amg International GmbH Receives European CE Mark Approval for ARCHIMEDES Biodegradable Biliary and Pancreatic Stent
WINSEN, Germany, June 14, 2018 /PRNewswire/ -- amg International GmbH (amg), a wholly owned subsidiary of Dublin, Ireland based Q3 Medical Devices Limited (Q3), announced that it has received CE Mark approval for the ARCHIMEDES Biodegradable Biliary and Pancreatic Stent, allowing the company to begin selling the product in Europe and other markets.
ARCHIMEDES is the only fully biodegradable biliary and pancreatic 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. It is intended as an option to avoid repeat procedures to remove traditional non-biodegradable plastic stents, avoiding adding additional cost of care and risk for patients.
Eric K. Mangiardi, CEO of Q3 said, "The ARCHIMEDES Biodegradable Stent represents a major breakthrough in the treatment of obstructive biliary and pancreatic disorders, and also in the field of biodegradable and bioresorbable materials and their application in medical devices moving forward." He added, "This technology has numerous benefits for patients, doctors, and healthcare providers as it has the potential to reduce complication rates typically associated with plastic stents and removal procedures."
"This CE Mark approval is a major advancement in the treatment of obstructive biliary and pancreatic disorders and provides physicians such as myself, a truly innovative and advanced treatment option for my patients," said Dr. Sundeep Lakhtakia of the Asian Institute of Gastroenterology in Hyderabad, India. "This is great news, as a fully biodegradable stent has the potential to reduce complication rates and procedural costs typically associated with biliary and pancreatic stenting," Noted Dr. Paul Yeaton, Chief of Gastroenterology at the Carilion Clinic in Roanoke, VA.
In a recent safety and efficacy clinical study conducted in India and Malaysia, the ARCHIMEDES Biodegradable Biliary/Pancreatic Stent showed zero stent related complications during the study period including 53 patients.
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 a strong global partnerships, and an ever growing strategic investor base, including China Pioneer Pharma Holdings Limited listed on the Hong Kong Exchange (1345) 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 | CEO | Q3 Medical Devices Ltd.
Email: 197167@email4pr.com
Phone: +353867827296
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SOURCE Q3 Medical Devices Limited
