Endologix has received investigational device exemption (IDE) approval from FDA for a new pivotal study to evaluate the safety and effectiveness of the Nellix Chimney Endovascular Aneurysm Sealing System for the endovascular treatment of complex abdominal aortic aneurysms (AAA).
The 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 juxta-renal, para-renal, and suprarenal AAA. The application of endovascular aneurysm sealing for patients with complex aneurysms will offer innovative new technology to a group of patients that are underserved by the current standard of care, the Irvine, CA-based company said.
The pivotal study will recruit 120 patients with complex AAA in up to 50 centers, both in the United States and outside the United States. Enrollment is expected to begin early next year.
"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," said CEO John Onopchenko.
Boston Scientific to Distribute Endologix Products in China
Also on Friday, Endologix disclosed an agreement naming Boston Scientific the exclusive distributor of Endologix products in China beginning with AFX2, but eventually including all of the products in the company's EVAR and EVAS portfolio.
China represents a roughly 200 million end-user market opportunity for EVAR and EVAS, Onopchenko said during the company's second-quarter earnings call.
"Our teams will work closely together in order to establish a strong EVAR and EVAS brand identity in China leveraging Boston’s scale, established distribution network in the region, and proven track record of success in the vascular space," Onopchenko said. "We also view this as a validation of our technology and our ability to draw the market to us by way of our focus on outcomes data."
Onopchenko said Endologix is currently working through the regulatory process in China.
"Complexity in our business is a function of both products and markets and sometimes we need to make decisions that simplify the business in order to position us better for the long term," he said. "An example of a market-based choice we recently made is exiting South Korea where the likelihood of profitability was low and primarily driven by reimbursement. Over the past 12 months, we have shown that we are taking a disciplined and strategic approach to our portfolio and to the geographic areas that we serve in order to improve execution and profitability."
The company has had a series of setbacks over the past two years but appears to be moving in the right direction.
In June the company's CE mark for the Nellix system was reinstated, allowing the device to return to the European market. In January, Endologix initiated a voluntary recall of the existing inventory of its Nellix endovascular aneurysm sealing system. The company decided to limit the device to use under clinical protocol with pre-screened patients that adhere to the current indications. The company's CE mark for the Nellix system was subsequently suspended. Endologix said the reinstatement followed an assessment of clinical evidence.