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.

    Categoria

    Vascular Intervention Coronary Resorbable Magnesium Scaffold

    Product Highlights

    Delivers like a DES5

    Optimal vessel support6,7

    Magnesium fully resorbed after 12 months8

    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

    Clinical Highlights

    Product Overview

    Freesolveᵀᴹ

    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.