Terumo Aortic, which formed earlier this month from a merger between Terumo Corp. (TYO:4543) subsidiary Vascutek and Bolton Medical, said today it launched an early feasibility study of its RelayBranch thoracic stent-graft system.
The Sunrise, Fla.-based company said that the first two patients in the study have been implanted with the device by Dr. Luis Sanchez and Dr. Marc Moon of St. Louis’ Washington University, with the procedures performed at Barnes Jewish Hospital.
“RelayBranch expands the range of endovascular treatment options for a high risk population. We are very pleased to be able to offer an endovascular alternative to our patients,” Dr. Sanchez said in a press release.
In the study, researchers will explore the safety and efficacy of the RelayBranch thoracic stent-graft system in treating patients with thoracic aortic pathologies which require proximal treatment to the origin of the innominate artery, Terumo Aortic said.
The RelayBranch thoracic stent-graft system is designed as an endovascular alternative for patients who require surgical interventions that are difficult to approach through a standard procedure, the company said.
The system consists of a main body graft deployed in the descending aorta and features two anterograde tunnels and a large cannulation window. Branch grafts are deployed within the tunnels for the innominate artery and left common carotid artery, the company said.
“Terumo Aortic is uniquely positioned to collaborate directly with surgeons and address unmet clinical needs. We are excited to provide patients with a less invasive treatment option through this innovative technology,” CTO John Canning said in a prepared statement.
The newly launched trial is the first US clinical trial of a double branch system designed for treating thoracic arch pathologies.