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Freesolveᵀᴹ

Metallic Performance¹⁻³. Fully Resorbable*⁴

Indicated for de novo coronary artery lesionsa

 

Support
Resorbable coronary scaffolds widen coronary artery stenoses and provide temporary vessel support. Thereby, scaffolds enable unobstructed blood flow in the coronary arteries with low rates of stent thrombosis (ST) and target lesion revascularization (TLR).

Resorb
By degrading after fulfilling their scaffolding function, they offer all options of future therapies.

Category

Vascular Intervention Coronary Resorbable Magnesium Scaffold

Product Highlights

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Delivers like a DES5

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Optimal vessel support6,7

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Magnesium fully resorbed after 12 months8

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Excellent safety and efficacy2,3

Delivers like a DES5

Push5

Better than contemporary DES

Track5

Better than contemporary DES

Optimal vessel support6,7

Predictable, homogenous resorption process⁶

Equal resorption between struts6

Uniform shape due to homogenous strut resorption6

More than 3 months vessel support6,7

Magnesium fully resorbed after 12 months8

>99% of struts no longer visible at 12 months8

Excellent saftey and efficacy2,3

BIOMAG-I First-In-Human (FIH) trial3

Product Overview

Freesolveᵀᴹ

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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
Delivery system
Catheter type Rapid exchange
Catheter length 140 cm
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
Rate burst 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
Nominal Pressure
(NP)
atm**
ø (mm)
10
2.52
10
3.04
10
3.54
Rated Burst
Pressure (RBP)
atm**
ø (mm)
16
2.72
16
3.29
16
3.79
*1 atm = 1.013 bar        

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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References

Target Lesion Failure (TLF) is a composite of Target-Vessel Myocardial Infarction (TV-MI), clinically-driven Target Lesion Revascularization (CD-TLR) and Cardiac Death. *99.3% resorbed at 12 months (markers are not resorbable), based on clinical data; **based on QCA paired data. a. Indications as per IFU; b. BIOMAG-I case in normal cine projection, courtesy of Prof. Michael Haude, Rheinland Klinikum Neuss GmbH, Lukaskrankenhaus, Neuss, Germany; c. Xience Sierra DES (Abbott); d. Angiographic and OCT Analyses derived from two different BIOMAG-I cases, courtesy of Prof. Michael Haude, Rheinland Klinikum Neuss GmbH, Lukaskrankenhaus, Neuss, Germany; e. The 4P protocol was respected. 

1. IIB Benchtest data, BIOTRONIK data on file; 2. Haude M. et al., the Lancet eClinicalMedicine 2023;59: 101940; 3. Haude, M. et al., EuroIntervention 2023;19:1-1 published online May 2023; 4. Seguchi M et al. OCT-Analysis 12M, presented at ESC 2023; 5. BIOTRONIK data on file, IIB Benchtest data: Freesolve in comparison to BIOTRONIK Orsiro Mission and Abbott Xience Sierra; 6. Based on pre-clinical data, Seguchi, M. et al., EuroIntervention 2023;18-online publish-ahead-of-print January 2023; 7. BIOTRONIK data on file, in comparison to predecessor device; 8. Based on intravascular OCT analysis of the BIOMAG-I trial presented by Dr. M. Seguchi at ESC 2023; 9. BIOTRONIK data on file; 10. Byrne, RA. et al., Eur Heart J 2015;36:2608-2620; 11. Haude M., et al. Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial. Eur Heart J. 2016;37:2701-9. 12. BIOMAG-I: two-year clinical outcomes of the resorbable magnesium Scaffold-DREAMS 3G, Moderated e-Poster presented by Prof. M. Haude at EuroPCR 2024.

BIOSOLVE-II and BIOMAG-I based on Kaplan-Meier failure estimate analysis.

BIOlute, BIOmag, BIOMAG, BIOSOLVE, Orsiro, Orsiro Mission, Magmaris & Freesolve are trademarks or registered trademarks of the BIOTRONIK Group of Companies. All other trademarks are the property of their respective owner.