pToWin Assesses Phenox's pConus Bifurcation Aneurysm Device in Wide-Neck Intracranial Aneurysms

September 20, 2015—Phenox GmbH announced the start of the pToWin study, with the first patient enrolled on September 2. The prospective, multicenter, single-arm pToWin study aims to assess safety and efficacy of the company’s pConus bifurcation aneurysm implant for the treatment of wide-neck intracranial aneurysms. 

According to Phenox, centers in Europe and South America will assess the pConus implant in their daily clinic routine. A core lab will assess aneurysm occlusion after treatment and again at 6 and 12 months posttreatment. The study will enroll 100 patients during the next 2 years, and the results will be published after completion.

Principal investigator Prof. Alessandra Biondi, MD, is leading the study. In the company’s press release, Prof. Biondi commented, “pConus provides the interventional neuroradiologist with an important tool to treat complex wide-neck bifurcation aneurysms and this study will help the interventional community to better understand it’s benefits.” Prof. Biondi is a neuroradiologist at CHU Besançon in Besançon, France.

According to the company, the pConus is designed to support the coil mass at the level of the neck of those aneurysms that cannot be easily coiled or surgically treated. It combines features of an endoluminal stent with an intra-aneurysmal implant. 

Additionally, Phenox advised that it will soon begin a prospective, multicenter, postmarket clinical follow-up study (DIVERSION-p64), which will investigate the safety and efficacy of the p64 flow modulation device, an advanced flow diverter.

The company also noted it has completed the ARTESp study of acute recanalization of thromboembolic stroke with the pReset device for endovascular stroke treatment, the results of which will be presented at several upcoming neurological congresses and will be published.