In recent years, many developments have been made to the tools and techniques used to treat IAs via endovascular intervention. Specifically, to the detachable coils themselves. In March 2018, the US Food and Drug administration granted Balt USA 510(k) clearance for the Optima Coil Systemâ„¢. Earlier this year, the list of devices included within the system has expanded to include OptiMAX Complex Super Soft and Complex Soft coils. It consists of coils that come in Standard, Soft and Super Soft profiles and allows for instant detachment from the pusher. The APPLY study is a prospective, single-center investigator-initiated study meant to assess the use of the Balt Optimaâ„¢ Coil System. The site is looking to enroll approximately 30 subjects over the course of two years. The Optima Coil Systemâ„¢ is commercially available in the United States as such this study is looking for real-world data.
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Occlusion Rates
Timeframe: 12 Months
Mortality
Timeframe: 12 Months