Safety and Effectiveness Study

The Angio-Seal Vascular Closure Device with a self-tightening suture was evaluated in a multicenter non-randomized study designed to examine the safety and effectiveness of femoral artery closure using the 8F and 6F Angio-Seal Device following arterial cannulation during diagnostic angiography and percutaneous coronary intervention procedures. The study was conducted in the United States at nine institutions involving 306 patients. Patients eligible for participation included candidates for early ambulation and patients who were clinically indicated for a diagnostic or an interventional cardiac procedure involving access through the femoral artery using an 8F sheath or smaller for the 8F Angio-Seal or a 6F sheath or smaller for the 6F Angio-Seal. Exclusion criteria included patients with known allergies to the materials used in the device, severe acute non-cardiac systemic disease, evidence of systemic infection, coagulopathy, thrombolytic medication use reducing fibrinogen to less than 100 mg/dl, use of intra-aortic balloon pump support (ipsilateral), sheath in place for more than 36 hours, suspected double wall puncture, pre-existing hematoma, pregnancy/lactation, or indication that the puncture had been made in the profunda femoris or at the bifurcation of the common femoral artery.

CONTRAINDICATIONS

There are no contraindications to the use of this device. Attention is drawn to the warnings and precautions.

WARNINGS

• Do not use if the temperature indicator dot on package has changed from light gray to dark gray or black.

• Do not use if the package is damaged or any portion of the package has been previously opened.

• Do not use if the items in the kit appear damaged or defective in any way.

• Do not use the Angio-Seal Device where bacterial contamination of the procedure sheath or surrounding tissues may have occurred as this may result in an infection.

• Do not use the Angio-Seal Device if the procedure sheath has been placed through the superficial femoral artery and into the profunda femoris as this may result in collagen deposition into the superficial femoral artery. This may reduce blood flow through the vessel leading to symptoms of distal arterial insufficiency.

• Do not use the Angio-Seal Device if the puncture site is at or distal to the bifurcation of the superficial femoral and profunda femoris artery, as this may result in

1) the anchor catching on the bifurcation or being positioned incorrectly, and/or

2) collagen deposition into the vessel. These events may reduce blood flow through the vessel leading to symptoms of distal arterial insufficiency.

• Do not use the Angio-Seal Device if the puncture site is proximal to the inguinal ligament as this may result in a retroperitoneal hematoma.

PRECAUTIONS

Special Patient Populations The safety and effectiveness of the Angio-Seal Device has not been established in the following patient populations:

• Patients undergoing an interventional procedure who are being treated with warfarin.

• Patients who have known allergies to beef products, collagen and/or collagen products, or polyglycolic or polylactic acid polymers.

• Patients with pre-existing autoimmune disease.

• Patients undergoing therapeutic thrombolysis.

• Patients punctured through a vascular graft.

• Patients with uncontrolled hypertension (> 180 mm Hg systolic).

• Patients with a bleeding disorder, including thrombocytopenia (< 100,000 platelet count), thrombasthenia, von WilleBrand’s disease, or anemia (Hgb < 10 mg/dl, Hct < 30).

• Pediatric patients or others with small femoral artery size (< 4 mm in diameter). Small femoral artery size may prevent the Angio-Seal™ anchor from deploying properly in these patients.

• Patients who are pregnant or lactating.

Possible adverse events for vascular closure devices include, but are not limited to: bleeding or hematoma, AV fistula or pseudoaneurysm, infection, allergic reaction, foreign body reaction, inflammation or edema. This device should only be used by a licensed physician (or other health care professional authorized by or under the direction of such physician) possessing adequate instruction in the use of the device, e.g., participation in an Angio-Seal physician instruction program or equivalent.