Cook scores FDA approval for its new PTA balloon dilatation catheter

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Cook Medical has received FDA approval to market its balloon dilatation catheter, the Advance 35LP, which is intended for use in patients with lesions in the femoral, iliac and renal arteries.

The Advance line comprises three percutaneous transluminal angioplasty (PTA) balloons (14LP, 18LP, 35LP) that range in size and composition to treat lesions in the peripheral arteries, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulas, the company said.

The Advance 35LP balloon, compatible with a .035-inch guidewire, addresses above-the-knee blockages. The Advance 18LP, compatible with a .018-inch guidewire, is geared toward the femoral artery and popliteal region of the leg. The Advance 14LP, compatible with a .014-inch guidewire, is reserved for treatment of the anatomies of the lower leg, including the popliteal and infrapopliteal arteries.

The Bloomington, Ind.-based Cook said that Advance 35LP will play a role in its Leg Therapy Program, an initiative geared toward helping physicians address the anatomical challenges of treating peripheral vascular disease.