Vascular Intervention // Coronary
Resorbable Magnesium Scaffold (RMS)
In a class of its own.
Magnesium alloy: Favorable mechanical properties of a robust Magnesium backbone
Robust Magnesium backbone
The mechanical strength of Magnesium is superior to polymers like PLLA.1
Magmaris has a 38% lower recoil after 1 hour.2
Strong radial resistance
No significant diameter change under increasing physiological pressure.3
Rounded edges and smooth surface
The electropolished rounded edges and smooth surface of the Magmaris scaffold generate less resistance during delivery of the scaffold to the lesion.
Confirmed clinical safety and efficacy*
Confidence through evidence
All n-values represent the actual number of patients enrolled.
* Based on BIOSOLVE-II, -II/-III and -IV, for patient populations see study details.
◊ 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 (CD-TLR).
° 0.5% scaffold thrombosis rate excluding cases with early antiplatelet or anticoagulant interruption.
Δ0.4% of cases without early antiplatelet or anticoagulant interruption at post procedure.
Fast resorption time
~95% of Magnesium resorbed at 12 months8
A more deliverable scaffold
More than 70% of physicians who have used Magmaris RMS in clinical practice have rated the device to be better than a polymeric scaffold.10*
Better lesion crossing
Up to 40% lower lesion entry and crossing force.11
Better trackability in tortuous anatomy
42% less peak force.12
73% more force transmitted from hub to tip.13
* Absorb, Abbott
** BioFreedom, Biosensors
Indicated for de novo coronary artery lesions.*
1-3, 10-13. BIOTRONIK data on file; 4. Bennett J. Performance and safety of the resorbable magnesium scaffold, Magmaris in a real-world setting – Primary and secondary endpoint analysis of the full cohort (2,066 subjects) of the BIOSOLVE-IV, Presented at: TCT 2021, November 2021, Orlando, USA. ClinicalTrials.gov: NCT02817802; 5. Torzewski J. Safety and performance of Magmaris at 36-months: BIOSOLVE-IV first cohort. Presented at: EuroPCR; 2022; ClinicalTrials.gov: NCT02817802; 6. Haude M, Ince H, Kische S, et al. Sustained safety and performance of the second-generation sirolimuseluting absorbable metal scaffold: Pooled outcomes of the BIOSOLVE-II and -III trials at 3 years. Cardiovascular Revascularization Medicine. 2020. doi: 10.1016/j.carrev.2020.04.006; 7. Haude M, Toelg R , Lemos P.A et al. Sustained safety and performance of a second-generation sirolimus-eluting absorbable metal scaffold: Long-term data of the BIOSOLVE-II first-in-man trial at 5 years. Cardiovascular Revascularization Medicine. 2021. doi: 10.1016/j.carrev.2021.07.017; 8. Joner M, Ruppelt P, Zumstein P, et al. Preclinical Evaluation of Degradation Kinetics and Elemental Mapping of First and Second Generation Bioresorbable Magnesium Scaffolds. EuroIntervention. 2018 Feb 20. pii: EIJ-D-17-00708. doi: 10.4244/EIJ-D-17-00708. [Epub ahead of print]; 9. BIOSOLVE-II case, GER443-012. Courtesy of Prof. M. Haude, Rheinland Klinikum Neuss GmbH, Neuss, Germany 2015. 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. Magmaris and BIOlute are trademarks or registered trademarks of the BIOTRONIK Group of Companies. Absorb is a trademark or registered trademark of the Abbott Group of Companies. BioFreedom is a trademark or registered trademark of Biosensors International Group, Ltd.
*Indication as per IFU.
|Scaffold material||Proprietary Magnesium alloy|
|Markers||Two tantalum markers at each end|
|Active coating||BIOlute bioabsorbable Poly-L-Lactide (PLLA) eluting a limus drug|
|Drug dose||1.4 μg/mm2|
|Strut thickness/width||150 μm/150 μm|
|Maximum expandable diameter||Nominal Diameter +0.6 mm|
|Catheter type||Rapid exchange|
|Recommended guide catheter||6F (min. I.D. 0.070")|
|Crossing profile||1.5 mm|
|Guide wire diameter||0.014"|
|Usable catheter length||140 cm|
|Balloon material||Semi-rystalline polymer|
|Coating (distal shaft)||Dual coated|
|Marker bands||Two swaged platinum-iridium markers|
|Proximal shaft diameter||2.0F|
|Distal shaft diameter||2.9F|
|Nominal pressure (NP)||10 atm|
|Rated burst pressure (RBP)||16 atm|
|Balloon Diameter x Length (mm)|
|Rated Burst Pressure||atma||16||16|
|a) 1 atm = 1.013 bar|