Terumo Aortic announced today that the first two patients have been successfully enrolled in the RelayBranch Early Feasibility Study. This trial will assess the safety and efficacy of the RelayBranch Thoracic Stent-Graft system in patients with thoracic aortic pathologies requiring treatment proximal to the origin of the innominate artery. Luis Sanchez, M.D., Chief of the Section of Vascular Surgery and Marc Moon, M.D., Chief of the Section of Cardiac Surgery, Washington University in St. Louis - Barnes Jewish Hospital, performed the procedures.
The standard operative approach in patients with aortic arch pathology is a median sternotomy. The distal aspect of the arch and proximal descending thoracic aorta are difficult to expose through a sternotomy and pose an additional risk to the patient. The RelayBranch Thoracic Stent-Graft system establishes an endovascular alternative for patients requiring this type of surgical intervention. Presently, there are no commercial endovascular treatment options available for patients with thoracic arch pathologies. Dr. Sanchez commented “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. Moon will present details of the cases at the 98th Annual AATS meeting on Tuesday, May 1st in San Diego, CA.
The RelayBranch Thoracic Stent-Graft system consists of a Main-Body Graft which is deployed in the ascending aorta and features two anterograde tunnels that give way to a large cannulation window. Branch Grafts are then deployed within these tunnels for both the innominate artery and left common carotid artery. The tunnels have Lock Stents incorporated into them which were designed to provide a secure engagement with the Branch Grafts and prevent modular disconnection. This Early Feasibility Study is the first US clinical trial of a double branch design for the treatment of thoracic arch pathologies.
Terumo Aortic has leveraged their NBS (Non-Bare Stent) technology in the design of the Main Body which features a fully covered proximal end that is clasped to the delivery system to enable an accurate deployment. “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” said John Canning, CTO of Terumo Aortic.
The RelayBranch system incorporates the use of the RelayPro delivery system that is currently under clinical trial in the US. RelayPro is a low profile next-generation delivery system that features a mechanical advantage mechanism allowing for a controlled and accurate deployment of the prosthesis. The RelayPro delivery system also features the dual sheath and self-aligning technologies that have been the pillars of the Relay family of products.
The RelayBranch system highly complements the thoracic portfolio that Terumo Aortic delivers along with its standard surgical grafts and hybrid devices. This comprehensive portfolio places them in a unique category as the only company to offer both Surgical and Endovascular solutions for thoracic arch pathologies.