First clinical report on Comaneci device shows good aneurysm occlusion

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In the Journal of NeuroInterventional Surgery (JNIS), Tufail Patankar (Department of Neuroradiology, Leeds Teaching Hospital, Leeds, UK) and colleagues present the first clinical report on the use of the Comaneci device (Rapid Medical) for the treatment of cerebral aneurysms. In the three-case experience, the investigators found that the Comaneci device can be used to achieve good cerebral aneurysm occlusion, while providing similar benefits to balloon remodelling but alleviating the associated time constraints.


The only other published report on the use of the Comaneci device appeared in JNIS in January of this year. The investigators studied 20 New Zealand white rabbits in which aneurysms were created using elastase and ligation of the right common carotid artery. The aneurysms were then embolised with bare platinum coils along with adjunctive treatment using the Comaneci device or a Hyperglide balloon (Covidien). Assessments were made for endothelial injury using scanning electron microscopy and light microscopy. In that paper, authors Rishi Gupta et al reported that the Comaneci device is a “new adjuvant treatment for bridging of wide necked aneurysms with the advantage of averting flow arrest during deployment. There does not appear to be any evidence of significant endothelial damage during deployment in preclinical studies.”


According to Patankar et al, the Comaneci temporary bridging device has a compliant neck bridge and allows for continuous diameter and radial force adaption. “The user can control the amount of pressure applied on the neck, allowing variable expansion. The wire outer diameter is 80μm. The metal coverage of the device is variable, however in a straight 3mm vessel, it will be about 7.5%, with a cell size under these conditions of 1.44mm2,” they write.


In this series, the investigators treated a 50-year-old woman who presented with a World Federation of Neurosurgical Societies (WFNS) grade 1, Fisher grade 4 acute subarachnoid haemorrhage; a 52-year-old woman who presented with an acute WFNS grade 1, Fisher grade 2 subarachnoid haemorrhage secondary to a wide-necked 7mm posterior communicating aneurysm; and a 32-year-old man who presented electively with recurrence from previously treated carotico-ophthalmic aneurysm; the aneurysm had ruptured three months previously causing a subarachnoid haemorrhage.


The authors report that “good aneurysm occlusion was demonstrated in all three cases. Case No 1 had a post procedure MRI scan that showed a few scattered foci of restricted diffusion in the territory of the middle cerebral artery. There was no area of cortical infarction. At discharge, no significant motor neurological deficits were reported. On review in clinic at three months, the patient was found to have mild left-sided weakness (affecting the leg more than the arm). On examination, the Medical Research Council power grade was at worst 4/5. Case Nos 2 and 3 had no neurological symptoms.”


They conclude stating, “The benefits of the Comaneci device are that it is a temporary bridging device with no occlusion to distal flow for both sidewall and bifurcation aneurysms…. This device may prove to be an important addition to the neurointerventionist’s armamentarium in successfully treating cerebral aneurysms”.

 


NeuroNews spoke to Patankar about his experience with the clinical use of the Comaneci device.

 


Did you encounter any complications or challenges with the use of the Comaneci device?


No complications were encountered with the use of the device. As the device shortens, it is important to place the device appropriately across the neck of aneurysm.

 


What are the limitations associated with the device?


There are limited sizes available and there is a shortening of device following deployment. Also, you need a 21 sized catheter for delivery.

 


What are the potential advantages of the Comaneci device over conventional balloon assisted coiling?


The advantages of the Comaneci device are:

  • No need for inflation/deflation during coiling
  • No time pressure as seen with balloon use
  • Risk of thromboembolic disease and distal hypoperfusion is decreased