Valcare Medical Announces Enrollment of First Two Patients in AMEND™ TS EU Pilot Study
The Floridant/10270548

TAMPA, Fla., May 14, 2024 ~ Valcare Medical, Inc., a leading innovator in transcatheter-based mitral solutions, has announced the successful completion of the first two enrollments in their AMEND TS European pilot study. The procedures were performed by Dr. Bruno Melica and his team at Vila Nova de Gaia Hospital in Portugal.

The purpose of this study is to build upon the positive results from the first in human experience, where 33 patients were successfully treated with the AMEND Trans-Septal System. The AMEND TS EU Pilot Study aims to evaluate the safety and performance of the AMEND Trans-Septal System as the primary technique in a comprehensive mitral repair approach. This approach includes using mitral annuloplasty as a standalone therapy or in combination with other 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. It is designed to replicate the effectiveness of traditional annuloplasty rings used during open-heart surgery but can be implanted through a less invasive, percutaneous approach.

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Dr. Bruno Melica, an Interventional Cardiologist at Vila Nova de Gaia Hospital, expressed his excitement about successfully implanting the AMEND annuloplasty ring in the first two patients enrolled in the study. He stated that these procedures mark a significant advancement in addressing an unmet need for high-risk patients suffering from severe functional mitral regurgitation.

Steve Sandweg, CEO of Valcare Medical, Inc., also commented on this milestone achievement. He stated that enrolling the first two patients in the AMEND EU Pilot Study is an important step towards providing a surgical-style result for high-risk patients with severe functional mitral regurgitation. Sandweg also expressed his gratitude towards Dr. Melica and his team for their support and collaboration during this study.

The AMEND TS EU Pilot Study plans to enroll a total of 20 patients from various European sites and follow each patient for 12 months. After the completion of this study, Valcare intends to continue working with the FDA on a future IDE submission.

It is important to note that the AMEND device is still investigational and limited to investigational use only. The products are not available for sale or commercial distribution at this time. Valcare Medical, Inc. remains committed to providing innovative solutions for patients with mitral valve issues and looks forward to the potential future availability of the AMEND Trans-Septal System.
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