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."

 

Contact Info

For advertising rates and opportunities, contact:
Craig McChesney
484-581-1816
cmcchesney@bmctoday.com

Stephen Hoerst
484-581-1817
shoerst@bmctoday.com

Charles Philip
484-581-1873
cphillip@bmctoday.com

About Endovascular Today

Endovascular Today is a publication dedicated to bringing you comprehensive coverage of all the latest technology, techniques, and developments in the endovascular field. Our Editorial Advisory Board is composed of the top endovascular specialists, including interventional cardiologists, interventional radiologists, vascular surgeons, neurologists, and vascular medicine practitioners, and our publication is read by an audience of more than 22,000 members of the endovascular community.

Website Design by Sides Media