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Tack endovascular system

Device-Type

Dissection repair device

Manufacturer

Philips


The Tack endovascular system is a first-of-its-kind, minimal-metal dissection repair device, purpose-built for precision treatment of post-PTA peripheral arterial dissections to promote healing, improve outcomes, and preserve limbs.

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. 


The Tack endovascular system has been rigorously studied in the Tack Optimized Balloon Angioplasty (TOBA) trials. These trials are unique in that they are the only clinical trials to investigate 100% dissected vessels. The TOBA II, TOBA III, and TOBA II BTK studies add to the large body of clinical evidence supporting the use of the Tack endovascular system, further demonstrating that post-PTA dissection repair with the Tack endovascular system improves outcomes for both POBA and DCB angioplasty for patients with PAD and CLI.


Product highlights

The Tack implant features adaptive sizing which allows the device to adapt to tapering anatomy while maintaining a relatively constant radial force, so that a single Tack implant can be used across a range of vessel diameters.

• 4F/.014” and 6F/.035” OTW delivery systems

• 120, 135, and 150 cm working lengths

• Four or six pre-loaded Tack implants

• Self-sizes to tapering vessel diameters from 1.5-4.5 mm, 3.5-6.0 mm, and 4.0-8.0 mm with a single system

• Accurate (≤1 mm) deployment

• Nitinol with gold radiopaque markers

Features and Benefits


Purpose built

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

Precision repair

Focal treatment with minimal metal treats only the area where dissections are present and avoids covering portions of healthy tissue.

Preserves options

Preserves options

Leaves behind significantly less metal than stents, preserving vessel integrity, future treatment options and—ultimately—limbs.

Adaptive sizing

Adaptive sizing

Only the Tack endovascular system features adaptive sizing – which allows each Tack implant to adapt to tapering anatomy 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.


Safety informations

Intended use:

The Tack endovascular system (6F, 3.5-6.0 mm and 4.0-8.0 mm) is intended for use in the superficial femoral and proximal popliteal arteries ranging in diameter from 3.5 mm to 6.0 mm and 4.0 mm to 8.0 mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s). The Tack endovascular system (4F, 1.5-4.5 mm) is intended for use in mid/distal popliteal, tibial and peroneal arteries, ranging in diameter from 1.5 mm to 4.5 mm, 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. Philips 3721 Valley Centre Drive, Suite 500 San Diego, CA 92130 USA www.philips.com/IGTdevices ©2020 Koninklijke Philips N.V. All rights reserved. Approved for external distribution. D058801-00 122020 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. Tack endovascular system and Tack are registered trademarks of Intact Vascular, Inc. Adaptive sizing is a trademark of Intact Vascular, Inc.

Device Documents

Related Device SKUs

* Select 2 or more (upto 4) SKUs to compare.
SKU Name Device SKUs Model Tack implant length Treatment range (RVD) Catheter length Number of Tacks
Tack endovascular system (4F)
154150041 6.0 mm 1.5-4.5 mm 150 cm 4
Tack endovascular system (6F)
156120061 6.0 mm 3.5-6.0 mm 120 mm 6
Tack endovascular system (6F)
206135061 8.0 mm 4.0-8.0 mm 135 cm 6
  • Model : 154150041
  • Procedure : -
  • Tack implant length : 6.0 mm
  • Treatment range (RVD) : 1.5-4.5 mm
  • Catheter length : 150 cm
  • Number of Tacks : 4
  • Model : 156120061
  • Procedure : -
  • Treatment range (RVD) : 3.5-6.0 mm
  • Catheter length : 120 mm
  • Number of Tacks : 6
  • Tack implant length : 6.0 mm
  • Model : 206135061
  • Procedure : -
  • Tack implant length : 8.0 mm
  • Treatment range (RVD) : 4.0-8.0 mm
  • Catheter length : 135 cm
  • Number of Tacks : 6

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