Endologix has announced the first commercial implant and the US commercial release of its recently US Food and Drug Administration (FDA)-approved Alto endograft for the treatment of abdominal aortic aneurysms (AAA).
“Alto represents a differentiation from traditional endovascular aneurysm repair (EVAR) and, with its introduction, a significant landmark for Endologix. With its unique anatomically adaptive sealing technology, Alto offers patients improved acute outcomes and the ability to preserve long-term durability. The Alto launch, enabled by our world-class field team and supported by treating physicians committed to ensuring the best outcomes for each of their patients, will transform the treatment of aortic disorders,” commented John Onopchenko, chief executive officer of Endologix.
He continued: “We are steadfast in our belief that our products, pipeline and plan of clinical investigation will realise meaningful, life-long benefits for patients and establish a new, higher standard of aortic care. With our recent announcement of the agreement to take Endologix private, we anticipate having access to new financing and are poised to execute on our mission and reach our full potential.”
According to a press release, Alto offers a workhorse endograft with broad indications to treat the widest range of patients. Alto’s unique, anatomically adaptive sealing technology and 7mm neck indication is designed to ensure a precise seal near the renal arteries for every case. In addition, the Alto design enables a very low profile (15Fr OD) for treating patients with small vessels and challenging access, and has an integrated balloon for convenience in optimising the seal during the procedure. The core anatomically adaptive sealing technology, which has been studied in nearly 1,300 patients in the ENCORE database, demonstrates favourable midterm durability evidenced by successful aneurysm exclusion and five-year freedom from aneurysm-related mortality.
“This new endograft, as seen in the ELEVATE IDE trial, has allowed us to treat patients on label with short necks and challenging access without adjunctive devices or access routes,” said Sean Lyden, chairman of the Department of Vascular Surgery, Cleveland Clinic (Cleveland, USA), National Primary Investigator for the ELEVATE IDE trial, for which he was compensated by Endologix for that role. Lyden, who performed the first commercial implant of the Alto endograft, also said, “A device with a polymer sealing ring at 7 mm has expanded the number of patients that can be offered minimally invasive endovascular repair that are not treatable with other commercial infrarenal fixation devices.”
The Alto endograft builds and improves upon the anatomically adaptive sealing technology, which has been studied in over 1,300 patients in ENCORE and ELEVATE.
“Alto is differentiated from traditional devices for EVAR through the use of a conformable liquid polymer. This technology offers many advantages, including its low-profile graft design with a durable, customised, anatomically adaptive aortic seal,” said Matt Thompson, chief medical officer at Endologix. “In addition to being a workhorse device, Alto may offer incremental advantages, particularly in specific patient cohorts, such as women, patients with challenging access, patients needing fast-track EVAR and patients with poor predicted durability using traditional EVAR grafts.”
In speaking about Endologix’s portfolio and clinical pipeline, Thompson added, “Endologix offers the most differentiated portfolio of AAA endovascular technologies available. The introduction of Alto is a critical landmark for Endologix and the next step in our journey to address the current unmet needs of EVAR, which also includes a randomised control trial for Alto and pivotal trials (EVAS2 and ChEVAS ONE) for breakthrough therapies.”
The first commercial implant marks the official start of the US release of the Alto abdominal stent graft system. The commercial release of Alto will be supported by a world-class team of sales representatives and clinical specialists at Endologix, all focused on the collective objective of improving the health and lives of patients with aortic disorders through a steadfast commitment to delivering innovative and trusted EVAR solutions.