Endologix Nellix Endovascular Graft for Abdominal Aortic Aneurysms

Endologix Nellix Endovascular Graft for Abdominal Aortic Aneurysms

IRVINE, Calif., Sept. 6, 2012 (GLOBE NEWSWIRE) — Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today achievement of the CE (Conformite Europeenne) Mark of the current version of the Nellix® EndoVascular Aneurysm Sealing System for the treatment of patients with abdominal aortic aneurysms (“AAA”). Nellix is an innovative new endovascular aneurysm sealing (“EVAS”) system designed to simplify endovascular procedures, treat a broader range of patients, and provide enhanced clinical outcomes. The Nellix System is not approved in the United States for either investigational use or commercial sale.

Endologix is currently implementing a few enhancements to the Nellix System intended to further optimize the device for commercialization. When complete, the Company will submit these enhancements to its Notified Body, with expectations of gaining CE Mark approval for the commercial version of the device and beginning a limited market introduction of the enhanced system in Europe by the end of the second quarter 2013.

John McDermott, President and Chief Executive Officer, said, “Nellix has the potential to treat more AAA patients and get better clinical outcomes than any other device for the endovascular repair of AAA. Receiving CE Mark for the current version of the system is an important regulatory milestone and we look forward to providing this ground-breaking technology to physicians and their patients in 2013.”

About Endologix, Inc.

Endologix, Inc. (the “Company”) develops and manufactures minimally invasive treatments for aortic disorders. The Company’s focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 75%, making it a leading cause of death in the U.S. Additional information can be found on Endologix’s Web site at www.endologix.com.

Forward-Looking Statements

Except for historical information contained herein, this news release contains forward-looking statements relating to enhancements to, further CE Mark receipt, and the commercial launch and clinical acceptance to the Nellix System, the accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix. Many factors may cause actual results to differ materially from anticipated results, including delays in, product research and development efforts, regulatory submissions and approvals and other economic, business, competitive and regulatory factors. The Company undertakes no obligation to update its forward looking statements. Please refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2011, and the Company’s other 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.

IRVINE, Calif., Sept. 6, 2012 (GLOBE NEWSWIRE) — Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today achievement of the CE (Conformite Europeenne) Mark of the current version of the Nellix® EndoVascular Aneurysm Sealing System for the treatment of patients with abdominal aortic aneurysms (“AAA”). Nellix is an innovative new endovascular aneurysm sealing (“EVAS”) system designed to simplify endovascular procedures, treat a broader range of patients, and provide enhanced clinical outcomes. The Nellix System is not approved in the United States for either investigational use or commercial sale.

Endologix is currently implementing a few enhancements to the Nellix System intended to further optimize the device for commercialization. When complete, the Company will submit these enhancements to its Notified Body, with expectations of gaining CE Mark approval for the commercial version of the device and beginning a limited market introduction of the enhanced system in Europe by the end of the second quarter 2013.

John McDermott, President and Chief Executive Officer, said, “Nellix has the potential to treat more AAA patients and get better clinical outcomes than any other device for the endovascular repair of AAA. Receiving CE Mark for the current version of the system is an important regulatory milestone and we look forward to providing this ground-breaking technology to physicians and their patients in 2013.”

About Endologix, Inc.

Endologix, Inc. (the “Company”) develops and manufactures minimally invasive treatments for aortic disorders. The Company’s focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 75%, making it a leading cause of death in the U.S. Additional information can be found on Endologix’s Web site at www.endologix.com.

Forward-Looking Statements

Except for historical information contained herein, this news release contains forward-looking statements relating to enhancements to, further CE Mark receipt, and the commercial launch and clinical acceptance to the Nellix System, the accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix. Many factors may cause actual results to differ materially from anticipated results, including delays in, product research and development efforts, regulatory submissions and approvals and other economic, business, competitive and regulatory factors. The Company undertakes no obligation to update its forward looking statements. Please refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2011, and the Company’s other 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.

Endologix (Irvine, CA) has announced that European regulators gave the go-ahead to launch the Nellix EndoVascular Aneurysm Sealing System on the continent. It is designed to virtually seal the aortic aneurysm sac to relieve any pressure on the fragile artery as blood bypasses through the device.

Though the company is glad of the current approval, it plans on submitting application for a slightly improved version of the Nellix with the hope of making it available to physicians in Europe in the 2nd quarter of next year.

Here are the requirements that were used to select patients for clinical trials of the Nellix:

Non-aneurysmal aortic neck length of ? 5mm

Non-aneurysmal aortic neck diameter of 16 to 36mm

Maximum aortic blood flow lumen diameter of ? 60mm

Common iliac artery diameter of 8 to 35mm

Some details on the clinical trials performed using the Nellix from the product page:

In initial clinical trial experience involving 34 patients outside of the United States (Krievins DK, et al., EVAR using the Nellix Sac-anchoring Endoprosthesis: Treatment of Favourable and Adverse Anatomy, EUR J Vasc Endovasc Surg (2011), doi: 10.1016/j.ejvs.2011.03.007), 100% implant success was observed. To two year follow-up, no aneurysm rupture, conversion to open surgery or stent graft migration has been observed. One secondary procedure for distal Type I endoleak has been performed (2.9% of patients). Physician feedback has been positive, particularly as it relates to ease of use and versatility to treat both standard and more challenging aneurysm anatomies.

Source : http://investor.endologix.com/releasedetail.cfm?ReleaseID=704983

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