Valcare Medical has announced the successful completion of the first two enrolments in the AMEND TS European pilot study. Bruno Melica and the team from Vila Nova de Gaia Hospital (Vila Nova de Gaia, Portugal), performed the procedures.
The purpose of the study is to build upon the positive results from the first in human experience in which 33 patients were successfully treated with the Amend transseptal system.
The AMEND TS EU pilot study will evaluate the safety and performance of the Amend transseptal system as the primary technique in a comprehensive mitral repair approach comprising mitral annuloplasty as a standalone therapy or in combination with additional approved technologies to achieve a surgical-level repair.
The Amend mitral valve repair device is a closed, D-shaped semi-rigid annuloplasty ring with proprietary anchoring capabilities. Amend is designed to replicate the efficacy of the traditional annuloplasty rings used to treat mitral regurgitation during open-heart surgery, but is implanted via a less invasive, percutaneous approach.
“We are thrilled to have successfully implanted the Amend annuloplasty ring in the initial two patients enrolled in the Amend TS EU pilot study,” commented Melica. “These procedures mark a significant advancement in addressing an unmet need for patients at high risk for mitral valve surgery.”
“The enrolment of the first two patients in the AMEND EU pilot study marks an important milestone in Valcare’s mission to provide a surgical-style result for high-risk patients suffering from severe functional mitral regurgitation,” said Steve Sandweg, CEO, Valcare Medical. “We are grateful to Dr Melica and his team for their incredible support and collaboration during this study and look forward to continuing this important journey together.”
The AMEND TS EU pilot study will enrol a total of 20 patients in several European sites and follow each patient for a period of 12 months. Following completion of the EU pilot study, Valcare plans to continue working with the US Food and Drug Administration (FDA) on a future interventional device exemption (IDE) submission.
