Magnesium Elektron, U.K., announces that a ten-year research program with Biotronik, Germany, has resulted in Elektron’s SynerMag 410 alloy system being selected as the platform material in the Biotronik magnesium coronary scaffold. This is the world’s first clinically proven magnesium-based bioresorbable scaffold for cardiovascular applications.
In 2006, the two companies entered into a joint research and development program aimed at developing a bioresorbable magnesium coronary scaffold. Data from a recent Biosolve clinical study of SynerMag was published in The Lancet, and will also serve as the basis for receiving CE approval for the device.
“The joint collaboration between our two companies has been the key element in the advancement of this new platform technology,” says Graham Wardlow, Managing Director of Magnesium Elektron’s operations in the U.K. “The demands of the application and its operating environment included many challenges, and we could not have achieved the advances in alloy technology if it had not been for the commitment of everyone involved in the program. 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.”
The alloy system is produced 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 of its kind.
