Valcare’s AMEND TS EU Pilot Study Expanded to Italy

July 25, 2024—Valcare Medical Inc. announced that the AMEND TS European Union (EU) pilot study of the company’s Amend transseptal system for mitral repair has been expanded to Italy. Valcare previously announced the commencement of the study with the initial cases conducted in Portugal earlier this year.

The company stated that the Italian Ministry of Health has approved the extension to include multiple centers throughout Italy. Maria Cecilia Hospital in Cotignola, part of GVM Care and Research, Italian Healthcare Group, was the first hospital in Italy to enroll and treat a patient in the study.

“We are honored to be the first Italian site to treat a patient with Amend in the EU pilot study,” commented Fausto Castriota, MD, who is Director of the Interventional Cardio-Angiology Unit at Maria Cecilia Hospital. “This marks a significant achievement not only for our hospital but also for the broader medical community as we strive to find innovative treatment solutions for patients suffering from severe mitral regurgitation who are unable or unwilling to have surgery.”

According to Valcare, the study will evaluate the safety and performance of the Amend device as the primary technique in a comprehensive mitral repair approach of mitral annuloplasty as a standalone therapy or in combination with additional approved technologies to achieve a surgical-level repair.

Valcare stated that the Amend mitral valve repair device is a closed, D-shaped semirigid annuloplasty ring with anchoring capabilities. The percutaneously implanted device is designed to replicate the efficacy of the traditional annuloplasty rings used to treat mitral regurgitation during open heart surgery.

The Amend device is investigational and limited to investigational use only. It is not available for sale or commercial distribution, advised the company.