TOBA III Trial of Intact Vascular's Tack Endovascular System Commences Enrollment

June 2, 2016—Intact Vascular, Inc. announced that its Tack Optimized Balloon Angioplasty III (TOBA III) clinical trial has commenced enrollment in Europe. The first patient enrolled in TOBA III was treated by Prof. Klaus Brechtel, MD, at the Franziskus-Hospital in Berlin, Germany.

The TOBA III study is a prospective, multicenter, single-arm study designed to investigate the safety and efficacy of Intact Vascular’s Tack endovascular system in combination with Medtronic plc’s In.Pact Admiral drug-coated angioplasty balloon (DCB) in the treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries. The study will be conducted at multiple sites across Europe and will enroll 200 patients, including a subgroup of patients with long arterial lesions. Eligible patients will have PAD treated with balloon angioplasty using the In.Pact Admiral and have a dissection in the artery wall immediately after angioplasty.

According to Intact Vascular, 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.

In the company’s announcement, Prof. Brechtel commented, “One of our key goals when using DCBs to perform peripheral angioplasty is to minimize inflammation of the treated artery and leave little foreign material behind. The Tack system is designed to allow us to repair arterial damage after angioplasty while minimizing vessel irritation and leaving far less metal behind than we would with the traditional stenting approach.” Prof. Brechtel continued, “The TOBA III trial will provide us with valuable information about the combination of two very promising technologies designed to treat PAD. We are thrilled to be the first center to begin enrollment in this important study.”

Intact Vascular stated that it is also conducting the TOBA II study, which is investigating the combination of the Tack endovascular system with uncoated angioplasty balloons and the Lutonix DCB (Bard Peripheral Vascular, Inc.) in patients with superficial femoral and popliteal artery disease. The company is also planning to assess the performance of the Tack device after balloon angioplasty in patients with below-the-knee artery disease in the TOBA II BTK clinical trial.

The company received European CE Mark approval for the 6-F Tack endovascular system, and approval for the 4-F device is pending. In the United States, the Tack endovascular system is not available for sale and is limited to investigational use only in the TOBA II study, advised Intact Vascular.