JANUARY 27, 2015 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that positive twelve-month results from its Tack Optimized Balloon Angioplasty (TOBA) clinical trial were presented at the LINC 2015 conference by, co-principle investigator, Dr. Marc Bosiers, Head Department of Vascular Surgery, at A.Z. St. Blasius Hospital in Belgium. Professor Dierk Scheinert, M.D. from University Hospital Leipzig in Leipzig, Germany is also a co-principle investigator.
The Tack Optimized Balloon Angioplasty (TOBA) study enrolled 138 subjects at 13 sites in Europe. All study subjects were suffering from severe peripheral arterial disease in one or both legs. They were treated with the Tack Endovascular System™ following standard balloon angioplasty in the superficial femoral and popliteal 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 study included:
89.5% freedom from clinically driven target lesion revascularization (CD-TLR) rate at 12 months. CD-TLR accounts for repeat procedures, or re-interventions, due to recurrent symptoms related to the treated lesion.
76.4% 12-month Kaplan-Meier patency rate. Patency means a sustained restoration of adequate blood flow was achieved through the treated segment of the diseased artery. Most of the subjects had significant dissections, which are graded from A to F. In the study, 74% of the patients had dissections graded C or higher, and less than 5% of the patients had simple Grade A dissections, based on independent core lab adjudication.
98.5% technical success rate.
No migration or movement of Tack implants throughout the 12 month follow up period.
Dr. Bosiers stated, “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.”
Patients in the study demonstrated a marked improvement in their ability to walk and a reduction in the leg pain they experienced, as measured by the Rutherford Classification System, a 7 stage scale ranging from no symptoms (class 0) to gangrene (class 6). 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 (no symptoms). Patients also reported significantly less pain, with no pain during exercise increasing from 5.4% before treatment to 76.2% at 12 months. In addition, Ankle Brachial Index (ABI), a measure of blood flow to the legs, improved 38% from baseline at 12 months. Equally important, no subjects had a major amputation at 12 months.
Professor Marianne Brodmann, M.D., Professor of Angiology at the Medical University of Graz, Austria, who was the lead enroller in the trial, said, “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.”
Based on these promising results, the Company is pursuing an expanded study (TOBA II) 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.
Intact Vascular, Inc.
Andrea Dunkle, 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.
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