Cardiosolutions Dexterity Steerable Introducer

FDA-Cleared Indications

• Introduction and placement of catheters into the vascular system.
• Use when vascular access is required for diagnostic or therapeutic catheter-based procedures.

Clinical Applications

• Providing vascular access for catheter-directed embolization procedures.
• Introducing and positioning catheters during interventional cardiology procedures.
• Supporting catheter placement for other diagnostic or therapeutic vascular interventions.

Reported off-label uses

• Use in selected neurointerventional procedures that require steerable catheter access, when permitted by institutional policy and the treating physician.
• Use in selected peripheral vascular and visceral interventions beyond the specific FDA-cleared labeling, based on physician judgment and applicable instructions for use.

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 device is available in different sizes; the appropriate size depends on the access vessel, catheter or guidewire compatibility, and the planned procedure.
• Clinicians should review the current instructions for use for compatible catheters, guidewires, maximum pressure ratings, and steering limitations.
• The steerable mechanism requires training and careful handling to reduce the risk of vessel injury, dissection, perforation, or device damage.
• MRI safety should be confirmed in the current labeling before scanning. Do not assume the device is MR Safe or MR Conditional without manufacturer documentation.
• Contraindications, warnings, anticoagulation requirements, and access-site precautions should be assessed before use.