Michael Barbella, Managing Editor11.30.22
Endologix LLC is touting promising results from its ELEVATE (Expanding Patient Applicability with Polymer Sealing Ovation ALTO Stent Graft) IDE Study, which reports the clinical outcomes of the ALTO Abdominal Stent Graft System.
The ELEVATE study enrolled 75 patients between March 2017 and February 2018 in 16 U.S. centers. The trial included patients with infrarenal abdominal aortic aneurysms (AAA) with neck diameters of 16-30mm at 7mm below the lowest renal artery. Patients were followed for 30 days, six months, and one year by clinical evaluation, computed tomography, and abdominal X-ray imaging. The study concluded that the Endologix ALTO stent graft is safe and effective in treating AAA with appropriate anatomy at one year. The results presented included:
“The publication of results of the ELEVATE Study represent a foundational block of the evidence that we are building for our ALTO product line” Endologix President/CEO Matt Thompson said. “To further expand this evidence base, we have recently begun enrolling patients in the JAGUAR randomized controlled trial, which is a randomized comparative study examining the hypothesis that the ALTO endograft will have superior durability to competitive endografts secondary to a significant reduction in post-EVAR aortic neck dilatation. We believe that ALTO plays a significant role in the management of AAA based on its durability, low-profile, and broadest patient applicability within EVAR.”
Featuring a unique, patented, sealing technology, the ALTO Abdominal Stent Graft System is the latest generation of innovative therapies for AAA patients. ALTO utilizes a low-profile delivery system and, unlike standard EVAR devices, features an exclusive Adaptive Sealing Technology that molds in-situ to the patient’s specific aortic neck anatomy.
Endologix LLC is a global medical device company that develops therapies for the interventional treatment of vascular disease. Endologix’s therapeutic portfolio includes products in various stages of development that are designed to treat diseases with clinically relevant unmet needs. These products are designed to treat a wide spectrum of vascular disease from abdominal aortic aneurysms to lower limb peripheral vascular disease. Endologix’s current commercial EVAR products include the AFX 2 Endovascular AAA System and the ALTO Abdominal Stent Graft System. On Oct. 1, 2020, Endologix became a private company, wholly owned by Deerfield Management, an investment management firm committed to advancing healthcare through investment, information, and philanthropy. In April 2021, Endologix completed the acquisition of PQ Bypass Inc., a privately held medical technology, adding the DETOUR System and TORUS Stent Graft to its product pipeline. The DETOUR System and the TORUS Stent Graft have not been approved for sale by any regulatory body. The DETOUR System is an investigational device, limited by United States law to investigational use. Endologix has offices and manufacturing sites in Irvine and Santa Rosa, Calif.
Reference
Sean P. Lyden, D. Christopher Metzger, Steve Henao, Sonya Noor, Andrew Barleben, John P. Henretta, Levester Kirksey, One-year safety and effectiveness of the Alto abdominal stent graft in the ELEVATE IDE trial, Journal of Vascular Surgery, (2022), ISSN 0741-5214.
The ELEVATE study enrolled 75 patients between March 2017 and February 2018 in 16 U.S. centers. The trial included patients with infrarenal abdominal aortic aneurysms (AAA) with neck diameters of 16-30mm at 7mm below the lowest renal artery. Patients were followed for 30 days, six months, and one year by clinical evaluation, computed tomography, and abdominal X-ray imaging. The study concluded that the Endologix ALTO stent graft is safe and effective in treating AAA with appropriate anatomy at one year. The results presented included:
- A 96.7% treatment success rate at 12 months
- A 4% all-cause mortality at 12 months; no AAA-related mortality occurred
- A 5.3% major adverse event rate at 30 days
“The publication of results of the ELEVATE Study represent a foundational block of the evidence that we are building for our ALTO product line” Endologix President/CEO Matt Thompson said. “To further expand this evidence base, we have recently begun enrolling patients in the JAGUAR randomized controlled trial, which is a randomized comparative study examining the hypothesis that the ALTO endograft will have superior durability to competitive endografts secondary to a significant reduction in post-EVAR aortic neck dilatation. We believe that ALTO plays a significant role in the management of AAA based on its durability, low-profile, and broadest patient applicability within EVAR.”
Featuring a unique, patented, sealing technology, the ALTO Abdominal Stent Graft System is the latest generation of innovative therapies for AAA patients. ALTO utilizes a low-profile delivery system and, unlike standard EVAR devices, features an exclusive Adaptive Sealing Technology that molds in-situ to the patient’s specific aortic neck anatomy.
Endologix LLC is a global medical device company that develops therapies for the interventional treatment of vascular disease. Endologix’s therapeutic portfolio includes products in various stages of development that are designed to treat diseases with clinically relevant unmet needs. These products are designed to treat a wide spectrum of vascular disease from abdominal aortic aneurysms to lower limb peripheral vascular disease. Endologix’s current commercial EVAR products include the AFX 2 Endovascular AAA System and the ALTO Abdominal Stent Graft System. On Oct. 1, 2020, Endologix became a private company, wholly owned by Deerfield Management, an investment management firm committed to advancing healthcare through investment, information, and philanthropy. In April 2021, Endologix completed the acquisition of PQ Bypass Inc., a privately held medical technology, adding the DETOUR System and TORUS Stent Graft to its product pipeline. The DETOUR System and the TORUS Stent Graft have not been approved for sale by any regulatory body. The DETOUR System is an investigational device, limited by United States law to investigational use. Endologix has offices and manufacturing sites in Irvine and Santa Rosa, Calif.
Reference
Sean P. Lyden, D. Christopher Metzger, Steve Henao, Sonya Noor, Andrew Barleben, John P. Henretta, Levester Kirksey, One-year safety and effectiveness of the Alto abdominal stent graft in the ELEVATE IDE trial, Journal of Vascular Surgery, (2022), ISSN 0741-5214.