FDA Clears Cook’s Advance 35LP PTA Balloon for Femoral, Iliac, Renal Arteries


July 16, 2009

July 16, 2009 – Cook Medical received clearance today from the FDA to market its newest balloon dilatation catheter, the Advance 35LP, which is intended for use in patients with lesions in the femoral, iliac and renal arteries.

The Advance 35LP will play an integral part in Cook’s Leg Therapy Program, an initiative geared toward helping physicians address the anatomical challenges of treating peripheral vascular disease (PVD) and deliver clinically effective interventional solutions to the patients who need them most. Commonly associated with diabetes, hypertension and coronary disease, PVD can result in amputation or death if left untreated. Few are aware of the minimally invasive treatment options available apart from amputation or surgical bypass, the latter of which is the current gold standard in treating this disease.

The Advance line comprises three low-profile 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 Advance 35LP balloon, compatible with a .035-inch wire guide, is designed to address common above-the-knee blockages. The Advance 18LP, compatible with a .018-inch wire guide, is geared toward the femoral artery and popliteal region of the leg. 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.

Each balloon features a low crossing profile and small-sheath compatibility, which helps reduce the need for an invasive arterial entry and may shorten patient recovery time. Advanced thermal setting of the balloon folds improves rewrap and sheath pull-back, and a unique double-lumen shaft construction using optimized nylon-blend material reduces balloon inflation/deflation time and improves pushability while maintaining kink resistance.

For more information: www.cookmedical.com