March 20, 2019
Endospan's Nexus Stent Graft System Receives CE Mark Approval
March 19, 2019—Endospan announced that it has received European CE Mark approval for its Nexus stent graft system for the endovascular repair of aortic arch disease comprising both aneurysms and dissections.
Endospan advised that it will conduct a limited market release across Europe and continue its evaluation in a postmarket study to demonstrate its continued long-term safety and effectiveness for providing improved outcomes for patients.
According to the company, the Nexus device is a low-profile branched endovascular stent graft that was designed and engineered specifically for the aortic arch to allow ease of deployment while achieving a durable effective repair and minimizing the risk of stroke and other cardiovascular complications. The Nexus stent graft system is intended to repair the aortic arch from inside the aorta without the need to open a patient's chest or cut the aorta. The procedure is entirely minimally invasive using small blood vessels in the arm and groin, which can significantly reduce recovery time for patients, stated Endospan.
Professor Mario Lachat, MD, commented in the company's press release, “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.”