Femoropopliteal dissection repair using the Tack Endovascular System following plain balloon angioplasty (POBA)

93.5%

12m K-M Freedom
from CD-TLR

78.4%

12m K-M
Primary Patency

97.1%

Freedom from
MALE + POD at 30 days

CONCLUSION:

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.

To learn more about this study, visit www.clinicaltrials.gov and search for NCT02235675.

93.5%

12m K-M Freedom
from CD-TLR

78.4%

12m K-M
Primary Patency

97.1%

Freedom from
MALE + POD at 30 days

CONCLUSION:

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.

To learn more about this study, visit www.clinicaltrials.gov and search for NCT02235675.