When surgeons remove a diseased part of the intestine during gastric surgery, the reconnection of the two healthy ends, usually with suturing or stapling, is called an anastomosis. When the procedure goes well, the patient is ready to go home within a few days, but if there is a leak at the surgery site this is a potentially serious complication that requires further intervention and a much longer hospital stay. Stepping up to solve the leakage problem is PLIO Surgical, a Trinity College spin-out which has developed a minimally invasive medical device that provides a safer and more effective alternative to traditional closing techniques for this type of challenging surgery.
Surgeons do their utmost to avoid leaks but where they do happen the patient’s hospital stay goes up by an average of 12 days. And if faecal matter enters the abdominal cavity as a result of the leak, this can lead to sepsis and even death. “Despite advances in surgical techniques and tools, the anastomotic leakage rate continues to be high – 20 per cent in certain procedures,” explains PLIO Surgical’s chief executive Cristina Purtill.
“Creating a surgical anastomosis is a complex procedure normally completed by hand-suturing or surgical stapling. Hand suturing requires a high level of surgical skill and adds 30 minutes to the operation, increasing the risk of infection and blood loss. On the other hand, metallic staples are not absorbed by the body and they create a ring in the intestine that can lead to strictures and obstructions that can cause problems during the rest of a patient’s life.
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“It is very difficult to anchor anything within the bowel as it’s designed to keep things moving along, but our device uses magnets instead of stapling to bring the ends of the intestine together,” adds Purtill who comes from a background in the multinational healthcare sector and became interested in entrepreneurship while studying for an MBA at Georgia Tech in Atlanta.
“Specially designed (and patented) tissue anchors grip the inside of the slippery intestine without the need for suturing or stapling and the magnets compress the tissue allowing the healing to happen,” Purtill says. “Once this happens the device detaches and passes naturally leaving nothing behind in the patient.”
Another unique feature of PLIO’s device is its elasticity which means it can be neatly compressed within a delivery system. Once the target site is reached it gets pushed out and bounces back to its original implant shape. The softness of the device also makes the anastomosis procedure much easier from a surgical perspective, Purtill says.
The initial application of the PLIO device will be for colon cancer. In 2020, 1.9 million people were diagnosed with the disease and this is expected to rise to 2.9 million by 2040 due to greater longevity and a combination of poor lifestyle factors. Other applications for the device will include Crohn’s disease and bariatric surgery.
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The company is at pre-submission stage with the Food and Drug Administration and the first human clinical studies will begin within the next two years. The device will have a shorter road to regulatory approval than permanent medical devices as it only remains inside the body for 30 days.
PLIO is the latest innovation to emerge from Trinity’s thriving medical devices incubator which is run by Prof Bruce Murphy. The ground-breaking Croí Valve device, which treats defective heart valves, also started life there. PLIO has been in development since 2020 and was spun into the incubator in 2022. It will shortly take a major step towards commercialisation as Purtill and her current team of two prepare for a seed round of €3.6 million to finish the product development and expand the team with additional engineers as well as regulatory and clinical experts. PLIO’s development to date has been supported by an Enterprise Ireland commercialisation funding grant of about €500,000.
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