Angioslide Announces FDA 510(K) Clearance of PROTEUSTM Below the Knee Device
Published: May 03, 2012
Angioslide Ltd. a provider of Embolic Capture Angioplasty solutions, today announced that it has received FDA 510(K) clearance for its new 3X100mm PROTEUS device for treating Peripheral Artery Disease in below the knee (BTK) vasculature. The new 3/100mm device accommodates 0.014" guide-wires, which significantly broadens the potential use of PROTEUS technology.
Angioslide's proprietary technology combines the functionality of a balloon angioplasty device with the addition of built-in embolic capture. PROTEUS is a competitive PTA (Percutaneous Transluminal Angioplasty) balloon with features similar to leading PTA balloons (deflation time, pushability, crossing profile). Then, during deflation, the PROTEUS captures and retrieves potentially harmful embolic material. The capture of embolic material is enabled by the inward folding of the balloon, which creates a low pressure cavity. The negative pressure in this cavity generates an aspiration effect, pulling embolic material into the cavity. When retrieved through the sheath, PROTEUS removes the captured material from the body.
Below-the-Knee (BTK) interventions are often characterized by patients with long and diffuse lesions, diabetic foot ulcers and/or Critical Limbs Ischemia (CLI). PROTEUS 3X100 offers physicians, for the first time, the ability to capture and remove embolic material with a single device during these challenging interventions.
"Introduction of the new dedicated, BTK, low-profile 0.014" PROTEUS platform, supports Angioslide continuing commitment to improve procedure outcomes. Distal embolic complications in this compromised group of patients further risk blood flow to the foot. PROTEUS will become a necessary device in the "tool-box" of physicians practicing "endovascular-first" approach," said Lihu Avitov, Angioslide CEO.
Founded in 2005, Angioslide is a privately held medical device company that developed a unique Embolic Capture Angioplasty solution, PROTEUS, which provides a combination of PTA balloon and embolic capture. The PROTEUS device addresses an unmet need for an easy-to-use, efficient and cost-effective embolic particle capture solution for the peripheral vascular disease market. It is the first device of its kind to receive FDA clearance for use in lower limbs. The device has also received European CE Mark approval for lower limb use and is being marketed in selected regions in Europe. Angioslide headquarters are located in Caesarea, Israel, and Denver Colorado. For more information visit our website at http://www.angioslide.com
SOURCE Angioslide Ltd.