Terumo Aortic’s RapidLink Pivotal IDE Study Begins 

January 9, 2026—Terumo Aortic announced enrollment of the first patient in the RapidLink pivotal trial, which will evaluate the safety and effectiveness of the company’s RapidLink device for the repair or replacement of supra-aortic vessels during open surgical repair of aortic disease involving the thoracic aorta.

The company stated that the study, which is being conducted under an FDA investigational device exemption (IDE), will collect information on patients who are already having surgery to repair their aorta and who will have the RapidLink device implanted into one or more of the aortic arch vessels.

According to Terumo Aortic, investigators will enroll up to 150 patients across two study arms—elective and emergent—at up to 30 centers in the United States and Europe. Patients will be followed for a minimum of 2 years postprocedure, noted the company.

The first patient was enrolled by Puja Kachroo, MD, at Washington University in St. Louis in St. Louis, Missouri.

The Global Principal Investigator of the trial is Malakh Shrestha, MBBS, from the Mayo Clinic College of Medicine & Science in Rochester, Minnesota.

“The RapidLink device provides a transformative solution for complex aortic arch procedures,” commented Dr. Shrestha in the Terumo Aorta’s press release. “It simplifies the most technically demanding aspects of hybrid aortic arch repair, reducing procedural complexity, operative time, and patient risk.”