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Magmaris®

In a class of its own.

Magmaris is the first clinically proven resorbable Magnesium scaffold.1-4 It is currently indicated for de novo lesions with a reference vessel diameter and lesion length closely matching the available Magmaris sizes.ᵃ⁵

Category

Vascular Intervention Coronary Resorbable Magnesium Scaffold

Product Highlights

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Confirmed clinical safety and efficacyb6-8

Confidence through evidence

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Fast Magnesium resorption time

~95% of Magnesium resorbed at 12 months9

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Better deliverabilityc10

Magnesium allows for a smoother scaffold surface11

Confirmed clinical safety and efficacyb6-8

Magmaris RMS has an excellent safety and efficacy profile up to 24-month follow-up.d12

Fast Magnesium resorption time9

The resorption process of Magnesium starts at the surface of the Magnesium backbone and continues inwards until only a footprint (amorphous calcium phosphate) is left.9

Better deliverabilityc10

More than 70% of physicians who have used Magmaris RMS in clinical practice have rated the device to be better than a polymeric scaffold.h11

Better lesion crossing

Up to 40% lower lesion entry and crossing force.11

Better trackability in tortuous anatomy

42% less peak force.11

Better pushability

73% more force transmitted from hub to tip.11

Product Overview

Magmaris

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Technical Data

Scaffold  
Scaffold material Proprietary Magnesium alloy
Markers Two tantalum markers at each end
Active coating BIOlute® (resorbable 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

Delivery system  
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-crystalline 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
Rate burst pressure (RBP) 16 atm

Compliance Chart

    Balloon diameter (mm)
    ø 3.00 ø 3.50
Nominal Pressure (NP) atm* 10 10
ø (mm) 3.00 3.54
Rated Burst Pressure (RBP) atm* 16 16
ø (mm) 3.29 3.82
*1 atm = 1.013 bar      

Ordering Information

Scaffold

ø (mm)
Scaffold

length (mm)
   
  15 20 25
3.00 412526 412527 412528
3.50 412529 412530 412531

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References

a. Indication as per IFU; b. Based on BIOSOLVE-II, -II/-III and -IV, for patient populations see study details; c. compared to leading polymeric scaffold - Abbott Absorb; d. BIOSOLVE-IV 2-year follow-up for the full cohort (n=2066 patients); e.Target Lesion Failure (TLF) defined as a composite of Cardiac death, Target-Vessel Myocardial Infarction (TV-MI); emergent Coronary Artery Bypass Grafting (eCABG); Clinically-Driven Target Lesion Revascularization (CD-TLR); f. 0.4% of cases without early antiplatelet or anticoagulant interruption at post procedure; g. 0.5% scaffold thrombosis rate excluding cases with early antiplatelet or anticoagulant interruption; h. Absorb, Abbott; i. BioFreedom, Biosensors.

1. Erbel R. Temporary scaffolding of coronary arteries with bioabsorbable magnesium stents: a prospective, non-randomised multicentre trial. Lancet. 2007 Jun 2;369(9576):1869-1875. doi: 10.1016/S0140-6736(07)60853-8; 2. Haude M et al. Safety and performance of the drug-eluting absorbable metal scaffold (DREAMS) in patients with de-novo coronary lesions: 12 month results of the prospective, multicentre, first in-man BIOSOLVE-I trial. Lancet. 2013 Mar 9;381(9869):836-44; 3. Wang et al. Vascular restoration therapy and bioresorbable vascular scaffold. Regenerative Biomaterials, 2014, 49–55. doi: 10.1093/rb/rbu005; 4. Haude M et al. Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month|results of a prospective, multicentre, non-randomised, first-in-man trial. Lancet.2016;Jan 2;387(10013):31-9. doi: 10.1016/S0140-6736(15)00447-X. Epub 2015 Oct 12; 5. Fajadet J et al._Magmaris preliminary recommendation upon commercial|launch: a consensus from the expert panel on 14 April 2016. EuroIntervention. 2016;12:828-833; 6. Torzewski J. Safety and performance of Magmaris at 24 month follow up of BIOSOLVE IV. Presented at: eEuroPCR; 2021; virtual congress. ClinicalTrials.gov: NCT02817802; 7. Haude M. Long-term clinical data of the BIOSOLVE-II study with the drug-eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries - BIOSOLVE-II. Presented at the: e-Course PCR, 25.June 2020, Paris, France; 8. Haude M, et al. Sustained safety and performance of the second-generation sirolimus-eluting 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; 9. 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]; 10. Schmidt et al. In vitro performance investigation of bioresorbable scaffolds – standard tests for vascular stents and beyond. Cardiovasc Revasc Med. 2016 Sep;17(6):375-83. doi: 10.1016/j.carrev.2016.05.001. Epub 2016 May 13; 11. BIOTRONIK data on file; 12. Bennett J. Safety and Efficacy of the Resorbable Magnesium Scaffold, Magmaris in a Real-World Setting – 24-month Follow-up of the Full Cohort (2066 subjects) of the BIOSOLVE-IV Registry. Presented at: TCT, September 2022, Boston, USA. ClinicalTrials.gov: NCT02817802; 13. 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; 14. Torzewski J. Safety and performance of Magmaris at 36-months: BIOSOLVE-IV first cohort. Presented at: EuroPCR; 2022; ClinicalTrials.gov: NCT02817802; 15. Haude M, et al. Sustained safety and performance of the second-generation sirolimus-eluting 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; 16. Haude M, 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; 17. BIOSOLVE-II case, GER443-012. Courtesy of Prof. M. Haude, Rheinland Klinikum Neuss GmbH, Neuss, Germany 2015; 18. Torzewski J. Safety and performance of Magmaris at 48 months: BIOSOLVE-IV first cohort. Presented at: EuroPCR; 2023; ClinicalTrials.gov: NCT02817802.

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.

All other trademarks are the property of their respective owners.

Change of Ownership: Vascular Intervention Products

The  BIOTRONIK Vascular Intervention Business, with the exception of IMDS products, has been acquired by Teleflex, Inc. with effect as of July 1st, 2025. These products are no longer part of the BIOTRONIK Group’s portfolio and are now operated and supplied by Teleflex.

For questions or further information relating to the former BIOTRONIK Vascular Intervention Business, please use the contact form. Any contact requests will be forwarded to the vascular intervention team at Teleflex.