TyshakX
Presentational Presentational

Percutaneous Transluminal Valvuloplasty (USA)

TYSHAK® Line

TYSHAK® balloon catheters were designed in collaboration with Prof Mike Tynan and Prof Shakeel Qureshi.  They are designed with a low profile that delivers high performance. Manufactured from a micro-thin, non-compliant balloon material, these innovative balloon catheters require small introducers. The reduced sheath size helps minimize vessel trauma and entry-site complications. A short, flexible distal tip provides superior maneuverability. With well-defined shoulders and balloon tapers, TYSHAK® catheters glide easily through smaller and difficult-to-negotiate vessels. They are available in a range of diameters (2.0-30.0mm) and lengths (1.0-10.0cm). 

Unique Benefits

TYSHAK® PTV balloons are coaxially constructed with a non-compliant balloon for correct inflation size. The balloon is made of a micro-thin material which allows for an exceptionally low profile, requires the smallest introducers possible, and has extremely fast inflation and deflation times. The distal shaft through the balloon is highly flexible for maximum trackability. This, combined with the pushability of the coaxial shaft, provides outstanding tracking performance.

The catheter bodies are Polymeric, DEHP-free, and not made with natural rubber latex. The balloons are a thermoplastic elastomer; non-compliant - which will not exceed +/- 10% of the labeled balloon size at RBP or nominal pressure, are DEHP-free, and not made with natural rubber latex.

  • Balloon Diameters (mm):  2.0-25.0
    Balloon Lengths (cm):  1.0-10.0
    Rated Burst Pressure (ATM): 1.5-10
    Introducer Size (FR):  4-11
    Indication:  PTV of the Pulmonary Valve
     

    TYSHAK IFUs:

    US: IFU-102BA
    CANADA: RM0425-02
    INTERNATIONAL: RM0344-01; RM0425-02

     

    Post Market Surveillance Form
    Post Market Surveillance Form NCI

  • Lower profile and lower-rated burst pressure (RBP) than TYSHAK®

    Balloon Diameters (mm):  4.0-30.0
    Balloon Lengths (cm):  2.0-10.0
    Rated Burst Pressure (ATM): 1.5-6
    Introducer Size (FR):  4-10
    Indication:  PTV of the Pulmonary Valve

    TYSHAK II IFUs:

    US: IFU-105BA
    CANADA: RM0425-04
    INTERNATIONAL: RM0344-03; RM0425-04
     

    Post Market Surveillance Form
    Post Market Surveillance Form NCI

  • The X-line version has a radiopaque braided inner tubing, which possesses extra high inner-lumen strength for increased pushability

    Balloon Diameters (mm):  8.0-25.0
    Balloon Lengths (cm):  2.0-6.0
    Rated Burst Pressure (ATM): 1.5-5
    Introducer Size (FR):  6-11
    Indication:  PTV of the Pulmonary Valve
     

    TYSHAK-X IFUs:

    US: IFU-102XB
    CANADA: RM0425-03
    INTERNATIONAL: RM0344-02; RM0425-03
     

    Post Market Surveillance Form
    Post Market Surveillance Form NCI

  • The TYSHAK NuCLEUS® catheter is suitable for PTV and pre-dilatation in transcatheter pulmonary heart-valve replacement procedures.  The balloon is designed with a waist formed into the middle of the balloon.  Upon reaching a specified pressure, the waist will expand between 90% to almost 100% of the rated balloon diameter.

    The innovative balloon design of the TYSHAK NuCLEUS® facilitates positive positioning while holding the balloon in the correct location prior to, and during, inflation.

    The TYSHAK NuCLEUS® requires a smaller introducer and has lower RBPs than NuCLEUS™

    Balloon Diameters (mm):  4.0-25.0
    Balloon Lengths (cm):  2.0-4.0
    Rated Burst Pressure (ATM): 2-5
    Introducer Size (FR):  6-11
    Indication:  PTV of the Pulmonary Valve


    TYSHAK-NuCLEUS IFUs:

    US: IFU-103B
    CANADA: RM0425-31
    INTERNATIONAL: RM0344-54; RM0425-31

    PMCF Tyshak NuCLEUS
    PMCF Tyshak NuCLEUS NCI

Balloon Diameter (mm) Balloon Length (cm) Introducer (FR) Shaft Size (FR) Usable Length (cm) Guide Wire (inches) Rated Burst Pressure (ATM) Catalog Number Product
2.0 1.00 4 3.5 70 0.018 10.0 PDC162 TYSHAK
4.0 1.00 4 3.5 70 0.018 5.0 PDC001 TYSHAK
4.0 2.00 4 3.5 70 0.018 5.0 PDC021 TYSHAK
4.0 2.00 4 4.0 70 0.021 6.0 PDC500 TYSHAK II
4.0 2.00 4 4.0 100 0.021 6.0 SN003 TYSHAK II
4.0 2.00 5 4.0 70 0.018 5.0 PDC172 TYSHAK
4.0 2.00 6 5.5 100 0.035 5.0 PDC138 TYSHAK
4.0 2.00 6 5.5 100 0.035 5.0 TN001 TYSHAK NUCLEUS
4.0 3.00 6 5.5 100 0.035 5.0 TN002 TYSHAK NUCLEUS
4.0 3.00 6 5.5 100 0.035 5.0 PDC141 TYSHAK
4.0 10.00 4 4.0 70 0.021 6.0 PDC551 TYSHAK II
5.0 1.00 4 3.5 70 0.018 5.0 PDC002 TYSHAK
5.0 2.00 4 3.5 70 0.018 5.0 PDC073 TYSHAK
5.0 2.00 4 4.0 70 0.021 6.0 PDC501 TYSHAK II
5.0 2.00 4 4.0 100 0.021 6.0 SN004 TYSHAK II
5.0 2.00 6 5.5 70 0.035 5.0 PDC003 TYSHAK
5.0 2.00 6 5.5 100 0.035 5.0 PDC029 TYSHAK
5.0 2.00 6 5.5 100 0.035 5.0 TN003 TYSHAK NUCLEUS
5.0 3.00 4 3.5 70 0.018 5.0 PDC022 TYSHAK
5.0 3.00 4 4.0 70 0.021 6.0 SO020 TYSHAK II
5.0 3.00 6 5.5 100 0.035 5.0 TN004 TYSHAK NUCLEUS
5.0 4.00 4 3.5 90 0.018 5.0 PDC049 TYSHAK
5.0 4.00 5 4.0 70 0.018 5.0 PDC035 TYSHAK
5.0 4.00 6 5.5 100 0.035 5.0 TN005 TYSHAK NUCLEUS
6.0 1.00 4 3.5 70 0.018 5.0 PDC004 TYSHAK
6.0 1.50 4 3.5 70 0.018 5.0 PDC173 TYSHAK
6.0 2.00 4 3.5 70 0.018 5.0 PDC061 TYSHAK
6.0 2.00 4 4.0 70 0.021 4.0 PDC502 TYSHAK II
6.0 2.00 4 4.0 100 0.021 4.0 SN005 TYSHAK II
6.0 2.00 5 4.0 70 0.021 5.0 PDC088 TYSHAK
6.0 2.00 5 5.0 70 0.025 5.0 PDC062 TYSHAK
6.0 2.00 6 5.5 70 0.018 5.0 PDC174 TYSHAK
6.0 2.00 6 5.5 70 0.035 5.0 PDC005 TYSHAK
6.0 2.00 6 5.5 100 0.035 5.0 PDC030 TYSHAK
6.0 2.00 6 5.5 100 0.035 5.0 TN006 TYSHAK NUCLEUS
6.0 3.00 4 3.5 70 0.018 5.0 PDC156 TYSHAK
6.0 3.00 4 4.0 70 0.021 4.0 SO021 TYSHAK II
6.0 3.00 6 5.0 70 0.025 5.0 PDC023 TYSHAK
6.0 3.00 6 5.5 100 0.035 5.0 PDC202 TYSHAK
6.0 3.00 6 5.5 100 0.035 5.0 TN007 TYSHAK NUCLEUS
6.0 4.00 5 5.0 90 0.025 5.0 PDC087 TYSHAK
6.0 4.00 6 5.0 70 0.025 5.0 PDC036 TYSHAK
6.0 4.00 6 5.5 100 0.035 5.0 TN008 TYSHAK NUCLEUS
6.0 5.00 6 5.5 70 0.035 5.0 PDC102 TYSHAK
6.0 6.00 6 5.0 90 0.025 5.0 PDC050 TYSHAK
6.0 8.00 6 5.5 100 0.035 5.0 PDC103 TYSHAK
7.0 1.50 5 4.0 70 0.021 5.0 PDC006 TYSHAK
7.0 2.00 4 3.5 70 0.018 5.0 PDC175 TYSHAK
7.0 2.00 4 4.0 70 0.021 4.0 PDC503 TYSHAK II
7.0 2.00 4 4.0 100 0.021 4.0 SN006 TYSHAK II

Disclaimer

All products are subject to individual country regulations in regards to the importation and/or sale of these products. Refer to Instructions for Use for a complete listing of indications, contraindications, warnings, and precautions.