AbsorbaSeal 5.6.7F Vascular Closure Device
Cyndrx, LLC
FDA Clearance Information
FDA-Cleared Indications
- Percutaneous closure of femoral arterial access sites.
- Use after diagnostic or interventional catheterization procedures.
- Use with 5F, 6F, or 7F procedural sheaths.
- Intended to reduce time to hemostasis and ambulation.
Clinical Applications
- Closure of femoral artery access after peripheral angiography or catheter-based peripheral intervention.
- Closure of femoral artery access after peripheral balloon angioplasty.
- Closure of femoral artery access after peripheral artery stenting.
- Closure of femoral artery access after endovascular aneurysm repair when the access sheath is 5F, 6F, or 7F.
- Closure of femoral arterial access after other diagnostic or interventional catheterization procedures using a labeled sheath size.
Practical Considerations
- The labeled procedural sheath sizes are 5F, 6F, and 7F; vessel anatomy and access-site conditions must also be suitable for closure-device use.
- The device is intended for femoral arterial access sites and is not labeled here for venous access or nonfemoral arterial access.
- Access-site imaging, including angiography or ultrasound when clinically appropriate, may help assess puncture location, vessel size, calcification, stenosis, and other factors before deployment.
- Use requires following the manufacturer’s instructions for deployment, compression or sealing, inspection for bleeding, and post-procedure monitoring.
- MRI safety status, contraindications, and compatibility with specific guidewires or introducer systems should be confirmed in the current instructions for use; they are not established by the information provided here.
Procedures that use this device
Frequently Asked Questions
What is the AbsorbaSeal vascular closure device used for?
It is used to close femoral arterial puncture sites after diagnostic or interventional catheterization procedures performed through 5F, 6F, or 7F sheaths. Its labeled purpose is to reduce time to hemostasis and ambulation.
What sizes does AbsorbaSeal fit?
The FDA indication covers procedures using 5F, 6F, or 7F procedural sheaths. The appropriate device and technique must be confirmed in the current manufacturer’s instructions for use.
Is AbsorbaSeal MRI safe?
MRI safety labeling cannot be determined from the information provided. Check the current manufacturer’s instructions for use or the facility’s device-safety database before MRI.
How long does the AbsorbaSeal closure last?
The device is used to achieve closure of the femoral arterial access site after the procedure; the FDA indication provided does not specify a fixed duration of device performance. Healing and follow-up depend on the access site, vessel condition, and the closure system’s design.
How much does the AbsorbaSeal vascular closure device cost?
The price varies by hospital, distributor, contract, and procedure. Patients should ask the treating facility and insurer about device and procedure costs, coverage, deductibles, and out-of-pocket responsibility.