Terumo’s Ultimaster™ Stents Gain MDR Approval for High-Bleeding Risk Patients

Medical technology company, Terumo, has announced that it has received Medical Device Regulation (MDR) approval for an expanded indication of its Ultimaster Nagomi™ and Ultimaster™ Tansei™ stent systems.

The new approval ensures that the devices can be used on patients with high bleeding risk, including those eligible for dual antiplatelet therapy (DAPT) as short as one month after demonstrating that 1-month DAPT is safer than a more prolongated regimen in high-bleeding risk patients.

Terumo Europe announces that it has received MDR approval for an expanded indication of its Ultimaster Nagomi™ and Ultimaster™ Tansei™ sirolimus eluting coronary stent systems.​

This new approval covers patients at high bleeding risk, including those eligible for dual antiplatelet therapy (DAPT) as short as one month.

Patients at high risk of bleeding constitute a substantial portion of the population, approximately 45%1,2 of all PCI patients. This approval marks a significant milestone in addressing a major clinical need.

This new indication has been granted thanks to Terumo Europe's robust clinical data3,4,5 and the results of the landmark MASTER DAPT study3, reinforcing the safety and performance of the stent systems in this specific patient population.

Prof. Marco VALGIMIGLI, Deputy Chief of Cardiology, Istituto Cardiocentro Ticino, Lugano, CH, commented: “Ultimaster™ is the only stent with evidence showing that 1-month DAPT is safe and actually safer than a more prolongated regimen in high-bleeding risk patients".

This achievement underscores Terumo Europe's commitment to advancing patient care by offering innovative solutions tailored to specific clinical needs. By expanding the indication for high bleeding risk patients, the company continue to support physicians in optimizing treatment strategies while enhancing patient safety.

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