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# Intact Vascular Endovascular System Ok’d
- URL: https://www.fdaweb.com/intact-vascular-endovascular-system-okd/
- Published: 2020-04-14T12:00:00.000Z
- Updated: 2026-09-14T16:11:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146563

FDA has approved Intact Vascular’s Tack Endovascular System (4F), described by the company as a minimal metal implant for precision dissection repair in the mid/distal popliteal, tibial and peroneal arteries. Approval was based on data from the company’s Tack Optimized Balloon Angioplasty II Below the Knee clinical trial, which Intact Vascular says is the first study to enroll patients with advanced disease below-the-knee and 100% dissected vessels. The study enrolled patients suffering from critical limb ischemia, a condition associated with high rates of amputation and mortality. Intact Vascular says the study met all primary endpoints with 100% acute dissection resolution and 73.8% of wounds healed or improved at six months.  
  
The device is designed to repair dissections following peripheral balloon angioplasty, the company says. It is pre-loaded with six self-expanding nitinol devices for above-the-knee interventions, or four for below-the-knee interventions. The system is also designed to “minimize vessel inflammation, promote healing, improve outcomes and preserve future treatment options for peripheral arterial disease patients,” it says.