Charles Sternberg, Assistant Editor05.26.21
amg International GmbH, a wholly owned subsidiary of Q3 Medical Devices Limited (Q3), has received CE Mark approval for its second fully biodegradable product, the Unity-B balloon expandable biodegradable biliary stent (BEBS) for endoscopic use. The Unity-B will compliment Archimedes, the CE approved pancreaticobiliary biodegradable implant.
The Unity-B Biodegradable implant was developed as a complimentary biodegradable metallic stent to amg's Archimedes biodegradable pancreaticobiliary stent, which is currently available in fast, medium, and long-lasting degradation profiles.
The Unity-B biodegradable stent is a large diameter balloon expandable implant that is introduced endoscopically and is intended to facilitate the drainage of obstructed ducts requiring larger openings. The Unity-B biodegradable stent is designed to replace the global market for metal biliary implants.
Much like the Archimedes, the Unity-B biodegradable stent was developed as an alternative to avoid the second removal procedures required with the traditional fully and partially covered self-expanding metallic stents. The amg biodegradable portfolio provides an advanced treatment option to the traditional plastic and metallic implants used by Gastroenterologists, Surgeons, and Interventional Radiologist to reduce the total cost of care and complications associated with the older generation of non-biodegradable plastic and metallic implants.
"The CE mark approval of the Unity-B stent represents yet another milestone for amg International and all the companies of Q3 Medical and our mission to 'Create Value By Helping People'. In these uncertain times, being able to reduce the total cost of care using advanced, clinically proven products is more important than ever," said Eric K. Mangiardi, CEO of Q3. "As we continue the development of additional biodegradable technologies to expand our portfolio for use in the gastrointestinal tract and for the vasculature, we are striving to shift the paradigm for treatments by reducing complications and eliminating the need for additional removal procedures associated with the current treatment options.
"The approval of the Unity-B balloon-expandable biodegradable stent represents yet another major innovative breakthrough that provides my patients and I, a more optimal treatment solution for obstructed biliary ducts versus traditional non-degradable technology. These next-generation biodegradable stents can prove to be a game changer for endoscopic management of biliary obstruction. Additionally, with the current state of the global pandemic, biodegradable implants provide the opportunity to reduce both, the cost and avoidable exposure, through the elimination of the second removal procedure of conventional stents - thus lowering the overall burden to the healthcare systems around the world," said Dr Sundeep Lakhtakia of the Asian Institute of Gastroenterology in Hyderabad, India.
Clinical Study
In a recent safety and efficacy clinical study conducted, the Unity-B balloon expandable biodegradable biliary stent system showed no (0) Adverse Events and no (0) Serious Adverse Events reported as related or even possibly related to the Unity-B study device.
"The final clinical success evaluation resulted to a success rate of 94.4% which is outstanding in comparison to the ESGE 2012 guideline for traditional products, which just for stent dysfunction already reports 41%, 27% and 20% failure rate for plastic stents, uncovered SEMS (self-expandable metallic stents) and covered SEMS, respectively," stated Dr. Hairol A. Othman.
Further procedural success was almost 100% compared to the ESGE 2018 guideline which reports that ERCP procedures fail in 10% - 20% of patients. Dr. Hairol A. Othman and colleagues of Sunway Medical Centre, Kuala Lumpur, Malayasia further stated, "the result from our multi-center clinical study is very encouraging."
"This is positive news, as this new Biodegradable toolkit of the Unity-B balloon expandable biodegradable stent (BEBS) replacement for metal stents coupled with the ARCHIMEDES biodegradable replacement for plastic stents gives us the potential to reduce complication rates and procedural costs for removal typically associated with the older technology. In addition, the advancements can also be expanded to other indications in the gastrointestinal tract like the esophagus, colon, and pseudocyst drainage applications further expanding its utility and benefits," noted Dr. Paul Yeaton, chief of gastroenterology at the Carilion Clinic in Roanoke, VA.
The Unity-B Biodegradable implant was developed as a complimentary biodegradable metallic stent to amg's Archimedes biodegradable pancreaticobiliary stent, which is currently available in fast, medium, and long-lasting degradation profiles.
The Unity-B biodegradable stent is a large diameter balloon expandable implant that is introduced endoscopically and is intended to facilitate the drainage of obstructed ducts requiring larger openings. The Unity-B biodegradable stent is designed to replace the global market for metal biliary implants.
Much like the Archimedes, the Unity-B biodegradable stent was developed as an alternative to avoid the second removal procedures required with the traditional fully and partially covered self-expanding metallic stents. The amg biodegradable portfolio provides an advanced treatment option to the traditional plastic and metallic implants used by Gastroenterologists, Surgeons, and Interventional Radiologist to reduce the total cost of care and complications associated with the older generation of non-biodegradable plastic and metallic implants.
"The CE mark approval of the Unity-B stent represents yet another milestone for amg International and all the companies of Q3 Medical and our mission to 'Create Value By Helping People'. In these uncertain times, being able to reduce the total cost of care using advanced, clinically proven products is more important than ever," said Eric K. Mangiardi, CEO of Q3. "As we continue the development of additional biodegradable technologies to expand our portfolio for use in the gastrointestinal tract and for the vasculature, we are striving to shift the paradigm for treatments by reducing complications and eliminating the need for additional removal procedures associated with the current treatment options.
"The approval of the Unity-B balloon-expandable biodegradable stent represents yet another major innovative breakthrough that provides my patients and I, a more optimal treatment solution for obstructed biliary ducts versus traditional non-degradable technology. These next-generation biodegradable stents can prove to be a game changer for endoscopic management of biliary obstruction. Additionally, with the current state of the global pandemic, biodegradable implants provide the opportunity to reduce both, the cost and avoidable exposure, through the elimination of the second removal procedure of conventional stents - thus lowering the overall burden to the healthcare systems around the world," said Dr Sundeep Lakhtakia of the Asian Institute of Gastroenterology in Hyderabad, India.
Clinical Study
In a recent safety and efficacy clinical study conducted, the Unity-B balloon expandable biodegradable biliary stent system showed no (0) Adverse Events and no (0) Serious Adverse Events reported as related or even possibly related to the Unity-B study device.
"The final clinical success evaluation resulted to a success rate of 94.4% which is outstanding in comparison to the ESGE 2012 guideline for traditional products, which just for stent dysfunction already reports 41%, 27% and 20% failure rate for plastic stents, uncovered SEMS (self-expandable metallic stents) and covered SEMS, respectively," stated Dr. Hairol A. Othman.
Further procedural success was almost 100% compared to the ESGE 2018 guideline which reports that ERCP procedures fail in 10% - 20% of patients. Dr. Hairol A. Othman and colleagues of Sunway Medical Centre, Kuala Lumpur, Malayasia further stated, "the result from our multi-center clinical study is very encouraging."
"This is positive news, as this new Biodegradable toolkit of the Unity-B balloon expandable biodegradable stent (BEBS) replacement for metal stents coupled with the ARCHIMEDES biodegradable replacement for plastic stents gives us the potential to reduce complication rates and procedural costs for removal typically associated with the older technology. In addition, the advancements can also be expanded to other indications in the gastrointestinal tract like the esophagus, colon, and pseudocyst drainage applications further expanding its utility and benefits," noted Dr. Paul Yeaton, chief of gastroenterology at the Carilion Clinic in Roanoke, VA.
