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# Intact Vascular PMA for Endovascular System Approved
- URL: https://www.fdaweb.com/intact-vascular-pma-for-endovascular-system-approved/
- Published: 2019-04-15T12:00:00.000Z
- Updated: 2026-09-15T01:20:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143869

FDA has approved an Intact Vascular PMA for the Tack Endovascular System, a dissection repair device implanted post-angioplasty in patients with peripheral arterial disease. Approval was based on data from the company’s Tack Optimized Balloon Angioplasty II (TOBA II) pivotal trial, which demonstrated safety and effectiveness. The trial met all primary endpoints with 92% of dissections completely resolved following treatment, according to the company.

It says inflation of an angioplasty balloon and resulting mechanical stress injures vessels and creates dissections. “These dissections are prevalent, underdiagnosed and underestimated,” it says. “If left untreated, dissections can compromise clinical outcomes, resulting in acute thrombosis and arterial occlusions, leading to lower long-term patency rates and repeat procedures.”