Intact Vascular's TOBA 1-Year Clinical Study Results Published

August 15, 2016—Intact Vascular, Inc. announced that the 1-year results from its Tack Optimized Balloon Angioplasty (TOBA) clinical study were published in the Journal of Vascular Surgery (JVS; 2016;64:109–116).

According to the company, the TOBA study enrolled 138 patients at 13 sites in Europe. All study participants had peripheral artery disease caused by blockages in the superficial femoral or popliteal arteries. All participants underwent percutaneous transluminal balloon angioplasty, and any dissections resulting from the procedure were repaired using the Tack endovascular system.

The Tack implant is designed to repair dissections in the artery wall while leaving a minimal amount of foreign material in the artery, which reduces mechanical stress on the artery, leaves the artery in its most natural state, and preserves future treatment options.

Some key conclusions from the TOBA study include: 98.5% participants achieved technical success, 76.4% 12-month primary patency,  89.5% freedom from target lesion revascularization, and 82.8% of participants had a Rutherford classification grade ≤ 1 at 12 months, representing a significant improvement in function from baseline.

Marc Bosiers, MD, of A.Z. St. Blasius Hospital in Dendermonde, Belgium, was the Principal Investigator for the TOBA study. In the company’s press release, Dr. Bosiers commented, “These 1-year results from the TOBA study demonstrate that the minimal metal approach associated with the Tack implant produces positive, lasting results in patients with severe peripheral artery disease. This is a high-cost, resource-intensive disease, so treatments with long-term effectiveness, such as combining angioplasty with the Tack implant, bring substantial benefits for patients and payers alike.”

Intact Vascular advised that the 6-F Tack endovascular system received CE Mark approval, and approval for the 4-F device is pending. The Tack sysytem is not available for sale or use in the United States.

Based on the TOBA results, Intact Vascular has been enrolling participants in an expanded study, TOBA II, that is being conducted at more than 35 United States and European centers under investigational device exemption approval. The company plans to submit data from TOBA II in support of a premarket approval application with the US Food and Drug Administration.

Recently, the company commenced enrollment in TOBA III, a European postapproval study conducted to assess the combination of the Tack implant and drug-coated balloon angioplasty in the superficial femoral and popliteal arteries.