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.
Valcare Medical, Inc. Expands AMEND TS EU
Pilot Study to Italy
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
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SOURCE Valcare Medical