TACK ENDOVASCULAR SYSTEM®

Precision Dissection Repair

The Tack Endovascular System® (6F) is an FDA approved implant for precision dissection repair following balloon angioplasty with a first-of-its-kind solution that is designed to maintain vessel integrity and enhance blood flow to promote healing, improve outcomes and preserve limbs.

There has been no purpose-built solution to address the dissections caused by POBA and DCB procedures in above-the-knee (ATK) and below-the-knee (BTK) therapeutic interventions. The Tack® implant is designed to fulfill this unmet need.

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Fulfilling an unmet need

 

In ATK Vessels

Stents used for dissection repair may introduce new complications and prevent retreatment. Twelve month TOBA study results prove that use of the Tack implant in ATK vessels has a positive effect on patency and target lesion revascularization (TLR) rates, leaving behind minimal metal and preservint future treatment options.

In BTK vessels

Treatment of BTK disease is extremely challenging and interventions including stents and balloons have limited efficacy. No stent is approved for BTK use, yet the off-label use of coronary stents is well=documented. The Tack implant is the first purpose-built dissection repair device designed for use in narrow BTK vessels.

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.

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