FDA Clearance For First Below-The-Knee Embolic Capture Device

In short
Israeli company Angioslide Ltd. describes itself as a provider of Embolic Capture Angioplasty solutions. The company has 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 device accommodates 0.014″ guide-wires, which significantly broadens the potential use of PROTEUS technology.
Background

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.

Angioslide’s proprietary technology is the first of its kind to receive FDA approval. It works by rather cleverly combining 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).

During balloon 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.

Company comments

“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.

Availability

The device has CE Mark approval for lower limb use and is being marketed in selected regions in Europe.

Source: Angioslide Ltd., PR Newswire