Phenox has announced that the pCONus Bifurcation Aneurysm Implant has been granted CE mark approval for commercialisation within the European Union and any country that accepts CE mark approval. The pCONus implant is a new category of intraluminal stent intended to treat complex, wide neck intracranial bifurcation aneurysms.
Hermann Monstadt, managing director at phenox, said: “phenox continues to expand its portfolio of easy to use innovative tools to help physicians treat patients with complex intracranial aneurysms that have unmet clinical needs. This approval adds support to our strategy of focusing on creative solutions for complex clinical problems.”
The pCONus implant is a new class of endoluminal device that is designed to support the mass of coils at the level of the neck of wide neck bifurcation aneurysms that cannot be easily coiled or surgically treated. It combines features of an endoluminal stent with an intra-aneurysmal implant.
According to the company, 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 Implant is detached via an electrolytic detachment process.
According to Ralf Hannes, chief technical officer at phenox, “the pCONus 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.”
Hans Henkes, Katharinenhospital, Stuttgart, Germany said: “the pCONus implant allows me to simplify my treatment strategy for these extremely complex lesions. The simplicity of the system allows me to focus on the coil occlusion rather than the multiple devices that otherwise would be required to protect the branches of the parent artery. It makes a very complex, difficult procedure extremely simple and safe.”
Phenox is planning to conduct a post market surveillance study of 100 patients in order to capture long term data for up to 24 months post treatment.