April 26, 2023 – Terumo today announced that its Ultimaster Nagomi™ drug-eluting coronary stent system has received certification under the European Union's Medical Device Regulation (MDR), alongside the launch of a large-scale post-market study evaluating the device's performance in complex percutaneous coronary intervention (PCI).
The Ultimaster Nagomi stent system is designed to offer enhanced deliverability and conformability, supporting interventional cardiologists in treating a wide range of coronary lesion complexities, including challenging anatomies.
The newly launched post-market study will generate real-world clinical data on the performance of the Ultimaster Nagomi system specifically in complex PCI procedures, further building the evidence base supporting its use.
"Achieving MDR certification and launching this large-scale study underscores our commitment to providing robust clinical evidence for the Ultimaster Nagomi system," said a Terumo representative. "We look forward to generating meaningful real-world data that will benefit both physicians and patients."
