Life Seal Vascular Announces Successful Treatment of First Two Patients in the ASCEND First-in-Human Study

Life Seal Vascular treats first two patients in ASCEND FIH study, successfully implanting the Cygnum ASMD as an adjunct to EVAR for active sac management.

LAKE FOREST, CA, UNITED STATES, December 2, 2025 /EINPresswire.com/ -- Life Seal Vascular, Inc., a company pioneering next-generation solutions to improve the long-term durability of endovascular aneurysm repair (EVAR), today announced the first clinical implants of their Cygnum™ Aneurysm Sac Management Device (ASMD). Two patients were enrolled in the Aneurysm SaC ManagemENt Device for Abdominal Aortic Aneurysms (ASCEND) study in New Zealand.

The Cygnum™ device lines the aneurysm sac prior to deployment of the EVAR graft and is designed to prevent type II endoleaks and reduce the need for reintervention in the long-term.

“Both our patients were at particularly high risk for type II endoleaks, and I am pleased to report that both procedures were successfully completed,” said Professor Andrew Holden, MBChB, FRANZCR, EBIR, Principal Investigator for the ASCEND FIH study. “The Cygnum ASMD integrated seamlessly into the EVAR workflow and deployment was straightforward. The post deployment imaging demonstrated excellent positioning and good apposition of the Cygnum device to the aortic wall. We are looking forward to reporting the longer term outcomes in the future.”

The ASCEND FIH study (NCT07020611) is evaluating the safety and efficacy of the Cygnum ASMD as an adjunct to EVAR.

“This milestone marks Life Seal Vascular’s transition into a true clinical-stage company,” said Matt Thompson, MD, Co-CEO of Life Seal Vascular. “Our strategy is centered on generating rigorous clinical evidence to support this disruptive innovation, which we believe has the potential to obliterate type II endoleaks and related costly reinterventions. Cygnum represents a novel approach to active sac management, and we believe it can pave the way for a new standard of care for EVAR.”

Life Seal Vascular will continue enrollment in New Zealand and is preparing to expand the early clinical experience into other geographies as part of its broader global clinical development strategy.

Regulatory Status

The Cygnum™ Aneurysm Sac Management Device is an investigational device and is not approved for sale or commercial use in any geography, including the United States, European Union, New Zealand, or Japan. Its use is limited exclusively to approved clinical studies.

About Life Seal Vascular

Life Seal Vascular (www.lifesealvascular.com) is a privately held medical device company dedicated to developing innovative solutions to revolutionize endovascular treatment. The company’s proprietary technology is designed to eliminate endoleaks, the primary cause of secondary interventions following endovascular aneurysm repair. By striving to improve safety and effectiveness of endovascular procedures, Life Seal Vascular aims to enhance patient outcomes, optimize healthcare resources and lower the cost of care.  

Media Relations
Life Seal Vascular Inc.
+1 612-840-2723
media@lifesealvascular.com

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