Heartspan Steerable Introducer Kit

FDA-Cleared Indications

• Use as an introducer system to facilitate the placement of catheters during intravascular procedures.
• Use when controlled positioning and manipulation of catheters within the cardiovascular system are required.

Clinical Applications

• Facilitating catheter placement during cardiac electrophysiology procedures.
• Providing steerable access for catheter-based evaluation or treatment of cardiac arrhythmias.
• Supporting catheter navigation during procedures performed in a cardiac catheterization or electrophysiology laboratory.

Reported off-label uses

• Use of steerable introducer sheaths in selected non-cardiac endovascular procedures may be described in clinical practice, but use must follow the specific device labeling and institutional protocols.

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 kit is intended for single use and should be handled using sterile technique.
• Available size, length, curve, and catheter compatibility should be confirmed before the procedure.
• The operator should be trained in vascular access, introducer-sheath manipulation, and management of potential cardiac or vascular complications.
• MRI safety depends on the exact device configuration and labeling; confirm the current manufacturer instructions before MRI exposure.
• Potential contraindications and precautions include local or systemic infection, uncontrolled bleeding risk, vascular access problems, and any contraindication to the planned cardiac procedure.