Mitral insufficiency

Affluent Medical : Affluent Medical announces the launch of a capital increase of around €13 million with preferential subscription rights maintained by shareholders

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Monday, February 13, 2023
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Sébastien Ladet, Chief Executive Officer of Affluent Medical, said: "Affluent Medical enters 2023 with a clear roadmap and strong ambitions.

Key Points: 
  • Sébastien Ladet, Chief Executive Officer of Affluent Medical, said: "Affluent Medical enters 2023 with a clear roadmap and strong ambitions.
  • The development of accessories for Epygon and the industrialization of medical devices Epygon and Artus would be postponed.
  • Each shareholder of Affluent Medical may subscribe for 13 ABSARs on an irreducible basis for 28 existing shares held, i.e.
  • Preferential subscription rights will be traded on Euronext Paris from February 10, 2023 to February 23, 2023, inclusive, under ISIN code FR001400FL20.

Affluent Medical reports excellent safety and performance interim result of its Optimize II pivotal clinical study with Kalios TM , adjustable mitral ring, in the treatment of mitral regurgitation.

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Tuesday, July 26, 2022
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Affluent Medical reports excellent safety and performance interim result of its Optimize II pivotal clinical study with Kalios TM , adjustable mitral ring, in the treatment of mitral regurgitation.

Key Points: 
  • Affluent Medical reports excellent safety and performance interim result of its Optimize II pivotal clinical study with Kalios TM , adjustable mitral ring, in the treatment of mitral regurgitation.
  • Affluent Medical reports excellent safety and performance interim result of its Optimize II pivotal clinical study with KaliosTM, adjustable mitral ring, in the treatment of mitral regurgitation
    Affluent Medical (ISIN code: FR0013333077 Ticker: AFME), a French medtech specializing in the international development and industrialisation of innovative medical prostheses, at a clinical stage, to treat cardiac mitral valve pathology and urinary incontinence, today reports excellent safety and performance interim result of its Optimize II pivotal study with KaliosTM adjustable mitral ring.
  • KaliosTM also would have the potential to improve the longer-term treatment of recurrent mitral regurgitation.
  • Today we report interim data of the first 16 patients with analysis completed in May 2022 from our pivotal Optimize II study.

Affluent Medical : 2021 full-year results and update on clinical programs.

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Friday, April 1, 2022
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According to Affluent Medical estimates, fewer than 4% of the 4 million patients with severe mitral insufficiency benefit from surgery.

Key Points: 
  • According to Affluent Medical estimates, fewer than 4% of the 4 million patients with severe mitral insufficiency benefit from surgery.
  • [6]
    Affluent Medical is currently developing two medical devices to address the treatment of mitral insufficiency: Kalios and Epygon.
  • Following the positive results of the Optimise study, Affluent Medical initiated a clinical study, Optimise II pivotal for its Kalios device.
  • Affluent Medical develops innovative, next-generation minimally invasive implants to restore essential physiological functions in these areas.

EDWARDS MITRIS RESILIA VALVE RECEIVES FDA APPROVAL FOR MITRAL REPLACEMENT SURGERIES

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Thursday, March 31, 2022
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The MITRIS RESILIA valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve.

Key Points: 
  • The MITRIS RESILIA valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve.
  • The introduction of the MITRIS RESILIA valve completes the portfolio of surgical heart valve innovations incorporating the advanced RESILIA tissue, including an aortic valve, an aortic valved conduit and now a mitral valve.
  • In addition to FDA approval, the MITRIS RESILIA valve has also received regulatory approval in Japan, Canada, and other countries globally.
  • Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Carpentier-Edwards PERIMOUNT, MITRIS, MITRIS RESILIA, PERIMOUNT, and RESILIA are trademarks of Edwards Lifesciences Corporation.

NeoChord Appoints Martin B. Leon, M.D. as Executive Chair of the U.S. Early Feasibility Study of the NeoChord Transcatheter NeXuS System

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Monday, March 14, 2022
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as Executive Chair of the U.S. early feasibility study (EFS) of the NeoChord Transcatheter NeXuS System, a transformational device for mitral chordal repair.

Key Points: 
  • as Executive Chair of the U.S. early feasibility study (EFS) of the NeoChord Transcatheter NeXuS System, a transformational device for mitral chordal repair.
  • I look forward to working with the NeoChord team as Executive Chair of this early feasibility study in the U.S., particularly given the exciting potential of the NeXuS Transcatheter Mitral Repair Technology, said Dr. Leon.
  • The NeoChord NeXuS Transcatheter Mitral Chordal Repair device is unique from other mitral valve repair technologies in maintaining a natural physiologic functionality of the mitral valve.
  • NeoChord is now adding the minimally invasive transcatheter chordal repair system NeoChord NeXus to its portfolio and is underlining the leading position in degenerative mitral valve chordal treatment.

NeoChord Announces Positive 30-day Results with Transcatheter NeXuS System for Mitral Chordal Repair Using Multiple Chords to a Single Anchor

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Monday, November 22, 2021
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The procedure was completed with the NeoChord Transcatheter NeXuS System, a transformational device for mitral chordal repair, and the results track the first patient enrolled in NeoChords early feasibility study.

Key Points: 
  • The procedure was completed with the NeoChord Transcatheter NeXuS System, a transformational device for mitral chordal repair, and the results track the first patient enrolled in NeoChords early feasibility study.
  • The NeoChord NeXuS Transcatheter Mitral Chordal Repair device is unique from other mitral valve repair technologies in maintaining a natural physiologic functionality of the mitral valve.
  • NeoChord is a privately held medical technology company leading the advancement of beating heart mitral valve repair in patients suffering from mitral valve regurgitation.
  • NeoChord is now adding the minimally invasive transcatheter chordal repair system NeoChord NeXus to its portfolio and is underlining the leading position in degenerative mitral valve chordal treatment.

Global Structural Heart Devices Market Opportunities Report 2021: Mitral Valve Repair and Replacement Platforms Could Exceed the Growth of Aortic Valve Therapies - ResearchAndMarkets.com

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Tuesday, November 16, 2021
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The "Global Structural Heart Devices Growth Opportunities" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Structural Heart Devices Growth Opportunities" report has been added to ResearchAndMarkets.com's offering.
  • The uptake of structural heart therapies has increased drastically over the past decade with advancements in catheter-based treatment.
  • Heart valve therapies hold the majority revenue share in the structural heart intervention market due to higher adoption of proven methods, clinical expertise, and prevalence of valvular heart diseases (VHD).
  • In line with this trend, myriad devices designed for mitral valve repair and replacement procedures are expected in the market to solve the huge unmet need for mitral valve treatment.

Medtronic announces early data for the Intrepid™ transcatheter mitral valve replacement (TMVR) system using new transfemoral delivery system

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Saturday, November 6, 2021
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DUBLIN and ORLANDO, Fla., Nov. 6, 2021 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today presented early data for its self-expanding Intrepid™ transcatheter mitral valve replacement (TMVR) system in patients with severe, symptomatic mitral valve regurgitation (MR) utilizing the transfemoral access route. Presented as Late-Breaking Clinical Science at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation, data from the first 15 patients enrolled in an Early Feasibility Study of the Intrepid Transfemoral System showed 100% survival and no stroke, a median procedure time of 46 minutes, and none/trace MR in all implanted patients at 30 days. The data were published simultaneously in the Journal of the American College of Cardiology (JACC): Cardiovascular Intervention.

Key Points: 
  • DUBLIN and ORLANDO, Fla., Nov. 6, 2021 /PRNewswire/ --Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today presented early data for its self-expanding Intrepid transcatheter mitral valve replacement (TMVR) system in patients with severe, symptomatic mitral valve regurgitation (MR) utilizing the transfemoral access route.
  • Mitral regurgitation (MR) occurs when blood flows backward through the mitral valve and into the atrium each time the left ventricle contracts.
  • The Intrepid valve has been used to treat more than 350 patients as part of global clinical trials.
  • Using a delivery catheter to insert the valve into the heart, the new replacement valve is expanded directly into the malfunctioning mitral valve.

NeoChord Announces Successful Completion of First in Human Procedure with its NeoChord NeXuS Transcatheter Mitral Chordal Repair Technology

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Monday, October 4, 2021
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ST. LOUIS PARK, Minn., Oct. 04, 2021 (GLOBE NEWSWIRE) -- NeoChord, Inc. , a privately-held medical technology company leading the advancement of beating heart mitral valve repair in patients suffering from mitral valve regurgitation, today announced successful completion of the first-in-human procedure with the NeoChord NeXuS Transcatheter Mitral Chordal Repair technology (TMVr).

Key Points: 
  • ST. LOUIS PARK, Minn., Oct. 04, 2021 (GLOBE NEWSWIRE) -- NeoChord, Inc. , a privately-held medical technology company leading the advancement of beating heart mitral valve repair in patients suffering from mitral valve regurgitation, today announced successful completion of the first-in-human procedure with the NeoChord NeXuS Transcatheter Mitral Chordal Repair technology (TMVr).
  • We are pleased with the positive result of this first-in-human procedure of the NeoChord NeXuS Transcatheter Mitral Chordal Repair device.
  • The NeoChord NeXuS Transcatheter Mitral Chordal Repair device is unique from other mitral valve repair technologies in maintaining a natural physiologic functionality of the mitral valve.
  • NeoChord is now adding the minimally invasive transcatheter chordal repair system NeoChord NeXuS to its portfolio and is underlining the leading position in degenerative mitral valve chordal treatment.

Affluent Medical : Successful first post-operative adjustment of KaliosTM mitral ring.

Retrieved on: 
Thursday, September 16, 2021
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Affluent Medical : Successful first post-operative adjustment of KaliosTM mitral ring.

Key Points: 
  • Affluent Medical : Successful first post-operative adjustment of KaliosTM mitral ring.
  • Affluent Medical (ISIN: FR0013333077 - ticker: AFME), a French medtech specialising in the international development and industrial scale-up of innovative medical prostheses, at a clinical stage, to treat urinary incontinence and cardiac mitral insufficiency, today announces the success of the first ever KaliosTM mitral ring adjustment on a patient suffering from post-operative recurrence of severe mitral insufficiency.
  • Following successful implantation of a KaliosTM adjustable mitral ring, a simple trace of residual leakage was observed in a patient, who was operated in August 2020 for major mitral insufficiency (4+) [1] ,following a myocardial infarction.
  • Affluent Medical's Chief Medical Officer Prof. Franois Laborde confirmed that the KaliosTM device was a major breakthrough in treating mitral regurgitation and its recurrence, which happens between 30% and 40% of the redo mitral incompetence as reported in the medical literature.