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Aptus Endosystems gets FDA approval for EndoStapling System.

M2 PHARMA-November 22, 2011-Aptus Endosystems gets FDA approval for EndoStapling System(C)2011 M2 COMMUNICATIONS

22 November 2011 - US medical device firm Aptus Endosystems Inc said on Monday it had received 510(k) approval from the US Food and Drug Administration (FDA) for its Aptus EndoStapling System, which will now be known as the HeliFX Aortic Securement System.

The new helical anchor technology allows physicians to perform minimally invasive endovascular aneurysm repair (EVAR) while still providing the control and potential long term durability of an open surgical repair, the company said.

The HeliFX System provides for independent endograft fixation and is designed to mimic the hand suturing performed during open surgical repair of abdominal aortic aneurysm (AAA), a life-threatening condition if left untreated affecting an estimated 1.5m Americans.

The technology enables physicians to repair endovascular grafts that have migrated away from the implant site, have developed or are at risk of developing endoleaks, which are commonly seen after EVAR. In such cases, augmented fixation and/or sealing is needed to regain or maintain effective aneurysm exclusion. The system is also applicable during initial EVAR procedures to enhance an endograft's inherent fixation and sealing mechanisms.

The HeliFX system received CE mark for use in the EU in May 2011. The US approval allows HeliFX to be used with Cook's Zenith, Gore's Excluder, and Medtronic's AneuRx, Endurant and Talent endografts in both initial implant and secondary repair settings. Use with other endografts has not been assessed to date.

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Publication:M2 Pharma
Date:Nov 22, 2011
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