July 11, 2012—Angioslide Ltd. (Wheat Ridge, CO) announced the United States introduction of its 3- X 100-mm Proteus device, a percutaneous transluminal angioplasty (PTA) balloon with an embolic suction mechanism for treating peripheral artery disease in below-the-knee (BTK) vasculature.
According to the company, the Proteus accommodates a 0.014-inch guidewire to enable PTA revascularization in BTK vessels while capturing and removing embolic particles. 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.
Angioslide stated in the press release that with the successful completion of the initial BTK cases in the United States, the company would begin a wider launch of the device. Prakash Makam, MD, of Community Hospital in Munster, Indiana, performed the first BTK procedure with the Proteus in the United States.
“With Proteus having been successfully used to treat lesions in the superficial femoral artery, I had the opportunity to deploy the device in BTK procedures,” commented Dr. Makam in the press release. “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 ischemia patients.”
As reported on May 2, Angioslide announced FDA clearance for the Proteus device for use in lower limb vessels: the femoral, iliac, iliofemoral, 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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