FDA Clears Angioslide’s Proteus PTA Balloon for Below-the-Knee PAD
May 2, 2012—Angioslide Ltd. (Wheat Ridge, CO) announced that it has received 510(k) clearance from the US Food and Drug Administration for its 3- X 100-mm Proteus percutaneous transluminal angioplasty (PTA) balloon for treating peripheral artery disease below the knee. The new low-profile device accommodates 0.014-inch guidewires.
The Proteus device offers physicians the ability to capture and remove embolic material with a single device during below-the-knee interventions in patients who often have long and diffuse lesions, diabetic foot ulcers, and/or critical limb ischemia.
Angioslide stated that its technology combines the functionality (deflation time, pushability, crossing profile) of a PTA device with a built-in embolic capture mechanism that captures and retrieves embolic material during deflation. The embolic capture is enabled by the inward folding of the balloon, which creates a low-pressure cavity. The negative pressure generates an aspiration effect, pulling embolic material into the balloon cavity. When retrieved through the sheath, Proteus removes the captured material from the body.
"Distal embolization is an under-appreciated possibility when performing below-the-knee interventions, especially in thrombotic or calcified lesions," commented John R. Laird, MD, Medical Director and Professor of Medicine at UC Davis Vascular Center in Davis, California. "The 3-mm Proteus catheter is a nice addition to our armamentarium for these challenging PAD cases."