FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Intact Vascular’s Dissection Repair Device Gains CE Mark

April 17, 2019
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Intact Vascular has received the CE Mark for its Tack Endovascular System, an implantable device used to treat injuries and dissections after angioplasties.

The device is intended for implantation in peripheral arterial disease patients after they have received an angioplasty procedure to restore arterial blood flow.

The implant treats vessel injuries and dissections caused by angioplasty balloon inflation, which can cause acute thrombosis and arterial occlusions if untreated.

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