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

daniel.periard@h-fr.ch

22.1.2019

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

Magmaris technical properties

3

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)

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

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

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

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

• …

Man 85 y.

CLI

Rutherford 4

occlusion of

the tibio-

fibular trunk

Magmaris

3.5 x 25

DEB

after 6 months

Calcified lesions

24.11.2016tantalum marker

Calcified lesions

24.11.2016

13.03.2018

Bifurcation and calcifications

Bifurcation and calcifications

Magmaris

3.5 x 15

Magmaris

3.5 x 25

Complex bifurcation dissection

Complex bifurcation dissection

Magmaris 3.5 x

15 in poplitea-

trunk transition,

covering the

anterior tibialis

origin

Anterior tibial artery origin

Anterior tibial artery originMagmaris

3.5 x 15 in

the origin

of the

anterior

tib.

Saphenous bypass

pre-

anastomotic

saphenous

bypass

stenosis

post-

anastomotic

fibular

occlusion

Saphenous bypass

PTA and

Magmaris

3.5 x 15

PTA and

Magmaris

3.5 x 25

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

Patients characteristics

Characteristics of the BTK target lesions treated by Magmaris stent implantation

Immediate result of intervention

Clinical outcomes at 1 year

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

I thank you for your attention

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

daniel.periard@h-fr.ch

22.1.2019