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# Biotronik PMA Approved for Orsiro Drug-eluting Stent
- URL: https://www.fdaweb.com/biotronik-pma-approved-for-orsiro-drug-eluting-stent/
- Published: 2019-02-22T12:00:00.000Z
- Updated: 2026-09-15T01:07:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143448

FDA has approved a Biotronik PMA for its Orsiro drug-eluting stent (DES) system. The company says the device is the first DES to outperform the clinical standard, Abbott’s Xience.

Orsiro is indicated for use in percutaneous coronary intervention procedures. The cobalt chromium metal stent elutes sirolimus via BIOlute, a bioabsorbable polymer coating, according to Biotronik. Beneath the coating is the company’s proBIO, a passive coating on the bare metal surface, designed to reduce nickel ion release, it says.

Approval was based on data from the [BIOFLOW-V](https://c212.net/c/link/?t=0&l=en&o=2383496-1&h=1027366718&u=https%3A%2F%2Fwww.biotronik.com%2Fen-us%2Fnewsroom%2Fpress-releases%2Fpress-release-vi-tct-bioflow-v-sep-24-en&a=BIOFLOW-V&ref=fdaweb.com) pivotal trial, which “demonstrated significantly lower rates for target lesion failure (TLF) and target vessel myocardial infarction (MI) at 12 months in comparison to Xience in a large, complex patient population (n=1,344),” Biotronik says. “At two years, treatment with Orsiro further improved event rates in comparison to Xience, including a significant reduction in target lesion revascularization (TLR) and spontaneous MI.”