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HERZLIYA, Israel, January 28, 2021, /PRNewswire=KYODO JBN/--

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.