September 26, 2019
Intact Vascular Announces Positive 1-Year Data From TOBA III Clinical Trial
September 27, 2019—Intact Vascular, Inc. announced 1-year results of its TOBA III clinical trial, which achieved both primary and secondary endpoints. Marianne Brodmann, MD, Principal Investigator, presented the data during the High Impact Clinical Research session at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, which was sponsored by the Cardiovascular Research Foundation and held September 25–29 in San Francisco, California.
In the company’s announcement, Dr. Brodmann commented, “I am extremely pleased with the clinically compelling results of the TOBA III study. The Tack system provides a safe and effective solution for treating postangioplasty dissections. I believe this new therapeutic paradigm will change the standard of care for above-the-knee interventions.”
According to the company, TOBA III is a multicenter, single-arm, prospective study investigating the combination of Intact Vascular’s Tack endovascular system with Medtronic’s In.Pact Admiral drug-coated balloon as a treatment in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA).
Conducted in Europe, the study enrolled 201 patients, including 169 patients with arterial lesions ≤ 150 mm in length and a subset of 32 patients with long arterial lesions (> 150 and ≤ 250 mm). All patients had peripheral artery disease and underwent balloon angioplasty, consequently experiencing at least one dissection requiring repair.
The company reported that results from the 169 patient standard lesion cohort (≤ 150 mm) demonstrated 97.7% complete dissection resolution, 95% Kaplan-Meier vessel patency, and 97.5% Kaplan-Meier freedom from clinically driven reintervention at 12 months. This was accomplished with a 0.6% bailout stent rate.
The results add to the clinical evidence supporting the use of the Tack system for post–percutaneous transluminal angioplasty (PTA) dissection repair and further demonstrate the long-term effectiveness of the technology, noted Intact Vascular.
The observational data from the long lesion subset (> 150 and ≤ 250 mm) was analyzed separately. Results from these 32 patients demonstrated 98.8% complete dissection resolution and 89.3% Kaplan-Meier vessel patency, with 96.8% Kaplan-Meier freedom from clinically driven reintervention at 12 months and a 0% bailout stent rate.
Intact Vascular advised that the Tack endovascular system has received European CE Mark approval. In the United States, the 6-F Tack endovascular system is approved by the FDA for use in the SFA and PPA, ranging from a 3.5- to 6-mm reference vessel diameter, for treatment of post-PTA dissections. The 4-F Tack system is an investigational device limited by Federal law to investigational use.