INDICATIONS, SAFETY, AND WARNINGS Enteer Re-entry System

Note: Safety information provided is for the United States.  Please refer to your region’s Instructions for Use for specific details.

This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call Medtronic at (877) 526-7890. Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions. 


Enteer Re-entry Guidewire

REFERENCE STATEMENT

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The Enteer™ Re-entry Guidewire is intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal angioplasty (PTA). The Enteer Guidewire is not to be used in cerebral blood vessels. When used as part of the Peripheral System, the Enteer Guidewire is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices..

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.


Enteer Re-entry Catheter

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The Enteer™ Re-entry Catheter is indicated for directing, steering, controlling and supporting a guidewire in order to access discrete regions of the peripheral vasculature. When used as part of the Peripheral System, the Enteer Catheter is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

FTSOP113326-51 Rev. 1B