FDA Approves Terumo Aortic’s RelayPro Thoracic Stent Graft

August 6, 2021—Terumo Aortic announced it has received FDA approval of RelayPro, the company’s low-profile, next-generation thoracic stent graft device designed for use in thoracic endovascular aortic repair for patients with small access vessels. Approval is for the treatment of patients with thoracic aortic aneurysms (TAAs) and penetrating atherosclerotic ulcers (PAUs).

According to the company, RelayPro, which has had CE Mark approval since 2017, shares the same stent design, materials, and dual-sheath technology as Terumo’s RelayPlus but features a 3- to 4-F outer profile reduction. RelayPro also has a low profile, the option for a nonbare- and bare-stent design, and a wide range of sizes to meet specific anatomic needs.

The company noted that approval follows the successful completion of the prospective, multicenter, nonblinded, nonrandomized RelayPro aneurysm study in the United States and Japan. The study included 110 patients with TAAs and PAUs.

Wilson Y. Szeto, MD, Co-National Principal Investigator of the study, remarked, “RelayPro’s ability to navigate smoothly over the arch as a result of the dual-sheath system enables accurate deployment, and combined with the low profile of the device, this allows me to successfully treat complex anatomy with precision.” Dr. Szeto, MD, is Chief of Cardiovascular Surgery at Penn Presbyterian University of Pennsylvania Health System in Philadelphia, Pennsylvania.

“One of the key features and benefits of RelayPro is being able to choose from a range of sizes and tapers, allowing me to tailor my device selection to meet the individual needs of each patient and adapt to complex anatomy and morphology,” commented Co-National Principal Investigator Venkatesh G. Ramaiah MD, Chief of Vascular and Endovascular Surgery at Honor Health Network in Scottsdale, Arizona. “In addition, the unique delivery system, the low profile, and the options of bare stent and nonbare stent are clear differentiators. This is a landmark advancement in the endovascular treatment of thoracic aneurysms.”