Lumen Biomedical, a medical device company, has received the FDA clearance for the LBI embolectomy system for use in the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
The LBI embolectomy system consists of a 0.014'' guide wire containing a three-dimensional fiber-based element used in combination with the previously cleared Xtract aspiration catheter. The expandable element conforms to the vessel wall while pulling thrombus under aspiration towards the large, single-lumen design of the catheter.
System bench testing demonstrated excellent thrombus removal compared to a balloon embolectomy catheter, with the potential for less vessel trauma. The models cleared treat vessel diameters ranging from 3.5 to 7mm, the company said.
The LBI embolectomy system is based on the same core technologies used in the company's embolic protection system currently under FDA 510(k) review for carotid use.
Matthew Ogle, CEO of Lumen Biomedical, said: "Receiving embolectomy clearance is an important milestone for Lumen Biomedical; affirming the belief that our platform of device technology has a potential for broad applications within the human vasculature."