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US FDA Grants Approval To Cook Medical’s Advance 35LP PTA Balloon Dilatation Catheter

Cook Medical announced that FDA has granted approval to market the Advance 35LP PTA Balloon Dilatation Catheter. This device is designed for use in patients with lesions in the femoral, iliac and renal arteries.

The company’s Advance 35LP will play an integral part in the company’s Leg Therapy Program. The program is an initiative geared towards aiding physicians address the anatomical challenges of treating Peripheral Vascular Disease (PVD) and deliver clinically effective interventional solutions to the patients who need them most.

Advance line includes three low-profile balloons (14LP, 18LP, 35LP) that vary in size and composition to treat lesions in the peripheral arteries as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulas. The Advance 35LP balloon, compatible with a .035-inch wire guide, is designed to address above-the-knee blockages. The Advance 14LP, compatible with a .014-inch wire guide, is reserved for treatment of the most tortuous anatomies of the lower leg, including the popliteal and infrapopliteal arteries. The Advance 18LP, compatible with a .018-inch wire guide, is geared toward the femoral artery and popliteal region of the leg.

All three balloons features a low crossing profile and small-sheath compatibility that helps reduce the need for an invasive arterial entry and also may shorten patient recovery time. Balloon’s advanced thermal setting folds improves rewrap and sheath pull-back, and a double-lumen shaft construction using optimized nylon-blend material reduces balloon inflation/deflation time and also improves pushability while maintaining kink resistance