Valcare Medical Announces First-in-Human Implant of AMEND™ Transseptal Annuloplasty Ring

HERZLIYA, Israel, Jan. 29, 2021 /PRNewswire/ -- Valcare Medical Ltd., a developer of transcatheter solutions for mitral and tricuspid valve repair and replacement, announced that it has successfully completed the first-in-human implantation of its AMEND™ annuloplasty ring via a transseptal approach. The transseptal AMEND procedure was performed at the Schulich Heart Centre at Sunnybrook Health Sciences Centre in Toronto under Health Canada's Special Access Program.

Valcare'sAMENDThe mitral valve repair device is an innovative and clinically validated D-shaped semi-rigid closed ring with unique anchoring capabilities. The AMEND system is designed to deliver the clinical standard of care for surgical treatment through safer and simpler catheter-based procedures. This platform also serves as the foundational architecture for the Valcare mitral valve replacement system and tricuspid valve repair solutions.

The surgery was performed by three MDs from the Schulich Heart Centre: Eric Cohen, Andrew Czarnecki, and Gideon Cohen.

“We are pleased to have the opportunity to bring Valcare’s innovative technology to patients. The first case demonstrated the AMEND device’s unique anchoring and steering capabilities, enabling annular sizing adjustment and reduction of mitral regurgitation (MR),” stated Dr. Andrew Czarnecki. “Implantation of the AMEND annuloplasty ring reshaped the annular geometry, facilitating a posterior leaflet edge-to-edge repair that was not feasible prior to implantation. We look forward to continuing this collaboration to improve the quality of life for our patients.”

Dr. Gideon Cohen added, “This unique technology provides us with another important tool to treat patients who were previously considered inoperable. We are pleased to offer this procedure to a patient who had no other surgical or device options.”

“This exciting achievement paves the way for standardizing the AMEND device and establishing it as the gold standard in mitral valve repair surgery. Following confirmation of the safety and efficacy of apical ring implantation, we are now employing this annuloplasty ring via a transseptal approach. The unique design of AMEND offers a transcatheter-style solution, providing a platform with multiple therapeutic options for patients—either as a standalone treatment or in combination with edge-to-edge repair or chordal reconstruction,” said Shuki Porath, CEO of Valcare Medical. “We highly value the opportunity to collaborate with the outstanding team at the Schulich Heart Centre in Toronto, whose expertise will help Valcare Medical expand innovative treatments for heart disease patients.”

Valcare will soon begin patient recruitment for the AMEND Plus pilot clinical study and will initiate an FDA Early Feasibility Study (EFS).

AMENDDeviceFor Research Use Only. Not for Commercial Use. 

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Valcare Medical

Valcare MedicalValcare Medical is a private medical device company dedicated to providing innovative transcatheter technologies for the treatment of mitral and tricuspid regurgitation. Valcare strives to make its developed medical devices an integral part of every structural heart procedure.

Contact Person 

Mr. Shuki Porath, CEO
Valcare Medical Ltd.
sporath@valcaremedical.com 

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