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TO ENSURE PROPER DEPLOYMENT AND USE OF THIS DEVICE AND TO PREVENT INJURY TO PATIENTS, READ ALL INFORMATION CONTAINED IN THESE INSTRUCTIONS
FOR USE.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
DESCRIPTION
The Angio-Seal™ Evolution™ Vascular Closure Device consists of the Angio-Seal Evolution Device, an insertion sheath, an arteriotomy locator (modi
fi
ed dilator) and a guidewire.
The Angio-Seal Evolution Device is composed of an absorbable collagen sponge and a specially designed absorbable polymer anchor that are connected by an absorbable self-
tightening suture (STS). The device seals and sandwiches the arteriotomy between its two primary members, the anchor and the collagen sponge. Hemostasis is achieved primarily
by the mechanical means of the anchor-arteriotomy-collagen sandwich, which is supplemented by the coagulation-inducing properties of the collagen. The device is contained in a
delivery system that stores and then delivers the absorbable components to the arterial puncture. The delivery system features a device handle with a gear driven collagen compaction
mechanism that facilitates proper technique for delivery and deployment of the absorbable unit. The Angio-Seal Vascular Closure Device components are not made from latex rubber.
This product is MR safe.
INDICATIONS
The Angio-Seal Device is indicated for use in closing and reducing time to hemostasis at the femoral arterial puncture site in patients who have undergone diagnostic angiography
procedures or interventional procedures using an 8 French or smaller procedural sheath for the 8F Angio-Seal Device and a 6 French or smaller procedural sheath for the 6F Angio-Seal
Device.
The Angio-Seal Device is also indicated for use to allow patients who have undergone diagnostic angiography to ambulate safely as soon as possible after sheath removal and device
placement.
The Angio-Seal Device is also indicated for use to allow patients who have undergone an interventional procedure to ambulate safely after sheath removal and device placement.
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.
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.
If repuncture at the same location of previous Angio-Seal Device use is necessary in
90 days, re-entry 1 cm proximal to the previous access site can be performed safely, based on
published medical literature. Before considering Angio-Seal use, a femoral angiogram of the site is indicated. [Applegate, R.; Rankin, K.; Little, W.; Kahl, F.; Kutcher, M., “Restick following
initial Angioseal use.”
Catheterization and Cardiovascular Interventions –
Of
fi
cial Journal of the Society for Cardiac Angiography and Interventions
, Feb 2003; 58(2) p181-4.]
“If patients have clinically signi
fi
cant peripheral vascular disease, based on published medical literature, the Angio-Seal Device can be deployed safely in patient arteries > 5 mm
diameter when there is found to be no luminal narrowing of 40% or greater within 5 mm of the puncture site.” [Abando, A.; Hood, D.; Weaver, F.; Katz, S.; “The use of the Angioseal
device for femoral artery closure.”
J Vasc Surg
2004;40:287-90.]
Dispose of contaminated device, components, and packaging materials utilizing standard hospital procedures and universal precautions for biohazardous waste.
