Intact Vascular and its investigators have completed enrollment and follow-up in the following three separate studies of the Tack Endovascular System®.
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 twelve-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.
Lutonix© is a registered trademark of Bard Peripheral VascularRead Press Release
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.Read Press Release
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.
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 twleve-month follow-up has been completed.
Twelve-month results were presented in Orlando, Florida at the SCAI Congress by Dr. Christian Wissgott.Read Press Release
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, is currently enrolling patients in the United States, Europe and New Zealand.TOBA II BTK Site Locator
This first-in-man study evaluated the safety and feasibility of using the Tack Endovascular System® in patients with vascular flaps in the infrainguinal arteries following angioplasty dissection.
The data demonstrated that the system was safe, and were published in the Journal of the American Journal of Cardiology: Cardiovascular Interventions.