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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Endologix Inc | NASDAQ:ELGX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.22 | 0.2344 | 0.24 | 0 | 01:00:00 |
ENDOLOGIX, INC.
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(Exact name of registrant as specified in its charter)
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Delaware
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000-28440
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68-0328265
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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2 Musick, Irvine, CA
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92618
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(Address of principal executive offices)
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(Zip Code)
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Registrant's telephone number, including area code: (949) 595-7200
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N/A
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(Former name or former address, if changed since last report)
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¬
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¬
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¬
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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¬
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, $0.001 par value
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ELGX
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The Nasdaq Stock Market, LLC
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•
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The Safety Update does not constitute a recall or correction to the AFX Endovascular Stent Graft System (“AFX System”), including the Company’s AFX2 system (which is the Company’s current commercial AFX endograft system in the United States).
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•
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The Company does not believe that the data from Rothenberg et al. regarding the AFX2 system, has an adequate sample size or contains sufficient detail to draw clinically meaningful conclusions. The data presented included only 13 patients with 2-year follow-up, no details of aortic anatomy and no breakdown of endoleak sub-classification.
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•
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The safety and efficacy of the Company’s AFX2 system are supported by multiple data sets, including the LEOPARD trial (the only randomized controlled trial of EVAR providing the highest level evidence on AFX Duraply and AFX2 systems), real-world data from a vascular registry, the Company’s benchmarked complaint data, and meta-analyses of current literature.
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•
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Through the prospective analysis of over 60,000 patients implanted with the AFX System, the Company is confident that (i) its AFX2 system currently achieves patient outcomes equivalent to other contemporary commercialized endografts, when assessed holistically, and (ii) changes to the manufacturing process for the AFX2 system, along with updates to the AFX2 Instructions for Use (IFU), are associated with a reduction in the occurrence of Type III endoleaks when compared with AFX Strata.
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Exhibit
Number
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Description
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Endologix Response Regarding FDA Safety Communication: AFX Endovascular AAA System.
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ENDOLOGIX, INC.
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Date: October 31, 2019
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/s/ Vaseem Mahboob
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Vaseem Mahboob
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Chief Financial Officer
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1 Year Endologix Chart |
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