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Clinical Study Overview

Study Name Study Type Patients Status Primary Endpoint
BIOFLOW-V RCT 1,334 36-month FU available TLF at 12 months
BIO-RESORT RCT 3,514 Completed, 36-month FU available TVF at 12 months
BIOSTEMI* RCT 1,300 24-month FU available TLF at 12 months
BIONYX
RCT 2,488 36-month FU available TVF at 12 months
BIOSCIENCE RCT 2,119 Completed, 60-month FU available TLF at 12 months
Taglieri et al. Network Meta-Analysis 99,039 - TLF at 12 months and the longest FU available
Madhavan et al. Meta-Analysis 20,701 - TLF at latest FU reported
BIOFLOW-I FIM 30 Completed, 12-month FU available LLL at 9 months
BIOFLOW-II RCT 452 Completed, 60-month FU available LLL at 9 months
BIOFLOW-III Single arm registry 1,356 Completed, 60-month FU available TLF at 12 months
BIOFLOW-IV RCT 575 Completed, 60-month FU available TVF at 12 months
BIOFLOW-VI RCT 440 48-month FU available LLL at 9 months
BIOFLOW-VII Single arm registry 556 Enrollment completed TLF at 12 months
SORTOUT-IX RCT 3,151 24-month FU available TLF at 12 months
SMART-CHOICE RCT 3,000 Primary endpoint reached MACCE at 12 months
SORTOUT-VII RCT 2,525 36-month FU available TLF at 12 months
BIOFLOW-INDIA Single arm registry 120 Completed LLL at 9 months
BIOFlow-SV Single arm registry 1,000 TBA TLF at 12 months
HATTRICK-OCT RCT 44 Primary endpoint reached Strut coverage at 3 months
ORIENT RCT 372 Primary endpoint reached LLL at 9 months
BIOLUX-RCT RCT 210 12-month FU available LLL at 6 months
ISAR OCT RCT 39 Primary endpoint reached Strut coverage at 6 months
ESODE RCT 600 Enrolling MACE at 12 months
BIODEGRADE RCT 3,850 Primary endpoint reached TLF at 18 months
SCAAR All comers registry 69,570 24-month FU available -

∆ a selection of the full clinical program of the Orsiro family.

*Orsiro DES is not currently indicated for STEMI patients in the US.

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 a lesion length of ≤ 36 mm.

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