Magnesium Elektron announces long-term research and development collaboration with Biotronik and production of Synermag® 410 bioresorable alloy system
10th March 2016
MANCHESTER, England–(BUSINESS WIRE)–Magnesium Elektron, a world leader in the development, manufacture and supply of high-performance magnesium alloys, announced that BIOTRONIK, a leading developer, manufacturer and distributor of cardio and endovascular medical technology, has been its partner in the development of its SynerMag® bioresorbable magnesium alloys for cardiovascular application.
The two companies entered into a joint research and development program in 2006 aimed at developing a bioresorbable magnesium coronary scaffold. The ten-year research program has resulted in Elektron’s SynerMag® 410 alloy system being used as the platform material in the BIOTRONIK Magnesium Scaffold, the world’s first clinically proven magnesium-based bioresorbable scaffold. The latest generation BIOTRONIK Magnesium Scaffold was clinically evaluated in the recent BIOSOLVE II study.
The clinical data from BIOSOLVE II will be used to obtain CE approval for the device, and the release of the data was accompanied by publication in the prestigious journal, The Lancet. Graham Wardlow, Managing Director of Magnesium Elektron’s operations in the U.K. and involved in the BIOTRONIK program since 2006, commented, “The joint collaboration between our two companies has been the key element in the advancement of this new platform technology.
The demands of the application and its operating environment threw up many challenges, and we could not have achieved the advances in alloy technology if it were not for the commitment of everyone involved in the program and the outstanding technical feedback we received from BIOTRONIK on the performance of our materials. We look forward to the product launch of the BIOTRONIK Magnesium Scaffold and the advancement of the SynerMag® range of bioresorbable magnesium alloys into new medical fields.”
Production of Elektron’s SynerMag 410 alloy system takes place in a new purpose- built manufacturing and testing facility in Manchester, U.K. The facility, which achieved ISO 13485 approval in 2014, is one of the most advanced facilities of its kind and ensures BIOTRONIK has a class-leading facility in its supply chain that will directly support its own production activities for the BIOTRONIK Magnesium Scaffold.
About Magnesium Elektron
Founded in 1936, Magnesium Elektron (www.magnesium-elektron.com) is an operating company of Luxfer Group (NYSE: LXFR, www.luxfer.com), a global materials technology company specializing in the design and manufacture of high-performance materials, components and gas-containment devices for environmental, healthcare, protection and specialty end-markets.
One of the world’s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring®; Pulsar, the world’s first 4 F compatible stent for treating long lesions; Orsiro, the industry’s first hybrid drug-eluting stent; and the world’s first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI® technology.