[Irvine, CA] - phenox Inc. a leading medical device company in the Neurovascular industry, announced the presentation of the primary results of The pRESET for Occlusive Stroke Treatment (PROST) Randomized Clinical Trial at the International Stroke Conference in Dallas, TX on February 8th at 9:30am CST. This highly anticipated event marks a significant milestone in the company's efforts to advance the treatment of occlusive stroke.
The PROST trial was conducted to evaluate the safety and efficacy of phenox's pRESET Thrombectomy Device, which has recently received 510k Clearance by the FDA for use in the US. The trial design randomized patients to be either treated with the pRESET Thrombectomy Device or the Solitaire Revascularization Device by Medtronic, the current market leader in the US.
The PROST primary and secondary endpoints were successfully achieved. These results lead to the FDA’s decision to not only clear the device for use in the US but in addition grant the device an indication to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received thrombolytic therapy.
“PROST is the first randomized clinical trial comparing a novel versus an established stent-retriever technology, establishing a new scientific benchmark for stroke device trials. Our study confirms the overall safety and efficacy of pRESET in treating LVO acute ischemic stroke patients" said Dr. Raul Nogueira, co-principal investigator of the trial and Director of the University of Pittsburgh Medical Center Stroke Institute.
“We’d 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 randomized study, especially during the early days of the COVID-19 pandemic which challenged our study enrollment norms” said Dr. Ricardo Hanel, co-principle investigator of the trial and Director for Baptist Neurological Institute in Jacksonville, Florida
phenox Inc. is dedicated to improving the lives of stroke patients and their families by providing innovative solutions that deliver fast, effective, and safe treatment options. The company's commitment to advancing the field of stroke treatment is demonstrated through its ongoing research and development efforts.
For more information about the pRESET Thrombectomy Device or to request a demonstration, please contact Phenox Inc. at email@example.com
NeVa Stent Retriever
Pinch’ing the clot – solumbra technique for distal thrombectomies – are we there yet?