TAMPA, Fla., July 25, 2024 /PRNewswire/ — Valcare Medical Inc., a leading innovator in transcatheter-based mitral solutions, announces the expansion of the AMEND™ TS EU Pilot Study to Italy. The Italian Ministry of Health has approved the extension to include multiple centers 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 Trans-Septal 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 innovative 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 (RA), 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 honored to be the first Italian site to treat a patient with AMEND in the EU Pilot Study,” said Dr. Fausto Castriota, who serves as the 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.”
“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, Inc. “This expansion marks an important milestone for Valcare’s clinical strategy and will help expedite enrollment in our EU study.”
About Valcare Medical
At Valcare Medical, our mission is to transform mitral valve therapy through the development of advanced, minimally invasive solutions. Our goal is to eliminate the need for open-heart surgery in patients with severe mitral regurgitation. We aim to minimize patient risk and maximize procedural outcomes by providing strong clinical evidence for the effectiveness of our technologies. We aspire to improve patients’ quality of life while increasing life expectancy by offering a safer and more effective alternative to traditional surgical methods.
The AMEND device is investigational and limited to investigational use only. The products are not available for sale or commercial distribution.
CONTACT: info@valcaremedical.com
SOURCE Valcare Medical
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