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First successful below-the-knee procedures with the Proteus device performed in the USA

Friday, 13 Jul 2012 13:47

Angioslide, a provider of embolic capture angioplasty solutions, has announced the successful deployment of a 3X100mm Proteus device for treating peripheral artery disease in below-the-knee (BTK) vasculature at Community Hospital in Munster, USA. Accommodating a 0.014” guide-wire, the new device allows physician to perform a PTA revascularisation in BTK vessels while capturing and removing embolic particles. 

“With Proteus having been successfully used to treat lesions in the SFA (superficial femoral artery), I had the opportunity to deploy the device in BTK procedures,” said Prakash Makam, Community Hospital. “It is an effective, easy to use tool that provides an alternative for removal of embolic material, including micro particles, that could compromise downstream vasculature flow and perfusion to the foot. This is especially important when treating high-risk, diabetic and critical limb ischaemia patients.”

Angioslide’s proprietary technology combines the functionality of a balloon angioplasty device with the addition of capture and removal of particles released during intervention. Capture of embolic material is enabled by the inward folding of the balloon through a dedicated handle, which creates a suction effect that pulls embolic material into the cavity. When retrieved through the sheath, Proteus removes the captured material from the body.

“We are excited to provide a solution for capture and removal of embolic debris for below-the-knee intervention, where the clinical consequences of emboli are amplified by small vessel diameter,” said Lihu Avitov, CEO, Angioslide. “The current set of tools available on the market for BTK intervention are suboptimal, and we look forward to meeting this important clinical need. With the successful completion of our first cases in the USA, we will introduce our product to a wider number of centers.”

According to a company release, the Proteus is the first device of its kind to receive FDA clearance for use in lower limbs (the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries). The device has also received European CE mark approval for lower limb use and is being marketed in selected regions in Europe.

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