Endospan Receives FDA Go-Ahead for Aortic Arch Stent Graft Trial

The FDA has granted Endospan an investigational device exemption for its NEXUS aortic arch stent graft system, allowing the company to begin a late-stage trial.

The multi-arm trial will evaluate the system’s safety and effectiveness in treating thoracic aortic lesions involving the aortic arch. The minimally invasive system will be evaluated in participants at up to 30 sites, the company said.

The NEXUS system received a breakthrough device designation from the FDA earlier this year.