Terumo Aortic Begins Rapidlink Pivotal IDE Study

Terumo Aortic has enrolled the first patient in the RapidLink pivotal Investigational Device Exemption (IDE) study in the United States and Europe.* The study aims to evaluate the safety and effectiveness of the RapidLink device to repair or replace supra-aortic vessels during open surgical repair of aortic disease involving the thoracic aorta.

The study will collect information on patients who are undergoing surgery to repair their aorta and who will have the RapidLink device implanted into one or more of the aortic arch vessels.

Achieving the first enrollment in this U.S. Food and Drug Administration-approved IDE study is a major milestone that introduces an intuitive deployment system that integrates seamlessly into existing surgical workflows. Its design reduces the number of procedural steps, enabling faster and more precise graft placement. By streamlining the hybrid approach, RapidLink will allow more surgeons to treat complex aortic arch pathologies with confidence and consistency.

“Today we are delighted to mark the first implant of the RapidLink device in this Pivotal Study,” stated Jeffrey Mifek, global vice president, Clinical and Medical Affairs at Terumo Aortic. “RapidLink has the potential to revolutionize aortic arch surgery. Its ability to make these advanced surgeries available to more patients will greatly improve patient care and further demonstrates Terumo Aortic’s commitment to advancing aortic care.”

The study will include up to 30 centers in the United States and Europe. Up to 150 patients are expected to be enrolled across two study arms—elective and emergent. The device is designed to be used in all three supra-aortic vessels for repair or replacement. Patients will then be followed for at least two years post procedure.

The first patient was enrolled by Puja Kachroo, M.D., associate professor of Cardiac Surgery and co-director of the Aortic Center at Washington University in St. Louis.

“The RapidLink device provides a transformative solution for complex aortic arch procedures. It simplifies the most technically demanding aspects of hybrid aortic arch repair, reducing procedural complexity, operative time, and patient risk,” stated global principal investigator Malakh Shrestha, Ph.D., director of Mayo Clinic Aortic Center, director of Aortic Surgery, Cardio Vascular Surgery, and professor of Surgery, Mayo College of Medicine & Science – The Mayo Clinic.

Terumo is a global medical innovation company. Founded in Tokyo in 1921, the company provides a range of solutions in therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

* Limited by federal law to investigational use.