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Malin's EMBA device receives FDA approval

22 August 2017 07:43

Malin announced that its EMBA device, known as the Hourglass Peripheral Embolisation Plug, was granted US FDA 510(k) clearance to commence marketing in the US.

The Hourglass peripheral embolisation plug represents a breakthrough in peripheral embolisation devices in that it is designed to provide precise, secure, over-the-wire delivery and immediate occlusion with a single integrated device.

Executive Vice President Sean Murphy said: "The FDA approval of the Hourglass device is a major milestone and clears the way for a revolutionary peripheral embolisation device to be marketed in the US, with the device already approved in Europe.

"It enables the physicians to enhance the treatment of stroke and improve the quality of life in their patients."

"This is the first integrated, over-the-wire device designed for peripheral embolisation procedures," said George Wallace, co-developer of the Hourglass.

"The goal with over-the-wire design is to provide physicians with accurate, stent-like delivery of the device in the vessel."

The Hourglass Peripheral Embolisation Plug has a CE certificate and is approved for commercialisation in EU nations.

The embolic plug has undergone clinical studies in a broad range of interventional cases in New Zealand and Ireland.

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Related Company: MLC

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