Xinetix took this product from concept feasibility model to commercial ready design in fourteen months.
Initially tasked with software validation of an early-stage concept breadboard, Xinetix performed validation testing to obtain IRB approval for early international clinical investigations. Following verification of efficacy, Xinetix was engaged to develop a clinical prototype for use in US clinical trials.
The Aegea Polaris Steam Ablation System was developed by Xinetix under EN13485 compliant design controls in just under 14 months. Based upon knowledge gained in early clinicals, Xinetix met and exceeded clinical unit design requirements, producing a commercial ready system design.
Xinetix then manufactured initial pilot production units while at the same time developing manufacturing processes. The Polaris design and process documentation were eventually transferred to a third party contract manufacturer for production scale up. Successful US clinical trials resulted in Aegea receiving FDA clearance to market in November 2017.
To view the procedure go here: https://maratreatment.com/physicians/how-mara-works/
