Six-Month TOBA-BTK Results Presented for Intact Vascular's Tack Endovascular System

January 26, 2016—Intact Vascular, Inc. announced that 6-month results from its Tack Optimized Balloon Angioplasty—Below-the-Knee (TOBA-BTK) clinical study were presented at LINC 2016, the Leipzig Interventional Course, being held January 26–29 in Leipzig, Germany. TOBA-BTK Principal Investigator Marianne Brodmann, MD, who is Head of the Clinical Division of Angiology at the Medical University of Graz in Austria, presented the data.

The Tack endovascular system is 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.

According to the company, the TOBA-BTK study enrolled 35 patients at six sites in Europe. All patients had critical limb ischemia in one or both legs. Thirty-two of the patients were treated with the 4-F Tack endovascular system after standard balloon angioplasty in the tibial and peroneal arteries. The TOBA-BTK findings included 87.1% 6-month primary patency, 93.5% 6-month assisted primary patency, 93.5% freedom from target lesion revascularization, 96.8% amputation-free survival, 100% freedom from death, and 100% freedom from major amputation.

Patients in the study demonstrated a marked improvement, as measured by the Rutherford classification system. The study data suggest that an increasing number of patients continue to improve, with a 70% reduction in patients with Rutherford class 5 disease at 6 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 6 months.

In the company’s press release, Prof. Brodmann stated, “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 minimizing 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.”

Professor Brodmann added, “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.”

Intact Vascular advised that based on these promising 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 United States investigators.

The 6-F Tack device has European CE Mark approval, and approval for the 4-F device is pending. The Tack endovascular system is not available for sale or use in the United States, the company stated.