June 1, 2020
QualiMed Receives CE Mark Approval for GSQ and SCQ 5-F Vascular Devices
June 1, 2020—QualiMed announced that it has received European CE Mark clearance for two additional peripheral vascular devices in its Micro Invasive Technologies (MIT) platform. The company has commenced a limited launch of the devices in five countries in Europe. QualiMed is a wholly owned subsidiary of Q3 Medical Devices Limited, which is headquartered in Dublin, Ireland.
According to the company, the low-profile QualiMed SCQ support catheter in combination with the GSQ guiding sheath provides a miniaturized platform for the treatment of endovascular diseases. The addition of the newly approved devices completes QualiMed's dedicated product portfolio of small diameter 5-F products that enable vascular interventionists to treat endovascular disease with the smallest entry possible.
The MIT platform consists of a range of miniaturized devices designed to reduce the size of the puncture site surface area by 150% or more. The technology allows transradial and transbrachial access approaches and the 5-F size does not require the use of vascular closure devices.
The complete MIT platform includes guidewires and support catheter to reach and cross the lesion, an introducer/guiding sheath to approach the vascular system, and balloons and stents (both balloon and self-expandable) to treat endovascular disease, stated QualiMed.