Femoropopliteal dissection repair using the Tack Endovascular System following plain balloon angioplasty (POBA) or Lutonix® drug-coated balloon angioplasty

92.1%

Dissection Resolution

86.5%

12m K-M Freedom
from CD-TLR

79.3%

12m K-M
Primary Patency

100%

Freedom from Fracture

99.9%

12m Freedom from
Implant Migration

0.5%

Bail Out Stent Rate

CONCLUSION:

High patency rate and high freedom from CD-TLR position Tack to be a clinically important treatment option for focal dissection repair after balloon angioplasty.

STATUS: This study has met its primary endpoints, and patients are in follow-up phase.

DESCRIPTION: This multi-center, U.S. and European study is designed to evaluate the safety and effectiveness of the Tack Endovascular System® for the repair of dissection(s) type(s) A through F resulting from percutaneous transluminal balloon angioplasty (PTA) using standard and drug-coated balloon angioplasty (BARD Lutonix®) in the superficial femoral and proximal popliteal arteries.

This study received FDA IDE approval in August 2015 and subject enrollment is complete. There were 213 patients enrolled at 33 United States and European sites and twenty-four-month follow up has been completed. This study is in the follow-up phase. To learn more about this study, visit www.clinicaltrials.gov and search for NCT02522884.

Twelve-month results were presented in Las Vegas, Nevada at the VIVA 2018 Conference by Dr. William Gray and manuscript is pending publication.

Lutonix® is a registered trademark of BD Interventional.

92.1%

Dissection Resolution

79.3%

12m K-M
Primary Patency

99.9%

12m Freedom from
Implant Migration

86.5%

12m K-M Freedom
from CD-TLR

100%

Freedom from Fracture

0.5%

Bail Out Stent Rate

CONCLUSION:

High patency rate and high freedom from CD-TLR position Tack to be a clinically important treatment option for focal dissection repair after balloon angioplasty.

STATUS: This study has met its primary endpoints, and patients are in follow-up phase.

DESCRIPTION: This multi-center, U.S. and European study is designed to evaluate the safety and effectiveness of the Tack Endovascular System® for the repair of dissection(s) type(s) A through F resulting from percutaneous transluminal balloon angioplasty (PTA) using standard and drug-coated balloon angioplasty (BARD Lutonix®) in the superficial femoral and proximal popliteal arteries.

This study received FDA IDE approval in August 2015 and subject enrollment is complete. There were 213 patients enrolled at 33 United States and European sites and twenty-four-month follow up has been completed. This study is in the follow-up phase. To learn more about this study, visit www.clinicaltrials.gov and search for NCT02522884.

Twelve-month results were presented in Las Vegas, Nevada at the VIVA 2018 Conference by Dr. William Gray and manuscript is pending publication.

Lutonix® is a registered trademark of BD Interventional.