Transeptal Mitral Annuloplasty With the AMEND System: 6-Month Results of First in Man Cohort, by Drs. Melica, Carasso, Butnaru, Gogorishvili, Metreveli, Modine, Kurashvili, Farkash, Meerkin, has been accepted for publication in Circulation: Cardiovascular Interventions.

Background: The AMEND implant is a semi-rigid closed D-shaped annuloplasty ring deployed through a transvenous transeptal approach. It is aimed to affect selective anteroposterior dimensional reduction, improving leaflet coaptation, and reduce mitral regurgitation (MR). We report the 6-month outcomes of the first cohort treated.

Methods: Thirteen patients with the grade 3 or 4 functional MR were treated in 2 studies in Georgia and Israel, and with compassionate approvals in Portugal and France. They underwent mitral repair with the AMEND annuloplasty and were followed for 6 months.

Results: There were no deaths, myocardial infarctions, strokes or cardiac surgery. There were 2 pericardial effusions, 1 acute and the second at 4 months. There was no anchor disengagement or device dehiscence over the follow-up period. There was a single patient who was readmitted with heart failure, and the iatrogenic atrial septal defect was closed. At 6 months the overall anteroposterior dimensional reduction achieved acutely was maintained, with MR reduction being stable, with 11 of 13 patients with ≤grade 1 MR.

Conclusions: In this small multicenter cohort of patients, the AMEND annuloplasty procedure demonstrated promising safety, with stable and significant reduction of MR maintained over the 6-month follow-up period.
Read more here

Listen to Dr. Paul Sorajja, Interventional Cardiologist at Banner University Medical Center Phoenix, describe the first implantation of the AMEND annuloplasty ring via a novel trans-septal system designed to help a leaky mitral valve. Video here: New catheter procedure treats leaky heart valves – Arizona PBS

For additional news coverage:

Medical breakthrough helps patients avoid open heart surgery – Fox 10 Phoenix

Phoenix hospital performs groundbreaking heart procedure – KTAR.com

First case of transcatheter mitral annuloplasty performed in AMEND EFS trial – Cardiovascular News

Banner Health performs 1st US mitral valve repair implant – Becker’s Cardiology

Banner Health doctor pioneer in heart valve repair – Daily Independent

First-in-America Implantation of AMEND Annuloplasty Ring in Mitral Regurgitation, With Paul Sorajja, MD | HCPLive

Watch DeviceTalks host Tom Salemi interview Steve Sandweg CEO and Dr. David Meerkin CMO as they discuss how Valcare’s AMEND™ TMVr Annuloplasty System is re-engineering mitral valve repair. Register here to gain immediate access to view the webinar recording.

Webinar Overview

Surgical Annuloplasty has long been the gold standard for restoring mitral valve function. But until now, replicating that level of anatomical precision through a catheter-based approach has remained one of structural heart’s toughest challenges.

In this webinar, DeviceTalks explores the work behind Valcare Medical’s AMEND™ Transcatheter Mitral Valve RepairSystem, a proprietary investigational transcatheter mitral annuloplasty system designed to perform surgical-like mitral repair.

Topics covered:

• Unmet needs with existing transcatheter mitral valve repair.
• Annuloplasty is base technique in almost all surgical mitral repair irrespective of base pathology.
• About the proprietary design of the AMEND™ TMVr Annuloplasty System.
• Where this technology fits in the evolving transcatheter mitral repair ecosystem.

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.