WallabyPhenox Boldly Sets New Benchmark in Evidence-Based Medicine With the PROST Trial

IRVINE, Calif., February 5, 2024 (Newswire.com) - WallabyPhenox, a global pioneer in stroke healthcare innovation, has announced the publication of PROST in JAMA Neurology. Visit JAMA Neurology to view the publication. Commenced in 2019, this clinical study marks a significant advancement in the treatment of strokes caused by large vessel occlusion (LVO), a condition contributing to severe disability and mortality worldwide.

Tackling the Global Impact of Acute Ischemic Stroke

Acute ischemic stroke, resulting from an obstruction in the arteries leading to the brain, is a leading cause of disability and the second leading cause of death globally. In the United States alone, AIS affects an estimated 800,000 individuals annually. The urgency for more effective treatments is underscored by the high incidence and impact of this condition.

A Novel Trial Design Sets a New Standard for Stroke Trials 

PROST, through a head-to-head comparison of the pRESET thrombectomy device with the Solitaire device, has established a new benchmark in the realm of stroke device trials. This randomized clinical trial, including 340 patients, has confirmed the non-inferiority of the pRESET device in achieving functional independence and overall disability reduction at 90 days. With 54.9% of patients in the pRESET group reaching functional independence, the study reinforces the device's role as a significant player in stroke care.  James Lago, WallabyPhenox CEO, said, “The confidence in our product design is second to none, and with PROST, we are giving physicians the confidence to treat patients with the highest level of evidenced-based medicine. It doesn’t stop with PROST, WallabyPhenox’s clinical leadership continues with the ongoing, high impact randomized clinical trials, DART and COATING.”

pRESET: A Safe and Effective Treatment Option

In terms of safety, the pRESET group recorded no incidences of either symptomatic intracranial hemorrhage (sICH) or embolization of new territory (ENT), a noteworthy finding in the treatment of LVO strokes. The efficacy of the device was further evidenced by 85.5% of patients treated with pRESET achieving eTICI 2b50 revascularization within three passes. These outcomes not only highlight the device's safety but also its effectiveness in restoring blood flow and reducing disability in patients with LVO stroke. Dr. Ricardo Hanel, a co-principal investigator in PROST, said, “The PROST trial marks a significant milestone in stroke research, being the first to conduct a randomized comparison of a novel stent-retriever technology against a well-established one. Results from PROST verify the safety and efficacy of pRESET and have led to an FDA Clearance with a reduction of disability claim for LVO patients known only to 3 devices in the US.” 

Subgroup Analysis and Future Research

The depth of data from the PROST trial provides a wealth of information for future research endeavors. “Now that the results have been published, it opens up the opportunity for secondary and sub-group analysis by other investigators that have greatly contributed to this study. The PROST body of data is important and will be impactful in further understanding efficacy in treating LVOs due to its high level of scientific rigor, large sample size, and real-world randomization,” said co-principal investigator, Dr. Raul Nogueira.

About WallabyPhenox

WallabyPhenox stands at the forefront of stroke healthcare research, with a steadfast commitment to enhancing patient outcomes. The company's focus on rigorous clinical trials and technological innovation continues to push the boundaries of stroke treatment, aiming to reduce the global burden of this life-altering condition. For additional information, visit Our Website and follow our Twitter(X) and LinkedIn.

Source: WallabyPhenox