Global interventional therapies firm Penumbra has received 510(k) approval from the US Food and Drug Administration for its ACE64 aspiration thrombectomy system.
The system has obtained approval for the revascularization of large vessel occlusions in patients with acute ischemic stroke.
Penumbra chairman and CEO Adam Elsesser said: "We are at an exciting moment in history when the effectiveness of mechanical thrombectomy is now firmly established, allowing the stroke community to focus on optimizing the delivery of care in stroke and improving patient outcomes.
"At Penumbra, we are continuing the pace of innovation to bring ever more effective tools to physicians in the fight against a devastating disease affecting so many patients worldwide."
According to the firm, the efficacy and safety of mechanical thrombectomy was demonstrated in the MR CLEAN trial and confirmed in additional randomized controlled stroke trials.
ACE64 is said to include the largest lumen aspiration thrombectomy device with a 0.064 distal inner diameter and a 0.068 proximal inner diameter. It is designed to evacuate large clot burdens from the neurovasculature.
Developed by using ACE tracking technology platform, the system obtained CE mark approval in December 2014 to treat acute ischemic patients with large vessel occlusive disease within eight hours of symptom onset.