Positive Six-Month Tack Optimized Balloon Angioplasty Below-the-Knee (TOBA-BTK) Results Presented at LINC 2016
WAYNE, PA – Jan. 4, 2016 – Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that positive six-month results from its Tack Optimized Balloon Angioplasty – Below-the-Knee (TOBA-BTK) clinical study were presented at the LINC 2016 conference by principal investigator, Dr. Marianne Brodmann, Head of the Clinical Division of Angiology, at Medical University of Graz in Austria.
The TOBA-BTK study enrolled 35 subjects at 6 sites in Europe. All study subjects were suffering from critical limb ischemia, a form of peripheral arterial disease, in one or both legs. Of the subjects enrolled, 32 were treated with the 4 French Tack Endovascular System following standard balloon angioplasty in the tibial and peroneal arteries. The Tack Endovascular System is a new technology designed to repair dissections (or tears) 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.
Some of the key conclusions from the TOBA-BTK study included:
- 87.1% 6-month primary patency
- 93.5% 6-month assisted primary patency
- 93.5% freedom from TLR
- 96.8% amputation-free survival
- 100% freedom from death
- 100% freedom from major amputation
Dr. Brodmann stated, “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 healthcare resources. 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.”
Patients in the study demonstrated a marked improvement, as measured by the Rutherford Classification System, a 7-stage scale ranging from no symptoms (class 0) to gangrene (class 6). The study data suggest that an increasing number of patients continue to improve, with a 70% reduction in patients with Rutherford class 5 disease at 6 months. This group of patients accounted for almost 90% of the patients studied. Most importantly, none of the patients have had a major amputation at 6 months.
Professor Brodmann said, “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 BTK disease. I look forward to presenting the 12-month TOBA-BTK data in the near future.”
Bruce J. Shook, Intact Vascular’s President & CEO, added, “These results represent exciting promise for patients suffering from critical limb ischemia. This population is severely underserved and growing. We are allocating significant resources at Intact Vascular toward development of the Tack implant technology for the treatment of critical limb ischemia, including a much expanded clinical development program.”
Based on these promising results, the company 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 U.S. investigators.
About Intact Vascular
Intact Vascular is a privately held medical device company that develops minimally invasive peripheral vascular products. The Tack Endovascular System™ is designed to optimize peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Visit www.intactvascular.com for more information.
This press release contains “forward-looking statements” concerning the development of Intact Vascular's products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Intact Vascular undertakes no obligation to update any forward-looking statements for any reason.
Intact Vascular, Inc.
Andrea Dunkle, [email protected], 1-484-253-1048
Tack Endovascular System™ and Tack™ are trademarks of Intact Vascular, Inc. The Tack Endovascular System™ is CE Mark Authorized under EC Directive 93/42/EEC. Not Available for Sale in the United States.
CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.