FDA Approves BIOTRONIK's Ultrathin Orsiro Stent for the Treatment of Coronary Artery Disease

Orsiro Achieves Statistically Lower Clinical Event Rates and Superior Patient Outcomes

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Feb 22, 2019, 12:10 ET

LAKE OSWEGO, Ore., Feb. 22, 2019 /PRNewswire/ -- BIOTRONIK today announced FDA approval of the Orsiro drug-eluting stent (DES) system. Orsiro is the first and only ultrathin DES to outperform the clinical standard, Xience.^1,2 Orsiro received CE marking in 2011 and has been used to treat more than one million patients worldwide to date.

"The Orsiro stent will be a welcomed addition to the US clinical practice as it already has been worldwide," says Dr. David Kandzari. "We have a drug-eluting stent that is superior with regard to many safety and efficacy endpoints that we haven’t observed with other contemporary drug-eluting stents."

The ultrathin strut Orsiro drug-eluting stent system is now available in the US for use in percutaneous coronary intervention procedures.

Orsiro's unprecedented clinical performance in the BIOFLOW-V pivotal trial 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). 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. The two year results presented at TCT 2018 and published in the Journal of the American College of Cardiology show a 37 percent lower TLF rate in favor of Orsiro (7.5 percent versus 11.9 percent TLF rate, p-value=0.015), a 47 percent lower ischemia-driven TLR rate, and a 70 percent lower rate of spontaneous MI (landmark analysis 31 days to two years follow-up).³

"Orsiro has set a new standard for safety and efficacy clinical endpoints, including statistically lower target lesion revascularization and target vessel MI rates," said Dr. David Kandzari, BIOFLOW-V US principal investigator, Piedmont Heart Institute, Atlanta. "BIOFLOW-V data are the best clinical outcomes witnessed with modern DES. It was largely thought that efficacy findings were unsurpassable, but Orsiro proves we can further reduce event rates with meaningful innovation."

For use in percutaneous coronary intervention (PCI) procedures, the cobalt chromium metal stent elutes sirolimus via BIOlute™, BIOTRONIK's bioabsorbable polymer coating. Beneath the bioabsorbable layer is BIOTRONIK's proBIO™, a passive coating on the bare metal surface, designed to reduce nickel ion release. The Orsiro stent system provides ultrathin stent struts without compromising radial strength, and a low crossing profile for easier lesion cross in complex PCI.⁴ It is available in 52 sizes ranging from 2.25 to 4.0 mm in diameter and lengths up to 40 mm, the longest available in the United States.⁵

"The FDA approval of Orsiro changes the dynamic of what had become a highly commoditized DES market," said Ryan Walters, President at BIOTRONIK, Inc. "We designed Orsiro for use even in challenging cases with features that make it unlike any other DES in the world. Hospital administrators now have available a DES that shows improved clinical event rates and interventionalists can rely on Orsiro's deliverability to treat complex lesions⁶ and challenging subgroups to achieve unprecedented patient outcomes. Patients, physicians and health systems deserve the best, and that is exactly what we are bringing to the US market."

Orsiro is now commercially available in the US.

References
¹Xience is a trademark or registered trademark of Abbott Cardiovascular Systems.
²Kandzari D et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. The Lancet 390.10105 (2017): 843-1852.
³http://www.onlinejacc.org/content/72/25/3287
⁴ BIOTRONIK data on file.
⁵ As per IFU.
⁶ Orsiro is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm and lesion length of ≤ 36 mm.

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 represented in over 100 countries. BIOTRONIK has US offices in New York City and Lake Oswego, Oregon.

For more information, visit: www.biotronik.com.
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SOURCE BIOTRONIK