1. The ANGIO-SEAL active closure anchor gives you the inside advantage. The anchor creates a mechanical seal from the inside out—here’s how:

• The anchor supports proper location for a reliable seal and collagen positioning1,2: 99.7% deployment success3 97.8% hemostasis by device

• The anchor and seal are bioabsorbed: – Fibrin coats the anchor within hours and becomes totally encapsulated in 7-14 days

– Anchor begins to hydrate and soften 24-36 hours after deployment

– Anchor is absorbed 95% at 42 days

– All components are absorbed within 60-90 days

• Arterial flow is not compromised, no evidence of chronic scar tissue or inflammation5,6

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 the

1) 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 whom 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.

Procedure

The Angio-Seal device is to be used only 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. Use a single wall puncture technique. Do not puncture the posterior wall of the artery. If a patient has had a procedure sheath left in place for longer than 8 hours, consideration should be given to the use of prophylactic antibiotics before insertion of the Angio-Seal device. The Angio-Seal device should be used within one hour of opening the foil pouch. The biodegradable components will begin to deteriorate upon exposure to ambient conditions. Observe sterile technique at all times when using the Angio-Seal device. The Angio-Seal device is for single use only and should not be reused in any manner. The Angio-Seal device must be inserted through the insertion sheath provided in the kit. Do not substitute any other sheath. Use only the arteriotomy locator provided in the kit to locate the puncture in the arterial wall. Follow physician orders regarding patient ambulation and discharge. If the Angio-Seal device does not anchor in the artery due to improper orientation of the anchor or patient vascular anatomy, the absorbable components and delivery system should be withdrawn from the patient. Hemostasis can then be achieved by applying manual pressure.

Based on clinical experience, the following describes possible treatments for risks or situations that are associated with use of the Angio-Seal device or vascular access procedures.

• Bleeding or hematoma - Apply light digital or manual pressure to the puncture site. If manual pressure is necessary, monitor pedal pulses.

• AV fistula or pseudoaneurysm - If suspected, the condition may be evaluated with duplex ultrasound. When indicated, ultrasound guided compression of a pseudoaneurysm may be used after the Angio-Seal device has been placed.

• Device non-deployment - If device pulls out with sheath upon withdrawal, apply manual or mechanical pressure per standard procedure. Examine the device to ensure all absorbable components have been withdrawn.

• Anchor fracture or embolism - Examine device to determine if anchor has been withdrawn. If bleeding occurs, apply manual or mechanical pressure to the puncture site per standard procedures. If anchor is not attached to the device, monitor the patient (for at least 24 hours) for signs of vascular occlusion. Clinical experience to date indicates that tissue ischemia from an embolized anchor is unlikely. Should ischemic symptoms appear, treatment options include thrombolysis, percutaneous extraction of the anchor or fragments, or surgical intervention.

• Infection - Any sign of infection at the puncture site should be taken seriously and the patient monitored carefully. Surgical removal of the device should be considered whenever an access site infection is suspected.

• Collagen deposition into the artery or thrombosis at puncture site - If this condition is suspected, the diagnosis can be confirmed by duplex ultrasound. Treatment of this event may include thrombolysis, percutaneous thrombectomy, or surgical intervention.

• Very thin patients - Collagen may protrude from the skin after tamping has been completed. Attempt to push the collagen under the skin using the tamper tube or a sterile hemostat. DO NOT apply vigorous tamping as this may result in anchor fracture.

DO NOT cut off the excess collagen, as the suture woven through the collagen may be cut and the integrity of the anchor/collagen sandwich could be compromised.

• Obese patients - The tamper tube may not be long enough to be exposed or grasped at the skin. Place fingers on either side of the suture, compress the surrounding tissue, and attempt to expose the tamper tube. If necessary, a sterile hemostat may be used to grasp the tamper tube so the collagen can be tamped adequately. The following potential adverse reactions or conditions may also be associated with one or more Angio-Seal device components (i.e., collagen, synthetic absorbable suture, and/or synthetic absorbable polymer):

• Allergic reaction

• Foreign body reaction

• Potentiation of infection

• Inflammation

• Edema