Preliminary results of the study demonstrate that the partially covered metal stent may palliate most patients with malignant biliary obstructions.

Press release: Boston Scientific Announces FDA Clearance and U.S. and European Availability of WallFlex® Biliary RX Covered Stents...

Product page: WallFlex® Biliary RX Stents...

Video below the fold demonstrating the features of the WallFlex Biliary RX:

Tuesday, October 6, 2009

PillCam SB Gets Expanded Indication in US

Given Imaging out of Yoqneam, Israel has received FDA clearance to market the firm's PillCam SB video capsules and the accompanying Agile pills for children two years of age and older. The PillCam SB is a swallowable video device meant for imaging of the small intestine onto an embedded memory chip and Agile is a supporting product for testing the gastrointestinal tract for clear passage of the PillCam.

-- PillCam SB is used by physicians to evaluate patients and detect small bowel abnormalities, such as obscure GI bleeding, iron deficiency anemia, suspected Crohn's disease, suspected small intestinal tumors, polyposis syndromes, as well as in suspected or refractory malabsorptive syndromes, such as celiac disease.
-- The Agile Patency System is an accessory to the PillCam video capsule intended to verify adequate patency of the gastrointestinal tract in patients with known or suspected strictures prior to administration of the PillCam video capsule. Clinical situations in which physicians may wish to confirm patency include suspicion of strictures due to Crohn's disease, chronic NSAID use, tumors and radiation enteritis.

PillCam capsule endoscopes are ingestible video capsules that enable physicians to visualize distinct portions of the GI tract. Patient friendly in nature, PillCam endoscopy typically is used on an outpatient basis and has been clinically validated, as evidenced by more than 1,000 peer-reviewed publications. To date, more than 1,000,000 patients worldwide have benefited from Given Imaging's PillCam capsule endoscopy.

Previously PillCam SB and Agile were indicated for children 10 years and older. PillCam SB is cleared for the visualization of the small bowel mucosa and may be used as a tool for the detection of abnormalities of the small bowel.

Press release: Given Imaging's PillCam(R) SB and Agile(TM) Patency System Cleared for Use in Young Children...

Product pages: PillCam SB; Agile Patency System...

Wednesday, July 1, 2009

F&S Awards Crospon for GERD Test Device

Crospon, out of Galway, Ireland, recently received Frost & Sullivan's 2009 European Gastroenterology Technology Implementation of the Year Award for the Endoflip device. The Endoflip delivers a balloon catheter to the gastroesophageal sphincter, a junction between the esophagus and stomach, and can test the strength of the muscles controlling its closure. Already approved in the EU, the company is seeking FDA's approval for the US market.

From the manufacturer:

Crospon has addressed the need for a GERD-focussed diagnostic platform by developing an integrated solution which facilitates real-time imaging of the lower esophageal sphincter in less than 10 minutes. The EndoFLIP® system constitutes a set of 16 electrodes that sit within a balloon catheter which is attached to a data recorder with a touch screen. This series of electrodes is capable of measuring resistance or impedance to calculate cross-sectional areas at different points along the balloon. At the commencement of the procedure, the deflated balloon catheter is attached to a prefilled syringe, which is inserted into the syringe pump on the front of the EndoFLIP® tool. Subsequently, the deflated balloon is then passed trans-orally or trans-nasally to the gastroesophageal junction whereby it permits a challenge test to the lower esophageal sphincter to determine its functionality.
The scientific principle behind EndoFLIP®’s implementation is impedance planimetry. This is a technique that can measure cross-sectional area electrically which in turn enables 16-slice display images. This display shows the changes in the estimated diameters of sphincteric regions in the body in real time, thereby permitting a real time image of the geometry in vivo of the human esophagus to be obtained. Crospon has submitted an application to the FDA for EndoFLIP®’s clearance in the US market. The company has already received CE mark certification from the National Standards Authority of Ireland.

Video below fold demonstrating the placement of the device:

Wednesday, May 27, 2009

Cook Introduces "High Definition Endoscopic Ultrasound" Technology Needle

Cook Medical has released a new needle for endoscopic ultrasound guided biopsies that promises to be three times brighter that other available needles. The company believes the system, designed to be used in conjunction with the EchoTip Ultra delivery device, that is compatible with most endoscopes, will deliver a better biopsy precision.

During an EUS procedure, the endosonographer inserts an endoscope, which has a small ultrasound transducer at its tip, through the patient's mouth into the esophagus, facilitating imaging from within the GI tract. EUS also enables tissue sampling through fine needle aspiration (FNA), a safer and less invasive alternative to open surgical biopsy. Under ultrasound guidance, a special needle inserted in the endoscope collects cells from targeted sites.

Cook Medical's EchoTip Ultra with HDFNA is a single-use, disposable needle intended for sampling of targeted submucosal GI lesions through the accessory channel of an ultrasound endoscope. The needle surface is dimpled with a high-definition pattern that greatly improves its visibility on an ultrasound monitor. This highly echogenic design provides increased assurance that the needle tip is within the target. With traditional EUS-guided FNA, multiple passes are usually necesary in order to get an accurate sample; with the enhanced visibility of EchoTip Ultra HDFNA needles, specimens can be obtained with potentially fewer needle sticks.

EchoTip Ultra with HDFNA has all the advantages of the original EchoTip Ultra products, with an integrated sheath adjuster that makes the needles compatible with a full range of echoendoscopes and an ergonomically designed handle integrated with a nitinol stylet for precise needle control, stability and flexibility. The safety lock ring easily slides and locks at the desired needle extension and a "Zero" reference mark indicates the needle's complete retraction within the sheath. In addition, EchoTip Ultra's metal Luer lock provides a secure, stable platform for performing EUS procedures.

Press release: First High-Definition Endoscopic Ultrasound (EUS) Technology Enhances Diagnostic Procedures...

Product page: EchoTip® Ultra Endoscopic Ultrasound Needles...

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Wednesday, May 13, 2009

BrainLab's Digital Lightbox Getting an Upgrade

BrainLab AG is planning on releasing an updated version of its Digital Lightbox multitouch clinical display. Still reminding us of a giant iPhone, the unit interfaces with EMRs to display and manipulate clinical images easily and intuitively, essentially making the keyboard or any other interface device unnecessary.

Here's what the company tells Medgadget about the new features in the latest release of the Digital Lightbox scheduled for this summer:

The new Video-input feature allows the integration of data on the Digital Lightbox, when it is located in the OR, from sources like micro-, endo- and arthroscopes; and video signals can be streamed from the OR and displayed on the Digital Lightbox when it is positioned in surgeons' offices or meeting rooms. This feature extends the range of application into new medical subspecialties, strengthening the value of Digital Lightbox as a core multi-disciplinary platform for hospital information networks.
When version 1.0 came to the market, a number of customers wanted the Digital Lightbox in rooms dedicated for teaching, patient education, tumor boards and internal meetings. The new External Display-out feature makes it possible to connect the Digital Lightbox to one or more additional displays or projectors, in or outside the room. This makes it more versatile for use in situations when large groups of medical experts come together and the even the 30" display of the Digital Lightbox isn't big enough.

Digital Lightbox also serves as the viewing display and remote control for VectorVision flex, combining an image-guided surgery platform with large-scale viewing, and fast data access and manipulation.

Here's a company video demonstrating the system:

Product page: Digital Lightbox

Flashback: Digital Lightbox Brings Minority Report to The OR (No Precognition Capabilities)

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Thursday, March 19, 2009

Cardinal's Endura Scrubs for the Modern Clinician

Cardinal Health is releasing a new line of clinical scrubs that the company believes will make your life safer, easier, and more comfortable. The big deal about Cardinal's Endura™ apparel line is the specialty fabric used, which is supposedly stronger and more breathable.

Some features from the product page:

Excess moisture is wicked away from your skin to keep you dry and cool, no matter what you’re doing.

Scrubs shouldn't leave you feeling restricted or confined. Endura™ scrubs move with your body and help maximize your gait and pace. In addition, the Maximum-Motion™ sleeve allows your shirt to stay tucked in even when you reach and stretch.

Our advanced, synthetic material is breathable, flexible and helps control your heat index and perspiration.

Our scrubs offer a shirt pocket and two side flanking pant pockets to tuck away the important things you want to keep close. The deep side pockets in our pants are angled to keep items in, whether you're sitting or standing.

The smooth fabric of Endura™ scrubs feels natural and soft on the skin.

People aren’t rectangular. So instead of making our scrubs rectangular, we looked at the actual dimensions of thousands of healthcare workers. The cut of our scrubs follows the natural line of your body and gets rid of the bulky feel and appearance of traditional scrubs.

A unique snap system allows you to customize pants length and avoid tripping, falling or slipping. Elastic on the waistband, in addition to a drawstring, helps position pants where you want them.

Strategically placed ventilation zones across the middle of the back and behind the knee keep you dry and comfortable.

Even after 90 washes, EnduraT scrubs are still going strong. Stronger than a brand-new pair of the top-selling traditional scrubs, in fact*. You'll also notice minimal color loss and lasting moisture-wicking abilities. The competitor's scrubs, on the other hand, typically only last 50 washes.

The top-selling traditional scrubs lose 15% lint when abraded. EnduraT scrubs lose only 1.4%, making them the lowest linting scrub on the market.

Made of the strongest material on the market, EnduraT scrubs outlast the competition. Our advanced, synthetic material is abrasion- and tear-resistant and has the most uniform strength in both directions.

EnduraT scrubs can be washed at cooler temperatures and dry faster than traditional scrubs. This requires less energy and can result in savings to your hospital.

Product page: Endura™ Performance Apparel

Press release: Cardinal Health launches new products for the operating room

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