Indications for Use
The EXOSEAL® Vascular Closure Device is indicated for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or
interventional catheterization procedures using a standard 5F, 6F, or 7F vascular sheath introducer with up to a 12 cm working length.
Additionally, the EXOSEAL® Vascular Closure
Device is indicated to reduce times to hemostasis and ambulation in patients who have undergone interventional catheterization procedures, using a standard 6F vascular sheath introducer
up to a 12 cm working length, who have received preprocedural and/or intraprocedural glycoprotein (GP) IIb/IIIa inhibitor therapy.
There are no contraindications to the use of this device. Attention is drawn to the Warnings, Precautions, and Special Patient Populations.
Special Patient Population
The safety and effectiveness of the EXOSEAL® Vascular Closure Device has not been established in the following patient populations:
- Patients with acute ST-elevation myocardial infarction ≤ 48 hours prior to the cardiac or peripheral catheterization procedure
- Patients with uncontrolled hypertension at time of closure (BP ≥ 180/110 mmHg)
- Patients who bruise or bleed easily or with a history of significant bleeding or platelet disorders, such as thrombocytopenia (with < 100,000 platelet count), Von Willebrand’s disease, anemia (Hgb < 10 g/dL, Hct < 30%), thrombasthenia, decreased fibrinogen (<200 mg/dl), and Factory V deficiency
- Patients with prior femoral vascular surgery or vascular graft in region of access site
- Patients with pre-existing systemic or cutaneous infection
- Patients who are known to be pregnant or who are lactating
- Patients on thrombolytic (e.g. streptokinase, urokinase, t-PA) ≤ 24 hours prior to the catheterization procedure
- Patients on Angiomax (bivalirudin) or other thrombin-specific anticoagulants or low molecular weight heparin ≤ 24 hours prior to the cardiac or peripheral catheterization procedure
- Patients with a BMI > 40 kg/m2
- Patients with symptomatic leg ischemia in the target vessel limb including severe claudication (, 30.48 meters / < 100 feet) or weak/absent pulse
- Patients with planned arterial access at the same access site ≤ 30 days following the femoral artery closure procedure
- Patients undergoing arterial puncture in the femoral artery or both legs
- Patients with prior target artery closure with any closure device, or closure with manual compression ≤ 30 days prior to the cardiac or peripheral catheterization procedure
- Patients with prior or recent use of an intra-aortic balloon pump through the arterial access site
- Patients with evidence of a preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to start of femoral artery closure procedure
- Patients with a tortuous targeted femoral artery
- Patients who within ≤ 1 cm of the puncture site have fluoroscopically visible calcium, atherosclerotic disease, or a stent
- Patients with a targeted femoral artery diameter stenosis ≥ 50%
- Patients with arteriotomies in vessels with diameters < 5mm
- Patients where there is difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
- Patients with antegrade puncture
- Heparinized patients with elevated pre-closure ACT level: > 250 seconds with GP llb/llla inhibitor, > 300 seconds without GP llb/llla inhibitor
- Patients experiencing cardiogenic shock (hemodynamic instability requiring intravenous medications or mechanical support) during or immediately post-catheterization
Please refer to the Instructions For Use for complete information.