Qvanteq AG today announced that it has enrolled the first patient in the First in Man (FiM) clinical study QUEST I, this is following earlier regulatory approval from the Dutch and Swiss authorities. The aim of the QUEST I study is to assess feasibility and safety of the Qstent, a bioactive, coating-free coronary stent. The Qstent has shown excellent in-growth and low thrombogenicity in pre-clinical studies.
Earlier in the year, Qvanteq AG obtained the ISO 13485 certification.
“Enrolling the first patient is a significant step towards clinical proof of concept for our bioactive and coating-free coronary stent”, commented Qvanteq’s CEO and founder Arik Zucker. “It is also the result of several years of strong commitment to bringing our technology to patients”, he added.
“This unique stent concept is indeed very exciting because there is no drug coating and therefore, it might well present clear benefits for the treated patients in terms of minimum dual antiplatelet treatment time. Fast endothelialization accompanied by low restenotic and low thrombogenicity potential offers patients a very valuable alternative to currently used stents in the clinic”, says Prof. Patrick W. J. C. Serruys, Chairman of QUEST I at Erasmus University, Thoraxcentrum, Rotterdam, NL.