TOBA II BTK clinical trial commences enrolment with first implant of Tack Endovascular System

Intact Vascular’s Tack endovascular system

Intact Vascular’s TOBA II BTK (Tack optimised balloon angioplasty II below the knee) clinical trial has commenced enrolment, with the first patient treated by Joseph Cardenas at Yuma Regional Hospital and the Heart, Lung and Vascular Center in Yuma, USA.

The TOBA II BTK study is a prospective, multicentre, single-arm study designed to investigate the safety and efficacy of the Tack Endovascular System in combination with standard balloon angioplasty in the popliteal and tibial arteries for the treatment of critical limb ischaemia (CLI). The Tack Endovascular System is a new technology designed to repair dissections in the artery wall that frequently occur as a complication of balloon angioplasty. The system allows physicians to repair these dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options. TOBA II BTK is the first known industry sponsored pivotal clinical trial approved by the US Food and Drug Administration to investigate a permanent vascular implant in arteries below the knee.

Cardenas stated, “One of our key goals when we perform angioplasty in patients with CLI is to restore blood flow to the foot, and keeping the treated arteries open over time is a major challenge. The Tack system is uniquely designed to repair dissections following angioplasty while minimising arterial inflammation and leaving little foreign material behind. I believe this represents an ideal combination for maintaining long-term arterial patency.”

The TOBA II BTK study will be conducted at up to 50 global sites and will enrol 232 patients in total. Eligible patients will have diseased popliteal or tibial arteries treated with balloon angioplasty and have a dissection in the artery wall immediately following angioplasty.

Cardenas added, “The TOBA II BTK trial will provide us with valuable information about this very promising technology designed to optimise angioplasty results in CLI. We are thrilled to be the first centre to begin enrolment in this important study.”

“Patients with CLI have significant comorbidities and an increased risk for amputation, yet they have very few treatment options,” said Bruce Shook, Intact Vascular’s president and chief executive officer. “The commencement of the TOBA II BTK trial represents an exciting step toward making the Tack Endovascular System available as new endovascular treatment for this debilitating disease.”

Intact Vascular is also sponsoring the TOBA II and TOBA III studies. TOBA II is investigating the combination of the Tack Endovascular System with both uncoated angioplasty balloons and the Lutonix drug-coated balloon (Bard) in patients with superficial femoral and popliteal artery disease. TOBA III is investigating the combination of the Tack Endovascular System with the IN.PACT Admiral drug-coated balloon (Medtronic) in a similar population.