PTS_X BALLOON _Rev
Presentational Presentational

Sizing

PTS®/PTS-X™

PTS®/PTS-X™ Sizing balloon catheters are designed for use in patients with cardiovascular defects where accurate measurement of the defect is important to select the appropriately sized occluder device.  The X-line inner braided catheter tubing provides an extra high inner lumen strength and improved pushability.

Largest Selection of Sizing Balloon Options Available

The PTS®/PTS-X™sizing balloons are available in over 60 size configurations.  Balloon diameters range from 10.0-40.0mm and lengths from 1.0-6.0cm and are available on 80cm and 110cm usable catheter lengths.    

The PTS® sizing balloon is super-thin for a low deflated profile that maintains tip flexibility.  The double tapered balloon has short tapers at the distal and proximal ends for enhanced transition across the stenosis and post dilatation ease of withdrawal into the introducer.  Platinum image bands facilitate reliable positioning of the balloon for accurately sizing the defect. 

The catheter body is Polymeric, DEHP-free, and not made of natural rubber latex.  The balloon is a thermoplastic elastomer; non-compliant - which will not exceed +/- 10% of the labeled balloon size at RBP, is DEHP-free, and not made of natural rubber latex.

PTS®: Specifications, Instructions for Use, and Forms

Balloon Diameters (mm):  20.0-40.0
Balloon Lengths (cm):  3.0-5.0
Rated Burst Pressure (ATM): 0.5-1.5
Introducer Size (FR):  8-9
Indication:  Recommended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.

PTS® IFUs:
US: IFU-360B
CANADA: RM0344-19M
INTERNATIONAL: RM0344-19M

Post Market Surveillance Form

PTS-X™: Specifications, Instructions for Use, and Forms

Balloon Diameters (mm):  10.0-40.0
Balloon Lengths (cm):  1.0-6.0
Rated Burst Pressure (ATM): 0.5-2.5
Introducer Size (FR):  6-9
Indication:  Recommended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.

PTS-X™ IFUs:
US: IFU-360XB
CANADA: RM0344-27N
INTERNATIONAL: RM0344-27N

Post Market Surveillance Form

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
40.0 3.00 9 8.0 110 0.035 0.5 PTS406 PTS
40.0 3.00 9 8.0 110 0.035 0.5 PTSX407 PTS-X
40.0 4.00 9 8.0 80 0.035 0.5 PTSX404 PTS-X
40.0 4.00 9 8.0 80 0.035 0.5 PTS404 PTS
40.0 4.00 9 8.0 110 0.035 0.5 PTS407 PTS
40.0 4.00 9 8.0 110 0.035 0.5 PTSX408 PTS-X
40.0 5.00 9 8.0 80 0.035 0.5 PTSX405 PTS-X
40.0 5.00 9 8.0 80 0.035 0.5 PTS405 PTS
40.0 5.00 9 8.0 110 0.035 0.5 PTS408 PTS
40.0 5.00 9 8.0 110 0.035 0.5 PTSX409 PTS-X
40.0 6.00 9 8.0 80 0.035 0.5 PTSX406 PTS-X
40.0 6.00 9 8.0 110 0.035 0.5 PTSX410 PTS-X

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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Tel: 407-352-5200

 

NuMED Inc.

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Hopkinton, NY
12965 USA
Tel: 315-328-4491

 

NuMED Canada

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Cornwall, Ontario
K6J1G3 CANADA
Tel: 613-936-2592