Endospan has announced that it has received CE mark for its Nexus stent graft system, to be used for branched endovascular repair in the aortic arch.
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 hospitalisation 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.”
Mario Lachat of Hirslanden Clinic in Zurich, Switzerland, and leading implanter of Nexus says, “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.” Earlier this year, Lachat presented mid-term results of an open-label, non-randomised single-arm investigational clinical study graft system in 25 patients using the stent graft.
With no other off-the-shelf solution available, the approval of the stent graft system 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 the stent graft system 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 standardised 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.