February 24, 2020

BIOFLOW-V 3-Year Data Presented for Biotronik’s Ultrathin-Strut Orsiro DES

February 24, 2020—Biotronik announced that 3-year data from the BIOFLOW-V trial were presented at CRT 2020, the Cardiovascular Research Technologies scientific conference held February 22–25 in National Harbor, Maryland. The study results were published simultaneously by David E. Kandzari, MD, et al in Journal of the American College of Cardiology: Cardiovascular Interventions.

According to the company, the 3-year follow-up data demonstrate consistently lower clinical event rates and improvement in patient outcomes, reinforcing the differentiation of the ultrathin-strut Orsiro coronary drug-eluting stent (DES) versus the thin durable polymer Xience everolimus-eluting stent (Abbott).

The Orsiro cobalt chromium metal stent elutes sirolimus via Biotronik’s Biolute bioabsorbable polymer coating. Beneath the bioabsorbable layer is the company’s ProBio coating, a silicon carbide layer covering the bare-metal surface and designed to reduce nickel ion release. The Orsiro stent system is designed to provide ultrathin stent struts without compromising radial strength and a low crossing profile for easier lesion cross in complex percutaneous coronary interventions.

The FDA approved the Orsiro DES in February 2019, and the device received CE Mark approval in 2011.

In the pivotal BIOFLOW-V trial, the Orsiro DES demonstrated significantly lower rates for target lesion failure (TLF) and target vessel myocardial infarction (TV-MI) at 12 months in comparison to Xience in a large, complex patient population (n = 1,344). At 2 years, treatment with Orsiro further improved event rates compared with Xience, including a significant reduction in target lesion revascularization (TLR) and spontaneous MI.

According to the company, the 3-year results showed that Orsiro outperformed Xience across the most important secondary endpoints of BIOFLOW-V.

  • 40% lower TLF rate (8.6% vs 14.4%; P = .003)
  • 52% lower ischemia-driven TLR rate (3.4% vs 6.9%; P = .008)
  • 46% lower rate of TV-MI (5.5% vs 10.1%; P = .004)
  • 90% lower late/very late definite/probable stent thrombosis rate (0.1% vs 1.2%; P = .018)

Dr. Kandzari, the BIOFLOW-V United States Principal Investigator, commented in the company announcement, “Orsiro sets a new standard for safety and efficacy in long-term clinical endpoints, including statistically lower TLR and TV-MI rates. BIOFLOW-V data are the best clinical outcomes observed among comparative clinical trials with contemporary DES. It was widely believed that safety and efficacy with DES had plateaued, but Orsiro has surpassed the limits. Year after year, the results have been impressive.” Dr. Kandzari is from the Piedmont Heart Institute in Atlanta, Georgia.


February 24, 2020

Thirty-Day Data From Low-Risk TAVR Trial Published and Presented

February 20, 2020

FDA Approves Early Feasibility Study and Grants Breakthrough Device Designation for Cardiovalve System