PROST Stroke Trial Results Published in JAMA Neurology

PROST中风试验结果发表在JAMA Neurology上

IRVINE, CA / ACCESSWIRE / February 5, 2024 / 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..

加利福尼亚州欧文/ACCESSWIRE/2024年2月5日/全球中风医疗创新先驱WallabyPhenox宣布在JAMA神经病学杂志上发表PROST。访问JAMA Neurology查看出版物。这项临床研究始于2019年，标志着大血管闭塞（LVO）引起的中风治疗取得了重大进展，LVO是导致全球严重残疾和死亡的疾病。。

pRESET Thrombectomy Device

预设血栓切除装置

The novel stroke device used in the PROST trial from WallabyPhenox

WallabyPhenox在PROST试验中使用的新型中风装置

Tackling the Global Impact of Acute Ischemic Stroke

应对急性缺血性中风的全球影响

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..

由通向大脑的动脉阻塞引起的急性缺血性中风是导致残疾的主要原因，也是全球第二大死亡原因。仅在美国，AIS每年就影响大约80万人。这种情况的高发病率和影响突显了更有效治疗的紧迫性。。

A Novel Trial Design Sets a New Standard for Stroke Trials

一种新颖的试验设计为中风试验设定了新标准

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.

PROST通过将预设血栓切除装置与Solitaire装置进行头对头比较，在中风装置试验领域建立了新的基准。这项包括340名患者的随机临床试验证实了预设装置在90天内实现功能独立性和整体残疾减少方面的非劣效性。

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.

随着预设组中54.9%的患者达到功能独立，该研究加强了该设备在中风护理中的重要作用。WallabyPhenox首席执行官詹姆斯·拉戈（JamesLago）表示，“我们对产品设计的信心是首屈一指的，而使用PROST，我们让医生有信心用最高水平的循证医学治疗患者。

It doesn't stop with PROST, WallabyPhenox's clinical leadership continues with the ongoing, high impact randomized clinical trials, DART and COATING.'.

它并没有停止于PROST，WallabyPhenox的临床领导力继续进行持续的，高影响力的随机临床试验，DART和涂层。”。

pRESET: A Safe and Effective Treatment Option

预设：安全有效的治疗选择

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.

就安全性而言，pRESET组没有记录到症状性颅内出血（sICH）或新区域栓塞（ENT）的发生率，这是治疗LVO中风的一个值得注意的发现。85.5%接受预设治疗的患者在三次通过内实现了eTICI 2b50血运重建，进一步证明了该装置的疗效。

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.

这些结果不仅突出了该装置的安全性，而且还突出了其在恢复LVO中风患者血流和减少残疾方面的有效性。PROST联合首席研究员Ricardo Hanel博士说，“PROST试验标志着中风研究的一个重要里程碑，是第一个将新型支架回收器技术与成熟技术进行随机比较的试验。

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.'.

PROST的结果验证了pRESET的安全性和有效性，并导致FDA批准，减少了美国仅有3台设备已知的LVO患者的残疾索赔。

Subgroup Analysis and Future Research

亚组分析和未来研究

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.

PROST试验数据的深度为未来的研究工作提供了丰富的信息。”现在，研究结果已经公布，这为其他研究人员提供了进行二次和亚组分析的机会，这些研究人员对这项研究做出了巨大贡献。联合首席研究员Dr。

Raul Nogueira..

劳尔·诺盖拉。

About WallabyPhenox

关于袋鼠

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.

WallabyPhenox站在中风医疗保健研究的前沿，坚定地致力于提高患者的预后。该公司专注于严格的临床试验和技术创新，继续推动中风治疗的界限，旨在减轻这种改变生命状况的全球负担。

For additional information, visit Our Website and follow our Twitter(X) and LinkedIn..

有关更多信息，请访问我们的网站，关注我们的Twitter（X）和LinkedIn。。

Contact Information

联系方式

Bryan Rhodes

布莱恩·罗兹

US Marketing Director

美国市场总监

bryan.rhodes@wallabyphenox.com

bryan.rhodes@wallabyphenox.com

+1 (949) 353-0594

+1 (949) 353-0594

SOURCE: WallabyPhenox

资料来源：WallabyPhenox

View the original press release on newswire.com.

在newswire.com上查看原始新闻稿。