Terumo Aortic’s Custom Hybrid Thoracoabdominal Aortic Aneurysm Repair Device Implanted in FIH Procedure

September 21, 2021—Terumo Aortic announced the successful first-in-human (FIH) implantation of the company’s first custom-made thoracoabdominal hybrid device to treat thoracoabdominal aortic disease. The thoracoabdominal repair procedure using a hybrid open-stent graft was carried out by Professor Sebastian Debus, MD, and supported by Professor Sabine Wipper, MD, at University Heart Center Hamburg in Hamburg, Germany, where Prof. Debus is Chairman of the Department of Vascular Medicine at University Heart Center Hamburg.

According to the company, this procedure represents a key stage in the development of a device for the treatment of patients with thoracoabdominal aortic disease using minimally invasive surgical techniques. The custom-made hybrid device uses technology from the company’s existing hybrid portfolio and combines Terumo Aortic’s Gelweave woven surgical technology and stent graft technology to address the patient’s specific anatomy.

“This unique hybrid graft was designed in collaboration with Terumo Aortic to reduce the risk of complications associated with thoracotomy and extracorporeal circulation,” commented Prof. Debus in the company’s press release. “The device consists of a proximal stent graft for transabdominal retrograde delivery to the descending aorta combined with a distal six-branched abdominal device for open abdominal aortic repair. The preliminary end-to-side anastomosed branch to the iliac artery allows continuous retrograde flow to the distal aorta following proximal stent graft deployment, and visceral vessels are subsequently anastomosed.”

He further noted, “This is the ‘FIH’ device implanted; it was easy to implant, and the procedure was uneventful and straightforward. The patient showed ‘fast track’ recovery and postoperative course was without complications.”

Mark Miles, Chief Commercial Officer at Terumo Aortic stated in the announcement, “This milestone demonstrates our commitment to developing personalized solutions as part of our comprehensive surgical, endovascular, and hybrid portfolio. Pushing forward with this type of innovation enables clinicians to treat a broader range of patients with anatomies that are not suitable for off-the-shelf products.”