FreesolveTM

Resorbable Magnesium Scaffold (RMS)

Metallic Performance1-3. Fully Resorbablea4.

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Key Benefits

Delivers like a DES5

Optimal vessel support6,7

Magnesium fully resorbed
after 12 months8

Excellent safety and efficacy2,3

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Full Device

Proven Orsiro® Mission delivery system

Thin struts

Resorbable coating

Proprietary Magnesium alloy

Improved visibility

Resorption

Pre-procedure

Inital diagnostic

Post implantation

Immediatly after Implantation, struts are well apposed to the vessels wall.

6-month follow-up

While the Magnesium resorption process continues, endothelialization progresses.

12-month follow-up

The Magnesium resorption is completed. No struts appear in OCT.

>99%of struts no longer visible at 12 months8 Magnesium fully resorbed after 12 months8

Procedure

Experience shows that following 4 Ps for Freesolve RMS implantations may lead to better patient outcomes.

Patient Selection

Appropriate patient selection is crucial to achieve procedural success. Freesolve is currently indicated for de novo lesions, with a reference vessel diameter and lesion length closely matching the available Freesolve sizes. Each individual patient should receive best clinical care and should benefit from BRS Technology.

Proper Sizing

If uncertain about the vessel diameter, use QCA, IVUS and/or OCT for quantitative lesion evaluation. The diameters available are 2.5, 3.0, 3.5 and 4.0 mm, do not implant into vessels <2.5 mm or >4.2 mm in diameter. Angiogram generally underestimates the diameter of the vessel by 0.25 mm.

Pre-Dilatation

Pre-dilatation with a non-compliant balloon with a 1:1 balloon-to-artery ratio is mandatory. The balloon should expand fully. The residual stenosis before the Freesolve implantation is recommended to be less than 20 %. If the pre-dilatation goal is not achieved, use other balloon technologies such as scoring balloons.

Post-Dilatation

Post-dilatation with a non-compliant balloon 0.5 mm larger than the implanted scaffold expanded at high pressure (> 16 atm) is recommended. Please keep in mind that the Freesolve expansion limit is 0.6 mm beyond nominal scaffold size. During the learning phase, OCT is helpful to check for vessel and lumen dimensions, lesion length and struts’ malapposition.

Clinical Highlights

A wealth of clinical evidence

Study name

Study type

Patients in clinical study

Test model in pre-clinical study

Status

Endpoint

BIOMAG-II

Study typeRCT

Patients1,859

Test model in pre-clinical study-

StatusNot initiated

Primary endpointTLF at 12 months

RMS Registry

Study typeRegistry

Patients1,106

Test model in pre-clinical study-

StatusInitiated

Primary endpointTLF at 12 months

Study typeFIH

Patients116

Test model in pre-clinical study-

Status12m FUP available

Primary endpointIn-scaffold LLL at 6 months

BIOMAG-I OCT Analysis*

Study typeFIH

Patients69

Test model in pre-clinical study-

Status12m FUP available

Primary endpointVisible struts at 6 and 12 months

BIOMAG-I Return of vasomotion*

Study typeFIH

Patients14

Test model in pre-clinical study-

Status-

Primary endpointVasomotion assessment after Acetylcholine (Ach) and Nitroglycerine (NTG)

BIOMAG-I OCT Plaque characterization (AI-based OCT)*

Study typeFIH

Patients84/6m
46/12m

Test model in pre-clinical study-

Status-

Primary endpointComparison of different plaque characteristics

BIOMAG-I Plaque characterization*

Study typeFIH

Patients84

Test model in pre-clinical study-

Status-

Primary endpointImpact of plaque characteristics on in-stent LLL

BIOSOLVE-IV Full COHORT conducted with Magmaris

Study typeRegistry

Patients2,066

Test model in pre-clinical study-

Status36m FUP available

Primary endpointTarget Lesion Failure* at 12 months

Evaluation of the degradation kinetics*

Study typeAnimal study

Patients-

Test model in pre-clinical studymini swine

StatusCompleted

Primary endpointDegradation kinetics analysis: 99.6% backbone degradation for Freesolve™ at 12 months

Evaluation of thrombogenicity in a novel flow chamber system using human blood

Study typeIn-vitro study

Patients-

Test model in pre-clinical studyflow chamber study

StatusOngoing

Primary endpointPlatelet adhesion analysis

Preclinical animal safety and device characterization up to 4y

Study typeAnimal study

Patients-

Test model in pre-clinical studymini swine

StatusOngoing

Primary endpointSafety evaluation

Chronic Scaffolding Evaluation for DREAMS 3G

Study typeIn Silicon study

Patients-

Test model in pre-clinical studysimulation

StatusOngoing

Primary endpointResorption and Finite element analysis

*restricted access, sign-in required

Excellent safety profile2,3

2.6% Target Lesion Failure

0.0% Scaffold Thrombosis

0.0% Myocardial Infarction

0.0% Cardiac Death

Testimonials

Prof. Michael Haude (Rheinklinikum, Germany) talks about Freesolve™ and the BIOMAG-I First-In-Human trial outcomes and what impact this has for the future of scaffolds.

Prof. Michael Joner (German Heart Centre, Germany) explains the resorption process of the new generation RMS Fressolve™ and how this scaffold can have thinner struts and a resorption time of 12 months with a prolonged scaffolding time.

Dr. Masaru Seguchi (German Heart Centre, Germany) explains the aim of the BIOMAG-I OCT analysis, what the findings are and what the data means for the future of cardiology.

Specifications

Technical Data

Scaffold

Scaffold material

Proprietary BIOmag® Magnesium alloy

Strut thickness

ø 2.5 mm: 99 μm; ø 3.0/3.5 mm: 117 μm; ø 4.0 mm: 147 μm

Maximum expandable diameter

Nominal Diameter + 0.6 mm

Markers

One oval Tantalum marker at each end

Drug coating

BIOlute® resorbable Poly-L-Lactide (PLLA) eluting a limus drug

Scaffold material

Proprietary BIOmag® Magnesium alloy

Scaffold

Catheter type

Rapid exchange

Catheter length

140cm

Recommended guide catheter

6F

Crossing profile

ø 2.5 mm ≤ 1.3 mm; ø 3.0-4.0 mm ≤ 1.4 mm

Guide wire diameter

0.014”

Nominal pressure (NP)

10 atm

Rated burt pressure (RBP)

16 atm

Vessel Sizing

Scaffold ø (mm) (SD)

Recommended ø (mm) (RVD)

2.50

2.50 - 2.70

3.00

2.70 - 3.20

3.50

3.20 - 3.70

4.00

3.70 - 4.20

Compliance Chart

Balloon Diameter (mm)

ø 2.50

ø 3.00

ø 3.50

ø 4.00

Nominal pressure(NP)

atm*

10

10

10

10

ø (mm)

2.52

3.04

3.54

4.02

Rated Burst Pressure (RBP)

atm*

16

16

16

16

ø (mm)

2.72

3.29

3.79

4.35

Ordering Information

Scaffold ø (mm)

Scaffold length (mm)

13

18

22

26

30

2.50

443103

443104

443105

-

-

3.00

443108

443109

443110

482156

443111

3.50

443113

443114

443115

482157

443116

4.00

443118

443119

443120

482158

443121

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Metallic Performance1-3. Fully Resorbable.a4
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