Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease, announces publication a head-of-print in the Annals of Surgery of the “NEXUS Arch Multicenter Study Evaluating the Initial Experience with a Novel Aortic Arch Stent Graft System” by Planer et al.
The publication reports the 30 days and 1 year outcomes on performance and safety of the NEXUS™ Aortic Arch Stent Graft System in treating thoracic aortic lesions involving the aortic arch. The cohort includes 28 patients in prospective single arm clinical study, either under the first-in-man study (NCT02365454) or as compassionate use with systematic data collection (NCT03420066).
“The aortic arch repair remains the most challenging for both open cardiac surgery and endovascular repair” said David Planer M.D. from Hadassah - Hebrew University Medical Center, Jerusalem, Israel. “The high procedural success rate at 30 days without reports of aneurysm-related mortality, disabling stroke or device failure at 1 year, confirms the safety and effectiveness of the NEXUS™ device in this high-risk patient population.”
“The NEXUS Aortic Arch Stent Graft System is the first CE-certified off-the-shelf double stent graft system, developed specifically to address the morphology and hemodynamic challenges of the aortic arch and to mitigate the risk of stroke.”, said Kevin Mayberry, CEO. “This landmark publication is encouraging for the outcomes in the TRIOMPHE IDE study, currently enrolling towards US approval for the NEXUS™ Aortic Arch Repair Stent Graft System”.
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.
About Endospan
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.
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Contacts
Kevin Mayberry
CEO
kevin@endospan.com
