Phenox, a Wallaby Medical company, has today announced the presentation of the primary results of the PROST (Preset for occlusive stroke treatment) randomised clinical trial at the International Stroke Conference (ISC; 8–10 February 2023, Dallas, USA).
The PROST trial was conducted to evaluate the safety and efficacy of Phenox’s Preset thrombectomy device, which recently received 510(k) clearance from the US Food and Drug Administration (FDA) for use in the USA.
The trial design saw patients randomised to be treated with either the Preset thrombectomy device or the Solitaire revascularisation device (Medtronic)—the current market leader in the USA.
The PROST primary and secondary endpoints were successfully achieved, a Phenox press release notes, and these results led to the FDA’s decision to not only clear the device for use in the USA but, in addition, grant the device an indication to reduce disability in stroke patients with a persistent, proximal, anterior circulation, large vessel occlusion (LVO), and smaller core infarcts, who have first received thrombolytic therapy.
“PROST is the first randomised clinical trial comparing a novel versus an established stent-retriever technology, establishing a new scientific benchmark for stroke device trials,” said co-principal investigator of the trial Raul Nogueira (University of Pittsburgh Medical Center Stroke Institute, Pittsburgh, USA). “Our study confirms the overall safety and efficacy of Preset in treating LVO acute ischaemic stroke patients.”
“We would like to thank all of the co-investigators that participated in the PROST study and commend all research teams for their dedication to the first head-to-head device randomised study, especially during the early days of the COVID-19 pandemic, which challenged our study enrolment norms,” added co-principal investigator Ricardo Hanel (Baptist Neurological Institute, Jacksonville, USA).