FDA Grants Premarket Approval for Intact Vascular’s Dissection Repair Device

The FDA granted Intact Vascular’s pre-market approval application for an additional size of its Tack Endovascular System, a dissection repair device used to treat peripheral arterial dissections after balloon angioplasties.

A larger version of the device has now been cleared for superficial femoral and proximal popliteal arteries ranging from 4 to 8mm in diameter.

The device features adaptive sizing, which allows the implant to adapt to tapering vessels while maintaining a relatively steady radial force.