Ultraflex Ev Hemostasis Introducer

FDA-Cleared Indications

• Introduction and delivery of embolization coils during vascular procedures.
• Vascular access for procedures requiring placement of embolic coils to occlude or control blood flow.

Clinical Applications

• Delivery of embolization coils for treatment of selected aneurysms and pseudoaneurysms.
• Delivery of embolization coils to control bleeding from selected gastrointestinal or other vascular sources.
• Coil embolization of selected arteriovenous malformations or abnormal vascular connections.
• Coil occlusion of selected visceral, pelvic, or peripheral vessels when vascular embolization is indicated.

Reported off-label uses

• Use as an access sheath for delivery of other embolic materials or vascular devices when compatible with the catheter system and procedural technique.
• Use in selected venous embolization procedures, such as varicocele or ovarian-vein embolization, when the device size and configuration are appropriate.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The appropriate sheath size and length must be selected for the target vessel, access site, guidewire, delivery catheter, and embolization coil system.
• The device is used with fluoroscopic or other appropriate imaging guidance by clinicians trained in vascular access and embolization.
• Check compatibility with the intended catheter, guidewire, and coil system before use; do not force the device if resistance is encountered.
• Potential complications include bleeding, hematoma, arterial or venous injury, thrombosis, infection, vasospasm, embolization to an unintended location, and contrast-related complications.
• MRI safety and conditional use should be confirmed in the current manufacturer labeling. The FDA record alone does not establish that the device is MR Safe or MR Conditional.