TACK ENDOVASCULAR SYSTEM®

Device Overview

The Tack Endovascular System is a first-of-its-kind dissection repair device that is purpose-built to provide precision treatment of peripheral arterial dissections following balloon angioplasty, in either above- or below-the-knee therapeutic interventions.

Web Hand Image

Tack® implants feature Adaptive Sizing™ which allows the implant(s) to adapt to tapering vessels while maintaining a relatively constant radial force. This means that a single size Tack implant can be used across a wide range of vessel diameters. The systems are pre-loaded with 4 (BTK) or 6 (ATK) self-expanding nitinol Tack implants that can be deployed to treat multiple dissections using a single catheter and leave behind >70% less metal than stents.1

Play video to learn about the Adaptive Sizing™ mechanism of action.

Design Features

tack_6F_sm

6F system FDA approved for SFA and proximal popliteal treatment of post-PTA dissections

  • 6F/.035” ATK system
  • 6 pre-loaded 6F Tack implants
  • Adapts to treat vessel diameters from 3.5-6.0mm with a single system
  • Nitinol with gold radiopaque (RO) markers
Download ATK Specification Sheet

4F system designed for below-the-knee (BTK) interventions

  • F/.014” BTK system
  • 4 pre-loaded 4F Tacks
  • Adapts to treat vessel diameters from 1.5-4.5mm with a single system
  • Nitinol with gold radiopaque (RO) markers
CAUTION: Investigational device. Tack Endovascular System (4F) limited by federal (United States) law to investigational use. Not available for sale in the United States.

delivery_sm

High-Precision Delivery System

  • Standard over-the-wire delivery system
  • Design permits accurate (≤ 1mm) Tack implant deployment

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.

For informational purposes only. You should always consult with your doctor when seeking medical advice or considering treatment.
The TOBA II and TOBA III studies evaluated the Tack Endovascular System (6F, 3.5-6.0mm).

References
  1. Bosiers M, Scheinert D, Hendriks JMH, et al. Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty. J Vasc Surg 2016; 64(1):109-16.

PURPOSEBUILT. PRECISION REPAIR. PRESERVES OPTIONS.

Scroll to Top
Intact Vascular uses cookies to improve your experience on this website. Some of the cookies we use are essential for parts of the website to operate. Please be aware that if you continue without changing your cookie settings, you consent to this.