Magmaris

Vascular Intervention // Coronary
Resorbable Magnesium Scaffold (RMS)

Magmaris®

 

 



     Confirmed clinical safety and efficacy*

     Fast Magnesium resorption time

     Better deliverability

 

 

* Based on BIOSOLVE-II, -II/-III and -IV, for patient populations see study details.

 


Why Magnesium?

 

 

 

 


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






Stable recoil


Magmaris has a 38% lower recoil after 1 hour.2



**Absorb, Abbott



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





* 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 (CABG), and Clinically-Driven Target Lesion Revascularization (CD-TLR).
° Four out of five cases (0.1%) having 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











Better pushability


73% more force transmitted from hub to tip.13





* Absorb, Abbott
** BioFreedom, Biosensors


 

 


 

 

Magmaris®


Indicated for de novo coronary artery lesions.*





1-3, 10-13. BIOTRONIK data on file; 4. Torzewski J. Safety and performance of Magmaris at 24-month follow-up of BIOSOLVE-IV. Presented at: eEuroPCR; 2021; virtual congress. ClinicalTrials.gov: NCT02817802; 5. Haude M, Ince H, Kische S, 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; 6. 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: e-Course PCR; June 25, 2020; Paris, France. ClinicalTrials.gov: NCT01960504; 7. Haude M, Erbel R, Erne P, et al. Safety and performance of the Drug-Eluting Absorbable Metal Scaffold (DREAMS) in patients with de novo coronary lesions: 3-year results of the prospective, multicenter, first-in-man BIOSOLVE-I trial. EuroIntervention. 2016; 12: e160-6. doi: 10.4244/EIJY16M06_01; 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 M. Haude, Lukaskrankenhaus Neuss, Germany 2015.

BIOSOLVE-I,-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. 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

Technical Data

Scaffold
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
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-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

Compliance Chart

Balloon Diameter x Length (mm)
Nominal Pressure atm8 10 10
(NP) ø (mm) 3.00 3.54
Rated Burst Pressure atm8 16 16
(RBP) ø (mm) 3.29 3.82

Ordering Information

3.00 412526 412527 412528
3.50 412529 412530 412531

Contact

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Country/Region

VASCULAR INTERVENTION

Coronary Resorbable Magnesium Scaffold