magnesium resorbable drug- eluting scaffold (magmaris) for … · biosolve-ii case, ger443-001....
TRANSCRIPT
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Magnesium resorbable drug-eluting scaffold (Magmaris) for below the knee recanalisation: 12-months follow-up analysis
Dr Daniel PériardAngiology
HFR – Hôpital Cantonal de Fribourg
Switzerland
22.1.2019
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Disclosure
Speaker name:
Daniel Périard
I have the following potential conflicts of interest to report:
Consulting
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interestx
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Magmaris technical properties
3
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Magmaris resorption process over time
4
Double eye radiopaque markers
3m 6m
backbone
12m
B. BIOLUTECoating (polymer and limus drug)
24m0m
Drug
Mg
Implantation
PLLA - resorbable polymer
Providing a controlled drug release up to 90 days and is metabolized by the body into
carbon dioxide (CO2) and water (H2O)
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Magmaris resorption in OCT imaging
BIOSOLVE-II case, GER443-001. Courtesy of M. Haude, Lukaskrankenhaus Neuss, Germany 2015.
Immediately after implantation,
struts are well apposed to the
vessel wall.
While the magnesium resorption
process continues, endothelialization
progresses.
At 12 months after implantation,
the magnesium resorption is
almost completed.
Post-Implantation 6 month 12 month
20% wall covering
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Sizes and overinflation
6
Scaffold Diameter [mm]
Scaffold length [mm] 3.0 3.5
15 412526* 412529*
20 412527* 412530*
25 412528* 412531*
Scaffold Diameter [mm]
Max Diameter forPost-Dilatation [mm]
3.0 3.6
3.5 4.1
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Magmaris technical overview
7
BIOlute
Scaf
fold
Scaffold material Proprietary Magnesium alloy
Strut thickness/width 150/150 μm
Maximum expandable diameter Nominal Diameter +0.6 mm
Markers Two Tantalum markers at each end
Coating - drugBIOlute resorbable Poly-L-Lactide (PLLA) eluting a
limus drug
Del
iver
y Sy
stem
Catheter type Rapid exchange
Recommended guide catheter 6F
Crossing profile 1.5 mm
Guide wire diameter 0.014”
Nominal pressure [NP] 10 atm
Rated burst pressure [RBP] 16 atm
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Rational for use of resorbablescaffold in BTK arteries
• Stainless steel/cobalt chromium limus eluting stentsare validated tools for BTK interventions in CLI
• Magmaris’ mechanical properties are quite close
• Get patency of lesions with complex motion/crushingforce without leaving steel permanently
• Avoid permanent stiffness in particular cases (saphenous bypass, young patients,…)
• Allow re-interventions without accumulation of metal
• …
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Man 85 y.
CLI
Rutherford 4
occlusion of
the tibio-
fibular trunk
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Magmaris
3.5 x 25
DEB
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after 6 months
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Calcified lesions
24.11.2016tantalum marker
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Calcified lesions
24.11.2016
13.03.2018
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Bifurcation and calcifications
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Bifurcation and calcifications
Magmaris
3.5 x 15
Magmaris
3.5 x 25
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Complex bifurcation dissection
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Complex bifurcation dissection
Magmaris 3.5 x
15 in poplitea-
trunk transition,
covering the
anterior tibialis
origin
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Anterior tibial artery origin
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Anterior tibial artery originMagmaris
3.5 x 15 in
the origin
of the
anterior
tib.
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Saphenous bypass
pre-
anastomotic
saphenous
bypass
stenosis
post-
anastomotic
fibular
occlusion
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Saphenous bypass
PTA and
Magmaris
3.5 x 15
PTA and
Magmaris
3.5 x 25
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Study design
• Single center retrospective analysis
• Patients treated with Magmaris in BTK arteriesor leg bypass
• No exclusion!
• Outcomes :
– Any TLR, major amputation, death
– Clinical/TBI improvement
– Technical success
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Patients characteristics
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Characteristics of the BTK target lesions treated by Magmaris stent implantation
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Immediate result of intervention
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Clinical outcomes at 1 year
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conclusions
• The mechanical properties of Magmaris fitsfor BTK interventions in CLI
• No major amputation
• Only 7% TLR @1year
• Experience limited to the proximal leg arteries
• Resistance to crush forces is bit lower thanwith steel stents
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I thank you for your attention
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Magnesium resorbable drug-eluting scaffold (Magmaris) for below the knee recanalisation: 12-months follow-up analysis
Dr Daniel PériardAngiology
HFR – Hôpital Cantonal de Fribourg
Switzerland
22.1.2019
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