Granting of ‘Conformité Européenne’ a major milestone as Terumo gears up for global launches of next generation drug-eluting stent (DES)
Leuven, Belgium – building on the heritage of the successful Ultimaster™ stent, the Ultimaster™ TANSEI™ features optimized technology that will benefit clinicians and their patients worldwide. Granting of the CE Mark indicates that the product satisfies the requirements of relevant EU Directives and can be marketed throughout Europe. Terumo will launch Ultimaster TANSEI in Europe in May 2018, and expand in other countries (Middle East, Latin America, and Asia) sequentially.
The original Ultimaster DES has extensive real-world clinical data, having been studied in a population of over 40,000 patients. It has proven long-term safety¹ and efficacy, as demonstrated in the global clinical trial program that encompassed a wide range of different patient’s conditions, complex anatomy, and challenging procedures.
“Ultimaster is a trusted brand being used by cardiologists daily in procedures around the world,” Hikaru Samejima, President, Cardiac and Vascular Company of Terumo said. “With Ultimaster TANSEI we will optimize our proven technology even further for better clinical outcome.” The next-generation DES provides enhanced pushability² and excellent kink resistance² with a stainless steel tapered core wire at the exit port and advanced shaft technology². With Ultimaster TANSEI Terumo introduces a durable yet flexible tip, specially developed for stent application. This innovation will improve the deliverability² of the whole stent system considerably.
“TANSEI is the Japanese word for ‘diligent’ or ‘dedicated’. Mastering complexity has never been simpler,” Hikaru Samejima said. “Nearly three-quarters of the cardiologists are seeing in their daily practice fall into the ‘complex’ category. With Ultimaster TANSEI we want to simplify their job, giving them the opportunity to focus on their patients and not their tools,” he said.
Ultimaster/Ultimaster TANSEI have 1 month dual antiplatelet therapy (DAPT) CE Mark approval³ for patients in need to stop DAPT earlier. The Ultimaster TANSEI DES will be a core component of the currently enrolling MASTER DAPT study, which compares an abbreviated versus prolonged DAPT within current guidelines and instructions for use, following stent implantation in patients presenting with high bleeding risk (HBR) features. The global study will recruit 4,300 patients and has primary end-points of non-inferiority for net adverse clinical events; superiority for bleeding; and non-inferiority for ischaemic endpoints of abbreviated versus prolonged DAPT, at 1 year.
- Assessment of ‘safety’ refers to the side-effect profile and clinical events experienced (e.g. stroke, myocardial infarction, unplanned revascularisation, stent thrombosis).
- Tests performed by and data on file at Terumo Corporation.
- CE, Conformité Européene (European Conformity); DAPT, dual antiplatelet therapy. Ultimaster instructions for use
Source: Terumo, https://www.pcronline.com/News/Press-releases/2018/Terumo-receives-CE-Mark-for-Ultimaster-TANSEI-drug-eluting-stent