January 27, 2015
Intact Vascular's Tack Endovascular System Supported by 12-Month TOBA Data
January 27, 2015—Intact Vascular, Inc. announced that 12-month results from the TOBA (Tack Optimized Balloon Angioplasty) clinical trial were presented by Coprincipal Investigator Marc Bosiers, MD, at LINC 2015: the Leipzig Interventional Course in Leipzig, Germany. Dr. Bosiers is Head of the Department of Vascular Surgery at AZ St. Blasius Hospital in Dendermonde, Belgium. Professor Dierk Scheinert, MD, from University Hospital Leipzig in Germany is also a Coprincipal Investigator of TOBA.
The TOBA study is evaluating Intact Vascular’s Tack endovascular system, which is designed to repair dissections in the artery wall that may 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.
Intact Vascular advised that based on the TOBA results, the company is pursuing an expanded study, TOBA II, which will assess the performance of the Tack endovascular system in a larger population and will include United States investigators. The Tack endovascular system received European CE Mark approval in April 2012. The device is not commercially available in the United States.
According to Intact Vascular, the TOBA study enrolled 138 patients at 13 sites in Europe. All study patients had severe peripheral arterial disease in one or both legs. The patients were treated with Intact Vascular’s Tack endovascular system after undergoing standard balloon angioplasty in the superficial femoral and popliteal arteries.
The TOBA study demonstrated a 89.5% freedom from clinically driven target lesion revascularization rate at 12 months. Additionally, treatment with the Tack device resulted in a 76.4% 12-month Kaplan-Meier patency rate. Most patients had significant dissections that were graded A to F. In the study, 74% of the patients had dissections graded C or higher, and < 5% of the patients had simple grade A dissections, based on independent core lab adjudication. The technical success rate was 98.5%. Finally, there was no migration or movement of Tack implants throughout the 12-month follow-up period, reported the company.
In the Intact Vascular’s press release, Dr. Bosiers commented, “The TOBA experience demonstrates that the long-term results from angioplasty can be substantially improved if we repair arterial dissections using this new approach that minimizes vessel trauma and the metal we leave behind. The Tack supports the dissection and allows the vessel to heal while preserving future treatment options for patients.”
The company noted that patients in the study demonstrated a marked improvement in their ability to walk and a reduction in the leg pain. The study saw a reduction in patients with Rutherford class 3 disease from 73.8% before treatment to 5.7% at 12 months, with a majority of the patients achieving Rutherford class 0. Patients also reported significantly less pain, with no pain during exercise increasing from 5.4% before treatment to 76.2% at 12 months. Ankle-brachial index measurements improved 38% from baseline at 12 months. Additionally, there were no major amputations at 12 months.
Professor Marianne Brodmann, MD, Professor of Angiology at the Medical University of Graz in Austria, was the lead enroller in the TOBA trial. In the company’s press release, Prof. Brodmann commented, “This new approach of low radial force and spot treatment of dissections support our desire to leave as little metal behind as possible. I look forward to using the Tack in conjunction with drug-coated balloons and conducting further research to reduce lining the artery with stents.”