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May 4, 2016

Twelve-Month TOBA-BTK Results Presented for Intact Vascular's Tack System

May 4, 2016—Intact Vascular, Inc. announced that positive 12-month results from its Tack Optimized Balloon Angioplasty—Below-the-Knee (TOBA-BTK) clinical study were presented at the Society for Cardiovascular Angiography & Interventions 2016 scientific session by Christian Wissgott, MD, Assistant Director at Westküstenklinikum Heide in Heide, Germany.

The TOBA-BTK study is evaluating the Tack endovascular system, which is designed to repair dissections in the artery wall that frequently occur as a complication of balloon angioplasty. According to the company, 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 January, 6-month results from the TOBA-BTK study were presented at LINC 2016, the Leipzig Interventional Course in Leipzig, Germany. 

The TOBA-BTK study enrolled 35 patients at six sites in Europe and New Zealand. All patients had critical limb ischemia in one or both legs. Thirty-two patients were treated with the 4-F Tack endovascular system after undergoing standard balloon angioplasty in the tibial and peroneal arteries.

The company reported that the TOBA-BTK study showed a 12-month primary patency rate of 78.4% and a 12-month primary assisted patency rate of 89.2%. Additionally, treatment with the Tack endovascular system resulted in 93.5% freedom from target lesion revascularization, 84.5% amputation-free survival, and 87.1% freedom from major amputation. Moreover, 75% of patients in the study experienced a 4- or 5-step improvement in Rutherford classification from baseline (P < .0001) at 12 months.

In the company’s press release, Dr. Wissgott commented, “Restoring blood flow to the legs in patients with critical limb ischemia is vitally important to their quality of life and survival. We have few treatments that have a demonstrated ability to keep the small arteries below the knee open over 12 months, so these TOBA-BTK results are truly encouraging. These data suggest that repairing arterial dissections following angioplasty below the knee, using the minimal metal design approach of the Tack implant, can keep the treated arteries open and blood flowing.”

Dr. Wissgott continued, “The Tack endovascular system holds much promise for improving the long term outcomes associated with balloon angioplasty below the knee. I look forward to building on these exciting results in the expanded TOBA II BTK clinical trial that is currently being planned.”

Based on these results, Intact Vascular is pursuing an expanded study, TOBA II BTK, that will assess the performance of the Tack endovascular system in a larger population and will include United States and international investigators.

The 6-F Tack endovascular system received European CE Mark approval in April 2012. Approval in Europe for the 4-F Tack device is pending. Intact Vascular’s Tack endovascular system is not available for sale or use in the United States, advised the company.

Peter Schneider, MD, Chief of Vascular Therapy at the Kaiser Foundation Hospital in Honolulu, Hawaii, is Intact Vascular’s Founder and Chief Medical Officer. In the company’s announcement, he stated, “The existing treatments for arterial dissections below the knee involve leaving a great deal of metal behind and in the small arteries of the lower leg that is plagued with problems. The Tack implant takes a very novel approach and allows the treating physician to target therapy only where it is needed to promote healing of the injured artery.”

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