Invatec has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Amphirion Deep 150mm and tapered 210mm long percutaneous transluminal angioplasty balloons in the United States.
The Amphirion Deep long balloons join the pre-existing Amphirion Deep family of dedicated below-the-knee catheters, which are specifically designed to reach, access and treat arteries below the knee.
The 150mm and tapered 210mm long balloons are indicated to dilate stenoses in the femoral, popliteal and infrapopliteal arteries, while sharing the same unique design and quality features as the rest of the Amphirion Deep product line.
The unique tapered 210mm balloon is anatomically designed to provide more precise balloon-to-vessel conformability in the narrowed and tapered distal regions of the leg and foot.
Krishna Rocha-Singh, director of the Prairie Vascular Institute, Springfield, Illinois, USA, said: “Deep in the lower limb, below the ankle, the vessels narrow. The design of the tapered 210mm Amphirion allows the effective treatment of the most distal lesions.
“The tapered 210mm is an exceptional aid in the treatment of this very challenging patient population and greatly welcomed.”
“The availability of the Amphiron Deep long balloons underscores our commitment to offering a full range of peripheral solutions,” said Jack Springer, president of Invatec Inc.
“The 510(k) for the 150mm and unique tapered 210mm balloons has allowed us to offer more products to physicians, enabling the treatment of additional patients with below-the-knee disease. For many physicians, the Amphirion has become the product of choice and we are pleased to be able to extend the line to these new lengths.”