login
  Password reminder
NeuroNews
Contact the editor Visit NeuroNews Twitter feed Visit NeuroNews Facebook page
 

Phenox receives CE mark approval for pCONus Bifurcation Aneurysm Implant


Friday, 11 Jan 2013 11:54
Phenox implant
Phenox implant

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.




Add New Comment

Most popular


New device allows brain to bypass spinal cord and move paralysed limbs
Friday, 27 Jun 2014
For the first time ever, a paralysed man has moved his fingers and hand with his own thoughts after an electronic neural bypass for spinal cord injuries that reconnects the brain directly to muscles, ... New device allows brain to bypass spinal cord and move paralysed limbs

FDA IDE approval for PulseRider
Tuesday, 10 Jun 2014
The IDE allows Pulsar Vascular to begin a multicentre clinical trial in support of a humanitarian device exemption (HDE) to evaluate the PulseRider for US approval for wide neck aneurysms at or near ... FDA IDE approval for PulseRider

New insight into how the brain regulates its blood flow
Tuesday, 17 Jun 2014
In a new study published online in the Journal of the American Heart Association, researchers at Columbia Engineering report that they have identified a new component of the biological mechanism that ... New insight into how the brain regulates its blood flow

Features


Neuro-oncologic treatment for glioblastoma
Monday, 21 Jul 2014
Malignant gliomas are the most common type of primary malignant brain tumour, accounting for 80% of patients and an annual incidence of 5.26 per 100,000 population, or 17,000 new cases diagnosed per ... Neuro-oncologic treatment for glioblastoma

Early brain stimulation may help stroke survivors recover language function
Monday, 21 Jul 2014
Dieter Heiss, who presented on early brain stimulation for stroke patients at the 8th World Congress on Controversies in Neurology (CONy), 8–11 May, Berlin, Germany, writes for NeuroNews on how this ... Early brain stimulation may help stroke survivors recover language function

Profiles


William T Couldwell
Thursday, 24 Apr 2014
William T Couldwell is professor of neurosurgery in the Department of Neurological Surgery, U... William T Couldwell

Ali R Rezai
Monday, 10 Feb 2014
Ali R Rezai speaks to NeuroNews about his clinical and research career, which has been focused on ... Ali R Rezai

Cardiac Rhythm News Vascular News Cardiovascular News Interventional News Spinal News NeuroNews
BIBA Medical BIBA MedTech Insights CX Symposium ilegx
 
Password Reminder

BIBA Medical, 526 Fulham Road, Fulham, London, SW6 5NR.
TEL: +44 (0)20 7736 8788 FAX: +44 (0)20 7736 8283 EMAIL: 
info@bibamedical.com
© BIBA Medical Ltd is a company registered in England and Wales with company number 2944429.
VAT registration number 730 6811 50.
Site Map | Terms and Conditions