(Boursier.com) — Affluent Medicala French clinical-stage MedTech company specializing in the international development and industrialization of innovative medical prostheses, today announced positive clinical results from a pivotal study with its Kalios mitral ring, as well as the elements supporting the new company’s strategy regarding its structural cardiology activities.
Kalios: Positive interim results at 1 year from the pivotal Optimise II study involving 20 patients
The Company’s Kalios Ring is the only mitral annuloplasty device that can be adjusted percutaneously to treat residual and recurrent mitral regurgitation at any time after implantation, repeatedly and with a beating heart, thereby avoiding a new open heart surgery. The European pivotal Optimise II study on Kalios was designed to evaluate the safety and effectiveness of the device for the surgical treatment of mitral regurgitation with catheter adjustment.
The results announced today consist of an interim data set on 20 patients treated in five centers in Europe at 1 year after implantation. 13 of the patients had primary (degenerative) mitral regurgitation and 7 had secondary (functional) mitral regurgitation.
5 post-implant adjustments were performed and one patient was adjusted 11 months after the procedure. Of the 4 patients adjusted perioperatively, excellent results were observed (residual mitral regurgitation (MR) grade 2+, which meets the predefined efficacy criterion of the study. 12 patients showed an improvement in class functional of the NYHA, and 79% presented a functional class I or II. The safety profile of the study is excellent: no death, no myocardial infarction, no valve thrombosis and no endocarditis have been reported, until at 1 year.
Dr. Alberto Albertini, Head of the Department of Cardiothoracic Surgery at Hesperia Hospital Modena, Italy, explains: “The results of this 1-year interim analysis are remarkable. Five patients were able to be adjusted postoperatively and the results are excellent. By adjusting the catheter, mitral regurgitation was optimized or corrected without additional open heart surgery.”
The interim analysis of the primary endpoint of 1-year effectiveness of the adjustable mitral annulus in the pivotal study will be submitted for publication in a peer-reviewed journal.
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