Using a canine model of a large, terminal, carotid artery, venous pouch aneurysm, a comparison was made between treatment with standard coils and treatment with the Ballstent MicrocatheterTM.Methods
For the pilot coiling study, a single aneurysm was surgically constructed on a newly created carotid artery terminal bifurcation in a hound. After 21 days, the aneurysm measured 12 mm x 9 mm x 6 mm. Using standard technique, this aneurysm was treated with 18 coils (Axium™, Covidien). For the pilot Ballstent study, a similar sized aneurysm was created in a similar manner in the same model system and treated after 21 days with a prototype of the Ballstent comprising a thin-walled 8 mm gold metal balloon mounted, folded, wrapped, and compressed onto a 3.5 Fr microcatheter with a 0.018” guidewire. The compressed Ballstent was positioned in the aneurysm sac and expanded to occlude the aneurysm neck. An 8 mm diameter coil was then deployed through the guidewire lumen into the aneurysm dome to hold the expanded Ballstent in place at the aneurysm neck. The Ballstent was detached by electrolysis with 2 mA of DC current. For both treatments, angiography was performed immediately before and after device deployment. Treatment time, device number and cost, and degree of occlusion at the end of the procedure were measured. Four week terminal angiography and histopathology were performed for the pilot Ballstent study and are pending for the pilot coiling study.Results
For the coil treatment, 18 coils were placed over a 60-minute treatment period at a list price cost of $31,500. The degree of acute occlusion at the end of the coil treatment was estimated at 85–99% by angiography. For the Ballstent treatment, one Ballstent and one coil were placed over a 30-minute treatment period at an estimated cost of $11,750. The degree of acute occlusion with the Ballstent treatment was estimated at 100% by angiography. At 4 weeks, the Ballstent showed sustained occlusion of the aneurysm with well-organised, mature, and fully endothelialized neointima covering the entire aneurysm neck.Conclusion
When compared with standard coil treatment, the Ballstent has the potential to provide a faster, easier, and more cost-effective treatment with better occlusion rates. Transition to a 0.014” guidewire platform is underway.Disclosures
N. Franano: 4; C; Equity holder. 5; C; Employee. H. Loree: 4; C; Equity holder. 5; C; Employee. D. Groth: 2; C; Consultant. M. Lisowski: 2; C; Consultant. S. Brunell: 2; C; Consultant. R. Ainsworth: 2; C; Consultant. S. Rousselle: 2; C; Consultant. K. Murphy: 2; C; Consultant. 4; C; Equity holder.