HERZLIA, Israel--(BUSINESS WIRE)--Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease, announces the first implant of the NEXUS™ Aortic Arch Stent Graft System on a patient with a thoracic aortic aneurysm as part of the TRIOMPHE Study in Norfolk, Virginia, January 11, 2021.
The TRIOMPHE Study is a multi-arm, multi-center, non-randomized, prospective, clinical study to evaluate the safety and effectiveness of NEXUS™ in treating thoracic aortic lesions involving the aortic arch. The study will enroll 100 patients at up to 30 sites.
“Aortic arch repair has traditionally been one of the most technically challenging areas to repair, “said Jean M. Panneton, M.D., FACS, FRCSC, Vascular Surgery Chief and Program Director, EVMS, Norfolk, VA “Some of these patients currently don’t have many options that don’t come with a high degree of risk” confirmed Christopher J. Barreiro, M.D., Cardiothoracic Surgeon, Sentara Mid-Atlantic Cardiothoracic Surgeons, Norfolk, VA “The TRIOMPHE study investigates if NEXUS™ can safely extend minimally invasive, durable interventions to my patients while mitigating the risks of stroke, endoleaks and migration.”
“With the first patient enrolled in the TRIOMPHE IDE study, Endospan marks the next crucial milestone towards US approval for the NEXUS™ Aortic Arch Repair Stent Graft System”, said Kevin Mayberry, CEO. “The NEXUS™ is specifically engineered for total endovascular arch repair to address the specific challenges of the aortic arch anatomy. With this study, we aim to prove the NEXUS™ will provide surgeons a straightforward, minimally invasive solution for aortic arch repair that allows for procedural consistency with reliable patients outcomes.”
More than 120,000 patients suffer thoracic aortic arch disease every year in the USA and Europe, with only about 25% diagnosed or treated. Despite significant advancements, open surgical aortic arch repair maintains high mortality and morbidity. Patients with excessive perioperative risk or anatomical factors are not indicated for surgery, yet anatomical complexity and lack of approved devices for the arch has often prohibited endovascular repair. This makes the choice of treatment difficult or even impossible for some patients. Providing the alternative of minimally invasive repair decreases the requirement for extra corporal circulation and possibility of hypothermia, translating into reduced procedure and hospitalization time.
For more information on NEXUS, please visit: www.endospan.com.
Privately held Endospan, headquartered in Herzlia (Tel Aviv), Israel, is a pioneer in the endovascular repair of aortic arch disease including aneurysms and dissections. Endospan’s NEXUSTM Aortic Arch Stent Graft System is the first endovascular off-the-shelf system with CE Mark to treat a greatly underserved group of patients diagnosed with a dilative lesion in, or near the aortic arch. While minimally invasive endovascular repair has been the standard of care for Abdominal Aortic Aneurysm (AAA), Aortic Arch Disease patients with aneurysms or dissections have not been as fortunate and have had little choice but to undergo open-chest surgery with its invasiveness and risks, lengthy hospitalization periods, and prolonged recuperation. For additional information about Endospan, visit their website at www.endospan.com.
NEXUSTM Aortic Arch Stent Graft System is currently available for sale in Europe and is intended for investigational use only in the U.S.