June 25, 2020
One-Year TOBA II BTK Data Presented for Intact Vascular's Tack Endovascular System (4F)
June 25, 2020—Intact Vascular, Inc. announced that 1-year results from the Tack Optimized Balloon Angioplasty II Below-the-Knee (TOBA II BTK) clinical trial were presented online by coprincipal investigator Patrick Geraghty, MD, during the 2020 Vascular Interventional Advances (VIVA) Late-Breaking Clinical Trial livestream.
According to the company, the 1-year results showed sustained improvement in Rutherford category, toe-brachial index (TBI), and quality-of-life metrics after management of patients with post-percutaneous transluminal angioplasty dissection with the Tack endovascular system (4F), in conjunction with excellent limb salvage and amputation free survival rates.
By Kaplan-Meier estimates, the Tack device demonstrated 81.3% tacked segment patency, 78.6% target lesion patency, and 83.1% freedom from clinically driven reintervention at 1 year. No fractures, embolization, or migration of the Tack device were observed.
In the critical limb ischemia cohort, Tack implants demonstrated 96.1% target limb salvage and 89% amputation-free survival by Kaplan-Meier estimates.
“Effective treatment of below-the-knee arterial disease is a critical component of amputation prevention," commented Dr. Geraghty in the company's press release. "Now, with Tack implants, we have an on-label treatment for post-angioplasty dissection that provides excellent outcomes through the first year of follow-up. The Tack device is a valuable treatment option that augments an aggressive approach to endovascular limb salvage.” Dr. Geraghty is Professor of Surgery and Radiology at the Washington University School of Medicine in St. Louis, Missouri.
In April 2020, the company announced FDA approval of the Tack endovascular system (4F) for repair of postangioplasty dissections in the mid/distal popliteal, tibial, and/or peroneal BTK arteries ranging in diameter from 1.5 to 4.5 mm. The company announced the commercial introduction of the device in the United States on April 22.