Transcription of Instructions for Use - eifu.abbottvascular.com
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Instructions for Use - eifu.abbottvascular.com
MitraClip NT Clip Delivery System MitraClip NT System Clip Delivery System Ref No. CDS0501. Steerable Guide Catheter Ref No. SGC0101/Ref No. SGC0301. MitraClip System Accessories Stabilizer Ref No. SZR01ST. Lift Ref No. LFT01ST. Support Plate Ref No. PLT01ST. Instructions for Use WARNING: Read all Instructions carefully. Failure to follow these Instructions , warnings and precautions may lead to device damage or patient injury. Use of the MitraClip NT. should be restricted to those physicians trained to perform invasive endovascular and transseptal procedures and to those physicians trained in the proper use of the system. NOTE: The MitraClip NT Clip Delivery System Ref No. CDS0501 is fully compatible with Steerable Guide Catheter Ref No. SGC0101 and Ref No. SGC0301. The procedure step-by-step Instructions for the use of the Steerable guide have not changed. Please refer to the Instructions for use for Ref No. SGC0101 to obtain information on how Ref No.
The MitraClip® NT Clip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at
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