Health Canada Approval of Orsiro Mission Drug-Eluting Stent System in Canada – Now Commercially Available

BIOTRONIK  announced full commercial launch in Canada for its Orsiro^® Mission bioabsorbable polymer drug-eluting stent system (BP-DES) 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 a lesion length of up to 40 mm.  Since receiving Health Canada approval, BIOTRONIK is actively replacing Orsiro with the latest generation of Orsiro Mission.

The Orsiro DES is one of the thinnest* and most studied stents based on numerous randomized controlled trials with more than 55,000 patients enrolled in 68 studies¹ around the globe. Orsiro Mission DES features the same proprietary stent design and innovative bioabsorbable BIOlute^® coating with controlled drug release as the Orsiro stent and offers a delivery system with a more flexible shaft for higher trackability and a deeper embedded stent for better crossability performances.

The key highlights of the clinical evaluation for the Orsiro Mission** stent add to the large body of evidence of an even better deliverability and outstanding patient outcomes²:

• Even better deliverability: In comparison to Xience Sierra, Resolute Onyx and Synergy drug-eluting stents for bench tests on pushability, trackability and crossability, Orsiro Mission DES demonstrates to be first in class^3,4,5. Additionally three out of four cases show Orsiro Mission DES to have better deliverability in complex lesions^3,4.
• Outstanding patient outcomes⁶: The BIOFLOW-V five-year study with 1,334 patients found a 20 percent lower target lesion failure rate (TLF) and a 36 percent lower Target Vessel Myocardial Infarction (TV-MI) rate for Orsiro DES compared to the Xience DES and with a very low long term Stent Thrombosis*** (ST) rate of 0.7% after five years following implantation.⁴

"In recent years, BIOTRONIK has introduced a range of high-quality, innovative and industry leading Cardiovascular solutions to the Canadian market. The launch of our latest generation drug-eluting stent is another great example", said Angela McGonigle, Country Director BIOTRONIK Canada. "Now and in the future, we stay committed to providing Interventional Cardiologists with the most deliverable PCI devices for greater patient outcomes. We are excited to offer an even better DES and to make Orsiro Mission available throughout Canada."

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References:

1.     BIOTRONIK data on file, status January 2020.

2.     In comparison to Xience Sierra, Resolute Onyx and Synergy for bench tests on pushability, trackability and crossability, BIOTRONIK data on file.

3.     BIOTRONIK data on file.

4.     Evaluation of Market Acceptance.

5.     BIOTRONIK data on file.

6.     Based on investigator’s interpretation of BIOFLOW-V primary endpoint result. Kandzari D et al. Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents versus Thin Durable Polymer Everolimus-Eluting Stents for Coronary Revascularization: Final 5-year Outcomes from the Randomized BIOFLOW V Trial, Submitted manuscript to JACC, 2022: NCT02389946.

* 60µm ø 2.25 – 3.0 mm

**  Clinical data conducted with Orsiro, Orsiro Mission’s predecessor device can be used to illustrate Orsiro Mission clinical outcomes.

*** Definite or Probable Stent Thrombosis as per ARC definition

BIOlute, Orsiro and Orsiro Mission are trademarks or registered trademarks of the BIOTRONIK Group of Companies.

All other trademarks are the property of their respective owners.

Learn more about Orsiro^® Mission DES:  https://us.orsiro.com/orsiromission