PerQseal® Impella Early Feasibility Study

Exclusion Criteria

• •1. Evidence of systemic bacterial or cutaneous infection, including groin infection,
• •2. Known bleeding diathesis, definite or potential coagulopathy, platelet count \< 100,000/µl or subjects on long term anticoagulants with an INR \> 2 within 12 hours prior to index procedure,
• •3. Significant anemia (hemoglobin \<9 g/dL or hematocrit \< 27%), within 24 hours prior to index procedure,
• •4. Known type II heparin-induced thrombocytopenia,
• •5. Unilateral or bilateral lower extremity amputation.
• •6. Rest pain (e.g., Rutherford category 4 or greater), documented untreated iliac or common femoral artery diameter stenosis \> 50% or previous bypass surgery/stent placement in the common femoral artery of target leg,
• •7. Known existing nerve damage in the target leg,
• •8. Known allergy to any of the materials used in the PerQseal® device (refer to Instructions for Use),
• •9. Subject unsuitable for surgical repair of the target leg access site,
• •10. Subject has undergone a percutaneous procedure greater than 8 F sheath in the target leg, within the 90 days prior to index procedure,
• •11. Subject has undergone a percutaneous procedure of 8 F sheath or less using an absorbable or suture mediated closure device for hemostasis, in the target vessel, within the 90 days prior to index procedure,
• •12. Prior evidence of anterior calcification within 10 mm proximal or distal to arteriotomy site,
• •13. Target femoral artery diameter is less than 6 mm in diameter,
• •14. Subject is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up,
• •15. Subject has been previously enrolled in this clinical study.
• •16. Current COVID-19 infection (with or without symptoms), recent positive test for COVID-19, or recent exposure to a person with COVID-19 infection.
• •1. Initial common femoral arterial access achieved with manual palpation or blind arterial stick access, without use of an image guided approach (ultrasound or angiography).
• •2. Difficult dilation during initial target femoral artery access (e.g., that damages or kinks sheath dilators) while step-dilating up to the large-bore device,
• •3. During arterial puncture, the target femoral artery suspected to have experienced a back arterial wall needle puncture or underwent \> one needle puncture during the primary procedure,with a needle larger than a Micropuncture needle (18 gauge)
• •4. Subject has a tissue tract (i.e., estimated distance from skin entry point to arterial anterior surface at arteriotomy) expected to be greater than 8 cm,
• •5. Significant blood loss/transfusion (defined as requiring transfusion of 4 or more units of blood products) during primary procedure or within 30 days prior to index procedure,
• •6. Activated clotting time (ACT) \> 300 seconds immediately prior to sheath removal or if ACT measurements are expected to be \> 300 seconds for more than 24 hours after index procedure,
• •7. Target puncture site is in a vascular graft,
• •8. Target arteriotomy in the profunda femoris or superficial femoral artery or is in common femoral artery, but within 10 mm proximal of the bifurcation of the superficial femoral/ profunda femoris artery,
• •9. Target arteriotomy located above the inferior epigastric artery and/or above the inguinal ligament based on bony landmarks,
• •10. Subjects with an acute hematoma \> 4 cm diameter, arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the target access site,
• •11. Evidence of bleeding around the Impella sheath (BARC type 2 or higher),
• •12. Angiographic evidence of arterial laceration, dissection or stenosis within the femoral artery that would preclude use of the PerQseal® device,
• •13. Uncontrolled hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg) just prior to planned vascular closure.