DUBLIN--(BUSINESS WIRE)--Malin Corporation plc. (ISE:MLC, "Malin"), an Irish based and globally operating life sciences company, today announced that its EMBA device, known as the Hourglass™ Peripheral Embolisation Plug, was granted U.S. 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.
Malin 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.”
Andrew Cragg, MD, a Minneapolis, MN, USA-based interventional radiologist and Hourglass™ co-developer, noted: “The Hourglass™ device is designed to provide immediate occlusion in a wide range of vessel sizes with a single device. The device’s unique design was created to take advantage of natural hemodynamic forces to provide immediate, focal, stable occlusions.”
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.
About Malin Corporation plc.
Malin (ISE:MLC) is an Irish incorporated public limited company. Its purpose is to create shareholder value through the selective long-term application of capital and operational expertise to private, pre-IPO, pre-trade sale operating businesses in dynamic and fast growing segments of the life sciences industry. Through its operational involvement, Malin works with its investee companies to enable them to reach the full potential of their value proposition and to achieve commercial success. For more information visit www.malinplc.com