Endologix has received FDA approval for its AFX Endovascular AAA System for the treatment of abdominal aortic aneurysms. It uses a low profile, precise delivery system and proprietary stent graft material (STRATA).
Key features, from the press release:
- Low profile 17Fr introducer sheath — The entire family of AFX stent grafts, which range in diameter from 13 to 34 millimeters, are delivered through a low profile, hydrophilically-coated 17Fr introducer sheath — obviating the need for exchanges. Notably, this sheath technology, combined with the System’s percutaneous (9Fr) contralateral access, makes AFX the lowest profile device approved in the U.S. for the treatment of the most common AAAs — those with aortic neck diameters of 22 millimeters or larger.
- Precise delivery and deployment — The AFX delivery system features an ergonomic dial mechanism that provides physicians with precise, controlled stent graft positioning and deployment. These features were designed with significant input from endovascular specialists globally.
- STRATA expanded polytetrafluoroethylene (ePTFE) graft — AFX stent grafts are constructed using Endologix’s proprietary new STRATA graft material. STRATA is a durable, highly conformable material featuring enhanced stent graft sealing technology.
Press release: Endologix Announces FDA Approval of AFX™ Endovascular AAA System…
Company homepage: Endologix…