December 3, 2019
Published 12-Month TOBA II Data Support Intact Vascular’s Tack Endovascular System
December 3, 2019—Twelve-month results from the TOBA II study of Intact Vascular, Inc.’s Tack endovascular system were published by William A. Gray, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.
The aim of the TOBA (Tack Optimized Balloon Angioplasty) II study was to evaluate the Tack system for treating dissections following angioplasty in the superficial femoral artery (SFA) and/or proximal popliteal artery.
As summarized in JACC: Cardiovascular Interventions, the prospective, single-arm, multicenter study was composed of 213 patients, all with dissection following angioplasty. Eligibility included Rutherford classification 2 to 4 with a de novo or nonstented restenotic lesion in the SFA or proximal popliteal artery undergoing plain balloon or drug-coated balloon (DCB) angioplasty. After dilation, lesions with < 30% residual stenosis and the presence of one or more dissections were enrolled.
The 12-month efficacy endpoint was primary patency (freedom from duplex-derived binary restenosis) and clinically driven target lesion revascularization (CD-TLR).
Patient and lesion characteristics included:
- Mean age, 68 ± 9 years
- 43.2% had diabetes
- 23% of lesions were chronic total occlusions and approximately 60% had moderate to severe calcium
- Mean lesion length, 74.3 ± 40.6 mm
- Severe dissection (grade ≥ C) was present in 69.4%
- By operator choice, 57.7% underwent DCB angioplasty
- Most (92.1%) dissections resolved completely
- One bailout stent was required
- No 30-day major adverse events
The investigators reported that the 12-month efficacy endpoint was met with Kaplan-Meier primary patency of 79.3% and freedom from CD-TLR of 86.5%. At 12 months, there were no device fractures or clinically significant migrations, and significant improvements were noted in Rutherford category, ankle-brachial index, and quality of life.
TOBA II demonstrated the safety and efficacy of the Tack endovascular system for focal dissection repair following standard and DCB angioplasty, concluded the investigators in JACC: Cardiovascular Interventions.
Dr. Gray, Principal Investigator of the pivotal trial, presented the TOBA II data last year at VIVA 2018, the Vascular Interventional Advances annual conference. The findings supported FDA approval for the 6-F Tack endovascular system as a dissection repair device implanted after percutaneous transluminal angioplasty in patients with peripheral artery disease, which the company announced in April 2019 with plans for a limited initial release in the United States that will progress toward broader market commercialization.