FDA grants premarket approval for Intact Vascular’s dissection repair device

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TackThe US Food and Drug Administration (FDA) have granted Intact Vascular 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 4–8mm in diameter.

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


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