In the trial, Terumo will look to evaluate the effectiveness of Mirasol-treated apheresis platelets in plasma versus standard apheresis platelets in plasma, hoping that the data will support FDA premarket approval for the Mirasol PRT system.
“This study is intended as a step towards improving transfusion therapy and transfusion safety in the U.S. We’re excited to be a part of this study that hopefully will lead to measures that could further protect the nation’s blood supply from certain complications and threats of blood transfusions,” Miplate lead investigator Dr. Sherrill Slichter of Bloodworks Northwest said in a prepared statement.
The study is expected to take 3.5 years and will include involvement from up to 15 hospitals and blood centers as well as 556 patients, the company said. Eligible patients in the trial will have a platelet count of less than or equal to 10,000/µL, and require at least 2 platelet transfusions.
“In addition to being designed to support our PMA application for U.S. approval, this study is an important part of our ongoing efforts to advance blood safety and patient care. With a better clinical understanding of technologies like the Mirasol PRT system in the U.S., we can bring our customers a safe, simple and effective solution to help protect their patients from pathogens,” innovation & development exec VP Palani Palaniappan said in a press release.
In March, Terumo subsidiary MicroVention released results from a study of its HydroCoil embolic system, touting that the trial met its primary and secondary endpoints and showed low adverse composite outcomes.
The 513-patient prospective, randomized, controlled trial aimed to explore the use of the HydroCoil embolic system for treating endovascular aneurysms compared to bare platinum coils, the company said.