|By PR Newswire||
|March 24, 2014 03:00 AM EDT||
KUALA LUMPUR, Malaysia, March 24, 2014 /PRNewswire/ -- The Endoscopy Centre of UKM Medical Centre (UKMMC) is making history by successfully utilizing, first in Asia, a biodegradable stent on a 56 year old patient who presented acute cholangitis.
The novel biodegradable stent for biliary and pancreatic duct is a revolutionary new idea and it was made available by QualiMed Innovative Medizinprodukte GmbH, a Q3 Medical Devices Ltd, subsidiary, a well known innovative medical devices company from Germany.
The stent is made of well known polymers similar to the ones used in medical sutures. It remains in the biliary duct until the cholangitis is resolved, before it is slowly hydrolysed by the body. According to Dr. Hairol Othman, a consultant hepatobiliary and pancreas surgeon at UKMMC, a patient has to undergo another procedure to remove the stents, when using the conventional ones.
The Archimedes device comes with three degradation times to accommodate the various disease states that require different indwelling times for treatment. [Fast absorbing (weeks), medium absorbing (months), and a long last (closer to a half year)] Unlike traditional plastic biliary stents that are used hundreds of thousands of times per year and have to be removed and/or exchanged routinely to relieve the Archimedes device can be used and implanted using the exact techniques applied with the existing technology with the added benefit of allowing the bile to flow on the outside of the devices as well as through the center helping to minimize the potential for post implant obstruction while eliminating the cost and risk associated with the removal procedures. The elimination of removal procedures is expected to significantly reduce total procedure cost for the patients that are treated with the Archimedes device. The device is for investigational purposes only and is not CE or FDA approved at this time.
Speaking after the successful surgery, Dr. Hairol said: "Archimedes biodegradable stents are a revolutionary new concept in the biliary and pancreatic duct drainage. They are easy to deploy and very convenient for the patients. They negate the need for a repeat ERCP, hence reducing patients' anxiety and inconvenience. Plus, they do incur only one cost compared to conventional stents."
The Endoscopy Centre of UKMMC has been chosen to participate in the multi-centre phase 1 clinical trial for the biodegradable stents in Asia.
Speaking on behalf of Q3 Medical and QualiMed Eric K Mangiardi, CEO of Q3 Medical, commented: "This is a significant milestone for the company as we continue to explore developments in the area of biodegradable implants, that will improve efficacy and eliminate cost for the patients and care givers that treat them. We are continuing our development in the areas of fully covered biodegradable esopahageal and balloon expandible biodegradable, covered and uncovered biodegradable biliary and peripheral vascular devices that will further the advancement and treatment options for patients and doctors globally."
About Q3 Medical Devices Limited
Q3 Medical Devices Limited is an Irish based holding company with multiple operations in Germany and strong partnerships throughout Asia through its growing investor base, including China Pioneer Pharma Holdings Limited listed on the Hong Kong Exchange (1345). The holding and its companies are focused on the development, manufacturing and distribution of minimally invasive devices for the treatment of patients with cardiology, peripheral vascular and non-vascular diseases.
Q3 Medical Devices Limited 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, resulting in the growth of its distribution channels and accelerating its products offering, focusing on the minimally invasive treatment of patients with cardiology, peripheral vascular and non-vascular diseases.
QualiMed, a wholly owned subsidiary of Q3 Medical, was founded in 1997 in Winsen, Germany near Hamburg, where it develops, manufactures and sells implantable medical devices in the Cardiology, Peripheral Vascular, and Non Vascular areas. The innovations are focused in the areas of Biodegradable Products, Drug Device Combination Technologies, Catheter and Mechanical implant areas. Originally founded as an OEM, the company's products are now sold in over 50 countries worldwide through its OEM, Private Label, and Own Brand Networks. The company and its development partners have obtained CE and FDA approvals for more than 70 different products including 3 different drug eluting stents.
Forward Looking Statements
This announcement includes "forward-looking statements" which incorporates 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 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.
For more enquiries and/or photos of event, please contact
Q3 Medical Devices Ltd
QualiMed Innovative Medizinprodukte GmbH
Tel: +49(0)417165780 (main office)
UKM Medical Centre (UKMMC), Cheras
Ms. Normahani Md. Ramdani
Public Relations Officer
(Email) [email protected]
Department of Public Relations
UKM Medical Centre
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