Vascular Intervention // Coronary
Resorbable Magnesium Scaffold (RMS)
Magmaris®
Compelling safety data
Fast Magnesium resorption time
Better deliverability
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.
Compelling safety data
Confidence through evidence
*Target Lesion Failure. Composite of cardiac and unknown death, target vessel myocardial infarction, clinically driven target lesion revascularization and CABG.
** Patient underwent MIDCAB with subsequent DAPT interruption 5 days after the procedure.
Fast resorption time
~95% of Magnesium resorbed at 12 months7
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.9*
Better lesion crossing
Up to 40% lower lesion entry and crossing force.10
Better trackability in tortuous anatomy
42% less peak force.11
Better pushability
73% more force transmitted from hub to tip.12
* Absorb, Abbott
** BioFreedom, Biosensors
Magmaris
Indicated for de novo coronary artery lesions.*
1-3, 10-13. BIOTRONIK data on file; 4. Verheye S. Safety and Performance of the Resorbable Magnesium Scaffold, Magmaris in a Real World Setting - First Cohort Subjects at 12-month Follow-up of the BIOSOLVE-IV Registry. Presented at: TCT; September 25, 2019; San Francisco, USA. NCT02817802; (n = 2,054; 1,075 patients presented); 5. Haude M. Safety and Clinical Performance of the Drug Eluting Absorbable Metal Scaffold in the Treatment of Subjects with de Novo Lesions in Native Coronary Arteries at 36-month Follow-up-BIOSOLVE-II and -III, Presented at: TCT; September 27, 2019; San Francisco, USA; 6. Haude M, Ince H, Abizaid A. Long-term clinical data and multimodality imaging analysis 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: EuroPCR; May 23, 2018; Paris. France; 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-e166; 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.
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 Europe.
*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 | |||||||||||
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