TYSHAK® Line
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
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
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
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
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 7.0 | 2.00 | 5 | 4.0 | 70 | 0.018 | 5.0 | PDC126 | TYSHAK | |
| 7.0 | 2.00 | 5 | 4.0 | 70 | 0.021 | 5.0 | PDC109 | TYSHAK | |
| 7.0 | 2.00 | 6 | 5.5 | 70 | 0.025 | 5.0 | PDC176 | TYSHAK | |
| 7.0 | 2.00 | 6 | 5.5 | 100 | 0.035 | 5.0 | TN009 | TYSHAK NUCLEUS | |
| 7.0 | 2.00 | 7 | 6.0 | 75 | 0.035 | 5.0 | PDC124 | TYSHAK | |
| 7.0 | 3.00 | 4 | 4.0 | 70 | 0.021 | 4.0 | PDC509 | TYSHAK II | |
| 7.0 | 3.00 | 4 | 4.0 | 100 | 0.021 | 4.0 | SN010 | TYSHAK II | |
| 7.0 | 3.00 | 5 | 4.0 | 70 | 0.018 | 5.0 | PDC157 | TYSHAK | |
| 7.0 | 3.00 | 5 | 4.0 | 70 | 0.021 | 5.0 | PDC118 | TYSHAK | |
| 7.0 | 3.00 | 6 | 5.5 | 70 | 0.025 | 5.0 | PDC024 | TYSHAK | |
| 7.0 | 3.00 | 6 | 5.5 | 100 | 0.035 | 5.0 | TN010 | TYSHAK NUCLEUS | |
| 7.0 | 4.00 | 6 | 5.0 | 70 | 0.025 | 5.0 | PDC037 | TYSHAK | |
| 7.0 | 4.00 | 6 | 5.5 | 100 | 0.035 | 5.0 | TN011 | TYSHAK NUCLEUS | |
| 8.0 | 1.50 | 5 | 5.0 | 70 | 0.021 | 5.0 | PDC007 | TYSHAK | |
| 8.0 | 2.00 | 4 | 4.0 | 70 | 0.021 | 4.0 | PDC504 | TYSHAK II | |
| 8.0 | 2.00 | 4 | 4.0 | 100 | 0.021 | 4.0 | SN007 | TYSHAK II | |
| 8.0 | 2.00 | 5 | 4.0 | 70 | 0.018 | 5.0 | PDC127 | TYSHAK | |
| 8.0 | 2.00 | 5 | 5.0 | 70 | 0.025 | 5.0 | PDC177 | TYSHAK | |
| 8.0 | 2.00 | 6 | 5.5 | 70 | 0.025 | 5.0 | PDC063 | TYSHAK | |
| 8.0 | 2.00 | 6 | 5.5 | 100 | 0.035 | 5.0 | PDC045 | TYSHAK | |
| 8.0 | 2.00 | 6 | 5.5 | 100 | 0.035 | 5.0 | TN012 | TYSHAK NUCLEUS | |
| 8.0 | 2.00 | 6 | 6.0 | 100 | 0.035 | 5.0 | PDC300 | TYSHAK-X | |
| 8.0 | 3.00 | 4 | 4.0 | 70 | 0.021 | 4.0 | PDC510 | TYSHAK II | |
| 8.0 | 3.00 | 4 | 4.0 | 100 | 0.021 | 4.0 | SN011 | TYSHAK II | |
| 8.0 | 3.00 | 5 | 4.0 | 70 | 0.025 | 5.0 | PDC178 | TYSHAK | |
| 8.0 | 3.00 | 5 | 5.0 | 70 | 0.018 | 5.0 | PDC115 | TYSHAK | |
| 8.0 | 3.00 | 6 | 5.5 | 70 | 0.025 | 5.0 | PDC031 | TYSHAK | |
| 8.0 | 3.00 | 6 | 5.5 | 70 | 0.035 | 5.0 | PDC025 | TYSHAK | |
| 8.0 | 3.00 | 6 | 5.5 | 100 | 0.035 | 5.0 | TN013 | TYSHAK NUCLEUS | |
| 8.0 | 3.00 | 6 | 5.5 | 100 | 0.035 | 5.0 | PDC008 | TYSHAK | |
| 8.0 | 4.00 | 4 | 4.0 | 70 | 0.021 | 4.0 | SO029 | TYSHAK II | |
| 8.0 | 4.00 | 5 | 5.0 | 70 | 0.025 | 5.0 | PDC179 | TYSHAK | |
| 8.0 | 4.00 | 6 | 5.0 | 70 | 0.025 | 5.0 | PDC038 | TYSHAK | |
| 8.0 | 4.00 | 6 | 5.5 | 70 | 0.025 | 5.0 | PDC051 | TYSHAK | |
| 8.0 | 4.00 | 6 | 5.5 | 100 | 0.035 | 5.0 | PDC067 | TYSHAK | |
| 8.0 | 4.00 | 6 | 5.5 | 100 | 0.035 | 5.0 | TN014 | TYSHAK NUCLEUS | |
| 8.0 | 5.00 | 4 | 4.0 | 70 | 0.021 | 4.0 | SO032 | TYSHAK II | |
| 8.0 | 5.00 | 6 | 5.5 | 70 | 0.035 | 5.0 | SO011 | TYSHAK | |
| 8.0 | 6.00 | 4 | 4.0 | 70 | 0.021 | 4.0 | SO030 | TYSHAK II | |
| 8.0 | 6.00 | 6 | 5.5 | 70 | 0.025 | 5.0 | PDC052 | TYSHAK | |
| 8.0 | 6.00 | 6 | 5.5 | 100 | 0.035 | 5.0 | PDC068 | TYSHAK | |
| 8.0 | 8.00 | 6 | 5.0 | 100 | 0.021 | 5.0 | PDC147 | TYSHAK | |
| 8.0 | 8.00 | 6 | 5.5 | 100 | 0.035 | 5.0 | PDC069 | TYSHAK | |
| 9.0 | 2.00 | 5 | 5.0 | 90 | 0.025 | 3.5 | SO007 | TYSHAK II | |
| 9.0 | 2.00 | 5 | 5.0 | 100 | 0.025 | 5.0 | SN012 | TYSHAK | |
| 9.0 | 2.00 | 5 | 5.0 | 110 | 0.025 | 5.0 | PDC155 | TYSHAK | |
| 9.0 | 2.00 | 6 | 5.5 | 70 | 0.025 | 5.0 | PDC009 | TYSHAK | |
| 9.0 | 2.00 | 6 | 5.5 | 100 | 0.035 | 5.0 | PDC113 | TYSHAK | |
| 9.0 | 2.00 | 6 | 5.5 | 100 | 0.035 | 5.0 | TN015 | TYSHAK NUCLEUS | |
| 9.0 | 3.00 | 5 | 5.0 | 90 | 0.025 | 3.5 | PDC505 | 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.