William of Ockham would have been proud because, in this year’s American Gastroenterological Association’s Shark Tank pitch competition, a product clearly demonstrated Okham’s razor (which sometimes the simplest solution is the best) and came out as the winner at the AGA Tech 2021 Summit sponsored by AGA Center for GI Innovation and Technology.
Among five innovative products, ranging from an educational application to a high-tech anorectal sensor, all aimed at improving outcomes in patients with gastrointestinal disorders, the winner was … drumroll please …
This is. A needle. But not like any other needle.
Winner: Toufic Kachaamy, MD, FASGE, AGAF – The Sure Access Needle
The Sure Access needle, invented by Kachaamy, business leader in cancer treatment centers in America, Phoenix, is a simple device that overcomes a long-standing challenge presented by retrograde endoscopic cholangiopancreatography (ERCP): biliary access.
Many “ERCPs are considered difficult and sometimes fail, depending on the center and endoscopist,” Kachaamy said during a virtual presentation. “Most failures are due to failed initial access to the bile duct.”
In fact, one study cited a ductal cannulation failure rate of 5% to 15%, even among experienced hands.
Kachaamy noted that failure can have several consequences, including increased complications, higher cost, delayed care, longer hospitalization, and a greater likelihood of patient transfer.
He went on to explain why biliary access can be so difficult and how the safe access needle helps solve these problems.
“[The] two main limitations [during endoscopic ultrasound–guided biliary access] “We’re directing the cable to the narrow areas and cutting the cable while we’re manipulating the cable to get it where we want it,” Kachaamy said.[The Sure Access Needle] is a 19-22 gauge rotating needle with a soft side outlet for the thread to allow handling and direction of the thread without cutting it. “
Kachaamy highlighted the simple design, which will keep the cost of production below $ 300 per unit, and suggested that failed ERCPs are just the first potential indication of many. Future uses may include gallbladder access, peri-GI collection, gastrojejunostomy, and others.
In an interview, Kachaamy reacted to the victory, which follows two years of collaborative development with America’s cancer treatment centers.
“For people who are innovative, there is nothing that seems more rewarding than their ideas being recognized by adding something to the field and being able to help people and patients,” Kachaamy said. “Time [this is] very, very, very exciting. Very rewarding. Pride would probably be the best way to describe it. “
Kachaamy anticipates that the Sure Access needle will be commercially available within 1 to 2 years, pending regulatory approval. Meanwhile, he and his colleagues are looking for a strategic partner.
A shark speaks
V. Raman Muthusamy, MD, AGAF, immediate president of the AGA Center for Innovation and GI Technology and director of endoscopy at UCLA Health System, moderated the Shark Tank session and called it “the highlight” of the AGA Tech Summit.
Muthusamy and four other “sharks,” including a gastroenterologist, a venture capitalist, a regulator reviewer, and an entrepreneur, scored the launches using three equally weighted categories: launch quality, level of innovation, and impact. on the ground and the quality of the business plan and overall viability.
“We saw a full spectrum [of innovations]”, Said Muthusamy.” I think it was a nice session. “
Behind closed doors, the Sharks reduced the field to two of the best candidates. Ultimately, however, there could only be one winner: Kachaamy. His decision was aligned with a “Fan Favorite” audience poll.
“A lot of [Kachaamy’s win] “It had to do with possible applications and the common point of the problem,” Muthusamy said in an interview. He highlighted how the Sure Access Needle allows an immediate response to the ERCP error without the need for a second procedure.
Muthusamy also noted that several product designs previously failed to achieve what the Sure Access Needle has the potential to do.
“I think the feeling was that it seemed like a way that could address some of the limitations and challenges we’ve had with before. [attempts at solving this problem]Said Muthusamy.
For innovators who didn’t make the cut this year or those with products that are still in development, Muthusamy suggested it be introduced next year.
“We encourage our colleagues and AGA members to continue to implement this program,” Muthusamy said.
Other fish in the sea
Four more innovators entered the AGA Shark Tank this year. Here are snippets of releases:
Hans Gregersen, MD, PhD, MPH – Fecobionics
“Fecobionics is a simulated electronic stool with normal stool consistency and shape,” Gregersen said.
The balloon device, which contains multiple sensors, provides “real-time, quantitative, mechanistic information simulating defecation.”
“It … fits into the rectum,” Gregersen said. “It measures multiple pressures; it has gyroscopes that measure orientation; we can calculate the flexion of the device and we can calculate the shape of the device.”
According to Gregersen, Fecobionics has a “diagnostic potential for patients with fecal incontinence and to subtype patients with constipation“It highlighted fewer false positives than current technology, along with greater efficiency and lower cost.
Gregersen is a research professor at the California Medical Innovations Institute, San Diego.
Mary J. Pattison, RN – Trans-abdominal gastric surgical system ( TAGSS )
TAGSS is a trans-abdominal gastric access device that “represents a new and exciting means of addressing multiple gastrointestinal conditions that do not have a standardized approach,” Ms. Pattison. “Simply located as [percutaneous endoscopic gastrostomy tube], TAGSS offers harmful technology to address [gastroesophageal reflux disease], background application, achalasia, gastroparesis, gastric tumors and even obesity in a safe, efficient and cost-effective way. TAGSS offers the first real hybrid approach for endoscopic / laparoscopic collaboration “.
Pattison is a clinical nurse and endoscopy assistant at WestGlen GI Consultants, Weston, Mo.
Pankaj Rajvanshi, MD, FAASLD: Healthswim application
“Right now, most of the patient education is provided by Google,” Rajvanshi said, “and we want to change that. We’ve built a platform that will allow you, the doctor, to create personalized, curated, and credible content that is can deliver seamlessly to your patients continuously “.
Through the Healthswim app, patients subscribe to their providers and allow access to doctor-approved content. Subscribers also receive updates from the provider through their social media channels.
Rajvanshi is a gastroenterologist at Swedish Medical Center, Seattle.
Ali S. Karakurum, MD, FACP, FACG: a device for the elimination of esophageal eating disorders
“I would like to propose a device that consists of a transparent overflow, a cylindrical folding plastic basket fixed to the distal end of the ubsub … and a fixing wire fixed to the distal end of the basket that is controlled by using the handle of the box externally, ”Karakurum said. “The device advances progressively over the scope of the basket to include the food bolus under direct display. Once the food bolus is inside the basket, the wire loop at the end of the basket closes through the handle. external, the food bolus from the basket to safely remove it “.
Karakurum is a gastroenterologist at Advanced Gastroenterology & Endoscopy, Port Jefferson, New York
This article originally appeared on News on GI and Hepatology, the official newspaper of the AGA Institute.