Magmaris

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Magmaris Resorbable Magnesium Scaffold
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Picture Magmaris
Magmaris Resorbable Magnesium Scaffold
Image
Picture Magmaris
Magmaris Resorbable Magnesium Scaffold
Image
Picture Magmaris
Magmaris Resorbable Magnesium Scaffold

Magmaris

RESORBABLE MAGNESIUM SCAFFOLD

Indicated for de novo coronary artery lesions1

Click here for more information: www.magmaris.com


KEY FACTS
  • First clinically proven resorbable Magnesium scaffold
  • Compelling safety data2
  • Better deliverability6
  • ~95 % of Magnesium resorbed at 12 months3

 

Product Details

Magmaris BRS

First Clinically Proven Resorbable Magnesium Scaffold

No definite or probable scaffold thrombosis was observed with Magmaris.4 Previous generations showed no scaffold thrombosis up to 36 months.4


Resorption Graph

Fast Magnesium Resorption Time

~95 % of Magnesium resorbed at 12 months3


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Compelling Safety Data2

The optimal combination of the strut design, electropolished smooth scaffold surface and biocompatible coating facilitate rapid endothelial coverage:

15 % better endothelialization at 28 days3,6


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Robust Magnesium Backbone

Strong radial resistance:
No significant diameter change under increasing physiological pressure5


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No recoil increase:
Conventional polymeric scaffold7 diameter decrease >20 % within 1st hour5


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Metallic Scaffolds for Better Deliverability6

Magnesium allows for a smoother scaffold surface for:

  • Better lesion crossing - up to 40 % lower lesion entry and crossing force5,6

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  • Better trackability in tortuous anatomy - 29 % less peak force5,6

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The dual coated delivery system enables:

  • Better pushability - 34 % more force transmitted from hub to tip5,6

Magmaris rounded edges

Electropolishing Ensures Rounded Edges

Magmaris' smooth surface generates less resistance than the polymeric scaffold7


BIOSOLVE-I

  • Prospective, multi-center, first-in-man trial testing DREAMS (Drug-Eluting Absorbable Magnesium Scaffold)
  • Number of patients: 46
  • Primary endpoint: TLF at 6 and 12 months
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BIOSOLVE-II

  • Prospective, multi-center, first-in-man trial to evaluate the safety and performance of Magmaris with a maximum of two de novo lesions in two separate coronary arteries
  • Number of patients: 123
  • In-segment LLL at 6 months
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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


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Vascular Intervention

Coronary Resorbable Magnesium Scaffold


1 Indication as per IFU

2 BIOSOLVE-II

3 Pre-clinical trial. BIOTRONIK data on file

4 PROGRESS, BIOSOLVE-I, BIOSOLVE-II

5 BIOTRONIK data on file

6 comapred to polymeric scaffold (Abbott Absorb)

7 Abbott Absorb

8 1 atm = 1.013 bar