BIOTRONIK’s Orsiro Mission drug-eluting stent approved by FDA PRODUCT

BIOTRONIK has 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.

The Orsiro DES is one of the most studied stents available today through numerous randomized controlled trials (RCTs), registries and meta-analyses. 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 crossability.

“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 key highlights from the Orsiro drugeluting stent clinical program demonstrating outstanding outcomes include:

  • 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 outcomes.
  • 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.