ENDOLOGIX, INC. (NASDAQ:ELGX) Files An 8-K Other EventsItem 8.01 Other Events.
On December 13, 2016, Endologix, Inc. (the “Company”) announced that it received notice from its Notified Body in the European Union (the “Notified Body”) that the Company would be receiving a suspension of the CE Mark for the AFX® system (“AFX”) within a few days. The suspension by the Notified Body is due to reports of Type III endoleaks with a prior generation of the device. The Company has, for its current generation of AFX products, implemented device and graft material improvements and updated instructions for use resulting in a substantial reduction in reported Type III endoleaks. In addition, no reports of Type III endoleaks have been reported with the Company’s AFX2 system (“AFX2”). The Company intends to provide documentation of the foregoing reduction in Type III endoleaks to the Notified Body and anticipates the CE Mark for AFX and AFX2 to be re-instated in January 2017. The Company also intends to share this information and additional background on the improvements to AFX and AFX2 in an upcoming letter to physicians in January 2017.
During the suspension, the Company’s Nellix® EndoVascular Aneurysm Sealing System and Ovation® System are available to physicians in Europe. AFX and AFX2 systems that were shipped to customers prior to the effectiveness of the suspension can still be implanted and are expected to provide excellent clinical outcomes. AFX and AFX2 continue to be available in the United States, Japan, and other international markets.
Cautionary Note Regarding Forward-Looking Statements
This report contains statements that may be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to the anticipated re-entry of AFX and AFX2 into the European Union, the accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and some of which are beyond the control of the Company. Many factors may cause actual results to differ materially from anticipated results, including uncertainty in the substance and timing of the Notified Body’s actions, and competitive pressures. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. The Company undertakes no obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, and the Company’s subsequent filings with the Securities and Exchange Commission, for more detailed information regarding these risks and other factors that may cause actual results to differ materially from those expressed or implied
About ENDOLOGIX, INC. (NASDAQ:ELGX)
Endologix, Inc. is engaged in developing, manufacturing, marketing and selling medical devices for the treatment of aortic disorders. The Company’s products are intended for the treatment of abdominal aortic aneurysms (AAA). The AAA products are built on one of two platforms, including traditional minimally invasive endovascular repair (EVAR) or endovascular sealing (EVAS), its solution for sealing the aneurysm sac while maintaining blood flow through two blood flow lumens. The EVAR products include the Endologix AFX Endovascular AAA System (AFX), the VELA Proximal Endograft (VELA) and the Endologix Powerlink with Intuitrak Delivery System (Intuitrak). The EVAS product is the Nellix EndoVascular Aneurysm Sealing System (Nellix EVAS System). Its EVAS product is the Nellix EndoVascular Aneurysm Sealing System (Nellix EVAS System). It offers accessories to facilitate the optimal delivery of its EVAR products, including compatible guidewires, snares, and catheter introducer sheaths. ENDOLOGIX, INC. (NASDAQ:ELGX) Recent Trading Information
ENDOLOGIX, INC. (NASDAQ:ELGX) closed its last trading session up +0.09 at 6.58 with 8,013,733 shares trading hands.