April 22, 2020
Intact Vascular's Tack Endovascular System (4F) for BTK Arteries Introduced in the United States
April 22, 2020—Intact Vascular, Inc. announced the launch of its Tack endovascular system (4F) with the first commercial use of the device at multiple sites across the United States. The device is designed for use with balloon angioplasty in patients treated for critical limb ischemia (CLI).
On April 14, the company announced FDA approval of the device for postangioplasty dissection in the mid/distal popliteal, tibial, and/or peroneal below-the-knee (BTK) arteries ranging in diameter from 1.5 to 4.5 mm.
In the company's announcement, John Rundback, MD, commented, “Effectively treating the small arteries affected in CLI has always been challenging. Over the years, various technologies have attempted to address this unique vasculature but failed to provide an effective solution. Finally, I have an option that safely and effectively delivers better results below the knee for my CLI patients, and I am thrilled to incorporate this novel peripheral vascular implant into my treatment algorithm going forward.” Dr. Rundback is a vascular and interventional radiologist and partner at the American Endovascular & Amputation Prevention Services, LLC in Clifton, New Jersey, one of the initial implanting sites.
S. Jay Mathews, MD, added, “Intact Vascular has sponsored multiple large-scale, prospective studies that have generated a solid and robust body of clinical evidence to support post-angioplasty dissection repair with the Tack endovascular system. I am confident this game-changing technology will elevate the standard of care when performing endovascular procedures.” Dr. Mathews is an interventional cardiologist and endovascular specialist at Bradenton Cardiology Center in Bradenton, Florida, another initial implanting site.
Regulatory approval was based on data from Intact Vascular's Tack Optimized Balloon Angioplasty II Below-the-Knee (TOBA II BTK) clinical trial. The TOBA II BTK met all primary endpoints with 100% acute dissection resolution. The results demonstrated 95.7% amputation-free survival, 87.3% target lesion patency with significant improvement in toe-brachial index, and 92% freedom from clinically driven reintervention at 6 months per Kaplan-Meier estimates, stated the company.