Affluent Medical Presents Poster on First Successful Procedure with Epygon at the 2023 CSI Conference in Frankfurt

Affluent Medical Presents Poster on First Successful Procedure with Epygon at the 2023 CSI Conference in Frankfurt
 

• Transcatheter mitral valve implantation with Epygon prosthesis in E-poster session at CSI
• Device is the only biomimetic transcatheter cardiac mitral valve in development that mimics the native mitral valve and restores physiological blood flow
• Positive results from first patient implanted indicate the safety of the procedure, improvement of functional status and hemodynamic patterns
   

Aix-en-Provence, June 28, 2023 – 01:00 pm CEST – Affluent Medical (Euronext Paris: FR0013333077 – AFME), a French clinical-stage MedTech company specialized in innovative, minimally-invasive implants designed to restore key physiological functions in patients suffering from structural heart diseases as well as urinary incontinence, today announced that it will present an E-poster about its product Epygon at the CSI 2023, taking place June 28-30 in Frankfurt, Germany.
 

Poster Details:

Abstract Title: TRANSCATHETER MITRAL VALVE IMPLATATION WITH THE EPYGON PROSTHESIS: FIRST-IN-HUMAN

Poster Session: E-Poster: Valve Disease

Session start: Thursday, June 29, 7:00am-8.30am CEST

Location: CSI Lounge: Screen 1

“We are excited to inform the specialist audience about the first successful procedure with our Epygon system,” said Dr. Christophe Giot, Vice President Clinical Affairs. “Our device is the only biomimetic transcatheter cardiac mitral valve in development that mimics the native mitral valve and physiological blood flow. Implanted via a transcatheter route through a small incision in the chest and heart and equipped with a deployable hooking mechanism that allows the prosthetic to securely attach without the need for sutures, Epygon allows for a rapid and minimally invasive procedure on the beating heart, avoiding open heart surgery. The results we have seen so far from our first successful implantation in a high-risk patient are very promising, underlining the potential of our prosthetic to become a game-changer in structural cardiology.“

Positive results from the first patient implanted with the Epygon mitral valve were announced in April 2023 indicating the safety of the procedure, improvement of functional status and hemodynamic patterns. The patient, a 62-year-old woman, presented with a severe mitral insufficiency profile associated with comorbidities: severe diabetes, severe tricuspid regurgitation with a pacemaker, and ischemic heart disease, with risk of infarction. The transcatheter implantation of the Epygon device allowed to avoid an open-heart procedure, with a 15-minute valve positioning time and a short stay in intensive care. The patient was promptly discharged from the hospital for cardiac rehabilitation at D+5.

Shortly after the patient showed a significant improvement in health status. At the one- month follow-up, the patient’s functional status had improved, changing the New York Heart Association (NYHA) functional status from III to II, meaning that the patient is able to resume basic day to day activities without getting out of breath. The echocardiography showed excellent function of the Epygon valve.

Epygon is currently being evaluated in the ongoing first-in-human study titled Minerva – Mitral valve INsufficiency with Epygon tRanscatheter mitral VAlve system –, a prospective, multicenter, non-randomized, single-arm study of the minimally invasive medical device for mitral valve regurgitation. Conducted at nine clinical investigation centers in Italy, Austria, Spain and Serbia, the pilot study will include 10 to 15 adult patients with severe mitral regurgitation, with an NYHA functional class III to IV, an LVEF (ejection fraction) greater than or equal to 30% and at high risk for mitral valve surgery. The objective of the study is to evaluate the safety and efficacy of Epygon valve implantation at 30 days. Patients will be monitored for five years.

Affluent Medical anticipates presenting interim results from the first five patients of the Minerva pilot study at the Annual Meeting of the European Association for Cardio-Thoracic Surgery (EACTS) in October 2023.
 

About Epygon valve

Epygon is the first biomimetic transcatheter mitral valve that restores the natural vortex of blood flow in the left ventricle, thereby promoting recovery of ventricular function, particularly in frail patients with severely altered cardiac conditions. It is designed to potentially ensure superior clinical outcomes in patients with severe mitral regurgitation.

The unique features of the device include a single leaflet made of pericardial tissue combined with a D-shaped stent. The asymmetric nitinol stent with its anatomical anchoring systems ensures a stable anchoring under the mitral annulus by capturing the native leaflets and achieving an optimal fit with a low risk of LVOT (left ventricular outflow tract) obstruction. The transcatheter implantation makes it a rapid and minimally invasive procedure avoiding open heart surgery.
 

About Affluent Medical

Affluent Medical is a French MedTech company, founded by Truffle Capital, with the ambition to become a global leader in the treatment of structural heart diseases, which are the world's leading cause of mortality, and urinary incontinence currently affecting one in four adults.

Affluent Medical develops next-generation, minimally-invasive, innovative, adjustable, and biomimetic implants to restore critical physiological functions. The product candidates developed by the Company are currently in preclinical and clinical studies.

Subject to raising the necessary funds to finance its strategy and subject to positive results from ongoing clinical studies, the Company aims to progressively commercialize its products starting in 2025.

For more information: www.affluentmedical.com
 

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