FDA Approval and First Implant of Orsiro Mission Drug-Eluting Stent System in the U.S.

LAKE OSWEGO, Ore., Sept. 29, 2021 /PRNewswire/ -- BIOTRONIK announced today it received U.S. Food and Drug Administration (FDA) approval of its Orsiro® Mission bioabsorbable polymer drug-eluting stent system (BP-DES). The company also announced the first U.S. 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 United States.

"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-analyses¹. 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 outcomes³:

• BIOFLOW-V three-year study 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.
• A systemic review and meta-analysis published in the European Heart Journal with more than 20,000 patients demonstrated that ultrathin strut Orsiro DES was associated with a 15% reduction in long-term TLF compared with conventional second generation DES⁵.

"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, M.D., Chief Medical Officer, BIOTRONIK, Inc. "This emphasizes our commitment to excellence and reinforces our vision to ensure the highest quality."

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:

1. 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.
2. In comparison to Xience Sierra, Resolute Onyx and Synergy for bench tests on pushability, trackability and crossability. BIOTRONIK data on file.
3. 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.
4. 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.
5. Mahesh V Madhavan, James P Howard, Azim Naqvi, Ori Ben-Yehuda, Bjorn Redfors, Megha Prasad, Bahira Shahim, Martin B Leon, Sripal Bangalore, Gregg W Stone, Yousif Ahmad, Long-term follow-up after ultrathin vs. conventional 2nd-generation drug-eluting stents: a systematic review and meta-analysis of randomized controlled trials, European Heart Journal, 2021; ehab280, https://doi.org/10.1093/eurheartj/ehab280

About Orsiro® Mission:
https://us.orsiro.com/orsiromission

About BIOTRONIK: 
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries.

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