Phenox GmbH has announced the start of the pToWin study after enrolling the first patient on 2 September, 2015. The prospective, multicentre, single-arm study pToWin (pCONus treatment of wide neck intracranial aneurysms) aims to assess safety and efficacy of the pCONus bifurcation aneurysm implant.
After the completion of the ARTESp study (Acute recanalization of thrombo embolic stroke with pREset) Phenox GmbH has now launched the clinical investigation of yet another innovative medical device for endovascular stroke treatment. Coordinated by neuroradiologist Alessandra Biondi, CHU Besançon, France, internationally renowned centres in Europe and South America will assess the pCONus implant in their daily clinic routine. “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 its benefits,” says Biondi. A Core Lab will assess the aneurysm occlusion after the treatment and again at six and 12 months post treatment. The study will enrol 100 patients over the next two years and the results are to be published in a peer-reviewed scientific journal after completion.
The pCONus bifurcation aneurysm implant is a new category of intraluminal device intended to treat complex, wide neck intracranial bifurcation aneurysms. It 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. The implant features a distal end that opens like a blossoming flower and its petals rest on the inside of the aneurysm along the neck. The body of the implant is deployed in the parent artery and anchors the device securely in place. The device can be deployed completely and recovered completely for optimal, accurate and safe repositioning. When the operator is satisfied with its position the aneurysm is then coiled by passing a microcatheter inside the stent and through a nylon net at the base of the petals. Once the coiling is complete and the physician has removed the coiling microcatheter, the pCONus bifurcation aneurysm implant is detached via an electrolytic detachment process.
According to Ralf Hannes, chief technical officer at Phenox, “the pCONus bifurcation aneurysm implant offers a significant reduction in the amount of metal typically implanted in “Y stenting” technique. The design of the cells and the implant structure are such that there is less than 5% metal to artery surface coverage.”
“The treatment of wide neck bifurcation aneurysms can be complex, requiring multiple devices and manoeuvres,” says James Lago, Phenox’s consultant vice president of Sales & Marketing. “pCONus reduces the complexity of the treatment.”
Phenox further announced that the company will soon begin another important prospective, multicentre, Post Market Clinical Follow-up study, the Diversion-p64, that investigates safety and efficacy of the p64 Flow Modulation Device, the world’s most advanced flow diverter.