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Summary of Safety and Effectiveness

Prior to use, please consult the “Directions for Use”  for more information on Indications, Instructions, Warnings, Precautions and more detailed information on safe and effective use of the PROTEUS device.

Intended Use/Indications for Use

The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and removal of embolic material (e.g. debris, thrombus) during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.


The Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature is not intended for use in the renal, cerebral, coronary or carotid vasculature.


Contraindications

PROTEUS is contraindicated for: pediatric or neonatal use, patients who are contraindicated for angioplasty treatment and any vessel requiring treatment with balloon/stent greater than the maximum balloon diameter listed on the device label.

 

General Warnings/Cautions

The safety and efficacy of this device has not been evaluated for use in primary embolectomy or primary thrombectomy procedures.  Only physicians who are thoroughly trained in angioplasty interventional procedures and are trained in the proper use of the device should use the Angioslide PROTEUS™ Balloon Catheter. For additional information, read the Warnings/Cautions section of the Instructions for Use.


Precautions

The following complications may occur as a result of PTA, but may not be limited to:

  • Spasm reactions of vessel
  • Arterial wall injuries, including perforation and dissection
  • Access site injuries including hemorrhage or hematoma
  • Arteriovenous fistula, false aneurysm
  • Vascular thrombosis, systemic embolization
  • Infection
  • Pyrogenic reaction (fever)
  • Amputation
  • Death
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician

 

Instructions for Use - Download PDF

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