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August 5, 2020

Endologix Receives CE Mark for Alto Abdominal Stent Graft System

August 5, 2020—Endologix Inc. announced that the company’s Alto abdominal stent graft system has received CE Mark approval in the European Union (EU) for endovascular aneurysm repair (EVAR) in abdominal aortic aneurysms (AAAs).

On March 16, Endologix announced FDA approval of the Alto abdominal stent graft system. The United States commercial launch of the device was announced on July 30.

“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,” commented Matt Thompson, Chief Medical Officer of Endologix, in the company press release. “Alto will provide our physician partners and patients in the EU with a differentiated low-profile endovascular treatment option designed to improve durability over traditional EVAR. In addition, with Alto, we anticipate observing improved short-term outcomes relative to the Ovation iX abdominal stent graft system as a result of the design and manufacturing changes incorporated into Alto. Lastly, CE Mark of the Alto system is yet another critical milestone for Endologix as we seek to introduce a portfolio of devices to address the current unmet needs of EVAR.”

Also in the company’s announcement, Chief Executive Officer John Onopchenko stated, “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. 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.

“As we continue with the global rollout of the Alto system, which has commenced in the United States, 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.”

Endologix recently announced it has initiated a reorganization plan to become a private company.

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