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Intact Vascular secures FDA approval to modify balloon angioplasty trial

The FDA has given Intact Vascular a supplemental investigational device exemption to change the 12-month primary endpoint in a clinical trial of its Tack optimized balloon angioplasty to a six-month primary endpoint. The prospective, single-arm multicenter study seeks to assess the efficacy and safety of the device, along with standard balloon angioplasty, in treating critical limb ischemia in arteries below the knee.

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