Magmaris

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Magmaris Resorbable Magnesium Scaffold
Afbeelding
Picture Magmaris
Magmaris Resorbable Magnesium Scaffold
Afbeelding
Picture Magmaris
Magmaris Resorbable Magnesium Scaffold
Afbeelding
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


      Graph

      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


        Graph

        Robust Magnesium Backbone

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


          Graph

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


            Graph

            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

            Graph

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

            Graph

            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
              Magmaris Image

              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 materialProprietary Magnesium alloy
              MarkersTwo tantalum markers at each end
              Active coatingBIOlute bioabsorbable Poly-L-Lactide (PLLA) eluting a limus drug
              Drug dose1.4 μg/mm2
              Strut thickness/width150 μm/150 μm
              Maximum expandable diameterNominal Diameter +0.6 mm
              Delivery System
              Catheter typeRapid exchange
              Recommended guide catheter6F (min. I.D. 0.070")
              Crossing profile1.5 mm
              Guide wire diameter0.014"
              Usable catheter length140 cm
              Balloon materialSemi-rystalline polymer
              Coating (distal shaft)Dual coated
              Marker bandsTwo swaged platinum-iridium markers
              Proximal shaft diameter2.0F
              Distal shaft diameter2.9F
              Nominal pressure (NP)10 atm
              Rated burst pressure (RBP)16 atm

              Compliance Chart

              Balloon Diameter x Length (mm)
              Nominal Pressureatm81010
              (NP)ø (mm)3.003.54
              Rated Burst Pressureatm81616
              (RBP)ø (mm)3.293.82

              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