TORONTO, Canada,
21
April
2021
|
08:59
Europe/Amsterdam

Health Canada Approves BIOTRONIK’s Orsiro Drug-Eluting Stent for the Treatment of Coronary Artery Disease

Montreal Heart Institute’s Dr. Jean-François Tanguay performs Canada’s first implantation of the Orsiro ultrathin strut drug-eluting stent

BIOTRONIK received Health Canada approval of the Orsiro® drug-eluting stent (DES) system in March 2021. It is the first and only ultrathin strut DES to outperform the former clinical standard, Xience DES1. Orsiro has been used to treat almost three million patients worldwide to date.

We are very happy that the drug-eluting stent Orsiro from BIOTRONIK is now available in Canada to treat our patients,” said Dr. Jean-François Tanguay, Interventional Cardiologist, Montreal Heart Institute, Montreal, Quebec, Canada, the first to implant Orsiro DES in Canada. “This DES has the thinnest strut thickness at 60 microns. It has demonstrated superior results and should allow for improved vascular healing post implantation.”

For use in percutaneous coronary intervention (PCI) procedures, the cobalt chromium metal stent is covered by a hybrid coating: BIOTRONIK’s proBIOTM coating – an amorphous silicon carbide coating – covers the bare metal stent surface to reduce interactions with surrounding tissue, while BIOTRONIK’s BIOluteTM coating – a bioabsorbable Poly-L-Lactide (PLLA) eluting a limus drug – on the outer surface allows controlled drug release of the drug-eluting stent2. The Orsiro stent system provides ultrathin stent struts without compromising radial strength, and a low crossing profile for easier lesion cross in complex PCI2. It is available in 52 sizes ranging from 2.25 to4.0 mm in diameter and lengths up to 40 mm3.

“Health Canada’s approval of the Orsiro DES means a truly better choice for Canadians. This is a stand-out DES, backed by clinical trials that show significantly improved patient outcomes”, said Dean Wood, Managing Director at BIOTRONIK Canada. “Canadian interventional cardiologists can now rely on Orsiro’s deliverability to treat complex lesions4 while patients can benefit from the consistently low event rates demonstrated in trials. Patients, physicians and health systems deserve the best, and that is exactly what we are bringing to the Canadian market.”

Orsiro DES is now commercially available in Canada.

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References:

1 Kandzari 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.

2 BIOTRONIK data on file

3 As per IFU.

4 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.

 

Orsiro is a trademark or registered trademark of the BIOTRONIK Group of Companies.

Xience is a trademark or registered trademark of the Abbott Group of Companies.

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.