Biotronik gains FDA approval for the Orsiro Mission drug-eluting stent

Orsiro Mission DES
Orsiro Mission DES system

Biotronik has announced that it has received US Food and Drug Administration (FDA) approval of its Orsiro Mission bioabsorbable polymer drug-eluting stent system (BP-DES). The company also announced the first US implant and full commercial launch of the new DES system, which offers advanced deliverability and an ultrathin strut design considered the thinnest available in the USA.

“We welcome the availability of the Orsiro Mission DES in the US as a novel percutaneous coronary intervention device offering better outcomes,” said David Kandzari, chief of the Piedmont Heart Institute and Cardiovascular Service Line; director, Interventional Cardiology of the Piedmont Heart Institute; and chief scientific officer for Piedmont Healthcare in Atlanta, USA, whose facility is among the first to receive the newly approved device. “The outstanding deliverability and the extensive clinical data give strong evidence for continued Orsiro Mission adoption.”

TThe Orsiro Mission DES features the same proprietary stent design and innovative bioabsorbable coating with controlled drug release as the Orsiro stent. Improvements to the new Orsiro Mission DES system include a re-engineered delivery system and a new deep embedding process to further improve deliverability, including ‘best in class’ trackability and crossability, Biotronik said in a press release.

“We will continue to bolster our interventional cardiology portfolio with innovations like the Orsiro Mission and state-of-the-art PK Papyrus covered stent system to support and improve patient care,” said David Hayes, chief medical officer, Biotronik. “This emphasises our commitment to excellence and reinforces our vision to ensure the highest quality.”


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