FDA Approval and First Implant of Orsiro Mission Drug-Eluting Stent System in the U.S.
BIOTRONIK announced today it received U.S. Food and Drug Administration (FDA) approval of its Orsiro® Mission bioabsorbable polymer coronary drug-eluting stent system (BP-DES). The company also announced the first US implant and full commercial availability in the U.S.
"We welcome the availability of the Orsiro Mission DES in the US as a novel percutaneous coronary intervention device offering better outcomes," said Dr. 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."
The Orsiro DES is one of the most studied stents available today throughout numerous randomized controlled trials (RCTs), registries and meta-analyses*1. The 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 crossability2.
The key highlights from the Orsiro drug-eluting stent clinical program** demonstrating outstanding outcomes***3:
- BIOFLOW-V three-year study results with 1,334 patients shows that Orsiro DES offers a 40% lower target lesion failure rate (TLF) than Abbott's Xience DES, 46% lower target vessel myocardial infarction (TV-MI) rate, and 52% lower ischemia driven target lesion revascularization (TLR) rate. These findings suggest a new direction in improving next-generation drug-eluting stent technology and indicate that thinner struts are associated with improved clinical outcomes4.
- An extensive network meta-analysis of 77 RCTs published in JACC Cardiovascular Interventions with over 99,000 patients demonstrates that Orsiro DES had the highest probability of ranking as the best stent and was associated with a statistically significant lower rate of target lesion failure (TLF) than Abbott's Xience or Medtronic's Resolute1 DES.
- An investigator-initiated, multicenter, randomized, controlled superiority trial, establishing the superiority of Orsiro DES over durable-polymer everolimus-eluting stents including over 1,300 patients with acute ST Elevated Myocardial Infarction (STEMI). In the BIOSTEMI trial the ultrathin-strut Orsiro DES demonstrated superiority in the clinical primary endpoint of TLF at 12 months, which was further confirmed at 24 months with an incidence of 5.1%. In comparison, the Xience DES, showed an incidence of 8.1% at 24 months (Rate Ratio 0.58, 95% Bayesian credible interval, 0.40-0.84; posterior probability of superiority, 99.8%)5.
"Recent data has confirmed Orsiro Mission represents the best DES available to clinicians anywhere in the world," said Dr. Alexander Uhl, President Vascular Intervention at BIOTRONIK. "With the FDA approval we can now put an outstanding tool in the hands of US interventionalists."
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*in large RCTs, based on Taglieri et al. Meta-analysis, against currently used DES; ** Clinical data conducted with Orsiro, Orsiro Mission's predecessor device can be used to illustrate Orsiro Mission clinical outcomes; ***Based on investigator's interpretation of BIOFLOW-V primary endpoint results
Orsiro and Orsiro Mission are trademarks or registered trademarks of the BIOTRONIK Group of Companies.
All other trademarks or registered trademarks cited herein are the property of their respective owners.
References:
- Taglieri N, Bruno AG, Ghetti G, Marrozzini C, Saia F, Galié N, Palmerini T. Target Lesion Failure With Current Drug-Eluting Stents: Evidence From a Comprehensive Network Meta-Analysis. JACC Cardiovasc Interv. 2020 Dec 28;13(24):2868-2878. doi: 10.1016/j.jcin.2020.09.014. PMID: 33357524.
- In comparison to Xience Sierra, Resolute Onyx and Synergy for bench tests on pushability, trackability and crossability. BIOTRONIK data on file.
- Kandzari DE et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V). Lancet. 2017; 390(10105): 1843-1852
- Kandzari D et al. D et al. Ultrathin bioresorbable-polymer sirolimus-eluting stents versus thin durable-polymer everolimus-eluting stents for coronary revascularization: 3-year outcomes from the randomized BIOFLOW V trial. JACC: Cardiovascular Interventions. 2020. Supplementary material.
- Pilgrim et al. Biodegradable – versus durable-polymer drug-eluting stents for STEMI. Final 2-year outcomes of the BIOSTEMI trial. J Am Coll Cardiol. Cardiovasc Interven. 2021, doi: 10.1016/j.jcin.2020.12.011.
About Orsiro®Mission
