Thoracoabdominal Hybrid Graft

Description:

Overview

A surgical device designed to expedite repair of thoracoabdominal aortic aneurysms (Type II or greater), enabling distal aortic perfusion without the need for cardiopulmonary bypass.

Clinical Need
Thoracoabdominal aortic aneurysms (TAAAs) involving visceral arteries are challenging due to high morbidity and mortality risks in open surgical repairs, especially for high-risk patients. Existing solutions (fenestrated or branched) require complex planning and face anatomical limitations, increasing risk of endoleaks and bleeding. Open surgery risks visceral ischemia and prolonged clamp times. Current hybrid stent-graft approaches remain difficult to apply in thoracoabdominal aneurysms and often require cardiopulmonary bypass, increasing procedural complexity and risk. A solution that maintains perfusion without bypass would significantly improve outcomes.

Figure 1. Endovascular graft with quick connect feature for manifold device to provide blood flow to visceral arteries during thoracoabdominal aortic aneurysm (TAAA) procedures.

Solution
The Maniflo Thoracoperfusion Catheter System and the Maniflo Thoracohybrid Graft system. The Thoracoperfusion Catheter System is a quick-connecting perfusion manifold designed to work with market available stent grafts to provide perfusion during hybrid AAA repair procedures. The Thoracohybrid Graft system is an endovascular stent graft tailored to work in tandem with the quick-connecting perfusion manifold to reduce the risk for ischemia during these procedures.

Technology
The Maniflo™ Thoracoperfusion System is a temporary adjunct used during thoracoabdominal aortic aneurysm repair to maintain blood flow to the visceral organs. The system consists of a 4-to-1 manifold that shunts blood from a sheath placed in the descending aorta distal to the repair site, providing targeted perfusion to the celiac, superior mesenteric, and renal arteries. By sustaining end-organ perfusion during cross-clamp or endovascular exclusion of the aneurysm, the system reduces ischemic risk to critical abdominal organs and enables surgeons to perform complex repairs with greater confidence and control. The Maniflo™ Thoracohybrid Graft System is a novel endovascular implant designed to maintain blood flow the visceral arteries during the repair of thoracoabdominal aortic aneurysms and dissections. The system incorporates a branched stent graft with five integrated branches (four for the visceral vessels and one dedicated to perfusion) enabling the graft itself to serve as both the repair construct and the perfusion conduit. By allowing controlled shunting of blood through the perfusion branch and the use of clamps to guide flow, the system maintains visceral organ perfusion throughout the procedure while simultaneously securing the aneurysmal or dissected segment. This approach provides a durable repair strategy that integrates organ protection directly into the implant design.