Laminate Medical’s VasQ Fistula Supporting Device Gets FDA Investigational Device Exemption

Frank
August 23, 2017
319 Views

Laminate Medical Technologies, an Israeli firm, won an Investigational Device Exemption (IDE) from the FDA to begin a clinical trial of its VasQ device designed to support arteriovenous fistulas. The technology will hopefully benefit patients that receive hemodialysis via AVF in the upper extremity.

In many dialysis patients the fistulas that are created too often have trouble staying in shape and may require revision procedures. Additionally, the connection may narrow, leading to complications, and blood turbulence near the connection can lead to clots or cell lysis.

The VasQ device, made of Nitinol memory alloy, supports a fistula by wrapping around a vein and holding the artery so it doesn’t disconnect. The connection, being more secure and retaining its shape, prevents blockages, disconnections, and reduces the turbulence of blood as it moves through the fistula.

Here’s a bit of detail about the study approved by the FDA that will test the VasQ for safety and efficacy:

Here’s an informative video from Laminate Medical Technologies explaining the workings of the VasQ device:

Product page: VasQ…

Via: Laminate Medical…

Frank’s source: https://www.medgadget.com/2017/08/laminate-medicals-vasq-fistula-supporting-device-gets-fda-investigational-device-exemption.html

 

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