Stent Retrievers
EmboTrap® II Revascularization Device
Indications for Use
The EmboTrap® II Revascularization Device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Key Specifications
- Retrievable, self-expanding Nitinol shaped section at the distal end of a tapered Nitinol shaft
- Retriever sizes: 4×15 mm, 4×20 mm, 6×20 mm, 6×30 mm (diameter × length)
- Minimum microcatheter inner diameter: 0.021" for 4 mm diameter size, 0.027" for 6 mm diameter size
- Principal materials: Nitinol (distal shaped section and shaft), Platinum/Tungsten (distal and proximal marker/coil)
- Supplied sterile, single-use only
- Sterilization method: Ethylene Oxide (EO) with minimum SAL of 10–6
- Shelf life: 3 years
- Intended for use by physicians trained in neuro-interventional catheterization and ischemic stroke treatment
- Core wire: Nitinol guide-wire like shaft
- Design characteristics include radial force, flexibility, kink resistance, and radiopacity comparable to predicates
Description
The EmboTrap® II Revascularization Device is composed of a retrievable, self-expanding, Nitinol shaped section at the distal end of a tapered Nitinol shaft. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. The device is supplied sterile and intended for single-use only by trained physicians.