FDA clears Penumbra ACE64 for acute ischaemic stroke patients


Penumbra has announced that the company’s ACE64 aspiration thrombectomy system received 510(k) marketing clearance from the US Food and Drug Administration for the revascularisation of large vessel occlusions in patients with acute ischaemic stroke.

The efficacy and safety of mechanical thrombectomy has been demonstrated in the MR CLEAN trial and confirmed in additional randomised controlled stroke trials. According to Penumbra, ACE64 is the most advanced innovation in thrombectomy technology since these trials were conducted. With a unique construction that leverages breakthrough technology in materials science, ACE64 enables physicians to bring the most powerful clot extraction capability directly to the occlusion and remove clot en masse. Early experience from a European multicentre study, where ACE64 is already available, reported high rates of revascularisation at 96% TICI 2b/3, a fast procedure time of 37 minutes on average and mRS scores ≤2 at discharge of 48%.

“ACE64 is the latest technology improvement in mechanical thrombectomy,” said Rob T Lo, University Medical Center Utrecht, The Netherlands, a centre in the MR CLEAN trial. “I have used Merci and the different stent retrievers as well as the prior ACE aspiration thrombectomy system. With the new ACE64, I am achieving even higher revascularisation rates, particularly TICI 3, while reducing procedure times and minimising overall procedure costs. ACE64 is now my frontline tool for treating patients with acute ischaemic stroke.”

Penumbra’s aspiration thrombectomy devices use a minimally invasive “vacuum” inside the artery to remove a blood clot. The next-generation ACE64 features an even larger aspiration lumen compared with ACE to evacuate large clot burdens.

“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 optimising the delivery of care in stroke and improving patient outcomes,” said Adam Elsesser, chairman and chief executive officer. “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.”