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Percutaneous Transluminal Valvuloplasty (USA)

COEfficient™

COEfficient™ balloon catheters were developed in collaboration with Dr. Yashu Coe. The distinguishing feature of this high pressure balloon catheter is its extremely thin profile for a balloon with RBPs as high as 13 ATM.  The COEfficient™ valvuloplasty catheter is engineered for maximum steering and tracking.  The coaxial shaft design provides enhanced column strength and pushability combined with a flexible distal tip for optimum steerability.  The COEfficient™ is available in a range of diameters (4.0-12.0mm) and lengths (2.0-3.0cm) and can be used with even the smallest introducer sheaths (4-7FR).

Unique Benefits

COEfficient™ balloons are made of a thin material which allows an exceptionally low profile and therefore, requires small introducers for a high pressure balloon.  The COEfficient™balloon is coaxially constructed with a non-compliant high pressure balloon suitable for resistant stenosis.  The distal shaft through the balloon is highly flexible for exceptional maneuverability.  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 RBP, is DEHP-free, and not made with natural rubber latex.

Specifications, Instructions for Use, and Forms

Balloon Diameters (mm):  4.0-12.0
Balloon Lengths (cm):  2.0-4.0
Rated Burst Pressure (ATM): 7-13 
Introducer Size (FR):  4-7
Indication:  PTV of the Pulmonary Valve

COEfficient™ IFUs:
US: IFU-303B
CANADA: RM0344-83
INTERNATIONAL: RM0344-12J

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
12.0 2.00 6 3.5 135 0.018 7.0 COE136 COEFFICIENT
12.0 3.00 7 3.5 75 0.018 7.0 COE126 COEFFICIENT
12.0 3.00 7 3.5 135 0.018 7.0 COE153 COEFFICIENT
12.0 4.00 7 3.5 75 0.018 7.0 COE127 COEFFICIENT
12.0 4.00 7 3.5 135 0.018 7.0 COE154 COEFFICIENT

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.

 

NuMED for Children

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Windermere, FL
34786 USA
Tel: 407-352-5200

 

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2880 Main Street
Hopkinton, NY
12965 USA
Tel: 315-328-4491

 

NuMED Canada

45 Second Street West
Cornwall, Ontario
K6J1G3 CANADA
Tel: 613-936-2592