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:
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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...
More from Globes...
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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:
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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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Thursday, March 12, 2009
HemAway Toilet Seat Helps With Prolapsed Hemorrhoids
The HemAway® toilet seat was designed by a physician suffering from hemorrhoids who wanted a simple option to help retract the swollen tissue. By sitting down in the specialized seat and performing a few basic, carefully choreographed body movements, a patient supposedly can relieve the pain without applying ointment or having to reach back there at all. The product has FDA clearance and is now on sale direct from the manufacturer.
Here's a thought provoking animation showing how one would use the seat:
Product page: HemAway seat...
Press release: HemAway(R) Launches FDA-Cleared Painless Hemorrhoid Treatment Device
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Monday, March 2, 2009
Cook Medical Introduces LoopTip Wire Guide for ERCPs
Cook Medical is releasing a new endoscopic retrograde cholangiopancreatography (ERCP) wire guide for easier and less traumatic passage through the pancreatobiliary ductal system. With a newly designed closed distal loop, the Fusion LoopTip promises to avoid the nooks and crannies that can make passage difficult.
From a statement by Cook Medical:
Cook Medical's launch of Fusion® LoopTip™ sets a new standard for wire guide cannulation, the company announced... LoopTip delivers potentially less traumatic access and navigation of the pancreatobiliary ductal system when diagnosing and treating conditions of the biliary and pancreatic ducts.Designed with a nitinol core, the LoopTip wire guide is engineered to flex and deflect toward the open pathway. This delivers potentially less traumatic access and improved navigation of the pancreatobiliary ductal system, decreasing the risk of failed cannulation, perforation and post-ERCP pancreatitis. The nitinol core also provides kink resistance and shape retention.
The LoopTip wire guide also has a radiopaque coil spring that provides excellent fluoroscopic visibility. In addition, the spiral markings extending to the distal end of the wire guide provide an endoscopic view of the wire guide's movement during cannulation. The wire guide also comes in a variety of lengths to suit physician preference.
Here's a company animation demonstrating the guide's navigating abilities:
Press release: Cook Medical Adds First-of-Its-Kind Closed Distal Loop Wire Guide to Comprehensive Line of Cannulation Products
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Wednesday, February 18, 2009
Third Eye Retroscope Wins FDA OK
Traditional colonoscopes are forward looking devices that dwell in the mysterious realm of irregular shapes and deep caverns. Because folds within the cavity often prevent seeing around the bend, Avantis Medical Systems introduced the Third Eye Retroscope that we wrote about last October. The FDA just gave approval to the device that attaches to colonoscopes and acts like a rear view mirror, helping to avoid missed polyps.
Features and benefits of the device from the product page:
During colonoscopy, the Third Eye's unique “J” shape catheter design provides a retrograde view that complements the forward view of the colonoscope. Innovative chip-on-catheter-tip design with high quality video imaging provides superior visualization. An integrated light source on the catheter provides illumination without the need for a costly additional external light source. Retrograde view reveals areas behind folds in the colon wall. Improving detection rates is a goal shared by all of the major gastroenterology organizations. Retrograde view may minimize manipulation required to view areas behind folds. Activating a foot pedal captures still images from both the forward and retrograde views simultaneously. Third Eye catheter fits through the working channel of most colonoscopes. Third Eye video processor and monitor integrate with standard colonoscopy systems and display both forward and retrograde views on the same monitor.
Click on any of the below videos to see the Third Eye in action:
| Third Eye deploys through the Working Channel of a Colonoscope | Third Eye Withdrawal | Third Eye Finds Polyp Hidden Behind Fold |
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Product page: Third Eye® Retroscope®
Press release: Avantis Medical Systems Announces FDA 510(k) Clearance for the Third Eye(R) Retroscope(R) for Improved Polyp Detection in the Colon
Flashback: It's a Retrospectroscope... It's a Rectospectroscope...No It's Retroscope!
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Friday, February 6, 2009
Gaseous pH Monitoring in Airway Gets EU Marketing Clearance
Restech (Respiratory Technology Corporation) out of San Diego, California has won European approval to market the firm's Dx-pH Measurement System™. The device is intended to measure pH levels in the airway and provide guidance to the physician about overall pharyngeal acid exposure. We've covered this system before, as our flashbacks below testify.
From a press release obtained by Medgadget:
Ruling out acidic or alkaline reflux when determining etiology of chronic cough, recurrent laryngitis, sinusitis, and respiratory conditions is very important. Instead of empirically prescribing medications to inhibit reflux, based on symptoms with no real evidence-based diagnosis, doctors can now easily determine whether reflux is or isn't a factor.The Restech Dx–pH Measurement System is a revolutionary system that comfortably measures pH in the airway.
Gastric reflux in the upper airway, or laryngopharyngeal reflux, commonly takes a gaseous form that cannot be measured using conventional technology. The miniaturized pH sensor at the tip of the Dx–pH Probe is unique in its ability to measure pH in a non-liquid environment, such as the pharynx. By monitoring the pH levels in the pharynx, the Dx–System enables physicians to confirm or deny the presence of laryngopharyngeal reflux, and evaluate it as a possible contributor to their patients’ symptoms.The Dx–pH Probe’s miniaturized, patented sensor is housed in the tear-drop shaped tip at the distal end of a thin trans-nasal catheter. An LED blinks during placement, allowing the medical personnel to confirm the proper placement in the oropharynx. The small size and minimally invasive position of the Restech Dx–pH Probe allows patients to carry on normal, everyday activities including eating, talking and sleeping with more comfort than conventional esophageal pH probes.
The measurements taken by the pH sensor are sent wirelessly to a recording device which the patient carries throughout the study period. Upon completion of the study (usually 24 hours), the patient returns to the physician’s office where the data is downloaded and presented graphically for analysis using Restech’s custom Dx–pH DataView software.
Product page: Dx-pH Measurement System
Flashbacks: The Dx-pH Measurement System™ for Sleep Reflux; Detecting Reflux in Realtime
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Monday, January 5, 2009
Amimon's High Definition Wireless Video Goes Clinical
Stryker Endoscopy is launching a wireless high definition monitor for the clinical world. Utilizing wireless technology from Israel's Amimon Inc., the monitor can receive signals up to 1080i, which means uncompromising quality in OR imaging with fewer tangled cables getting in the way.
AMIMON has granted Stryker Endoscopy exclusive access to AMIMON’s technology for the medical endoscopy market.“Only AMIMON’s High-Definition Wireless Technology is capable of transmitting the surgical video with no perceptible lag or interference throughout the entire operating room. This will allow surgeons greater flexibility in positioning the surgical display while operating. In addition, the hospitals and surgery centers will save the hassle and cost of routing DVI cables through the ceilings and overhead booms,” said William Chang, Stryker Endoscopy’s Vice President of Research & Development and Chief Technology Officer.
AMIMON WHDI™ Technology - Overview ...
Globes: Wireless video co Amimon wins deal with Stryker...
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Tuesday, December 16, 2008
Scientists Probe New Technology to Detect Cancer in Barrett's
A new study in the US and Germany has begun to assess the viability of using a miniature endoscopic camera from Mauna Kea Technologies, a Paris, France company, to diagnose whether Barrett's esophagitis has progressed to a dysplastic or neoplastic state. We have reported about the Cellvizio® fibered confocal microscopy system, that allows a practitioner to insert one of the miniprobes (only 300 um to 2.8 mm in diameter) into a conventional endoscope and record microscopic level movies of the tissue, on number of occasions before: see our flashbacks below.
From the latest press release by the company:
"Until now, we haven't been able to differentiate dysplastic and cancerous tissue within the Barrett's segment, so we take random biopsies from the area in hopes that this will represent an accurate sample," said Prateek Sharma, MD, Professor of Medicine in the Division of Gastroenterology and Hepatology at the University of Kansas School of Medicine and the Veteran Affairs Medical Center, Kansas City, Missouri, USA and the trial's principal investigator. "With this study, we hope to confirm that viewing Barrett's tissue at the cellular level with the Cellvizio miniprobe increases our ability to identify and immediately remove abnormal tissue without as many biopsies." Columbia-Presbyterian Medical Center in New York City, the Veteran Affairs Hospital in Kansas City, Mayo Clinic in Jacksonville, Florida and Klinikum rechts der Isar in Munich, Germany plan to enroll more than 100 patients in the study, known as DONT BIOPCE (Detection Of Neoplastic Tissue in Barrett's Esophagus with In vivO Probe-based Confocal Endomicroscopy)."We hope to reproduce the positive results of our earlier Barrett's Esophagus studies in a wider group of physicians and patients," explained Sacha Loiseau, president, CEO and founder of Mauna Kea Technologies, the company that developed Cellvizio. "We believe this new study will help underscore the impact that more accurate biopsy targeting can have on therapeutic patient management, improved patient care and efficiency within the hospital."
Barrett's Esophagus occurs when gastroesophageal reflux disease causes stomach acid to leak back into the esophagus and damage the lining. This can increase the risk of cancer of the esophagus (adenocarcinoma), the symptoms of which can be difficulty swallowing or weight loss.
Mauna Kea's video introducing the Cellvizio GI:
Product page: Cellvizio® GI: first ever confocal miniprobes for GI endoscopy ...
Flashbacks: Endo-microscopy from Mauna Kea Technologies ; Endo-microscopy Technique Shows Promise for Early Colon CA Diagnosis
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Wednesday, November 12, 2008
iPill for Electronic Drug Delivery
Last November we covered Philips' application for a patent that described an electronic swallowable capsule that would deliver drugs close to where they would be most effective, or best absorbed in the gastrointestinal tract. Now Philips is introducing the iPill, a prototype device that features a pump to release a drug, a radio to communicate with the ex vivo world, an on board computer, and a battery to power it all.
Philips promises to show off the device in Atlanta at the annual meeting of the American Association of Pharmaceutical Scientists this month.
Press release: Philips' intelligent pill targets drug development and treatment for digestive tract diseases...
More from Reuters...
Flashbacks: Philips Electronic Drug Delivery Pill
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Monday, November 3, 2008
In a Clinical Trial, Hepatic MR Elastography Delivers Encouraging Results
Researchers at Mayo Clinic were able to show that magnetic resonance elastography (MRE), a modality that looks at tissue stiffness, can identify early signs of hepatic fibrosis. MRE can possibly become one day a noninvasive diagnostic technology of choice for liver fibrosis, replacing the percutaneous liver biopsy that we have to do nowadays.
From a statement by Mayo Clinic:
The study, which included 113 patients, will be presented Nov. 3 at The Liver Meeting, an annual gathering of the American Association for the Study of Liver Disease, in San Francisco. Study participants had undergone liver biopsy in the year preceding the study and had a wide variety of liver diseases, including nonalcoholic and alcoholic fatty liver disease, hepatitis C, hepatitis B, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis. Patients ranged in age from 19 to 78, and their body weight ranged from normal to severely obese."Results showed that elastography was highly accurate in detecting moderate-to-severe hepatic fibrosis even with the variety in age, types of liver disease and body size," says Dr. Talwalkar. Among the study's findings:
* The detection of cirrhosis by MRE when compared to liver biopsy results was 88 percent accurate.
* Patients with nonalcoholic fatty liver disease and no significant inflammation or fibrosis were identified with 97 percent accuracy.
"Using MRE, we can confidently avoid liver biopsies for patients with no evidence of advanced fibrosis, as well as for patients with cirrhosis," says Dr. Talwalkar.
Liver biopsies, conducted by extracting tissue samples with a needle, can underestimate the degree of hepatic fibrosis about 20 to 30 percent of the time because of the patchy distribution of fibrosis that occurs in the liver. Another drawback is that since liver biopsy is invasive, patients may be reluctant to have a biopsy performed and sometimes delay the procedure when liver disease is first suspected, says Dr. Talwalkar.
Here's a video of Dr. Jayant Talwalkar explaining the technology:
Press release: Mayo Clinic's New Imaging Technology Accurately Identifies a Broad Spectrum of Liver Disease ...
Image: Elastograms of a normal liver (top) and a fibrotic liver, validated by biopsy.
Flashback: MR Elastography for Liver Fibrosis
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Thursday, October 9, 2008
First Blood Test For IBS?
For many years, the diagnosis of IBS has been a catch-all diagnosis of exclusion and many thought it was nothing more than a psychosomatic illness. The first attempts to scientifically approach IBS began in in the late 70's but without diagnostic/pathological confirmation, researchers were limited to developing diagnostic questionnaires for diagnosis. Several sets of criteria have been developed over the years, beginning with the Manning Criteria and progressing through the Rome, Rome II and Rome III Criteria. The latter has a sensitivity of 71% and specificity of 88% which is quite good, but all this may change with the identification of biological markers by Prometheus Laboratories Inc. of San Diego, California.
From the press release:
Prometheus Laboratories Inc., a specialty pharmaceutical company, ... announced findings from its development of PROMETHEUS(R) IBS Diagnostic, the first and only blood test for irritable bowel syndrome (IBS). The findings suggest measurable differences in the expression of particular biomarkers in blood samples between IBS and non-IBS patients. The identification of these biomarkers, combined with a proprietary algorithm, led to the development of PROMETHEUS IBS Diagnostic. These findings were presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Orlando, Florida.Dr. Anthony Lembo, M.D., a gastroenterologist in the Division of Gastroenterology at Beth Israel Deaconess Medial Center and an Assistant Professor of Medicine at Harvard Medical School said “This test complements current symptom-based diagnostic practices by identifying patients with biomarker patterns consistent or inconsistent with IBS.”
Following an extensive analysis of approximately 600 to 700 pathways, each containing hundreds of potential IBS biomarkers, Prometheus scientists identified 16 biomarkers that showed sufficient altered expression. The expression levels of these 16 biomarkers were then measured in a sample cohort of more than 1,700 patients and analyzed to reveal optimal IBS prediction with a final set of 10 biomarkers, including some that enable Prometheus' proprietary protection. These biomarkers are associated with one or more of the following pathways related to digestion: motility, brain-gut axis, neuronal regulation and immune function.
Product page: PROMETHEUS® IBS Diagnostic...
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» It's a Retrospectroscope... It's a Rectospectroscope...No It's Retroscope! (October 8, 2008)
» 4D-ELF...Coming To A Colonoscope Near You (October 1, 2008)
» EndoBarrier, an Internal Condom, Gets Positive Results in Diabetic Clinical Trial (September 19, 2008)
» Virtual Colonography vs. Standard Colonoscopy (September 18, 2008)
» TOGA Stomach Stapling System Goes on Trial (August 25, 2008)
» Single Chip Stereo Endoscopy from Visionsense (August 13, 2008)
» New Light Sensor Mimicks Eye for Superior Camera Performance (August 6, 2008)
» Intestinal Robot Grabs Onto Cavity Walls (August 1, 2008)
» BreathID for Simple Liver Disease Identification Gets FDA's Trial OK (July 21, 2008)
» PillCam Used to Diagnose Crohn Disease (July 15, 2008)
» Radial Jaw 4 Biopsy Forceps From Boston Sci (July 2, 2008)
» Cook Medical Introduces Evolution Controlled Release Esophageal Stent System (June 13, 2008)
» Sedation Web Site... For Endoscopy (June 9, 2008)
» Is a Distally Controlled PillCam Coming? (June 3, 2008)
» Noninvasive Device Being Developed for Gastroesophageal Reflux Disease (May 21, 2008)
» BreathID Sniffs Success, Eyes FDA Approval (April 3, 2008)
» Endo-microscopy Technique Shows Promise for Early Colon CA Diagnosis (March 19, 2008)
» FDA Rejects PillCam Colon (February 20, 2008)
» Single Optical Fiber Endoscope (January 25, 2008)
» Philips Electronic Drug Delivery Pill (November 20, 2007)
» EndoCAD: A Real Time Upper GI Reference System (November 13, 2007)
» EndoCapsule Gets FDA Clearance (September 19, 2007)
» Siemens' Colonography Gets an Update (August 27, 2007)
» Eat Away, Just Don't Digest (August 9, 2007)
» Early Detection of Pancreatic Cancer: A New Hope (August 1, 2007)
» CE Approved Allium Stents (July 6, 2007)
» Odor-Reader Wins University of Bristol's New Enterprise Competition (July 5, 2007)
» Hydrogel Pill Expands in Your Stomach, Not in Your Hands (July 3, 2007)
» 560 Series HD Camera from Smith & Nephew (June 21, 2007)
» PillCam™ ESO 2 (June 14, 2007)
» GM Rice to Carry Cholera Vaccine (June 13, 2007)
» Video of The Aer-O-Scope™ (June 12, 2007)
» Endo-microscopy from Mauna Kea Technologies (June 8, 2007)
» Sedationless Colonoscopy: For Your Viewing Pleasure (June 7, 2007)
» Implantable RFID Tag to Wirelessly Monitor GERD (June 4, 2007)
» Spyglass™ Direct Visualization System to Cure ERCP Addiction (May 24, 2007)
» New HD Endoscopes and Computer-based Video Processors from Pentax (May 11, 2007)
» Lap Band Surgery Less Likely to Leave Patients Headed Towards Diabetes (May 3, 2007)
» World's First Auto Fluorescent Endoscope (April 30, 2007)
» Virtual Colonoscopies More Cost-Effective than Reality TV Colonoscopies (April 24, 2007)
» EsophyX™ (Endoluminal Fundoplication™) ELF System for GERD (April 19, 2007)
» Fantastic Robotic Voyage (cont.) (March 9, 2007)
» NEMO: Nano-based capsule-Endoscopy with Molecular Imaging and Optical biopsy (January 17, 2007)
» The FibroScan®: Noninvasive Proof that You Are Drinking too Much (January 9, 2007)
» British Scientists Build a Model Gut (November 13, 2006)
» GI Docs Not On Virtual Colonoscopy Bandwagon (October 27, 2006)
» PillCam Colon (October 23, 2006)
» Spectrally Encoded Mini Endoscope (October 19, 2006)
» Like a Snail Through GI (September 25, 2006)
» MR Elastography for Liver Fibrosis (September 12, 2006)
» FDA "Green Light" for Sale of SmartPill (July 21, 2006)
» The Dx-pH Measurement System™ for Sleep Reflux (June 27, 2006)
» New Colonoscopy Technology Coming Down the Chute (May 25, 2006)
» Given Imaging's Agile™ Patency System (May 19, 2006)
» The Oridion BreathID® (May 16, 2006)
» The Aer-O-Scope™ (April 24, 2006)
» The pH.p Capsule (April 12, 2006)
» Crohn's Disease: Too Much, or Not Enough? (February 24, 2006)
» Detecting Reflux in Realtime (February 16, 2006)
» SRS System: Endoscopic Partial Anterior Fundoplication (January 30, 2006)
» Boston Scientific Acquires More Stents (November 9, 2005)
» EGG Says: Go With Your Gut (November 2, 2005)
» Olympus Launches High-resolution Endo Capsule System in Europe (October 18, 2005)
» The Third Generation PillCam™ SB Launched (October 13, 2005)
» Camera Pills, with Teeth (October 6, 2005)
» Death of a Medgadget (September 29, 2005)
» Infrared Detection of Meat Contamination (September 29, 2005)
» FerriScan™ (June 29, 2005)
» GI View's Aer-O-Scope and Colonoscopy System (June 28, 2005)
» Robot Sought For Capsule Endoscope (June 1, 2005)
» Artificial Worm Movement for Colonoscopy Guidance (June 1, 2005)
» Capsule Endoscope by Olympus (May 25, 2005)
» BÂRRX Halo360 System (May 24, 2005)
» The Future of Feeding Tubes (April 19, 2005)
» Fastastic Voyage: Smart Pill to Expand Testing (April 13, 2005)
» MagnaChip Image Sensor for "Pill" Camera (March 7, 2005)
» Worms, slugs and the future of endoscopy (February 18, 2005)
» Biochip for inflammatory bowel disease (January 31, 2005)
» The CORTRAK system (January 21, 2005)
» Enhanced Micron CMOS image sensor for PillCam (January 19, 2005)
» New Endoscopic Camera in the Works? (January 4, 2005)
» PillCam (December 11, 2004)
