PURPOSE–BUILT. PRECISION REPAIR. PRESERVES OPTIONS.
Femoropopliteal dissection repair using the Tack Endovascular System (4F, 1.5-4.0mm) following plain balloon angioplasty (POBA)
12m K-M Freedom from CD-TLR
12m K-M Primary Patency
Freedom from MALE + POD at 30 days
Tack implant treatment of post-PTA dissection was safe and effective for treatment of BTK dissections and resulted in reasonable twelve-month patency and low rates of CD-TLR
DESCRIPTION: This was a multi-center study to evaluate the safety and effectiveness of the 4F Tack Endovascular System® in treating dissections that occur following Below-the-Knee (BTK) balloon angioplasty. There were 35 patients enrolled at 6 sites in Europe and New Zealand and twelve-month follow-up has been completed.
Twelve-month results were presented in Orlando, Florida at the SCAI Congress by Dr. Christian Wissgott and published in Catheterization and Cardiovascular Interventions.
These data reinforced Intact Vascular’s decision to conduct an Investigational Device Exemption trial for a permanent vascular implant below the knee. This study, called TOBA II BTK, has completed enrollment and is currently in follow-up.