Endologix Initiates Randomized Study of ALTO® Abdominal Stent Graft System

Sept. 29, 2021 12:00 UTC

Endologix Initiates Randomized Study of ALTO® Abdominal Stent Graft System

JAGUAR Study Evaluates ALTO Compared to Other Commercially Available EVAR Devices

 

IRVINE, Calif.--(BUSINESS WIRE)-- Endologix Inc. a leader in the treatment of vascular disease, today announced that the first patient has been enrolled in the company’s JAGUAR study to compare outcomes for the company’s ALTO® Abdominal Stent Graft System to other commercially available endovascular aneurysm repair (EVAR) devices for the treatment of abdominal aortic aneurysm (AAA).

JAGUAR (ObJective Analysis to GaUge EVAR Outcomes Through Randomization in a Real-world Population) is a prospective, randomized, multi-center study that will enroll approximately 450 patients at up to 60 sites worldwide. The study is designed for at least 300 patients to be randomly allocated to the ALTO cohort and 150 to the comparator group. All patients will be followed through five years. Results from the study will be independently adjudicated by a third party.

“The availability of compelling clinical evidence for EVAR devices is crucial for making informed treatment decisions and improving patient outcomes,” said Jean Panneton, MD, vascular surgeon with Sentara Vascular Specialists who treated the patient at Sentara Norfolk General Hospital.

JAGUAR has two primary endpoints: a clinical endpoint and an imaging endpoint. The clinical endpoint is a composite of aneurysm-related complications and consists of freedom from device-related interventions, conversion to open surgery, Type I and III endoleaks, clinically significant device migration, aneurysm enlargement, occlusion, aneurysm rupture and aneurysm-related death. The imaging endpoint is related to proximal neck dilation over time and allows for early insight into mechanisms of graft failure.

“Endologix is committed to investing in clinical evidence,” said Prof. Matt Thompson, chief medical officer of Endologix. “JAGUAR joins our LEOPARD study as the only two randomized clinical trials designed to evaluate comparative endograft performance. We believe that this real-world study will provide valuable insights to inform EVAR treatment decisions and improve patient outcomes.”

About the ALTO Abdominal Stent Graft System

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.

About Endologix

Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease. Endologix’s therapeutic portfolio includes a variety of products in various stages of development that are designed to treat diseases that currently have 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. Excellent clinical outcomes will be achieved through meticulous attention to product design, manufacturing, and training, all backed by industry-leading clinical evidence. Endologix’s abdominal aortic aneurysm (AAA) products are built on one of two platforms: Traditional minimally invasive endovascular aneurysm repair (EVAR) and endovascular aneurysm sealing (EVAS), which is investigational product. Endologix’s current commercial EVAR products include the AFX®2 device and the ALTO® Abdominal Stent Graft System. Endologix became a private company, wholly owned by Deerfield Management on Oct. 1, 2020. The company has offices and manufacturing sites in Irvine and Santa Rosa. To learn more about Endologix, please visit http://www.endologix.com/.

About Deerfield Management

Deerfield is an investment management firm committed to advancing healthcare through investment, information, and philanthropy. For more information, please visit www.deerfield.com.

Cautions Regarding Forward-Looking Statements

Except for historical information contained herein, this press release contains forward-looking statements, including statements regarding the JAGUAR clinical trial. Forward looking statements are subject to risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. The forward-looking statements contained in this press release speak only as of the date of this press release and Endologix undertakes no obligation to update any forward-looking statements contained in this press release to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

Contacts

Endologix LLC
Laura Brannon
949-595-7200
lbrannon@endologix.com

 
 

Source: Endologix LLC

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