Top medtech successes in gastroenterology and metabolic diseases this year

BOSTON – Gastroenterology as a specialty is in transition when it comes to technology, and gastroenterologists will have to decide whether to stay the course, performing procedures like endoscopies and colonoscopies, or also embrace additional technologies, a GI tech expert said at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

“We have the ability to seize the moment and transform the specialty into a major player in therapeutics that go beyond the gut to include conditions like diabetes, obesity, or other areas,” said Dr. Pankaj Jay Pasricha, past chair of the AGA Center for GI Innovation and Technology and director of the Johns Hopkins Center for Neurogastroenterology and Johns Hopkins division of digestive diseases in Baltimore. “It’s up to us.”

Nick Piegari/Frontline Medical News

Last year saw the approval of an array of devices in areas involving new endoscopic platforms, new tools for mucosal resection, and new strategies for improving the utility of endoscopic ultrasound, Dr. Pasricha said. To be employed appropriately, many of these devices will require GI professionals to seek additional training. One example includes the use of new minimally invasive balloon technologies to control obesity. Two, the Orbera Intragastric Balloon System (Apollo Endosurgery) and the ReShape Integrated Dual Balloon System (ReShape Medical) were singled out as examples.

“It’s not just simply a matter of dropping the balloon in and hoping for the best,” he said. “This requires careful training. The balloon is not an end to itself; it’s a tool for helping patients get to their goals. GIs either need to jump into this and say, ‘Yes, we want to expand’ or potentially lose business to bariatric surgeons. We will be pushed as a specialty to figure out how we want to deal with this.”

The American Gastroenterological Association has been working on this issue and is developing, in conjunction with the Society of American Gastrointestinal and Endoscopic Surgeons, The Obesity Society, and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, a program to guide gastroenterologists who want to develop comprehensive care management programs to treat obesity with a multimodal approach. The initiative, called “POWER: Practice Guide on Obesity and Weight Management, Education and Resources,” will be available later this year, along with a white paper and bundled payment model.

Overall, 2015 was a good year for GI technologies, although not as exciting as 2014, Dr. Pasricha said. Devices approved by the Food and Drug Administration last year included the Gastric-Emptying Breath Test (Advanced Breath Diagnostics), a breath test to aid in the diagnosis of delayed gastric emptying; the Splash M-Knife (Pentax Medical), a tool to achieve complete endoscopic submucosal dissection; the Eclipse System (Pelvalon), an appliance inserted into the vagina to treat fecal incontinence in women; and Ab Stats (GI Logic), a connected wearable stethoscope to monitor the digestive system after patients have surgery. Neuromodulation for inflammatory bowel disease and irritable bowel syndrome also is an emerging area for technology, he said.

In the field of endoscopy, Dr. Pasricha noted the ever-greater emphasis being placed by the manufacturers of endoscopes on tools for therapeutics.

“It has taken a long time for endoscope companies to recognize that they need to be players not just in providing the eyes but also the hands and the tools to address the pathology that we see in procedures,” Dr. Pasricha said.

In other news from 2015, outbreaks of carbapenem-resistant Enterobacteriaceae linked to patients undergoing procedures with duodenoscopes highlighted the need to move from risk reduction to risk elimination, Dr. Pasricha said. The AGA Center for GI Innovation and Technology worked closely with the FDA to ensure GIs had the guidance and resources they needed to eliminate the risk of patient infection from duodenoscopes. Following discussions with the AGA center leadership and other invested stakeholders, the FDA in October issued new guidelines to health care facilities for cleaning the devices and ordered the devices’ three manufacturers to conduct postmarket surveillance studies to better understand how the devices are reprocessed. Additional communications from the agency regarding this postmarket surveillance are likely forthcoming.

In a similar risk-elimination case, the FDA in March halted enrollment in a clinical trial of GI Dynamics’ EndoBarrier weight loss device after a few patients developed liver infections.

The AGA and its Center for GI Innovation and Technology recognizes that training is critical to the adoption of new technologies. The center is working to develop competency thresholds for new technologies and is developing an action plan to educate the next generation of interventionalists, Dr. Pasricha said: “We need to teach gastroenterologists how to do more skilled procedures than just diagnostic endoscopy or point and shoot procedures. We also need to teach surgeons how to be facile with flexible endoscopy.”

On the reimbursement front, the AGA center – working with the other GI societies – works to put together rational reimbursement codes to reflect the new reality of the complexities of interventional procedures, he said.

“We have learned that you should not even be getting involved in commercial development of new devices without first running it through the filter of economics,” Dr. Pasricha said. A good idea for a new technology by itself is not sufficient, “especially now with all the cost constraints.”

Dr. Pasricha is a consultant, advisor, or cofounder for Apollo Endosurgery, Pentax, EndoGastric Solutions, Crospon, GI Cryo, Glyscend, Enterastim, and GI Scientific.

Ted Bosworth contributed to this report.

BOSTON – Gastroenterology as a specialty is in transition when it comes to technology, and gastroenterologists will have to decide whether to stay the course, performing procedures like endoscopies and colonoscopies, or also embrace additional technologies, a GI tech expert said at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

“We have the ability to seize the moment and transform the specialty into a major player in therapeutics that go beyond the gut to include conditions like diabetes, obesity, or other areas,” said Dr. Pankaj Jay Pasricha, past chair of the AGA Center for GI Innovation and Technology and director of the Johns Hopkins Center for Neurogastroenterology and Johns Hopkins division of digestive diseases in Baltimore. “It’s up to us.”

Nick Piegari/Frontline Medical News

Last year saw the approval of an array of devices in areas involving new endoscopic platforms, new tools for mucosal resection, and new strategies for improving the utility of endoscopic ultrasound, Dr. Pasricha said. To be employed appropriately, many of these devices will require GI professionals to seek additional training. One example includes the use of new minimally invasive balloon technologies to control obesity. Two, the Orbera Intragastric Balloon System (Apollo Endosurgery) and the ReShape Integrated Dual Balloon System (ReShape Medical) were singled out as examples.

“It’s not just simply a matter of dropping the balloon in and hoping for the best,” he said. “This requires careful training. The balloon is not an end to itself; it’s a tool for helping patients get to their goals. GIs either need to jump into this and say, ‘Yes, we want to expand’ or potentially lose business to bariatric surgeons. We will be pushed as a specialty to figure out how we want to deal with this.”

The American Gastroenterological Association has been working on this issue and is developing, in conjunction with the Society of American Gastrointestinal and Endoscopic Surgeons, The Obesity Society, and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, a program to guide gastroenterologists who want to develop comprehensive care management programs to treat obesity with a multimodal approach. The initiative, called “POWER: Practice Guide on Obesity and Weight Management, Education and Resources,” will be available later this year, along with a white paper and bundled payment model.

Overall, 2015 was a good year for GI technologies, although not as exciting as 2014, Dr. Pasricha said. Devices approved by the Food and Drug Administration last year included the Gastric-Emptying Breath Test (Advanced Breath Diagnostics), a breath test to aid in the diagnosis of delayed gastric emptying; the Splash M-Knife (Pentax Medical), a tool to achieve complete endoscopic submucosal dissection; the Eclipse System (Pelvalon), an appliance inserted into the vagina to treat fecal incontinence in women; and Ab Stats (GI Logic), a connected wearable stethoscope to monitor the digestive system after patients have surgery. Neuromodulation for inflammatory bowel disease and irritable bowel syndrome also is an emerging area for technology, he said.

In the field of endoscopy, Dr. Pasricha noted the ever-greater emphasis being placed by the manufacturers of endoscopes on tools for therapeutics.

“It has taken a long time for endoscope companies to recognize that they need to be players not just in providing the eyes but also the hands and the tools to address the pathology that we see in procedures,” Dr. Pasricha said.

In other news from 2015, outbreaks of carbapenem-resistant Enterobacteriaceae linked to patients undergoing procedures with duodenoscopes highlighted the need to move from risk reduction to risk elimination, Dr. Pasricha said. The AGA Center for GI Innovation and Technology worked closely with the FDA to ensure GIs had the guidance and resources they needed to eliminate the risk of patient infection from duodenoscopes. Following discussions with the AGA center leadership and other invested stakeholders, the FDA in October issued new guidelines to health care facilities for cleaning the devices and ordered the devices’ three manufacturers to conduct postmarket surveillance studies to better understand how the devices are reprocessed. Additional communications from the agency regarding this postmarket surveillance are likely forthcoming.

In a similar risk-elimination case, the FDA in March halted enrollment in a clinical trial of GI Dynamics’ EndoBarrier weight loss device after a few patients developed liver infections.

The AGA and its Center for GI Innovation and Technology recognizes that training is critical to the adoption of new technologies. The center is working to develop competency thresholds for new technologies and is developing an action plan to educate the next generation of interventionalists, Dr. Pasricha said: “We need to teach gastroenterologists how to do more skilled procedures than just diagnostic endoscopy or point and shoot procedures. We also need to teach surgeons how to be facile with flexible endoscopy.”

On the reimbursement front, the AGA center – working with the other GI societies – works to put together rational reimbursement codes to reflect the new reality of the complexities of interventional procedures, he said.

“We have learned that you should not even be getting involved in commercial development of new devices without first running it through the filter of economics,” Dr. Pasricha said. A good idea for a new technology by itself is not sufficient, “especially now with all the cost constraints.”

Dr. Pasricha is a consultant, advisor, or cofounder for Apollo Endosurgery, Pentax, EndoGastric Solutions, Crospon, GI Cryo, Glyscend, Enterastim, and GI Scientific.

Ted Bosworth contributed to this report.

BOSTON – Gastroenterology as a specialty is in transition when it comes to technology, and gastroenterologists will have to decide whether to stay the course, performing procedures like endoscopies and colonoscopies, or also embrace additional technologies, a GI tech expert said at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

“We have the ability to seize the moment and transform the specialty into a major player in therapeutics that go beyond the gut to include conditions like diabetes, obesity, or other areas,” said Dr. Pankaj Jay Pasricha, past chair of the AGA Center for GI Innovation and Technology and director of the Johns Hopkins Center for Neurogastroenterology and Johns Hopkins division of digestive diseases in Baltimore. “It’s up to us.”

Nick Piegari/Frontline Medical News

Last year saw the approval of an array of devices in areas involving new endoscopic platforms, new tools for mucosal resection, and new strategies for improving the utility of endoscopic ultrasound, Dr. Pasricha said. To be employed appropriately, many of these devices will require GI professionals to seek additional training. One example includes the use of new minimally invasive balloon technologies to control obesity. Two, the Orbera Intragastric Balloon System (Apollo Endosurgery) and the ReShape Integrated Dual Balloon System (ReShape Medical) were singled out as examples.

“It’s not just simply a matter of dropping the balloon in and hoping for the best,” he said. “This requires careful training. The balloon is not an end to itself; it’s a tool for helping patients get to their goals. GIs either need to jump into this and say, ‘Yes, we want to expand’ or potentially lose business to bariatric surgeons. We will be pushed as a specialty to figure out how we want to deal with this.”

The American Gastroenterological Association has been working on this issue and is developing, in conjunction with the Society of American Gastrointestinal and Endoscopic Surgeons, The Obesity Society, and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, a program to guide gastroenterologists who want to develop comprehensive care management programs to treat obesity with a multimodal approach. The initiative, called “POWER: Practice Guide on Obesity and Weight Management, Education and Resources,” will be available later this year, along with a white paper and bundled payment model.

Overall, 2015 was a good year for GI technologies, although not as exciting as 2014, Dr. Pasricha said. Devices approved by the Food and Drug Administration last year included the Gastric-Emptying Breath Test (Advanced Breath Diagnostics), a breath test to aid in the diagnosis of delayed gastric emptying; the Splash M-Knife (Pentax Medical), a tool to achieve complete endoscopic submucosal dissection; the Eclipse System (Pelvalon), an appliance inserted into the vagina to treat fecal incontinence in women; and Ab Stats (GI Logic), a connected wearable stethoscope to monitor the digestive system after patients have surgery. Neuromodulation for inflammatory bowel disease and irritable bowel syndrome also is an emerging area for technology, he said.

In the field of endoscopy, Dr. Pasricha noted the ever-greater emphasis being placed by the manufacturers of endoscopes on tools for therapeutics.

“It has taken a long time for endoscope companies to recognize that they need to be players not just in providing the eyes but also the hands and the tools to address the pathology that we see in procedures,” Dr. Pasricha said.

In other news from 2015, outbreaks of carbapenem-resistant Enterobacteriaceae linked to patients undergoing procedures with duodenoscopes highlighted the need to move from risk reduction to risk elimination, Dr. Pasricha said. The AGA Center for GI Innovation and Technology worked closely with the FDA to ensure GIs had the guidance and resources they needed to eliminate the risk of patient infection from duodenoscopes. Following discussions with the AGA center leadership and other invested stakeholders, the FDA in October issued new guidelines to health care facilities for cleaning the devices and ordered the devices’ three manufacturers to conduct postmarket surveillance studies to better understand how the devices are reprocessed. Additional communications from the agency regarding this postmarket surveillance are likely forthcoming.

In a similar risk-elimination case, the FDA in March halted enrollment in a clinical trial of GI Dynamics’ EndoBarrier weight loss device after a few patients developed liver infections.

The AGA and its Center for GI Innovation and Technology recognizes that training is critical to the adoption of new technologies. The center is working to develop competency thresholds for new technologies and is developing an action plan to educate the next generation of interventionalists, Dr. Pasricha said: “We need to teach gastroenterologists how to do more skilled procedures than just diagnostic endoscopy or point and shoot procedures. We also need to teach surgeons how to be facile with flexible endoscopy.”

On the reimbursement front, the AGA center – working with the other GI societies – works to put together rational reimbursement codes to reflect the new reality of the complexities of interventional procedures, he said.

“We have learned that you should not even be getting involved in commercial development of new devices without first running it through the filter of economics,” Dr. Pasricha said. A good idea for a new technology by itself is not sufficient, “especially now with all the cost constraints.”

Dr. Pasricha is a consultant, advisor, or cofounder for Apollo Endosurgery, Pentax, EndoGastric Solutions, Crospon, GI Cryo, Glyscend, Enterastim, and GI Scientific.

Ted Bosworth contributed to this report.