FDA Advisory Committee Meeting

“My career goal has been to do things in an increasingly less-invasive manner,” says Dr. Robert D. Fanelli, MHA, chief of minimally invasive surgery and surgical endoscopy at The Guthrie Clinic in Sayre, Penn.

At the 2015 AGA Technology Summit, Dr. Fanelli will moderate a seminar on new technologies in obesity that, he says, is all about finding “the next step in reducing invasiveness” by bringing highly qualified endoscopic practitioners and minimally invasive surgeons together to talk about newly approved devices, devices in development, and new procedures.

While intragastric balloons, duodenal-jejunal sleeves, vagal nerve–blocking devices, endoscopic suturing, and new stenting techniques are all hot topics, “the reality is there are very few people doing any of this high-end stuff on a daily clinical basis; our goal is to change that.”

The seminar “is not just for the person who wants to know what the future will look like, but for surgeons and gastroenterologists looking to actually do some of these things now,” Dr. Fanelli said. It will include, besides the practice discussions, talks on marketing nonsurgical bariatric products and a perspective on obesity devices from insurers, investors, and representatives from the U.S. Food and Drug Administration.

Though obesity remains largely in the surgical realm – “Roux-en-Y isn’t going away,” Dr. Fanelli said – some of the new devices promise to tilt treatment away from the purely surgical approach toward an endoscopic one. Gastroenterologists are enthusiastic about the new wave of obesity devices that can be placed without surgery, bringing their field closer to the cutting edge of weight-loss intervention, Dr. Fanelli said, but cautioned that obesity always necessitates a multidisciplinary approach, whether treated surgically or medically.

“All of the enthusiasm about new procedures to be done has to occur within the context of a multidisciplinary weight-loss clinic with psychological evaluation, behavioral coaching, smoking cessation, and other components essential to improving population health,” he said.

Dr. Fanelli’s own surgical practice incorporates basic and advanced endoscopic procedures. “I’ve dedicated my career to running this kind of hybrid practice, and there are growing numbers of us out there,” said Dr. Fanelli.

One speaker at the seminar, Dr. Dmitry Oleynikov of the University of Nebraska Medical Center in Omaha will discuss outcome measures for bariatric procedures.

Dr. Fanelli pointed to Dr. Oleynikov as a surgeon emblematic of the increasingly fluid barriers between the fields of gastroenterology and surgery. “He’s a really inventive guy who has developed equipment, including a microrobotic surgical platform, and he’s a bariatric surgeon involved with endoscopy. I like the way he thinks, I like the way he’s designed his career path, and I think that he can help us establish creative discussion.”

Like many participants who will attend the summit, Dr. Fanelli is extensively involved in new product development – a key area of interest to participants at the seminar, which is sponsored by the AGA Center for GI Innovation and Technology.

One device Dr. Fanelli conceptualized, an intestinal sleeve that can be tuned using radiofrequency from outside, “was too expensive to produce, so it’s on the shelf right now.” Dr. Fanelli noted that this was the nature of the device development process – ideas can hang around a while until the time is right to revisit them.

The science behind the recently approved vagal nerve–blocking device is based on data and concepts accumulated over time, he added. “If you go back to some of the initial research that was done after bypass, with the identification of hormonal pathways and fat-burning triggers, that’s partly where stimulation devices came from,” he said. “A lot of ideas have been percolating for 5-15 years, and it gets to the point where you begin to see something concrete that emerges from it.”

Speaking directly to that idea – how to think about new obesity devices in a regulatory and research context – will be FDA’s Dr. Martha Betz. “Physicians, surgeons, and industry alike all want to know what the pathways to market are,” Dr. Fanelli said, adding that Dr. Betz and other members of the FDA Center for Devices and Radiological Health can help “outline a pathway by which the FDA can determine the safety of a device, but then it is up to insurers to recognize their responsibility in this process as well and to transparently outline the pathway to payment, even if only for limited use in collecting larger series of cases.”

This is where the AGA Center for GI Innovation and Technology comes in – to guide medical device and therapeutics innovators through the technology development and complex adoption process. The center also has a registry initiative that helps companies identify and gather the data and evidence required by physician members, payers, and regulatory agencies to demonstrate that the technologies improve patient outcomes and hopefully reduce costs to the system.

“This is the real benefit of the AGA registry initiative, to gather data, and with this unique conference; having all the stakeholders in one room is the best way of modernizing an outdated process that allows disruptive technologies to die on the vine,” Dr. Fanelli said.

“My career goal has been to do things in an increasingly less-invasive manner,” says Dr. Robert D. Fanelli, MHA, chief of minimally invasive surgery and surgical endoscopy at The Guthrie Clinic in Sayre, Penn.

At the 2015 AGA Technology Summit, Dr. Fanelli will moderate a seminar on new technologies in obesity that, he says, is all about finding “the next step in reducing invasiveness” by bringing highly qualified endoscopic practitioners and minimally invasive surgeons together to talk about newly approved devices, devices in development, and new procedures.

While intragastric balloons, duodenal-jejunal sleeves, vagal nerve–blocking devices, endoscopic suturing, and new stenting techniques are all hot topics, “the reality is there are very few people doing any of this high-end stuff on a daily clinical basis; our goal is to change that.”

The seminar “is not just for the person who wants to know what the future will look like, but for surgeons and gastroenterologists looking to actually do some of these things now,” Dr. Fanelli said. It will include, besides the practice discussions, talks on marketing nonsurgical bariatric products and a perspective on obesity devices from insurers, investors, and representatives from the U.S. Food and Drug Administration.

Though obesity remains largely in the surgical realm – “Roux-en-Y isn’t going away,” Dr. Fanelli said – some of the new devices promise to tilt treatment away from the purely surgical approach toward an endoscopic one. Gastroenterologists are enthusiastic about the new wave of obesity devices that can be placed without surgery, bringing their field closer to the cutting edge of weight-loss intervention, Dr. Fanelli said, but cautioned that obesity always necessitates a multidisciplinary approach, whether treated surgically or medically.

“All of the enthusiasm about new procedures to be done has to occur within the context of a multidisciplinary weight-loss clinic with psychological evaluation, behavioral coaching, smoking cessation, and other components essential to improving population health,” he said.

Dr. Fanelli’s own surgical practice incorporates basic and advanced endoscopic procedures. “I’ve dedicated my career to running this kind of hybrid practice, and there are growing numbers of us out there,” said Dr. Fanelli.

One speaker at the seminar, Dr. Dmitry Oleynikov of the University of Nebraska Medical Center in Omaha will discuss outcome measures for bariatric procedures.

Dr. Fanelli pointed to Dr. Oleynikov as a surgeon emblematic of the increasingly fluid barriers between the fields of gastroenterology and surgery. “He’s a really inventive guy who has developed equipment, including a microrobotic surgical platform, and he’s a bariatric surgeon involved with endoscopy. I like the way he thinks, I like the way he’s designed his career path, and I think that he can help us establish creative discussion.”

Like many participants who will attend the summit, Dr. Fanelli is extensively involved in new product development – a key area of interest to participants at the seminar, which is sponsored by the AGA Center for GI Innovation and Technology.

One device Dr. Fanelli conceptualized, an intestinal sleeve that can be tuned using radiofrequency from outside, “was too expensive to produce, so it’s on the shelf right now.” Dr. Fanelli noted that this was the nature of the device development process – ideas can hang around a while until the time is right to revisit them.

The science behind the recently approved vagal nerve–blocking device is based on data and concepts accumulated over time, he added. “If you go back to some of the initial research that was done after bypass, with the identification of hormonal pathways and fat-burning triggers, that’s partly where stimulation devices came from,” he said. “A lot of ideas have been percolating for 5-15 years, and it gets to the point where you begin to see something concrete that emerges from it.”

Speaking directly to that idea – how to think about new obesity devices in a regulatory and research context – will be FDA’s Dr. Martha Betz. “Physicians, surgeons, and industry alike all want to know what the pathways to market are,” Dr. Fanelli said, adding that Dr. Betz and other members of the FDA Center for Devices and Radiological Health can help “outline a pathway by which the FDA can determine the safety of a device, but then it is up to insurers to recognize their responsibility in this process as well and to transparently outline the pathway to payment, even if only for limited use in collecting larger series of cases.”

This is where the AGA Center for GI Innovation and Technology comes in – to guide medical device and therapeutics innovators through the technology development and complex adoption process. The center also has a registry initiative that helps companies identify and gather the data and evidence required by physician members, payers, and regulatory agencies to demonstrate that the technologies improve patient outcomes and hopefully reduce costs to the system.

“This is the real benefit of the AGA registry initiative, to gather data, and with this unique conference; having all the stakeholders in one room is the best way of modernizing an outdated process that allows disruptive technologies to die on the vine,” Dr. Fanelli said.

“My career goal has been to do things in an increasingly less-invasive manner,” says Dr. Robert D. Fanelli, MHA, chief of minimally invasive surgery and surgical endoscopy at The Guthrie Clinic in Sayre, Penn.

At the 2015 AGA Technology Summit, Dr. Fanelli will moderate a seminar on new technologies in obesity that, he says, is all about finding “the next step in reducing invasiveness” by bringing highly qualified endoscopic practitioners and minimally invasive surgeons together to talk about newly approved devices, devices in development, and new procedures.

While intragastric balloons, duodenal-jejunal sleeves, vagal nerve–blocking devices, endoscopic suturing, and new stenting techniques are all hot topics, “the reality is there are very few people doing any of this high-end stuff on a daily clinical basis; our goal is to change that.”

The seminar “is not just for the person who wants to know what the future will look like, but for surgeons and gastroenterologists looking to actually do some of these things now,” Dr. Fanelli said. It will include, besides the practice discussions, talks on marketing nonsurgical bariatric products and a perspective on obesity devices from insurers, investors, and representatives from the U.S. Food and Drug Administration.

Though obesity remains largely in the surgical realm – “Roux-en-Y isn’t going away,” Dr. Fanelli said – some of the new devices promise to tilt treatment away from the purely surgical approach toward an endoscopic one. Gastroenterologists are enthusiastic about the new wave of obesity devices that can be placed without surgery, bringing their field closer to the cutting edge of weight-loss intervention, Dr. Fanelli said, but cautioned that obesity always necessitates a multidisciplinary approach, whether treated surgically or medically.

“All of the enthusiasm about new procedures to be done has to occur within the context of a multidisciplinary weight-loss clinic with psychological evaluation, behavioral coaching, smoking cessation, and other components essential to improving population health,” he said.

Dr. Fanelli’s own surgical practice incorporates basic and advanced endoscopic procedures. “I’ve dedicated my career to running this kind of hybrid practice, and there are growing numbers of us out there,” said Dr. Fanelli.

One speaker at the seminar, Dr. Dmitry Oleynikov of the University of Nebraska Medical Center in Omaha will discuss outcome measures for bariatric procedures.

Dr. Fanelli pointed to Dr. Oleynikov as a surgeon emblematic of the increasingly fluid barriers between the fields of gastroenterology and surgery. “He’s a really inventive guy who has developed equipment, including a microrobotic surgical platform, and he’s a bariatric surgeon involved with endoscopy. I like the way he thinks, I like the way he’s designed his career path, and I think that he can help us establish creative discussion.”

Like many participants who will attend the summit, Dr. Fanelli is extensively involved in new product development – a key area of interest to participants at the seminar, which is sponsored by the AGA Center for GI Innovation and Technology.

One device Dr. Fanelli conceptualized, an intestinal sleeve that can be tuned using radiofrequency from outside, “was too expensive to produce, so it’s on the shelf right now.” Dr. Fanelli noted that this was the nature of the device development process – ideas can hang around a while until the time is right to revisit them.

The science behind the recently approved vagal nerve–blocking device is based on data and concepts accumulated over time, he added. “If you go back to some of the initial research that was done after bypass, with the identification of hormonal pathways and fat-burning triggers, that’s partly where stimulation devices came from,” he said. “A lot of ideas have been percolating for 5-15 years, and it gets to the point where you begin to see something concrete that emerges from it.”

Speaking directly to that idea – how to think about new obesity devices in a regulatory and research context – will be FDA’s Dr. Martha Betz. “Physicians, surgeons, and industry alike all want to know what the pathways to market are,” Dr. Fanelli said, adding that Dr. Betz and other members of the FDA Center for Devices and Radiological Health can help “outline a pathway by which the FDA can determine the safety of a device, but then it is up to insurers to recognize their responsibility in this process as well and to transparently outline the pathway to payment, even if only for limited use in collecting larger series of cases.”

This is where the AGA Center for GI Innovation and Technology comes in – to guide medical device and therapeutics innovators through the technology development and complex adoption process. The center also has a registry initiative that helps companies identify and gather the data and evidence required by physician members, payers, and regulatory agencies to demonstrate that the technologies improve patient outcomes and hopefully reduce costs to the system.

“This is the real benefit of the AGA registry initiative, to gather data, and with this unique conference; having all the stakeholders in one room is the best way of modernizing an outdated process that allows disruptive technologies to die on the vine,” Dr. Fanelli said.