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.
Intact Vascular secures FDA approval to modify balloon angioplasty trial
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