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Home » Endologix wins CE Mark for Alto abdominal stent graft system

Endologix wins CE Mark for Alto abdominal stent graft system

August 7, 2020 By Danielle Kirsh

EndologixEndologix (NSDQ:ELGX) this week said it received CE mark approval for its Alto Abdominal Stent Graft System.

“We are very excited to receive a CE Mark for the Alto system, that has been achieved through a strong partnership and collaboration with our European notified body, NSAI,” chief medical officer Matt Thompson said in a news release.

The Alto Abdominal Stent Graft System is an Ovation system for polymer endovascular aneurysm repair. It first received FDA approval in March this year.

“Alto offers a highly differentiated endovascular treatment option to AAA patients and includes design features that we believe will enhance ease-of-use, improve acute outcomes and preserve the long-term durability associated with patient-specific anatomically adaptive sealing,” CEO John Onopchenko said.

“We believe Alto, with its ultra-low profile and 7 mm aortic neck length indication, will provide patients and physicians with an endograft capable of treating the highest proportion of patients within the indications for use of the device,” Onopchenko said in a news release. “As we continue with the global roll-out of the Alto system, which has commenced in the U.S., Endologix is committed to investing in the highest levels of clinical evidence by initiating a head-to-head randomized controlled trial versus traditional undifferentiated EVAR grafts, with the intent of proving the superiority of Alto.”

Filed Under: Regulatory/Compliance Tagged With: Endologix

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About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at [email protected].

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