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Tack Endovascular System (6F) is FDA approved for SFA and proximal popliteal (3.5-6.0mm RVD) treatment of post-PTA dissections.

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The TOBA II clinical study was designed to investigate the safety and efficacy of the Tack Endovascular System® in the repair of post-angioplasty dissections in the femoropopliteal arteries. Dr. William A. Gray (TOBA II National Principal Investigator, System Chief of Cardiovascular Services at Main Line Health and President of Lankenau Heart Institute) presents the twelve-month data from this study.

TOBA Clinical Studies Program

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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

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Adaptive Sizing™ Animation

TOBA II Twelve-Month Pivotal Trial Data

William A. Gray, MD

Addressing Post-PTA Dissections with a Unique and Novel Approach

William A. Gray, MD

Repairing Focal Dissections with an Easy-to-Deploy Device

Joseph A. R. Cardenas, MD

Tack Endovascular System® MOA Animation