link to Video of Tack Endovascular System

This animation is provided for general information only. It is not intended to provide clinical instructions for use (IFU). Always read and understand the IFU supplied with the device prior to use.

Presentations and Publications

Tack Optimized Balloon Angioplasty: TOBA Trial 12 Month Results

(Presented by Dr. Marc Bosiers at LINC Conference 2015)

Key findings:

  • Key conclusions from the TOBA study included:
  • 89.5% freedom from clinically driven target lesion revascularization (CD-TLR) rate at 12 months. CD-TLR accounts for repeat procedures, or re-interventions, due to recurrent symptoms related to the treated lesion.
  • 76.4% 12-month Kaplan-Meier patency rate. Patency means a sustained restoration of adequate blood flow was achieved through the treated segment of the diseased artery. Most of the subjects had significant dissections, which are graded from A to F. In the study, 74% of the patients had dissections graded C or higher, and less than 5% of the patients had simple Grade A dissections, based on independent core lab adjudication.
  • 98.5% technical success rate.
  • No evidence of migration or movement of Tack implants throughout the 12 month follow up period.

Link:  Tack Optimized Balloon Angioplasty: TOBA Trial 12 months Results

First-In-Man Clinical Study Results Published

(Journal of the American College of Cardiology, April 2015)

Key Findings:

  • Successful dissection repair was achieved at all the lesion sites with the placement of the Tack implant, as determined by angiography. The key endpoints at 12 month follow up included:
  • 100% repair of dissection flaps
  • 12 month patency rates:
    • 87.5% for SFA and Popliteal vessels
    • 83.3% for SFA, Popliteal and Tibial vessels
    • 80.0% for only Tibial vessels
  • No limb loss
  • No implant migration.
  • One target lesion revascularization and death occurred, not related to the device or procedure

Link: American College of Cardiology: Cardiovascular Interventions