Navigation Links
Endologix Receives IDE Approval for Fully Percutaneous Approach to EVAR
Date:11/18/2009

IRVINE, Calif., Nov. 18 /PRNewswire-FirstCall/ -- Endologix, Inc. (Nasdaq: ELGX), developer of minimally invasive treatments for aortic disorders, announced today that it has received Investigational Device Exemption (IDE) conditional approval from the United States Food and Drug Administration ("FDA") to begin a prospective, multicenter, randomized clinical trial for a bilateral percutaneous approach to endovascular abdominal aortic aneurysm repair (EVAR) utilizing the Company's IntuiTrak(TM) endovascular delivery system for the Powerlink® family of stent grafts.

Standard EVAR procedures require an open surgical cut-down of one or both femoral arteries for delivery system access and device deployment. Percutaneous EVAR (PEVAR) procedures do not require an open surgical cut-down of either femoral artery, as access to the femoral artery is achieved via a percutaneous ("across the skin") approach. There are currently no medical devices approved by the FDA, or in pivotal clinical trials, for a percutaneous EVAR indication. The Company plans to initiate this first pivotal clinical trial for percutaneous EVAR in the first quarter of 2010. Based on the trial results, Endologix intends to submit a future PMA supplement for a broadened indication for the IntuiTrak endovascular delivery system to include PEVAR in suitable patients and will initiate widespread physician training programs on this technique.

John McDermott, Endologix President and Chief Executive Officer, said, "The approval for our percutaneous EVAR pivotal clinical trial further demonstrates Endologix's commitment to become the innovation leader in the repair of abdominal aortic aneurysms. The unique attributes of our products, including the ease-of-use and low-profile design of the IntuiTrak endovascular system, makes the percutaneous approach possible. In addition, our Powerlink System is the only endovascular stent graft that utilizes anatomical fixation, which has been shown in clinical trials to yield exceptional long-term patient outcomes."

The trial will utilize a "pre-close" technique facilitated by the Prostar® XL Percutaneous Vascular Surgical System or Perclose ProGlide® Suture-Mediated Closure System, both made by Abbott. Up to 20 U.S. clinical sites will enroll 150 patients in the randomized trial. One hundred patients will undergo PEVAR with closure facilitated by either the Prostar XL or Perclose ProGlide device, and 50 patients will undergo standard surgical cut-down EVAR. All patients will be treated with the IntuiTrak endovascular delivery system.

About Endologix, Inc.

Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Company's flagship product is the Powerlink® System, which is an endovascular stent graft 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. 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, specifically with respect to the initiation and timing of clinical trials, and the possible outcomes there from. Please refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2008, and the Company's other filings with the Securities and Exchange Commission, for more detailed information regarding regulatory and clinical risks and other factors that may cause actual results to differ materially from those expressed or implied.


    COMPANY CONTACT:                           INVESTOR CONTACTS:
    ----------------                           ------------------
    Endologix, Inc.                            The Ruth Group
    John McDermott, CEO                        Nick Laudico (646) 536-7030
    (949) 595-7200                             Zack Kubow   (646) 536-7020
    www.endologix.com

SOURCE Endologix, Inc.


'/>"/>
SOURCE Endologix, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Endologix to Present at Three Upcoming Conferences
2. Endologix Announces Pricing of Public Offering of Common Stock
3. Endologix Reports 42% Second Quarter 2009 Revenue Growth
4. Endologix to Report Second Quarter 2009 Financial Results on July 22, 2009
5. Endologix Added to Russell Indexes
6. Endologix Announces Live Web Cast of Presentation in SMH Capital Small Cap Spotlight on June 17, 2009 at 4:15 p.m. ET
7. Endologix Receives Nasdaq Letter on Director Independence
8. Endologix Announces Full Commercial Launch of IntuiTrak Express Delivery System
9. SHPS Receives Re-Accreditation from URAC for Consumer Education and Support Program
10. Guided Care receives Award for Innovation in Practice Improvement
11. Mississippi Baptist Medical Center Receives American College of Cardiology Foundation's NCDR ACTION Registry-GWTGTM Gold Performance Achievement Award
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... Park, KS (PRWEB) , ... February 08, 2016 , ... ... a leader in Mole removal products. , Moles are derived from a cluster of ... appear in all the wrong places and create a lifetime of embarrassment. Historically, ...
(Date:2/8/2016)... ... , ... Guruji Mahendra Kumar Trivedi is offering 3 days of accelerated personal ... birthday on February 10th. During this time, people can achieve better health, greater ... people from over 40 different countries as an “ordinary man with an extraordinary gift.” ...
(Date:2/8/2016)... ... ... According to research by the National Association of Dental ... certified or obtain continuing education. To increase patient awareness of the lack of ... to inform dentists and patients about the possible lack of skills and knowledge ...
(Date:2/7/2016)... (PRWEB) , ... February 07, 2016 , ... Women's Excellence ... National Wear Red Day. National Wear Red Day is the first Friday each ... Heart disease and stroke cause 1 in 3 deaths among women each year – ...
(Date:2/7/2016)... AZ (PRWEB) , ... February 07, 2016 , ... ... Neck and Facial Plastics, has added Kybella® to his medical and surgical expertise. ... a newly approved FDA injectable medication used as a non-surgical alternative for reduction ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... India , February 8, 2016 ... a new market research report "Ablation Technologies Market by ... (Csardiovascular, Cancer, Pain Management, Cosmetic Surgery, Ophthalmology, Gynecology) - ... studies the global market over the forecast period of ... $4.44 Billion by 2020, at CAGR of 10.5% from ...
(Date:2/8/2016)... Kan. , Feb. 8, 2016 /PRNewswire/ ... organization that formerly specialized in the development ... recently announced that it has divided its ... Capital. While Nueterra Capital will continue the ... services, NueHealth will operate a national system ...
(Date:2/8/2016)... , Feb. 8, 2016  A research team ... scientists has discovered details of how the abnormal breakage ... a particularly aggressive form of acute lymphoblastic leukemia (ALL). ... which genetic mutations trigger overproduction of immature cells, called ... The discoveries of the malfunction underlying the type called ...
Breaking Medicine Technology: