Country for PR: United Kingdom
Contributor: PR Newswire Europe
Thursday, January 28 2021 - 05:33
AsiaNet
Valcare Medical Announces First-in-Human Transseptal Implant of the AMEND[TM] Annuloplasty Ring for Mitral Valve Repair
HERZLIYA, Israel, January 28, 2021, /PRNewswire-AsiaNet/--

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[TM] 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 [https://www.valcaremedical.com/valve-repair-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.   

Valcare Medical 

Valcare Medical [https://www.valcaremedical.com/ ] is a privately held medical 
device company, dedicated to providing innovative transcatheter technologies 
for the treatment of mitral and tricuspid regurgitation. Valcare is developing 
medical devices, designed to become an integral part of every structural heart 
procedure.
Contact

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

Photo - 
https://mma.prnewswire.com/media/1428133/Valcare_Medical_Annuloplasty_ring.jpg  
Logo - https://mma.prnewswire.com/media/1428135/Valcare_Medical_Logo.jpg 

SOURCE: Valcare Medical Ltd.
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