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Cardiovascular

Cobalt-chromium Sirolimus Eluting Coronary Bifurcation Stent BIOSS LIM C with delivery system rapid exchange

Medical use
Coronary bifurcation stenting
Basic UDI-DI
5901297BIOSSLIMCP2

The Bioss Lim C stent is intended for percutaneous transluminal coronary angioplasty (PTCA) in patients with symptomatic coronary artery disease caused by de novo or restenotic atherosclerotic bifurcation lesions (with reference diameters of the distal main vessel ≤ 4.00 mm and proximal main vessel ≤ 5.00 mm).

The stent platform is made of cobalt-chromium alloy L605 and has cylindrical, segmented design with two diameters and repeating elements. The BiOSS LIM C stent consists of:

  • proximal part – with larger diameter;
  • distal part - with smaller diameter;
  • middle zone - with two struts connecting proximal and distal part for opening to side branch.

The proximal part is shorter than the distal one. The ratio of the proximal part to the distal one varies between 1.15 and 1.3.

The Rapid Exchange delivery system for stent BiOSS LIM C, consists of:

  • soft distal part - made of an outer tube, an inner tube and a polyamide balloon. It has two channels - external for balloon inflation and internal for the guidewire (side channel - RX port). Profiled bottle shaped balloon have smaller diameter in distal part and larger diameter in proximal part corresponding with stent shape. Three radiopaque markers are placed on inner tube to identify the stent position within the lesion. In addition, a hydrophilic coating is applied to the distal section of the catheter;
  • rigid proximal part. - consists of a fluoropolymer coated stainless steel tube and a cap with a single female luer port for inflation and deflation of the balloon.

The stent is delivered to the target lesion, expanded by balloon inflation and remains a permanent scaffolding implant due to its radial force of the stent acting on the vessel wall mimicking bifurcation geometry, preventing carina shift and providing access to the side branch.

The stent is coated with biodegradable polymer coating containing active pharmaceutical ingredient - sirolimus.

Intended purpose:

The Bioss Lim C stent is intended for percutaneous transluminal coronary angioplasty (PTCA) in patients with symptomatic coronary artery disease caused by de novo or restenotic atherosclerotic bifurcation lesions (with reference diameters of the distal main vessel ≤ 4.00 mm and proximal main vessel ≤ 5.00 mm).

    Technical data overview

    Stent platform material cobalt-chromium alloy L605
    Catheter coating  hydrophilic
    Polymer  biodegradable
    Anti-proliferative agent sirolimus
    Strut thickness  0.07 mm
    MRI MR Conditional
    Radiopacity excellent
    Radial force high
    Pushability and trackability excellent
    Inflation and deflation time very short
    Proximal shaft diameter 2F (0.65 mm)
    Distal shaft diameter 2.7F (0.90 mm)
    Compatible guidewire max. 0.014”
    Compatible guiding catheter 5F (0.056”)
    Nominal pressure 10 atm
    Rated Burst Pressure 16 atm
    Delivery system type Rapid Exchange
    Catheter length 140 cm
       

    Available versions

    MOST COMMONLY USED SIZES 

    Reference: Nominal
    stent diameter
    [mm]    		 Nominal
    stent length
    [mm]    		 Distal length /
    Stent length
    [%]    		 Proximal length /
    Stent length
    [%]
    Dist Prox
    ZSTB2.50x3.00x1614CS  2.50  3.00 16 55 37
    ZSTB2.50X3.25X1614CS  2.50  3.25 16 55 37
    ZSTB2.75X3.50X1614CS  2.75  3.50 16 55 37
    ZSTB3.00X3.50X1614CS  3.00  3.50 16 56 36
    ZSTB3.00X3.75X1614CS  3.00  3.75 16 54 38
    ZSTB3.50X4.25X1614CS  3.50  4.25 16 54 38
    ZSTB3.75X4.50X1614CS  3.75  4.50 16 56 37
    ZSTB3.75x4.75x1614CS  3.75  4.75 16 52 41
    ZSTB4.00x5.00x1614CS  4.00  5.00 16 52 41
    ZSTB2.50x3.00x1914CS  2.50  3.00 19 54 39
    ZSTB2.50X3.25X1914CS  2.50  3.25 19 54 39
    ZSTB2.75X3.50X1914CS  2.75  3.50 19 54 39
    ZSTB3.00X3.50X1914CS  3.00  3.50 19 55 38
    ZSTB3.00X3.75X1914CS  3.00  3.75 19 54 40
    ZSTB3.50X4.25X1914CS  3.50  4.25 19 54 40
    ZSTB3.75X4.50X1914CS  3.75  4.50 19 55 39
    ZSTB3.75x4.75x1914CS  3.75  4.75 19 51 37
    ZSTB4.00x5.00x1914CS  4.00  5.00 19 51 37
    ZSTB2.50x3.00x2414CS  2.50  3.00 24 56 38
    ZSTB2.50X3.25X2414CS  2.50  3.25 24 56 38
    ZSTB2.75X3.50X2414CS  2.75  3.50 24 56 38
    ZSTB3.00X3.50X2414CS  3.00  3.50 24 57 37
    ZSTB3.00X3.75X2414CS  3.00  3.75 24 56 39
    ZSTB3.50X4.25X2414CS  3.50  4.25 24 56 39
    ZSTB3.75X4.50X2414CS  3.75  4.50 24 57 38
    ZSTB3.75x4.75x2414CS  3.75  4.75 24 52 37
    ZSTB4.00x5.00x2414CS  4.00  5.00 24 52 37

     

    ON REQUEST
    (please contact us for more information)

    Reference: Nominal
    stent diameter
    [mm]    		 Nominal stent length [mm] Distal length /
    Stent length
    [%]    		 Proximal length /
    Stent length
    [%]
    Dist Prox
    ZSTB2.50x3.00x1514CS  2.50  3.00 15 54 39
    ZSTB2.50x3.25x1514CS  2.50  3.25 15 54 39
    ZSTB2.75x3.50x1514CS  2.75  3.50 15 54 39
    ZSTB3.00x3.50x1514CS  3.00  3.50 15 54 38
    ZSTB3.00x3.75x1514CS  3.00  3.75 15 54 37
    ZSTB3.50x4.25x1514CS  3.50  4.25 15 54 37
    ZSTB3.75x4.50x1514CS  3.75  4.50 15 47 44
    ZSTB3.75x4.75x1514CS  3.75  4.75 15 47 44
    ZSTB4.00x5.00x1514CS  4.00  5.00 15 47 44
    ZSTB2.50x3.00x1814CS  2.50  3.00 18 45 49
    ZSTB2.50x3.25x1814CS  2.50  3.25 18 45 49
    ZSTB2.75x3.50x1814CS  2.75  3.50 18 45 49
    ZSTB3.00x3.50x1814CS  3.00  3.50 18 45 48
    ZSTB3.00x3.75x1814CS  3.00  3.75 18 45 47
    ZSTB3.50x4.25x1814CS  3.50  4.25 18 45 47
    ZSTB3.75x4.50x1814CS  3.75  4.50 18 39 53
    ZSTB3.75x4.75x1814CS  3.75  4.75 18 39 49
    ZSTB4.00x5.00x1814CS  4.00  5.00 18 39 49
    ZSTB2.50x3.00x2314CS  2.50  3.00 23 50 45
    ZSTB2.50x3.25x2314CS  2.50  3.25 23 50 45
    ZSTB2.75x3.50x2314CS  2.75  3.50 23 50 45
    ZSTB3.00x3.50x2314CS  3.00  3.50 23 50 45
    ZSTB3.00x3.75x2314CS  3.00  3.75 23 50 44
    ZSTB3.50x4.25x2314CS  3.50  4.25 23 50 44
    ZSTB3.75x4.50x2314CS  3.75  4.50 23 52 42
    ZSTB3.75x4.75x2314CS  3.75  4.75 23 52 39
    ZSTB4.00x5.00x2314CS   4.00  5.00 23 52 39
               
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