Terumo Corp.‘s (TYO:4543) BCT subsidiary said today it won FDA 510(k) clearance for a labeling change of its Trima Accel automated blood collection system.
The updated classification extends the Trima Accel’s ability to store platelets in plasma from 5 days to 7, as well as operating with updated wireless capabilities, the company said.
“Collaborating with customers inspires our passion, innovation and quest to deliver higher levels of quality, safety and efficiency. This clearance from the FDA shows our commitment to continuous product improvement for our customers. The 7-day storage option and wireless capability provide blood centers enhanced capabilities for donor and inventory management while improving operational efficiencies, which help control operating costs. We are pleased with these FDA clearances and look forward to future opportunities to better serve our customers, the donors and the patients we all ultimately serve,” Terumo blood centers veep Greg Ballish said in a press release.
The company said the updated labelling and wireless capabilities will help improve operational efficiencies and streamline workflows for blood centers.
In June, Terumo launched the Misago RX self-expanding peripheral stent in the U.S. The announcement was made at the Society for Vascular Surgery’s annual meeting in Chicago.
The stent is designed to treat patients with peripheral artery disease in the superficial femoral artery or proximal popliteal artery, the Tokyo-based company said.
