Magnesium Elektron and Biotronik have partnered to develop the SynerMag bioresorbable magnesium alloys for applications in cardiovascular medicine.
The joint research and development program began in 2006, with the aim of developing a bioresorbable magnesium coronary scaffold. Ten years of research have led to Elektron’s SynerMag 410 alloy system comprising the Biotronik Magnesium Scaffold. According to a company release, this is 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 in an application for CE approval for the device. The release of this data was accompanied by publication in The Lancet.
Production of Elektron’s SynerMag 410 alloy system takes place in a new purpose-built manufacturing and testing facility in Manchester, UK. The facility, which achieved ISO International Standard 13485 approval in 2014, will directly support its own production activities for the Biotronik Magnesium Scaffold.