SAVION DLVR™ and SAVION FLX™ Guidewires

Indications, Safety and Warnings

Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

Boston Scientific SAVION DLVR™ and SAVION FLX™ Guidewires are intended to facilitate the placement of balloon dilatation catheters or other interventional therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature.

CONTRAINDICATIONS

None known.

WARNINGS

Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Severe reaction may occur in response to contrast agents that cannot be adequately premedicated.

When the guidewire is in the body, it should be manipulated only under fluoroscopy.

The hydrophilic coating of these guidewires increases the possibility of vessel wall perforation compared to non-hydrophilic coatings.

PRECAUTIONS

Carefully check and match therapeutic device compatibility to the wire prior to use.

ADVERSE EVENTS

Potential adverse events which may result from the use of the device include but are not limited to:

  • Abrupt closure
  • Allergic reaction (to contrast, device or other)
  • Angina or unstable angina
  • Arrhythmias
  • Bleeding/Hemorrhage
  • Cardiac tamponade/pericardial effusion
  • Death
  • Embolization (plaque, thrombus, device, tissue, or other)
  • Hematoma
  • Infection/Sepsis
  • Myocardial infarction or ischemia
  • Pain at the access site
  • Pseudoaneurysm
  • Renal insufficiency or renal failure
  • Stroke/cerebral vascular accident (CVA)/transient ischemic attack (TIA)
  • Thrombosis/Thrombus
  • Vasospasm
  • Vessel trauma (dissection, perforation, rupture or injury)

Some of the above potential adverse events may require additional urgent intervention or surgery.

 

92275338 Version A

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