Magmaris Clinical Study Overview

Study Name Sort descending Study Type Patients Status Primary Endpoint
BIOSOLVE-II FIM 123 60m FUP available In-segment LLL
at 6 months
BIOSOLVE-II-III Pivotal Trial 180 36m FUP available BIOSOLVE-II: In-segment
LLL at 6-month
BIOSOLVE-III Pivotal Trial 61 24m FUP available In-hospital Procedural
BIOSOLVE-IV FIRST COHORT Registry 1,075 48m FUP available Target Lesion Failure* at 12 months
BIOSOLVE-IV​ FULL COHORT​ Registry 2,066 24m FUP available Target Lesion Failure* at 12 months​
BIOSOLVE-IV​ FULL COHORT​ Subgroup analysis Registry 2,066 24m FUP available​ Target Lesion Failure* at 12 months​

Previous Generations Clinical Trials

Study Name Study Type Patients Status Primary Endpoint
BIOSOLVE-I FIM 46 Completed TLF (composite of CD,
TV-MI and cd-TLR) at
6 and 12 months
Progress FIM 63 Completed Composite of CD, non-
fatal MI and cd-TLR at
4 months

*Target Lesion Failure (TLF) defined as a composite of Cardiac Death, Target-Vessel Myocardial Infarction (TV-MI), emergent Coronary Artery Bypass Grafting (eCABG) and Clinically-Driven Target Lesion Revascularization (Clinically-driven TLR). FUP= Follow-up; All events have been adjudicated by an independent clinical event committee. BIOSOLVE-II and -IV based on Kaplan-Meier failure estimate analysis including censored observations. The pooled analysis of BIOSOLVE-II and -III based on frequency analysis. The 36-month data of BIOSOLVE-II and -III analysis reflecting a period up to 1’125 days at 3 years. Please consult IFU for indications and use in special populations. 
Magmaris is a trademark or registered trademark of the BIOTRONIK Group of Companies.
Magmaris is currently not available in the US. 

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