TACK ENDOVASCULAR SYSTEM®

Optimizing PTA with Precision Dissection Repair

The Tack Endovascular System was conceived by Dr. Peter Schneider, a renowned vascular surgeon, to complement POBA and DCB angioplasty procedures and repair peripheral arterial dissections. His belief that a device using less metal and less force than conventional stents would improve angioplasty outcomes, yield better healing, preserve retreatment options and save limbs.

TACK-ENDOVASCULAR-SYSTEM-artery before

Minimal Metal Precision Dissection Repair

Tack Lockup

PURPOSE-BUILT
The Tack Endovascular System is purpose-built to repair peripheral arterial dissections following balloon angioplasty in ATK and BTK therapeutic interventions.

 

PRECISION REPAIR
The Tack Endovascular System is a first-of-its-kind
solution for focal dissection repair.

 

PRESERVES OPTIONS 
A Tack implant leaves behind significantly less metal than stents, preserving vessel integrity, future treatment options and —ultimately— limbs.

Fulfilling an Unmet Need

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.

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 preserving 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 FDA-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 challenging BTK vessels.

Design Features

6F-Tack

ATK Implant

  • 6F/.035” ATK system
  • 6 pre-loaded 6F Tack Implants
  • Self-sizes to tapering vessel diameters from 3.5-6.0mm or 4.0-8.0mm with a single system
  • Nitinol with gold radiopaque (RO) markers
Download ATK Specification Sheet

4F-Tack-transparent

BTK Implant

  • 4F/.014” BTK system
  • 4 pre-loaded 4F Tack Implants
  • Self-sizes to tapering vessel diameters from 1.5-4.5mm with a single system
  • Nitinol with gold radiopaque (RO) markers
Download BTK Specification Sheet

High-Precision
Delivery System

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

Design Features

6F-Tack

ATK Implant

  • 6F/.035” ATK system
  • 6 pre-loaded 6F Tack Implants
  • Self-sizes to tapering vessel diameters from 3.5-6.0mm or 4.0-8.0mm with a single system
  • Nitinol with gold radiopaque (RO) markers
Download ATK Specification Sheet

4F-Tack

BTK Implant

  • 4F/.014” BTK system
  • 4 pre-loaded 4F Tack Implants
  • Self-sizes to tapering vessel diameters from 1.5-4.5mm with a single system
  • Nitinol with gold radiopaque (RO) markers
Download BTK Specification Sheet

High-Precision
Delivery System

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

Mechanism of Action

The Tack Endovascular is an FDA approved dissection repair device designed to maintain vessel integrity and enhance blood flow to promote healing, improve outcomes and preserve limbs.

Tack implants feature Adaptive SizingTM 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.

Play video to learn about the Tack Endovascular System
Play video to learn about Adaptive Sizing
Tack Endovascular System important safety information
The Tack Endovascular System (6F, 3.5-6.0mm and 4.0-8.0mm) is intended for use in the superficial femoral and proximal popliteal arteries ranging in diameter from 3.5mm to 6.0mm and 4.0mm to 8.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
 
The Tack Endovascular System (4F, 1.5-4.5mm) is intended for use in mid/distal popliteal, tibial and peroneal arteries, ranging in diameter from 1.5mm to 4.5mm, 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.
 
Potential complications include but are not limited to: access failure or abrupt closure; allergic/anaphylactoid reaction to anticoagulant and/or antithrombotic therapy or contrast medium; allergic reaction to Nitinol; amputation of lower extremity; anemia; angina / coronary ischemia / myocardial infarction; arrhythmia; arterial occlusion/(re)stenosis/dissection/thrombus; arterial spasm; arteriovenous fistula; blue toe syndrome; claudication or rest pain, worsened; death; disseminated intravascular coagulation; embolism; emergent repeat hospital intervention; fever; gangrene; gastrointestinal bleed from anticoagulation / antiplatelet medication; hematoma / hemorrhage; hypotension / hypertension; inadvertent venipuncture; infection / abscess at insertion site / cellulitis; inflammation; multi-organ failure; pain; pseudoaneurysm; renal insufficiency or failure; respiratory distress or failure; reperfusion pain; septicemia / bacteremia (sepsis); swelling / edema, peripheral; tachycardia; Tack implant embolization; Tack implant migration; Tack implant occlusion / restenosis; tissue necrosis; trauma to adjacent structures; stroke / TIA (hemorrhagic / embolic); and vascular complications which may require surgical repair.
 
Caution: Federal law restricts this device to sales by or on the order of a physician.

PURPOSEBUILT. PRECISION REPAIR. PRESERVES OPTIONS.

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