Codman Neuro has launched the CODMAN ENTERPRISE® 2 Vascular Reconstruction Device. This self-expanding stent and delivery system is used to treat wide-necked intracranial aneurysms and to help maintain the position of endovascular coils during and after the procedure.
Cerebral aneurysms can become thin and stretched and then rupture, similar to a balloon bursting, without warning. Wide neck aneurysms are aneurysms that have wide openings (necks) of at least 4mm or are at least twice as wide as the height of the top, or dome, of the aneurysm. This type of aneurysm is considered technically difficult to treat by the endovascular method.
The new CODMAN ENTERPRISE 2 System is designed to improve vessel wall conformability, while maintaining a stable structure at the neck of an aneurysm. The device helps secure the placement of endovascular coils and maintains blood flow through the artery. In addition, the stent is more visible under fluoroscopy than the previous device and has a self-flushing introducer to facilitate ease of use.
The CODMAN ENTERPRISE Vascular Reconstruction Device and the CODMAN ENTERPRISE 2 Vascular Reconstruction Device are approved by the FDA under a Humanitarian Device Exemption (HDE) in the United States only. The systems are authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of ≥2.5 mm and ≤4 mm. Wide-neck is defined as having a neck width ≥4 mm or a dome-to-neck ration <2.
Codman Neuro is featuring its new device at the forthcoming American Association of Neurological Surgeons/Congress of Neurological Surgeons (AANS/CNS) Joint Cerebrovascular Annual Meeting in Los Angeles, held in conjunction with the Society for Neurointerventional Surgeons (SNIS).
Company consultant, Neurointerventional Radiologist Donald Frei, MD of Denver, Colorado said; “The precision, conformability and occlusion that can be achieved when treating wide-necked aneurysms with the CODMAN ENTERPRISE 2 System are excellent. It was easy to use and deploy, and met all expectations for treatment. This is truly a next generation stent that helps overcome the clinical challenges of treating wide-necked aneurysms.”
“We have made important design improvements to the CODMAN ENTERPRISE 2 System so that it better fits vascular anatomy, is more visible on X-Ray, and is more easily deployed,” said P. Laxmin Laxminarain, Worldwide President of Codman Neuro. “This technology is specifically designed to enhance the way physicians repair wide-necked aneurysms, which can be life-threatening and very difficult to treat.”
Source: Codman Neuro