Angioslide announces FDA 510(k) clearance of Proteus below-the-knee device


Angioslide, a provider of embolic capture angioplasty solutions, announced on 2 May 2012 that it has received FDA 510(k) clearance for its new 3X100mm Proteus device for treating peripheral artery disease in below-the-knee vasculature. The new 3/100mm device accommodates 0.014” guidewires, 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. According to Angioslide, Proteus is a competitive percutaneous transluminal angioplasty balloon with features similar to leading 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.

“The introduction of the new dedicated, below-the-knee, 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.

The Proteus device is the first device of its kind to receive FDA clearance for use in lower limbs. The device has also received CE mark approval for lower limb use and is being marketed in selected regions in Europe.