Biotronik’s Orsiro Mission DES Approved for New Indications in Europe

January 14, 2025—Biotronik announced the approval of two new indications for the Orsiro Mission drug-eluting stent (DES): (1) 1-month dual antiplatelet therapy (DAPT) for high-bleeding-risk patients and (2) treatment of calcified lesions.

The company advised that labeling, including adapted instructions for use, will become effective in the coming months, pending further national regulatory approvals.

As described by Biotronik, 1-month DAPT for high-bleeding-risk patients allows interventionalists to offer personalized, shorter DAPT durations to these patients, in accordance with the most recent guidelines. The calcified lesions treatment indication allows interventionists to target more complex lesions with moderate or severe calcification, noted the company.

Biotronik added that these new indications complement the recent global regulatory approval of the Orsiro Mission DES (announced July 2024) for increased maximum allowed diameter (MAD) postdilation (2.25-3 mm, MAD: 4 mm; 3.5-4 mm, MAD: 5 mm).