Valcare Medical has announced the expansion of the AMEND TS EU pilot study to Italy.
The Italian Ministry of Health has approved the extension to include multiple centres throughout Italy, building upon the initial cases conducted in Portugal earlier this year.
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.
Following the Ministry of Health approval, the Maria Cecilia Hospital in Cotignola, part of GVM Care and Research, Italian Healthcare Group, became the first hospital in Italy to enroll and treat a patient in the AMEND TS EU pilot study.
“We are honoured to be the first Italian site to treat a patient with Amend in the EU Pilot Study,” said Fausto Castriota, who serves as the Director of the Interventional Cardio-Angiology Unit at Maria Cecilia Hospital (Cotignola, Italy). “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.”
“We are extremely pleased with the Italian Ministry of Health’s recent approval for our EU pilot study and grateful to Dr Castriota, his team, and the clinical trial unit for their outstanding collaboration and support,” said Steve Sandweg, CEO of Valcare Medical. “This expansion marks an important milestone for Valcare’s clinical strategy and will help expedite enrolment in our EU study.”
