Tack endovascular system for PAD gets US FDA approvalJune 9, 2019
Intact Vascular, Inc has received the US FDA approval for the Tack Endovascular System (6F), a dissection repair device implanted post-angioplasty in patients with the peripheral arterial disease (PAD).
The approval was based on data from Intact Vascular’s Tack Optimized Balloon Angioplasty II (TOBA II) pivotal trial, which demonstrated the safety and effectiveness of the Tack implant to resolve dissections following angioplasty.
The inflation of an angioplasty balloon and resulting mechanical stress inherently injures vessels and creates dissections. 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.
The TOBA II pivotal trial, notably the first peripheral vascular study to enroll patients with 100% dissected vessels, met all primary endpoints with 92% of dissections completely resolved following treatment, the company reported.