Terumo has received the CE mark for its Ultimaster Tansei drug-eluting stent. Building on the Ultimaster stent, a press release reports, the Ultimaster Tansei features optimised 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 drug-eluting has extensive real-world clinical data, having been studied in a population of over 40,000 patients. It has proven long-term safety and efficacy, as demonstrated in the global clinical trial programme that encompassed a wide range of different patient’s conditions, complex anatomy, and challenging procedures.
According to the press release, the next-generation drug-eluting provides enhanced pushability and excellent kink resistance with a stainless steel tapered core wire at the exit port and advanced shaft technology. With Ultimaster Tansei, Terumo hopes to introduce a durable yet flexible tip, specially developed for stent application. The press release notes that this innovation will improve the deliverability of the whole stent system considerably.
Hikaru Samejima, president, Cardiac and Vascular Company of Terumo, comments: “Ultimaster is a trusted brand being used by cardiologists daily in procedures around the world. With Ultimaster TANSEI we will optimise our proven technology even further for better clinical outcome.” He adds: “Tansei is the Japanese word for ‘diligent’ or ‘dedicated’. Mastering complexity has never been simpler. 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”.