Life Seal Vascular Announces Initial Implants of the Cygnum™ Aneurysm Sac Management Device in Japan

LAKE FOREST, CA, UNITED STATES, January 2, 2026 /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 successful treatment of two patients in Japan using its investigational Cygnum™ Aneurysm Sac Management Device (ASMD) under compassionate-use authorization.

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.

Two patients were treated by Dai Yamanouchi, MD, PhD, Chair of Vascular Surgery at Fujita Health University in Japan. The patients were determined to be at high risk for type II endoleaks based on pre-procedural assessment and prevailing clinical standards.

Persistent type II endoleaks are widely considered a failure of EVAR therapy and a significant driver of late aneurysm sac expansion and reintervention[1]. As a result, sac management and elimination of type II endoleaks remain a major focus of vascular care.

“I was very pleased with the Cygnum ASMD,” said Dr. Yamanouchi. “The device integrated well into the EVAR procedure and allowed effective management of the lumbar arteries and IMA. The workflow was intuitive, and the immediate sac lining with Cygnum and procedural outcomes were very encouraging.”

These compassionate-use implants represent an important step in expanding Life Seal Vascular’s global clinical experience with the Cygnum ASMD. Data generated from international use will help further characterize the safety profile of the device and inform future studies focused on long-term sac management.

“Many physicians have long recognized the clinical impact of type II endoleaks and the need to address them proactively,” said Matt Thompson, CEO of Life Seal Vascular. “These initial cases support our broader strategy to build robust clinical evidence around the safety of the Cygnum ASMD and, with future chronic follow-up, its potential to reduce type II endoleaks and associated reinterventions.”

Life Seal Vascular plans to continue expanding clinical experience with the Cygnum ASMD to build the evidence supporting its category defining aneurysm sac management therapy.

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.  

[1] Sieke et.al. “Nationwide Analysis of Persistent Type II Endoleak and Late Outcomes of Endovascular Abdominal Aortic Aneurysm Repair in Japan: A Propensity-Matched Analysis” Circ 2022; 145: 1056 – 1066.

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