FDA Clears Cook's Advance 35LP Catheter
July 15, 2009—Cook Medical (Bloomington, IN) announced that it has received clearance from the US Food and Drug Administration to market the Advance 35LP low-profile balloon dilatation catheter. The device is intended for use in patients with lesions in the femoral, iliac, and renal arteries. The Advance 35LP balloon is compatible with a 0.035-inch wire guide and is designed to address common above-the-knee blockages.
According to the company, the Advance 35LP workhorse device joins Cook Medical's Advance product line for the treatment of lesions in the peripheral arteries as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulas. The Advance 18LP is used for the femoral artery and popliteal interventions. The Advance 14LP is reserved for treating 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. Advanced thermal setting of the balloon folds improves rewrap and sheath pullback. Double-lumen shaft construction reduces balloon inflation/deflation time and improves pushability while maintaining kink resistance, the company stated.