Pinnacle Destination Peripheral Guiding Sheath

FDA-Cleared Indications

• Facilitate the introduction of interventional devices into the peripheral vasculature.
• Provide vascular access and support during peripheral endovascular procedures.
• Assist with delivery of compatible devices, including embolization devices, when used according to the applicable product labeling.

Clinical Applications

• Accessing peripheral arteries during endovascular embolization procedures.
• Providing support for delivery of embolization coils and other compatible interventional devices.
• Maintaining a stable conduit for catheter and guidewire exchanges in the peripheral vasculature.
• Supporting treatment of selected peripheral vascular abnormalities when compatible devices are introduced through the sheath.

Reported off-label uses

• Use as a guiding or support sheath in complex endovascular procedures beyond the specific indications or device combinations described in the labeling.
• Use in selected visceral, pelvic, or other vascular interventions based on operator judgment and anatomy.

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 sheath is available in multiple sizes; selection depends on vessel diameter, access site, device compatibility, and the intervention being performed.
• It is designed to resist kinking and provide support, but careful advancement under fluoroscopic or other appropriate imaging guidance is required.
• The sheath must be used with compatible guidewires, catheters, and interventional devices according to the manufacturer’s instructions for use.
• MRI safety depends on the exact model, materials, and labeling; confirm the device-specific MRI conditions before scanning.
• Potential concerns include vessel injury, bleeding, thrombosis, infection, dissection, perforation, embolization, and contrast-related complications.