Terumo Corporation announced that it has received CE mark approval for its drug-eluting stent, “Ultimaster”. The company will launch the Ultimaster drug-eluting stent in Europe, Latin America, and Asia (excluding Japan) in June 2014.
According to a press release, the Ultimaster employs bioresorbable polymer applied only to the vessel contacting surface to ensure targeted drug delivery. Moreover, the polymer and the drug are released simultaneously and within 3-4 months to eliminate long-term polymer exposure, a possible cause of late adverse events. These features are expected to reduce stent thrombosis and to produce favourable long term clinical outcomes.
The Ultimaster drug-eluting stent is based on bio-ergonomic stent design with a cobalt chromium alloy. Favourably low width/thickness of the stent struts enhances stent conformability to the vessel wall and faster healing process that could lead to better strut coverage. The platform is designed to enable the physicians to navigate the stent in tortuous anatomy and facilitate placement of the stent conformable to vessel curvature, further reducing stress on vessel wall for the aim of long-term patency, the press release reports.
“Ultimaster is a masterpiece of drug eluting stent with bioresorbable polymer, underpinned by our accumulated experience and expertise as a leading company in the technology,” says Hikaru Samejima, president of Terumo Interventional Systems. “Terumo will continue its commitment to innovation for true benefits for patients and physicians to provide genuine value to health care society.”
The press release adds, design hypothesis is further supported by robust clinical evidence from the comprehensive clinical programme. The results of CENTURY study confirmed high efficacy of Ultimaster drug-eluting with late loss at six months of 0.04mm. Despite the low late loss, the optical coherence tomography (OCT) assessed Ultimaster stent strut coverage at six months was 96.2±5.4%. At 12 months, the rate of target lesion revascularisation was 2.8%, the rate of target lesion failure 2.9%, major adverse cardiovascular event (MACE) 3.8%, with only one acute stent thrombosis.
CENTURY II study is global, multicentre, randomised trial that enrolled 1,123 patients in 58 hospitals in 13 countries. The primary endpoint results will be reported at the upcoming PCR 2014. There are additional studies on-going with Ultimaster stent, including studies that potentially would pave the way for reduced dual antiplatelet therapy.