Pulsar Vascular has obtained Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) for its PulseRider aneurysm neck reconstruction device, designed to treat intracranial bifurcation aneurysms.
The FDA IDE approval allows Pulsar Vascular to initiate a clinical trial in support of a Humanitarian Device Exemption (HDE) to assess the PulseRider for US approval for wide neck aneurysms at or near a bifurcation of the basilar tip or carotid terminus.
This trial, which is set to begin in the third quarter of 2014, will be conducted at multiple clinical sites in the US.
Pulsar Vascular CEO Rob Abrams said that the FDA’s approval of the PulseRider IDE allows the company to initiate this important study for its flagship product and validates its scientific platform technology.
"This approval represents another significant milestone for Pulsar Vascular and a step forward on the path to providing a new treatment option to both patients and physicians," Abrams added.
PulseRider is a minimally invasive aneurysm neck reconstruction device designed to be fully retrievable and repositionable. The device obtained CE Mark approval in 2013 and has been in use in Europe since early 2014.
Pulsar Vascular plans to expand the European market, while the US clinical trial is underway.