Syntellix AG issued the following announcement on Oct. 30.
The U.S. Food & Drug Administration (FDA), Silver Spring / Maryland, has granted Syntellix's MAGNEZIX® CS 3.2 device and proposed indication for use the designation of a "Breakthrough Device".
In order to receive the Breakthrough Device designation, the MAGNEZIX®-based implant had to meet tough criteria and thus prove that it "provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions" and, additionally, that it either "represents breakthrough technology", "offers significant advantages over existing approved or cleared alternatives" or that its "availability is in the best interest of patients".
Syntellix CEO and Chairman of the Executive Board Prof. Dr. Utz Claassen commented the breaking news for the company as follows: "We feel very honored by the fact that the institution which we deeply respect as the 'Cathedral' of regulatory authorities in the world has classified our implant as a 'Breakthrough Device', which by definition of the relevant FDA criteria implies more effective treatment of life-threatening or irreversibly debilitating human disease or conditions. The COVID-19 pandemic has brought infection risks into the focus of public interest. Therefore, our products, which naturally avoid implant removal surgeries and related risks, as well as their life-saving character become even more relevant as an elementary building block for healthcare systems worldwide. I am sure that the FDA decision will act as a reference and catalyst for patients, doctors, healthcare providers, and healthcare authorities around the globe."
About Syntellix:
Syntellix AG, a global biomaterials pioneer engaged in biomedical engineering, material & life science, is the world's market and technology leader in the field of bioabsorbable metallic orthopaedic implants. The company has already been honored with numerous important awards and prizes, including, amongst others, the Innovation Award of the German Economy 2012/13, the Future Award 2016 of the German Healthcare Economy, the German Medical Award 2017, the Innovator of the Year 2017 Award, and the German Innovation Award in Gold 2019; Syntellix implants were also a winner in the Product of the Year category of the Sustainability Award 2018 program, and lately the company has won the renowned Award of Excellence by the International Magnesium Association (IMA). In recent peer-reviewed medical-scientific publications concerning various clinical applications, MAGNEZIX® implants have been rated as "being advantageous" or even "clinically superior" to conventional titanium implants.
Original source can be found here.
