Herzliya, Israel, January 27 2021 / Valcare Medical Ltd. developer of transcatheter mitral and tricuspid valve repair and replacement solutions, announces that it has successfully completed its first-in-human transseptal delivery of the AMEND™ annuloplasty ring. The transseptal AMEND procedure was performed at the Schulich Heart Centre at Sunnybrook Health Sciences Centre in Toronto, under the Health Canada Special Access Program.
Valcare’s AMEND mitral valve repair device is an innovative, clinically proven, D-shaped, semi-rigid closed ring with unique anchoring capabilities. AMEND is designed to provide the clinical standard-of-care surgical treatment via safer and easier catheter-based procedures. The AMEND platform also serves as infrastructure for Valcare’s mitral replacement system and tricuspid repair solution.
The procedure was performed by Eric Cohen, M.D., Andrew Czarnecki, M.D. and Gideon Cohen, M.D. from the Schulich Heart Centre.
“We are pleased to have the opportunity to bring Valcare’s innovative technology to our patients. This first case demonstrated the AMEND devices’ unique anchoring and steering capabilities, enabling annular resizing and MR reduction” stated Dr Andrew Czarnecki. “Implantation of the AMEND ring reshaped the annular geometry facilitating leaflet edge-to-edge repair which was not possible prior to the implant. We look forward to continuing this collaboration, and improving our patients’ quality of life.”
Dr Gideon Cohen added “This unique technology provides us yet another important tool with which to treat patients previously deemed inoperable. We are pleased to have been able to offer this procedure to a patient who had no other surgical or device options.”
“This exciting achievement is the stepping stone to standardise the AMEND device as the gold-standard for mitral repair procedures. Following demonstration of safety and efficacy of the AMEND ring in transapical procedures, we are now delivering this D-shaped annuloplasty ring via a transseptal approach. AMEND’s distinctive design provides a transcatheter surgical-like solution and creates a platform for multiple treatment options for patients, as a stand-alone solution or in combination with edge-to-edge or chordal reconstruction therapies” said Shuki Porath, CEO Valcare Medical. “We appreciate the opportunity to work together with the excellent team at Schulich Heart Centre in Toronto, and benefit from their experience, assisting Valcare Medical in expanding innovative treatments for heart patients.”
Valcare will soon begin to enrol patients for its AMEND Plus pilot clinical study, and will launch an FDA early feasibility study (EFS).
The AMEND device is limited to investigational use and is not commercially available.