Terumo Aortic today announced enrolment of the first patient in the RapidLink pivotal investigational device exemption (IDE) study in the USA and Europe. The study is designed to evaluate the safety and effectiveness of the RapidLink device for the repair or replacement of supra-aortic vessels during open surgical repair of aortic disease involving the thoracic aorta.
The study 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.
Terumo Aortic describes achieving the first enrolment in this FDA-approved IDE as a “major milestone”, introducing an “intuitive” deployment system that integrates into existing surgical workflows. “Its design reduces the number of procedural steps, enabling faster and more precise graft placement,” a press release from the company reads. “By streamlining the hybrid approach, RapidLink will allow more surgeons to treat complex aortic arch pathologies with confidence and consistency.”
The study will include up to 30 centres in the USA and Europe, with Terumo Aortic anticipating up to 150 patients will be enrolled across the 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 a minimum of two years post procedure.
The first patient was enrolled by Puja Kachroo at the Washington University Aortic Center in St Louis, USA.
The global principal investigator, Malakh Shrestha (Mayo Clinic, Rochester, USA), commented: “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.”
Terumo Aortic advises that RapdiLink is an investigational device and is limited by federal law to investigational use.
