TRiCares SAS has announced the first implantation of its Topaz transfemoral tricuspid heart valve replacement system in a pivotal study in Europe.
The TRICURE European pivotal study is taking place at sites in Germany, Belgium, France and Switzerland, with additional countries expected to follow. The study will assess the safety and efficacy of Topaz in patients with significant tricuspid regurgitation (TR) who are not candidates for open heart surgery.
The trial aims to enrol nearly 80 patients and includes interim data analysis as well as long-term follow-up evaluations.
The first implantation took place at the Algemeen Stedelijk Ziekenhuis hospital, in Aalst, Belgium. The Topaz valve was implanted in an 81-year-old female patient suffering from torrential TR (grade 5 out of 5), with a history of surgical interventions, along with typical comorbidities.
The procedure, completed in approximately half an hour, was led by Liesbeth Rosseel. The post-intervention TR grade was reduced to zero, and the patient recovery to date has been positive.
To date, nearly 40 Topaz implantations have been performed across Europe and Canada. In the coming months, TRiCares will begin patient enrolment in the early feasibility study (EFS) in the USA, which was approved by the US Food and Drug Administration (FDA) earlier this year.
Joerg Hausleiter, professor of medicine and the deputy clinic director at the Ludwig-Maximilian University in Munich, Germany, said: “The TRICURE EU pivotal study is an important trial to prove that the Topaz valve can safely reduce, and even eliminate, TR in severely ill patients. I am honoured to be the coordinating principal investigator of this critical study, contributing to an innovative solution for a large patient group urgently seeking an effective treatment option.”
Rosseel, an interventional cardiologist at Algemeen Stedelijk Ziekenhuis, in Aalst, Belgium, commented: “I am pleased that the team here in Aalst performed the first implantation in the TRICURE EU pivotal study. The implantation was completed in approximately half an hour and reinforced the excellent outcomes that we previously observed in the TRICURE first-in-human study. We are encouraged by the patient recovery to date and look forward to supporting the trial in the weeks and months ahead.”
Ahmed Elmouelhi, president & CEO of TRiCares, added: “Initiating the TRICURE EU pivotal study marks an important milestone for TRiCares. It brings us one step closer to an effective solution for the millions of patients suffering from tricuspid regurgitation. I am proud of the progress made by the entire team at TRiCares and am grateful to the many sites and clinicians who committed their support to the TRICURE EU pivotal study.”
