The G-BA has announced it will not perform a § 137h evaluation on external stabilization of arteriovenous anastomosis using a scaffold
After a hospital submitted documents on the 6th of March, the Federal Joint Committee (G-BA) evaluated whether the method “external stabilization in arteriovenous anastomosis using a scaffold when implementing haemodialysis shunts” is eligible for a § 137h benefit assessment.
Approximately 10 weeks after the submission, the G-BA decided that the method is not based on a high-risk medical device. The scaffold is a risk-class IIb device, however it does not emit energy nor radioactive substances. It is therefore not classified as a high-risk medical device according to chapter 2 § 30 of the G-BA’s rules of procedure.