TYSHAK MINI®
Pediatric Valvuloplasty (USA)
TYSHAK MINI®
TYSHAK MINI® balloon catheters 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 MINI® catheters glide easily through smaller and difficult-to-negotiate vessels.
Lowest Profile among the TYSHAK® Line
The TYSHAK MINI® Pediatric PTV balloons are coaxially constructed with a non-compliant balloon for correct inflation size. The super-thin balloon is the lowest profile of any TYSHAK® balloon in its diameter.
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 body is Polymeric, DEHP-free, and not made with natural rubber latex. The balloon is a thermoplastic elastomer; non-compliant - which will not exceed +/- 10% of the labeled balloon size at nominal pressure, is DEHP-free, and not made with natural rubber latex.
Specifications, Instructions for Use, and Forms
Balloon Diameters (mm): 4.0-10.0
Balloon Lengths (cm): 1.0-4.0
Rated Burst Pressure (ATM): 3.5-6
Introducer Size (FR): 3-4
Indication: Pediatric PTV of the Pulmonary Valve
TYSHAK MINI® IFUs:
US: IFU-107B
CANADA: RM0344-04L
INTERNATIONAL: RM0344-04L
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 4.0 | 1.00 | 3 | 2.5 | 65 | 0.014 | 6.0 | SO095 | TYSHAK MINI | |
| 4.0 | 2.00 | 3 | 2.5 | 65 | 0.014 | 6.0 | PDC400 | TYSHAK MINI | |
| 5.0 | 1.00 | 3 | 2.5 | 65 | 0.014 | 6.0 | SO097 | TYSHAK MINI | |
| 5.0 | 2.00 | 3 | 2.5 | 65 | 0.014 | 6.0 | PDC401 | TYSHAK MINI | |
| 6.0 | 1.00 | 3 | 2.5 | 65 | 0.014 | 4.0 | SO098 | TYSHAK MINI | |
| 6.0 | 2.00 | 3 | 2.5 | 65 | 0.014 | 4.0 | PDC402 | TYSHAK MINI | |
| 7.0 | 1.00 | 3 | 2.5 | 65 | 0.014 | 4.0 | SO101 | TYSHAK MINI | |
| 7.0 | 2.00 | 3 | 2.5 | 65 | 0.014 | 4.0 | PDC403 | TYSHAK MINI | |
| 8.0 | 1.00 | 3 | 2.5 | 65 | 0.014 | 4.0 | SO102 | TYSHAK MINI | |
| 8.0 | 2.00 | 3 | 2.5 | 65 | 0.014 | 4.0 | PDC404 | TYSHAK MINI | |
| 9.0 | 1.00 | 4 | 3.5 | 65 | 0.014 | 3.5 | SO103 | TYSHAK MINI | |
| 9.0 | 2.00 | 4 | 3.5 | 65 | 0.014 | 3.5 | PDC405 | TYSHAK MINI | |
| 9.0 | 4.00 | 4 | 3.5 | 65 | 0.014 | 3.5 | PDC407 | TYSHAK MINI | |
| 10.0 | 1.00 | 4 | 3.5 | 65 | 0.014 | 3.5 | SO104 | TYSHAK MINI | |
| 10.0 | 2.00 | 4 | 3.5 | 65 | 0.014 | 3.5 | PDC406 | TYSHAK MINI | |
| 10.0 | 4.00 | 4 | 3.5 | 65 | 0.014 | 3.5 | PDC408 | TYSHAK MINI |
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.