Endologix has announced the investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence a new pivotal study to evaluate the safety and effectiveness of the Nellix Chimney EndoVascular Aneurysm Sealing System (chEVAS) for the endovascular treatment of complex abdominal aortic aneurysms (AAA). The company also announced an exclusive distributor agreement with Boston Scientific, to distribute Endologix products in China.
ChEVAS IDE trial
The chEVAS system is an endovascular abdominal aortic aneurysm therapy designed to combine the Nellix 3.5 endograft with parallel visceral stents to enable treatment of patients with juxtarenal, pararenal, and suprarenal AAA. The application of endovascular aneurysm sealing (EVAS) for patients with complex aneurysms will offer innovative new technology to a group of patients that are underserved by the current standard of care.
John Onopchenko, Chief Executive Officer for Endologix, commented, “We are pleased to receive IDE approval from the FDA to begin this study, which will recruit 120 patients with complex AAA in up to 50 centres, both in the USA and internationally. This approval marks another step forward on our path to re-establishing durable, predictable growth through a continued focus on execution and evidence-driven differentiation.”
Distribution in China
An agreement announced by Endologix names the Boston Scientific Corporation as the exclusive distributor for Endologix products in China. The long-term agreement includes distribution rights to Endologix’ current endovascular aneurysm repair (EVAR) and endovascular aneurysm sealing (EVAS) products, as well as the right of first negotiation for future product offerings.
“We are excited to partner with Boston Scientific to bring next-generation abdominal aortic aneurysm solutions to patients in China,” says Onopchenko. “China is one of the largest and fastest-growing EVAR markets in the world, representing an exciting market opportunity. We look forward to building our brand in this important market by leveraging the Boston Scientific team’s extensive experience introducing new products for patients suffering from vascular disease.”
As part of the agreement, Boston Scientific plans to invest in building a dedicated sales team to commercialise the Endologix products and drive adoption. Additionally, Endologix will provide commercial and clinical support and training to the Boston Scientific team, with the goal of ensuring that the best possible clinical outcomes are realised. Boston Scientific expects to begin selling these products upon local regulatory approval and subsequent commercial launch of the first product, anticipated in 2021.
The current portfolio of Endologix products includes the Ovation iX Abdominal Stent Graft and the AFX2 Endovascular Abdominal Aortic Aneurysm System, both of which are minimally-invasive solutions to repair aortic aneurysms and have received US FDA clearance and CE mark.