Invatec receives 510(k) clearance for below-the-knee long balloon

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Invatec, a provider of interventional products, has received 510(k) clearance from the FDA to market its Amphirion Deep 150 mm Long PTA Balloon and Tapered 210 mm Long PTA Balloon in the U.S.

The Amphirion Deep Long Balloons join the preexisting Amphirion Deep family of dedicated below-the-knee PTA catheters, which are designed to access and treat arteries below the knee, according to the Bethlehem, Pa.-based company.

The 150 mm and Tapered 210 mm Long Balloons are indicated to dilate stenoses in the femoral, popliteal and infra-popliteal arteries, while sharing the design and features as the rest of the Amphirion Deep product line. The Tapered 210 mm Long Balloon is anatomically designed to provide balloon-to-vessel conformability in the narrowed and tapered distal regions of the leg and foot.