Endologix touts 1st Ovation Alto stent graft implantations

Endologix (NSDQ:ELGX) last week announced that its Ovation Alto abdominal stent graft system has been used in its 1st 2 procedures to treat abdominal aortic anneurysms.

The procedures were performed at New Zealand’s Auckland City Hospital by Dr. Andrew Holden and Dr. Andrew Hill, the Irvine, Calif.-based company said.

“The 1st patients treated with the Ovation Alto system is a significant milestone for our new product strategy. It further enhances our leadership position in the development of unique sealing technologies for the treatment of AAA and broadens our product portfolio to address a wide range of anatomies, including the underserved complex AAA market. We would like to thank Dr. Holden and Dr. Hill for their collaboration in the first patients treated with the Ovation Alto system,” Endologix prez Bob Mitchell said in a press release.

The Ovation Alto device “expands EVAR to include the treatment of patients with complex AAAs,” the company said, specifically targeted towards patients with very short or otherwise challenging arotic neck anatomy.

“The Ovation Alto system has the potential to increase the number of AAA patients treated with EVAR due to its unique sealing technology and ultra-low profile design. The new system is designed to provide the broadest indications of all infrarenal EVAR devices, which represents an important advancement for physicians and their AAA patients,” Dr. Hill said in prepared remarks.

Endologix’s Ovation Alto is currently an investigational device that is not approved on any market, with a slated introduction into the E.U. in 2017 and the U.S. in 2018.

“The repositioned sealing ring in the Ovation Alto system expands the EVAR treatment of AAA patients to include short and challenging aortic necks, which represents a significant segment of the underserved complex AAA market. We are pleased to be the 1st center in the world to implant Ovation Alto and look forward to treating more patients and sharing our experience with the clinical community,” Dr. Holden said in a prepared statement.

In April, Endologix released 2nd quarter earnings and updated on its discussions with the FDA over its Nellix system for treating abdominal aortic aneurysms, saying the agency is requesting additional information and may need an Advisory Committee Panel before it can obtain approval.

The company said that without a required panel, it is hopeful it will receive premarket approval from the FDA for the device in the 1st quarter of 2017. With a required panel, the company expects approval some time in the 3rd quarter of 2017.

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