Positive six-month results from Intact Vascular’s TOBA-BTK (Tack Optimised Balloon Angioplasty—Below-the-Knee) clinical study have been reported at LINC 2016. The data were presented by principal investigator, Marianne Brodman, head of the Clinical Division of Angiology, at Medical University of Graz in Austria.
The TOBA-BTK study enrolled 35 participants at six European sites, all of whom were experiencing critical limb ischaemia in at least one leg.
Thirty-two participants were treated with the 4-French Tack endovascular system following standard balloon angioplasty in the tibial and peroneal arteries.
The Tack system is designed to leave a minimal amount of foreign material in the artery during the repair of arterial wall dissections. This should reduce mechanical stress on the artery and preserve future treatment options.
Conclusions from the TOBA-BTK study include:
- 87.1% 6-month primary patency
- 93.5% 6-month assisted primary patency
- 93.5% freedom from TLR
- 96.8% amputation-free survival
- 100% freedom from death
- 100% freedom from major amputation
Brodmann states, “The clinical outcomes of the TOBA-BTK experience are very positive in a patient population that is challenging to treat with current therapies, and consumes significant healthcare resources. This new approach to repairing arterial dissections below the knee demonstrates the benefit of minimising vessel trauma and leaving minimal metal behind. The Tack supports the dissection and allows the vessel to heal, while preserving future treatment options for our patients.”
Patients in the study demonstrated a marked improvement, as measured by the Rutherford Classification System, a seven-stage scale ranging from no symptoms (class zero) to gangrene (class six). The study data suggest that an increasing number of patients continue to improve, with a 70% reduction in patients with Rutherford class five disease at six months. This group of patients accounted for almost 90% of the patients studied. Most importantly, none of the patients have had a major amputation at six months.
Brodmann says, “This new approach of low radial force and spot treatment of dissections may be a perfect partner for use with drug-coated balloons in the treatment of BTK disease. I look forward to presenting the 12-month TOBA-BTK data in the near future.”
Bruce J Shook, Intact Vascular’s president & chief executive officer, adds, “These results represent exciting promise for patients suffering from critical limb ischaemia. This population is severely underserved and growing. We are allocating significant resources at Intact Vascular toward development of the Tack implant technology for the treatment of critical limb ischemia, including a much expanded clinical development program.”
Based on these results, the company is pursuing an expanded study (TOBA II BTK) that will assess the performance of the Tack Endovascular System in a larger population, and will include US investigators.