Angioslide Announces FDA 510(K) Clearance of PROTEUS(TM) Below The Knee Device
CAESAREA, Israel, May 2, 2012 /PRNewswire/ –
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
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(TM), which provides a combination
of PTA balloon and embolic capture. The PROTEUS(TM) 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
Contact: Shira Doron Marketing Director Mobile: +972-54-9011134 email@example.com
SOURCE Angioslide Ltd.