First NAVI™ patient at 8 months shows excellent mitral valve function and has returned to work
NaviGate Cardiac Structures, Inc. [NCSI] has received approval from Krakow, Poland, Ethics Committee to implant the Navi™ Valved Stent for correction of severe Functional Mitral Regurgitation (FMR).
NCSI has received approval from the regional Ethics Committee to implant the Navi™valved stent for the correction of severe mitral regurgitation (MR) in patients considered inoperable by standard cardiac surgery that requires open chest, open and arrested heart and cardiopulmonary bypass because of the very high or prohibitive-risk if subjected to that procedure. The physicians from the Jan Paul II Hospital have worked with the NCSI team in developing the delivery systems and techniques for the implantation of the Navi™ using animal models and have asked for the approval for patients under their care who presents with severe MR, a condition that is not self-repairable and that continues to render the patients frail and affects markedly their quality of life and speeds their path to death.
This center is the number one cardiovascular medicine center in Poland several years in a row and more than 15 multinational companies have used it for device clinical studies successfully (one of latest studies was for the Twelve Mitral valve, now the Intrepid of Medtronic).
Presently, the clinical Plan and study materials are in final review through the Ministry of Health and the company expects their approval in the next few weeks so that enrollment and treatment of patients may begin. This is part of the trans-atrial 30 patient feasibility study aimed at obtaining preliminary safety and some efficacy of the Navi™ mitral valved stent, the same implanted in our patient in the Center in Chile who has returned to work with a very well-functioning mitral valve replacement.
The company has also initiated the process of obtaining Ethics Committee approval at the University Hospital of Insubria, in Varese, Italy to add 10 patients to the feasibility study.