By AMANDA PEDERSEN
Medical Device Daily Senior Staff Writer
SAN DIEGO NinePoint Medical (Cambridge, Massachusetts) has developed a technology, the Nvision VLE imaging system, that allows clinicians to see beyond the tissue surface giving physicians a peek deep into the tissue at things they've never been able to see before. GI physicians will have a chance to see a live demonstration of the system on an animal model this week at the Digestive Disease Week (DDW) meeting in San Diego.
The company has already received FDA 510(k) clearance for a general indication (Medical Device Daily, Jan. 6, 2012) and in February it initiated a clinical trial to find out how well the technology works for imaging Barrett's esophagus (MDD, Feb. 23, 2012).
The company is currently about halfway through that trial, Charles Carignan, MD, president/CEO of NinePoint, told Medical Device Daily at DDW.
The meeting is jointly sponsored by the American Association for the Study of Liver Diseases (Alexandria, Virginia), the American Gastroenterological Association Institute (Bethesda, Maryland), the American Society for Gastrointestinal Endoscopy (Oak Brook, Illinois) and the Society for Surgery of the Alimentary Tract (Beverly, Massachusetts).
Nearly 16,000 GI researchers and clinicians plus a couple thousand exhibitors are in San Diego this week for DDW, where more than 5,000 new studies are being presented.
"Our goal at this meeting is to get people interested in the technology and let them see its promise," Carignan said. The company plans to formally launch the Nvision VLE imaging system a year from now at DDW 2013. In the meantime, "we're still refining it and getting input from the clinicians involved with our clinical trial," he said.
While the company does plan to market the technology for other indications, including pulmonary imaging, down the road, its initial focus is on Barrett's esophagus.
"There is just a big unmet need in the esophagus for Barrett's esophagus," Carignan said.
So far the clinicians who have used the Nvision VLE imaging system in the company's clinical trial have reacted positively about the technology, he said. But, he added, the challenge is to be able to train the physicians to understand what they are able to see with the system because they are seeing areas of the disease and things embedded deep in the tissue that they've never been able to look at before.
"They're enthusiastic because they can see so much detail," Carignan told MDD. "They're excited about what they can see, they just need to understand what it is they are looking at."
The company's goal for this year is to learn what a lot of the additional detail means and be able to train a broader group of physicians to use the technology and understand the new information they are getting from it. Over time the company also will be making improvements to the system and continuing to improve the resoltuion of the images.
"There's a trade off between increasing resolution and not overwhelming the physician with too much information," Carignan said.
He added that NinePoint has been fortunate to be able to raise the funds necessary to allow it to take its time developing and tweaking the technology before commercializing it, rather than rushing to get it out and having to learn from their mistakes while it's already on the market.
The company's single-arm, open-label observation trial is designed to evaluate the performance of the Nvision system to visualize subsurface tissue in patients undergoing esophagogastroduoenoscopy (EGD) for suspected or confirmed Barrett's esophagus, a condition that is one of the most common precursors to esophageal cancer.
In other DDW news:
GI Dynamics (Lexington, Massachusetts) noted that its EndoBarrier therapy, a treatment for Type 2 diabetes and/or obesity, will be the subject of several presentations and scientific sessions during the meeting this week.
On Sunday, Alex Escalona, MD, assistant professor of surgery in the Department of Digestive Surgery, Pontificia Universidad Católica de Chile (Santiago, Chile), provided an overview of EndoBarrier and presented a hands-on demonstration of the device at the workshop, "Xtreme Endoscopic Toolbox: New and Cutting Edge Therapies."
"EndoBarrier is a thin, flexible, sleeve-like liner that works by creating a physical barrier between food and a portion of the intestinal wall," Escalona said. "With EndoBarrier therapy, my patients report increased energy, feeling full for a longer period of time after eating, and immediate and continued weight loss."
In addition to the interactive workshop on Sunday, the EndoBarrier therapy was highlighted Sunday by Eduardo Moura, MD, PhD, director of endoscopy, digestive surgery department, Hospital das Clinicas, University of Sao Paulo, Brazil.
Another presentation on the device will be Tuesday by Paulo Sakai, MD, associate professor in the gastrointestinal endoscopy unit, at the University of Sao Paulo, Brazil.
"There is ongoing interest in the use of EndoBarrier therapy as demonstrated by the number of presentations offered at DDW and other medical conferences," said Mark Twyman, chief commercial officer at GI Dynamics. "Patients with Type 2 diabetes and/or obesity across the globe have achieved significant health improvements and treatment outcomes as a result of EndoBarrier Therapy."
The EndoBarrier device has been demonstrated to lower HbAic levels, achieve weight loss of more than 20%, and improve important metabolic measures including cholesterol, blood sugar and triglycerides, GI Dynamics noted.
W. L. Gore & Associates (Flagstaff, Arizona) said it has extended its distribution agreement in the U.S. and Canada with ConMed Endoscopic Technologies for the distribution and marketing of its Gore Viabil Biliary Endoprosthesis.
"We are very excited to announce this exclusive contract extension with ConMed," said Ron Anderson, Gore's medical products business leader. "This will assure that interventional gastroenterologists have increasing access to the Gore Viabil biliary endoprosthesis, which has the proven clinical benefits of low migration and long-term patency."
According to Gore, the device is engineered using advanced proprietary technology that has helped set the performance standard for fully covered metal stents and has brought proven clinical benefits to the patients that endoscopists serve. As the only fully covered biliary endoprothesis with atraumatic anti-migration fins, The Gore Viabil Biliary Endoprosthesis reduces stent migration with a reported migration rate of 0.3%.
The Gore Viabil Biliary Endoprosthesis has received FDA clearance for the palliative treatment of malignant biliary strictures, the company noted. Additionally, it is licensed in Canada for the treatment of benign and malignant biliary strictures and can be removed from such strictures for up to one-year post implant.
Published May 22, 2012