Biotronik has announced CE mark approval of two new indications for the Orsiro Mission drug-eluting stent (DES).
These include one-month dual antiplatelet therapy (DAPT) for high bleeding risk (HBR) patients, allowing practitioners to offer personalised, shorter DAPT durations to their patients at high risk of bleeding events, in accordance with the most recent guidelines.
Additionally, the Orsiro Mission DES has been approved for calcified lesion treatment, allowing practitioners to target more complex lesions with moderate or severe calcification.
These new indications complement the recent global regulatory approval of the Orsiro Mission DES for an increased maximum allowed diameter (MAD) post-dilation (2.25–3mm, MAD: 4mm, 3.5–4mm, MAD: 5mm).
Following these approvals, labelling including adapted Instructions for Use will become effective in the coming months, pending further national regulatory approvals.
