• FDA approves post-angioplasty dissection repair device

    • April 17, 2019
    • Posted By : admin
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    • Intact Vascular received FDA premarket approval for a first-of-its-kind, minimally invasive device to repair above-the-knee dissections, or tears in the artery wall, after balloon angioplasty to treat peripheral arterial disease, or PAD, the company said Monday.
    • Approval for the implant, called the Tack Endovascular System, was based on the company’s TOBA II pivotal trial that met its primary goals for safety and efficacy, with 92.1% of dissections resolved after treatment.
    • The Wayne, Pennyslvania-based medtech, which in January announced the launch of the Tack system in Europe, said it plans a limited initial release of the device in the United States that will progress to broader market distribution.

    Vessel dissection is a frequent outcome following angioplasty to treat PAD, with severe forms occurring in 42% of cases in one study. Vessels can be vulnerable to injury from stress caused by inflation of the angioplasty balloon. 

    A dissection can cause blood clots or blockages known as arterial occlusions. Stents are typically used to address dissections but face their own challenges, including fractures and restenosis, or artery re-clogging, which can necessitate a repeat procedure.

    Intact Vascular said its Tack implant is intended to preserve vessel integrity and improve blood flow after balloon angioplasty to unclog an artery. The device has minimal metal to reduce inflammation, uses low radial force, and is specifically designed for dissection repair, the company said.

    It is indicated for use in the superficial femoral and proximal popliteal arteries that carry oxygenated blood to the leg. The device can treat multiple dissections with a single catheter and leaves behind 70% less metal than a stent, according to Intact Vascular.

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