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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
4.0 2.00 4 3.5 75 0.018 13.0 COE101 COEFFICIENT
4.0 2.00 4 3.5 135 0.018 13.0 COE128 COEFFICIENT
4.0 3.00 4 3.5 75 0.018 13.0 COE102 COEFFICIENT
4.0 3.00 4 3.5 135 0.018 13.0 COE137 COEFFICIENT
4.0 4.00 4 3.5 75 0.018 13.0 COE103 COEFFICIENT
4.0 4.00 4 3.5 135 0.018 13.0 COE138 COEFFICIENT
5.0 2.00 4 3.5 75 0.018 12.0 COE104 COEFFICIENT
5.0 2.00 4 3.5 135 0.018 12.0 COE129 COEFFICIENT
5.0 3.00 4 3.5 75 0.018 12.0 COE105 COEFFICIENT
5.0 3.00 4 3.5 135 0.018 12.0 COE139 COEFFICIENT
5.0 4.00 4 3.5 75 0.018 12.0 COE106 COEFFICIENT
5.0 4.00 4 3.5 135 0.018 12.0 COE140 COEFFICIENT
6.0 2.00 5 3.5 75 0.018 12.0 COE107 COEFFICIENT
6.0 2.00 5 3.5 135 0.018 12.0 COE130 COEFFICIENT
6.0 3.00 5 3.5 75 0.018 12.0 COE108 COEFFICIENT
6.0 3.00 5 3.5 135 0.018 12.0 COE141 COEFFICIENT
6.0 4.00 5 3.5 75 0.018 12.0 COE109 COEFFICIENT
6.0 4.00 5 3.5 135 0.018 12.0 COE142 COEFFICIENT
7.0 2.00 5 3.5 75 0.018 11.0 COE110 COEFFICIENT
7.0 2.00 5 3.5 135 0.018 11.0 COE131 COEFFICIENT
7.0 3.00 5 3.5 75 0.018 11.0 COE111 COEFFICIENT
7.0 3.00 5 3.5 135 0.018 11.0 COE143 COEFFICIENT
7.0 4.00 5 3.5 75 0.018 11.0 COE112 COEFFICIENT
7.0 4.00 5 3.5 135 0.018 11.0 COE144 COEFFICIENT
8.0 2.00 6 3.5 75 0.018 10.0 COE113 COEFFICIENT
8.0 2.00 6 3.5 135 0.018 10.0 COE132 COEFFICIENT
8.0 3.00 6 3.5 75 0.018 10.0 COE114 COEFFICIENT
8.0 3.00 6 3.5 135 0.018 10.0 COE145 COEFFICIENT
8.0 4.00 6 3.5 75 0.018 10.0 COE115 COEFFICIENT
8.0 4.00 6 3.5 135 0.018 10.0 COE146 COEFFICIENT
9.0 2.00 5 3.5 75 0.018 10.0 SN032 COEFFICIENT
9.0 2.00 6 3.5 75 0.018 10.0 COE116 COEFFICIENT
9.0 2.00 6 3.5 135 0.018 10.0 COE133 COEFFICIENT
9.0 3.00 6 3.5 75 0.018 10.0 COE117 COEFFICIENT
9.0 3.00 6 3.5 135 0.018 10.0 COE147 COEFFICIENT
9.0 4.00 6 3.5 75 0.018 10.0 COE118 COEFFICIENT
9.0 4.00 6 3.5 135 0.018 10.0 COE148 COEFFICIENT
10.0 2.00 6 3.5 75 0.018 10.0 COE119 COEFFICIENT
10.0 2.00 6 3.5 135 0.018 10.0 COE134 COEFFICIENT
10.0 3.00 6 3.5 75 0.018 10.0 COE120 COEFFICIENT
10.0 3.00 6 3.5 135 0.018 10.0 COE149 COEFFICIENT
10.0 4.00 6 3.5 75 0.018 10.0 COE121 COEFFICIENT
10.0 4.00 6 3.5 135 0.018 10.0 COE150 COEFFICIENT
11.0 2.00 6 3.5 75 0.018 8.0 COE122 COEFFICIENT
11.0 2.00 6 3.5 135 0.018 8.0 COE135 COEFFICIENT
11.0 3.00 6 3.5 75 0.018 8.0 COE123 COEFFICIENT
11.0 3.00 6 3.5 135 0.018 8.0 COE151 COEFFICIENT
11.0 4.00 6 3.5 75 0.018 8.0 COE124 COEFFICIENT
11.0 4.00 6 3.5 135 0.018 8.0 COE152 COEFFICIENT
12.0 2.00 6 3.5 75 0.018 7.0 COE125 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.

 

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