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Press release content from Business Wire. The AP news staff was not involved in its creation.

Endospan Secures CE Mark Approval for Branched Endovascular Repair of the Aortic Arch with Its NEXUS™ Aortic Arch Repair System

March 19, 2019

HERZLIA, Israel--(BUSINESS WIRE)--Mar 19, 2019--Endospan, a pioneer in off-the-shelf, minimally invasive endovascular repair of Aortic Arch Disease comprising both aneurysms and dissections, today announced that it has received CE-marking for its NEXUS™ Stent Graft System.

Diseases of the aortic arch present surgeons with challenging surgical treatment options and risks to the patient due to it being the main blood supply to the upper body and brain and entire body and its proximity to the heart. The options currently available for the treatment of these pathologies require complex procedures such as open surgery with its invasiveness and risks, lengthy hospitalization periods, and prolonged recuperation, or combination procedures that use devices in an off-label capacity.

“More than 120,000 patients suffer thoracic aortic arch disease every year in the US and Europe, but only about 25% are diagnosed or treated,” said Kevin Mayberry, CEO. “Endospan will now expand the availability of NEXUS with a limited market release across Europe and continue its ongoing evaluation in a post-market study to demonstrate its continued long-term safety and effectiveness for providing improved outcomes for patients.”

Professor Mario Lachat of Hirslanden Clinic in Zurich Switzerland and leading implanter of Nexus said, “This is a major advancement in the treatment of aortic arch pathology that will lead the transformation for how we are able to effectively treat these complex, high-risk conditions with less trauma and reduced complication risks for patients.”

With no other off-the-shelf solution available, the approval of NEXUS™ now provides specialists with a “ready to treat” technology solution to repair the aortic arch from inside the aorta without the need to open the patient’s chest or cut the aorta. The procedure is performed entirely via minimally invasive access through the small blood vessels in the arm and groin, significantly reducing patient recovery time.

The CE mark approval for NEXUS™ represents a major milestone being the first low-profile branched endovascular stent-graft to be available off-the-shelf to cardiovascular specialists in Europe, enabling them to now perform standardized minimally invasive repair of the aortic arch. NEXUS™ was designed and engineered specifically for the aortic arch to allow ease of deployment whilst achieving a durable effective repair and importantly minimising the risk of stroke and other cardiovascular complications.

About Endospan

Privately held Endospan, headquartered in Herzlia (Tel Aviv), Israel, is a pioneer in the endovascular repair of Aortic Arch Disease, both aneurysms and dissections. With CE-marking in Europe, the NEXUS™ Stent Graft System is the first endovascular off-the-shelf system to treat Aortic Arch Disease: a greatly underserved group of patients diagnosed with a dilative lesion in, or near, the aortic arch.

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Ronald Trahan, +1-508-816-6730,rtrahan@ronaldtrahan.com



SOURCE: Endospan

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PUB: 03/19/2019 08:30 AM/DISC: 03/19/2019 08:31 AM