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GMED Reinstates CE Mark for Endologix Nellix System

The certification was suspended in January in connection with the company's voluntary recall of the device over concerns of suboptimal results when the system was used outside of its current instructions. Since then, the product was restricted to pre-screened patients who were consistent with its indications.

The company has had a series of setbacks over the past two years but appears to be moving in the right direction.

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Endologix reported a huge regulatory win this week.

The Irvine, CA-based company said its CE mark for the Nellix EndoVascular Aneurysm Sealing System has been 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.

“We continue to believe that the Nellix system has the potential to transform the treatment of patients with infra-renal abdominal aortic aneurysms,” said Matt Thompson, MD, chief medical officer at Endologix. “This therapy continues to generate positive results when used in patients that conform to the anatomical indications for use. We are delighted that the available data supports the reinstatement of our CE mark, and we look forward to utilizing this technology to improve the patient experience and drive better outcomes.”

The company said the Nellix will be available at approved centers in a post-market clinical investigational setting outside the United States. The device is not yet approved for the U.S. market, but the company said it is being investigated as part of the EVAS2 study. MD+DI previously reported that enrollment in the EVAS2 study is expected to wrap up during the third quarter of this year.

Endologix said it does not expect this reinstatement to impact its previously communicated financial guidance for 2019.

The company has had a series of setbacks over the past two years but appears to be moving in the right direction.

"We are shifting from a defensive position to an offensive position," CEO John Onopchenko said during the company's fourth-quarter earnings call in late February.

Endologix reported sequential sales growth of its Ovation system in the fourth quarter, which management said gives them confidence that the platform will return Endologix to growth in the second half of 2019.

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