Endospan Announces Positive One-Year Data from TRIOMPHE FDA Pivotal Study For the NEXUS® Aortic Arch Stent-Graft System

TEL AVIV, Israel--(BUSINESS WIRE)--Endospan, a privately held company pioneering solutions for the endovascular repair of aortic arch disease, today announced the one-year results of their TRIOMPHE Investigational Device Exemption (IDE) Study evaluating the NEXUS® Aortic Arch Stent-Graft System presented during the Society of Thoracic Surgeons (STS) Annual Meeting in New Orleans.

TRIOMPHE is a prospective, multicenter, three-arm trial designed to assess the safety and effectiveness of the NEXUS System in patients with aortic arch pathologies (dissection, aneurysm, PAU/IMH). The one-year results for the 94 high surgical risk patients in the three arms are promising for aortic arch treatment in Zone 0, a very difficult segment of the aorta to treat without high rates of co-morbidities such as mortality or stroke.

"The 12-month data from the TRIOMPHE study are highly encouraging for the treatment of aortic arch disease," said Dr. Brad Leshnower, national cardiac surgery principal investigator. "The sustained low stroke and mortality rates in a very high-risk patient population is a significant achievement.”

The following highlights were shared at STS.

	TRIOMPHE (N=94)
	30-Day (0-30)	1-Year (31-365)
Lesion Related Mortality	6.4% (n=6)	0.0%
Overall Disabling Stroke (Bypass + NEXUS) Post	7.4% (n=7)	1.1% (n=1)
Bypass	1.1% (n=1)	-
Post NEXUS	6.4% (n=6)	1.0% (n-1)
Renal Failure	0.0%	0.0%
*All events are adjudicated by CEC

Further, core lab analysis of stent-graft sealing shows no Type III or IV endoleaks and only 3 patients had a Ia or Ib endoleak, suggesting good sealing through 12 months.

"As a vascular surgeon, I am excited to see the one-year results from TRIOMPHE continue to mirror the positive results we have seen in the long-term data on NEXUS in Europe,” said Dr. Ross Milner, national vascular surgery principal investigator. “It is rewarding to be involved in bringing a less invasive treatment option like NEXUS to patients with complex aortic arch pathologies."

More than 120,000 patients suffer from thoracic aortic arch disease every year in the U.S. 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.

“NEXUS was designed specifically for the total aortic arch,” said Kevin Mayberry, Endospan CEO. “We are pleased to see that the one-year data for the TRIOMPHE study aligns with the pre-and-post commercialization data that has been published in Europe. The TRIOMPHE data continues to support NEXUS as a straightforward, minimally invasive solution for aortic arch repair that allows for procedural consistency with reliable patient outcomes.”

Disclosure: US: The NEXUS® Aortic Arch Stent-Graft System is pending PMA review by the FDA which includes a thorough, multi-stage, in-depth evaluation of the available safety and efficacy data. Outside of US: Device availability is subject to local regulations and guidelines.

About Endospan

Privately held Endospan, headquartered in Herzliya (Tel Aviv), Israel, is a pioneer in the endovascular repair of aortic arch disease including aneurysms and dissections. Endospan’s NEXUS® 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.