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

98.5%

Dissection Resolution

89.5%

12m K-M Freedom
from CD-TLR

76.4%

12m K-M
Primary Patency

100%

Freedom from
MAE at 30 days

CONCLUSION:

Tack implant treatment of post-PTA dissection was safe, produced reasonable patency, and resulted in low rates of target lesion revascularization

DESCRIPTION: This multi-center, post-CE mark study evaluated the performance of the Tack Endovascular System® in subjects with post-angioplasty dissections resulting from percutaneous transluminal balloon angioplasty of superficial femoral or popliteal arteries. There were 138 patients enrolled at 13 European sites and twelve-month follow up has been completed.

Twelve-month results were presented in Leipzig, Germany at the LINC Conference by Dr. Marc Bosiers and subsequently published in the Journal of Vascular Surgery. Additionally, twenty-four month results from a single-center in Heide, Germany were presented in New York, New York at the VEITHsymposium™ by Dr. Christian Wissgott.

The results supported Intact Vascular’s decision to conduct an Investigational Device Exemption trial, called TOBA II, which has completed enrollment and is currently in follow-up phase.

To learn more about this study, visit www.clinicaltrials.gov and search for NCT01663818.

98.5%

Dissection Resolution

76.4%

12m K-M
Primary Patency

89.5%

12m K-M Freedom
from CD-TLR

100%

Freedom from
MAE at 30 days

CONCLUSION:

Tack implant treatment of post-PTA dissection was safe, produced reasonable patency, and resulted in low rates of target lesion revascularization

DESCRIPTION: This multi-center, post-CE mark study evaluated the performance of the Tack Endovascular System® in subjects with post-angioplasty dissections resulting from percutaneous transluminal balloon angioplasty of superficial femoral or popliteal arteries. There were 138 patients enrolled at 13 European sites and twelve-month follow up has been completed.

Twelve-month results were presented in Leipzig, Germany at the LINC Conference by Dr. Marc Bosiers and subsequently published in the Journal of Vascular Surgery. Additionally, twenty-four month results from a single-center in Heide, Germany were presented in New York, New York at the VEITHsymposium™ by Dr. Christian Wissgott.

The results supported Intact Vascular’s decision to conduct an Investigational Device Exemption trial, called TOBA II, which has completed enrollment and is currently in follow-up phase.

To learn more about this study, visit www.clinicaltrials.gov and search for NCT01663818.