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.

TYSHAK®: Specifications, Instructions for Use, and Forms

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: RM0344-01J
INTERNATIONAL: RM0344-01J

Post Market Surveillance Form

TYSHAK II®: Specifications, Instructions for Use, and Forms

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: RM0344-03L
INTERNATIONAL: RM0344-03L

Post Market Surveillance Form

TYSHAK X™: Specifications, Instructions for Use, and Forms

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: RM0344-02J
INTERNATIONAL: RM0344-02J

Post Market Surveillance Form

TYSHAK NuCLEUS®: Specifications, Instructions for Use, and Forms

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: RM0344-54G
INTERNATIONAL: RM0344-54G

PMCF Tyshak NuCLEUS

Balloon Diameter (mm) Balloon Length (cm) Introducer (FR) Shaft Size (FR) Usable Length (cm) Guide Wire (inches) Rated Burst Pressure (ATM) Maximum Volume (cc) Catalog Number Product
16.0 5.00 8 7.0 100 0.035 3.5 PDC330 TYSHAK-X
16.0 6.00 7 7.0 100 0.035 2.5 PDC522 TYSHAK II
16.0 6.00 8 7.0 100 0.035 3.5 PDC197 TYSHAK
16.0 6.00 8 7.0 100 0.035 3.5 PDC331 TYSHAK-X
16.0 6.00 9 7.0 100 0.035 3.5 PDC144 TYSHAK
16.0 8.00 7 7.0 100 0.035 2.5 SO037 TYSHAK II
16.0 9.00 9 7.0 100 0.035 3.5 PDC125 TYSHAK
17.0 3.00 7 7.0 100 0.035 2.5 PDC523 TYSHAK II
17.0 4.00 7 7.0 100 0.035 2.5 PDC524 TYSHAK II
17.0 5.00 7 7.0 100 0.035 2.5 PDC525 TYSHAK II
17.0 5.00 9 7.0 100 0.035 2.0 SO012 TYSHAK
17.0 6.00 7 7.0 100 0.035 2.5 PDC526 TYSHAK II
17.0 6.00 9 7.0 100 0.035 2.0 PDC151 TYSHAK
17.0 8.00 7 7.0 100 0.035 2.5 SO038 TYSHAK II
17.0 8.00 9 8.0 100 0.035 2.0 PDC123 TYSHAK
18.0 2.00 8 7.0 100 0.035 2.0 PDC094 TYSHAK
18.0 2.00 9 8.0 100 0.035 2.0 PDC034 TYSHAK
18.0 3.00 8 8.0 100 0.035 2.0 PDC527 TYSHAK II
18.0 3.00 9 8.0 100 0.035 2.0 PDC017 TYSHAK
18.0 3.00 9 8.0 100 0.035 3.0 TN030 TYSHAK NUCLEUS
18.0 4.00 8 8.0 100 0.035 2.0 PDC528 TYSHAK II
18.0 4.00 9 7.0 80 0.035 2.0 PDC122 TYSHAK
18.0 4.00 9 8.0 85 0.035 2.0 PDC097 TYSHAK
18.0 4.00 9 8.0 100 0.035 2.0 PDC076 TYSHAK
18.0 4.00 9 8.0 100 0.035 3.0 TN031 TYSHAK NUCLEUS
18.0 5.00 8 8.0 100 0.035 2.0 PDC529 TYSHAK II
18.0 5.00 9 8.0 100 0.035 2.0 PDC041 TYSHAK
18.0 5.50 11 9.0 120 0.035 2.0 PDC142 TYSHAK
18.0 6.00 8 8.0 100 0.035 2.0 PDC530 TYSHAK II
18.0 6.00 9 8.0 100 0.035 2.0 PDC027 TYSHAK
18.0 8.00 9 8.0 100 0.035 2.0 PDC135 TYSHAK
18.0 8.00 9 8.0 100 0.035 2.0 PDC093 TYSHAK
18.0 10.00 10 8.0 100 0.035 2.0 PDC059 TYSHAK
19.0 6.00 9 8.0 100 0.035 2.0 PDC136 TYSHAK
19.0 9.00 9 8.0 100 0.035 2.0 PDC137 TYSHAK
19.0 9.00 9 8.0 100 0.035 2.0 PDC099 TYSHAK
20.0 2.00 8 8.0 100 0.035 2.0 SN001 TYSHAK II
20.0 3.00 8 8.0 100 0.035 2.0 PDC531 TYSHAK II
20.0 3.00 10 8.0 100 0.035 2.0 TN032 TYSHAK NUCLEUS
20.0 3.00 10 8.0 100 0.035 2.0 PDC042 TYSHAK
20.0 4.00 8 8.0 100 0.035 2.0 PDC532 TYSHAK II
20.0 4.00 9 8.0 100 0.035 2.0 PDC198 TYSHAK
20.0 4.00 10 8.0 100 0.035 2.0 TN033 TYSHAK NUCLEUS
20.0 4.00 10 8.0 100 0.035 2.0 PDC018 TYSHAK
20.0 5.00 8 8.0 100 0.035 2.0 PDC533 TYSHAK II
20.0 5.00 10 8.0 100 0.035 2.0 PDC048 TYSHAK
20.0 5.50 10 9.0 120 0.035 2.0 PDC085 TYSHAK
20.0 5.50 12 9.0 120 0.035 2.0 PDC143 TYSHAK
20.0 6.00 8 8.0 100 0.035 2.0 PDC534 TYSHAK II
20.0 6.00 9 8.0 100 0.035 2.0 PDC199 TYSHAK

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.

 

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