Indications

BTG CROSSING DEVICE INDICATIONS FOR USE


FDA Cleared Indications for Use

The CenterCross™ and CenterCross™ ULTRA catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.

The CenterCross™ ULTRA LV catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.

The MultiCross™ support catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary or peripheral vasculature and for guidewire exchange.

The MicroCross™ microcatheter is intended for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The MicroCross™ microcatheter is also intended to infuse and deliver saline and contrast agents.

Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.
 

CE Mark Indications for Use

The CenterCross™ and CenterCross™ ULTRA catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices beyond stenotic lesions, including chronic total occlusions (CTOs).

The MultiCross™ support catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary or peripheral vasculature and for guidewire exchange beyond stenotic lesions, including chronic total occlusions (CTOs).
 

The MicroCross™ microcatheter is intended for us as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures.  The MicroCross™ microcatheter facilitates placement of guidewires beyond stenotic lesions, including chronic total occlusions (CTOs). The MicroCross™ microcatheter is also intended to infuse and deliver saline and contrast agents.

Note: CenterCross™ ULTRA LV is not CE marked.

BTG CROSSING DEVICE CONTRAINDICATIONS STATEMENTS

FDA Cleared Contraindications Statements

The CenterCrossTM and CenterCrossTM Ultra are contraindicated for:

 

  • Vessels less than 2.5mm in diameter
  • Carotid vessels
  • Vessels in the neurovasculature
  • Venous system
 
The CenterCrossTM ULTRA LV is contraindicated for:
  • Vessels less than 2.5mm in diameter
  • Carotid vessels
  • Vessels in the coronary and neurovasculature
  • Venous system
 
The MultiCrossTM is contraindicated for:
  • Vessels less than 2.5mm in diameter
  • Carotid vessels
  • Vessels in the neurovasculature
  • Venous system

 
The MicroCrossTM is contraindicated for use in the neuro and cerebral vasculatures.
 

CE Mark Contraindications Statements

The CenterCrossTM and CenterCrossTM Ultra are contraindicated for:

  • Carotid vessels
  • Vessels in the neurovasculature
  • Venous system
 
The MultiCrossTM is contraindicated for:
  • Carotid vessels
  • Vessels in the neurovasculature
  • Venous system

 
The MicroCrossTM is contraindicated for use in the neuro and cerebral vasculatures.