INTENDED USE: The Tack Endovascular System (6F) is intended for use in the superficial femoral and proximal popliteal arteries ranging in diameter from 3.5mm to 6.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).

CONTRAINDICATIONS FOR USE: The Tack Endovascular System is contraindicated for the following:

1. Patients with residual stenosis in the treated segment equal to or greater than 30% after PTA.
2. Tortuous vascular anatomy significant enough to prevent safe introduction and passage of the device.
3. Patients with a known hypersensitivity to nickel-titanium alloy (Nitinol).
4. Patients unable to receive standard medication used for interventional procedures such as anticoagulants, contrast agents and antiplatelet therapy.

Prior to using the Tack Endovascular System, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

The Tack Endovascular System is CE Mark authorized under EC Directive 93/42/EEC. Tack Endovascular System^® and Tack^® are registered trademarks of Intact Vascular, Inc. Adaptive Sizing™ is a trademark of Intact Vascular, Inc.

Copyright © 2019. All rights reserved.

MKT-0133 Rev 01 US 042019