amg International GmbH Performs First Clinical Cases in Europe with New Biodegradable Biliary/Pancreatic Stent Since Receiving CE Mark in June

Published: Sep 13, 2018

 

The World's Only Biodegradable Biliary/Pancreatic Stent was CE Mark Approved in June 2018

 
 

DUBLIN, Sept. 13, 2018 /PRNewswire/ -- amg International GmbH (amg), a wholly owned subsidiary of Dublin, Ireland based Q3 Medical Devices Limited (Q3), announced that several clinical cases were performed in Europe with ARCHIMEDES, its new fully biodegradable biliary/pancreatic stent. The ARCHIMEDES biodegradable stent is deployed in the same manner as its traditional plastic counterpart, however, as a biodegradable implant it has the added benefit of eliminating the secondary implant removal procedure that the estimated 1.5 million annually placed plastic stents require. The biodegradable nature of the ARCHIMEDES stent allows patients to avoid the cost and complications associated with traditional plastic stents.

The ARCHIMEDES Biodegradable Biliary/Pancreatic Stent is currently the first and only, fully biodegradable stent approved for placement in obstructed biliary or pancreatic ducts in the world. While biliary and pancreatic duct stents are typically made of plastic or metal, amg's ARCHIMEDES stent is made of a combination of dissolving materials permitting different rates of degradation depending on the clinical indication. The ARCHIMEDES stent is designed to completely degrade via hydrolysis in approximately 12 days, 20, days or 11 weeks, depending on its composition. The stent is designed to maintain duct patency, without occlusion as it degrades, due to its patented design. Occlusion is a common problem with traditional stents and according to literature, may occur up to 30% of the time.

The first European clinical cases were completed across five sites in Spain, Italy, and Finland. In Spain, cases were performed by Dr. Manuel Perez-Miranda at the Hospital Universitario Rio Hortega in Valladolid, Spain and by Dr. Miguel Ángel Simón Marco and Dr. Julio Ducóns García at the Hospitals Quirónsalud Zaragoza in Zaragoza, Spain. In Italy several cases were completed in Milan by Dr. Andrea Anderloni and Dr. Alessandro Repici at Humanitas University and by Dr. Francesco Di Matteo at the Campus Biomedico di Romo in Rome. The initial cases in Finland were performed by Dr. Leena Kylanpaa and her team at the Meilahti Tower Hospital in Helsinki.

The cases varied showing the versatility of the ARCHIMEDES, ranging from prophylactic placement alongside a traditional metal biliary stent as a bridge to surgery for a patient with a large mass in the lower bile duct to serial placement for a patient in order to effectively drain the common bile duct following stone removal, and also to maintain patency of a choledochal stenosis following the removal of metal stent that had migrated into the duodenum.

"It's not just about saving money, though the ARCHIMEDES does that," said Dr. Kylanpaa, "it's also about the saving of the patient's time and that of the doctor's that is equally important [SIC] by not having to bring the patient back for the removal of the stent."

Dr. Alessandro Repici remarked, "This innovative, cutting-edge technology has the potential to resolve many unmet needs in the field of benign/malignant conditions."

"The initial clinical cases completed across Europe by these renowned physicians really showed the versatility and potential benefit of the ARCHIMEDES biodegradable stent across a wide variety of case types," said Eric K. Mangiardi, President and CEO of Q3 Medical Devices Limited. "Our goal in the development of the ARCHIMEDES Biodegradable Stent, as well as the other bioresorbable products in our portfolio, is to provide doctors with a revolutionary tool to truly help their patients while potentially minimizing known complications with the existing technology."

If you would like more information, please contact Eric K. Mangiardi at emangiardi@q3medical.com.

About Q3 Medical Devices Ltd.

Q3 Medical Devices Ltd. is an Ireland based holding company with multiple global operations in Germany, China, & the United States along with strong global partnerships, and an ever growing strategic investor base, including China Pioneer Pharma Holdings Limited listed on the Hong Kong Exchange and Boill Holding Group, Shanghai China. The holding and its companies are focused on the development, manufacturing and distribution of its novel bioresorbable, micro invasive, drug delivery, and core products platforms for interventional cardiology, peripheral vascular, and non-vascular diseases.

Q3 Medical Devices Ltd. was formed by a global group of entrepreneurs, manufactures, distributors, industry doctors, and investors, focused on the development and acquisition of medical device businesses with annual revenues between 1-10 Million. The acquisitions are targeted in areas that expand the groups manufacturing base and capabilities, grow its distribution channel and accelerate its products offering, focusing on the minimally invasive treatment of patients with cardiology, peripheral vascular and non-vascular diseases.

For further information, visit http://www.q3medical.com/.

Forward Looking Statements

This announcement includes "forward-looking statements" which incorporate all statements other than statements of historical facts, including, without limitation, those regarding the Group's financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Group's products and services), and any statements preceded by, followed by or that include forward-looking terminology such as the words "targets", "believes", "estimates", "expects", "aims", "intends", "will", "can", "may", "anticipates", "would", "should", "could" or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Group's control that could cause the actual results, performance or achievements of the Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group´s present and future business strategies and the environment in which the Group will operate in the future. Among the important factors that could cause the Group's actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to Q3 Medical's & QualiMed's funding requirements, regulatory approvals, clinical trials, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements are valid at the date of this announcement. The Group expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Group's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, readers are cautioned not to rely on any forward-looking statement.

Contact: Eric K. Mangiardi, President & CEO, Q3 Medical Devices Limited
Email: 201625@email4pr.com
Phone: +353867827296

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SOURCE Q3 Medical Devices Limited

 

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