TOBA-BTK study demonstrates positive 6-month results for novel dissection repair system in patients with CLI

A novel technology to repair dissections in the artery wall after angioplasty in below-the-knee arteries was associated with positive outcomes at 6 months, according to data presented at Leipzig Interventional Course.

For the TOBA-BTK study, researchers enrolled 35 patients with critical limb ischemia in one or both legs at six sites in Europe. All underwent standard balloon angioplasty in the tibial and peroneal arteries. Thirty-two of them were treated with the 4F dissection repair system (Tack Endovascular System, Intact Vascular Inc.) with the goal of removing most or all foreign material in the artery, reducing manual stress on the artery and preserving treatment options for the future.

During a presentation at Leipzig Interventional Course (LINC), Marianne Brodmann, MD, head of the clinical division of angiology, Medical University of Graz, Austria, reported that at 6 months, 87.1% of patients achieved primary patency, 93.5% achieved assisted primary patency, 93.5% were free from target lesion revascularization, 96.8% survived free from amputation, no patients died and none had major amputation.

“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 health care resources,” Brodmann said in a press release issued by Intact Vascular. “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.”

At 6 months, there was a 70% reduction in patients with Rutherford class 5 disease, with almost 90% of patients having a Rutherford class lower than 5, according to the release.

“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 [below-the-knee] disease,” Brodmann said in the release.

The system is not approved for use in the United States. Intact Vascular announced that it will pursue a larger study, TOBA II BTK, of the system that will include U.S. sites. – by Erik Swain

Reference:

Brodmann M, et al. Controversial Issues, New Insights and Pioneering Solutions for Critical Limb Ischemia: Clinical Trial Update. Presented at: Leipzig Interventional Course; Jan. 26-29, 2016; Leipzig, Germany.

Disclosure: Brodmann reports receiving honoraria from AstraZeneca, Bard Peripheral Vascular, Bayer, Biotronik, Boehringer Ingelheim, Bristol-Myers Squibb/Sanofi, Daiichi Sankyo, Medtronic, Novartis, Pfizer, Sanofi Aventis, Takeda and Terumo and consulting for Bard Peripheral Vascular and Covidien.