FDA has cleared Irish life sciences company Malin Corp for its Hourglass peripheral embolization plug.

The company said the Hourglass plug is designed to be deployed over-the-wire for peripheral embolization procedures, and can provide immediate occlusion with a single integrated device.

“This is the 1st integrated, over-the-wire device designed for peripheral embolization procedures. The goal with over-the-wire design is to provide physicians with accurate, stent-like delivery of the device in the vessel,” Hourglass co-developer George Wallace, said in prepared remarks.

“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,” Hourglass co-developer Dr. Andrew Cragg said in a press release.

Malin said that the Hourglass has already received CE Mark approval in the European Union, and has undergone clinical studies in New Zealand and Ireland.

“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,” Malin exec VP Sean Murphy said in a prepared statement.