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


Better outcomes observed in MR CLEAN non-general anaesthesia subgroup in post-hoc analysis
Thursday, 02 Apr 2015
In a post-hoc analysis of the use of general anaesthesia in the MR CLEAN trial (Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands) ... Better outcomes observed in MR CLEAN non-general anaesthesia subgroup in post-hoc analysis

Evidence builds for endovascular treatment of acute ischaemic stroke
Friday, 17 Apr 2015
With the publication of two more stroke trials, the evidence in favour of endovascular treatment in patients with acute ischaemic stroke has reached new heights. Data from SWIFT PRIME and REVASCAT ... Evidence builds for endovascular treatment of acute ischaemic stroke

Study suggests feasibility of Baby Trevo for treatment of distal cerebrovascular occlusions
Thursday, 14 May 2015
Diogo Haussen and colleagues (Emory University School of Medicine, Atlanta, USA) report that their initial data suggest that treatment of distal cerebrovascular occlusions with the Trevo XP ProVue 3x2... Study suggests feasibility of Baby Trevo for treatment of distal cerebrovascular occlusions

Features


New day in acute ischaemic stroke therapy
Friday, 17 Apr 2015
The newest generation of trials for acute ischaemic stroke, including MR CLEAN, ESCAPE, EXTEND IA and SWIFT PRIME, appear to have ushered in a new era in stroke therapy. Now, Joseph Broderick (... New day in acute ischaemic stroke therapy

Flow diverter technology for intracranial aneurysms
Tuesday, 31 Mar 2015
Gabor Toth writes for NeuroNews about the flow diverters that are currently available and the ongoing clinical trials that could have the potential to extend the indications of flow diverter therapy ... Flow diverter technology for intracranial aneurysms

Profiles


Robert E Harbaugh
Thursday, 14 May 2015
Robert E Harbaugh speaks to NeuroNews about how far neurosurgery has come, and as president of AANS ... Robert E Harbaugh

Joseph Broderick
Wednesday, 07 Jan 2015
Joseph Broderick speaks to NeuroNews about the future of neurology and his research, in particular, ... Joseph Broderick

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