Mitral valve

Affluent Medical : Excellent valve performance at 1 year follow up and rising recognition of Epygon biomimetic mitral valve.

Retrieved on: 
Wednesday, March 13, 2024

Affluent Medical : Excellent valve performance at 1 year follow up and rising recognition of Epygon biomimetic mitral valve.

Key Points: 
  • Affluent Medical : Excellent valve performance at 1 year follow up and rising recognition of Epygon biomimetic mitral valve.
  • The article summarizes the procedure and the follow up at 6 months, which showed continued good prosthetic performance.
  • Examination through a transesophageal echocardiogram revealed excellent valve performance, with neither mitral regurgitation nor paravalvular leak.
  • Mitral valve regurgitation is a serious and potentially fatal disease affecting 2% of the world's population, or approximately 160 million people.

Foldax, Inc. Signs Manufacturing Agreement with Dolphin Life Science India LLP to Expedite Upcoming Commercial Availability

Retrieved on: 
Tuesday, February 27, 2024

Foldax® Inc., a pioneer in the development of innovative, polymer heart valves, today announced a manufacturing agreement with Dolphin Life Science India LLP to enable in-country manufacturing of the TRIA™ polymer mitral surgical heart valve outside of the U.S. for the first time.

Key Points: 
  • Foldax® Inc., a pioneer in the development of innovative, polymer heart valves, today announced a manufacturing agreement with Dolphin Life Science India LLP to enable in-country manufacturing of the TRIA™ polymer mitral surgical heart valve outside of the U.S. for the first time.
  • The TRIA mitral valve is designed specifically to accommodate the anatomy and pressures of the mitral position.
  • Dolphin Life Science India LLP is an expert in manufacturing medical devices.
  • The company is registered with India’s regulatory bodies, the Drugs Controller General of India (DCGI), and the Central Drugs Standard Control Organization (CDSCO).

NeoChord, Inc. Appoints New Chief Executive Officer to Lead Commercialization Efforts and Study Novel First-Line Therapy for Mitral Valve Regurgitation

Retrieved on: 
Thursday, February 22, 2024

MINNEAPOLIS, Feb. 22, 2024 /PRNewswire/ --  NeoChord is a privately held, medical technology company and the world-leader in beating heart delivery of artificial chords in the treatment of mitral valve regurgitation.

Key Points: 
  • MINNEAPOLIS, Feb. 22, 2024 /PRNewswire/ --  NeoChord is a privately held, medical technology company and the world-leader in beating heart delivery of artificial chords in the treatment of mitral valve regurgitation.
  • The company appointed Todd Berg as Chief Executive Officer to oversee clinical and commercial programs for transeptal and transapical repair of damaged mitral valve chords resulting in regurgitation.
  • Berg has over 30 years of experience successfully developing and commercializing novel medical therapies and holds over 100 U.S. patents.
  • The opportunity to develop a first-line therapy for mitral valve disease, by resolving regurgitation early in the disease state, is incredibly compelling," said Berg.

NeoChord, Inc. Appoints New Chief Executive Officer to Lead Commercialization Efforts and Study Novel First-Line Therapy for Mitral Valve Regurgitation

Retrieved on: 
Thursday, February 22, 2024

MINNEAPOLIS, Feb. 22, 2024 /PRNewswire/ --  NeoChord is a privately held, medical technology company and the world-leader in beating heart delivery of artificial chords in the treatment of mitral valve regurgitation.

Key Points: 
  • MINNEAPOLIS, Feb. 22, 2024 /PRNewswire/ --  NeoChord is a privately held, medical technology company and the world-leader in beating heart delivery of artificial chords in the treatment of mitral valve regurgitation.
  • The company appointed Todd Berg as Chief Executive Officer to oversee clinical and commercial programs for transeptal and transapical repair of damaged mitral valve chords resulting in regurgitation.
  • Berg has over 30 years of experience successfully developing and commercializing novel medical therapies and holds over 100 U.S. patents.
  • The opportunity to develop a first-line therapy for mitral valve disease, by resolving regurgitation early in the disease state, is incredibly compelling," said Berg.

Your skin is a mirror of your health – here’s what yours might be saying

Retrieved on: 
Tuesday, January 30, 2024

It is the largest and most visible organ in the human body.

Key Points: 
  • It is the largest and most visible organ in the human body.
  • Being the most visible of our organs, the skin also offers us a view into the body tissues that it protects.
  • So don’t think of your skin merely aesthetically – think of it as a reflection of your health.

Bullseye

  • But while the vast majority of tick bites won’t make you ill, there is one rash that should prompt a visit to your doctor if you spot it.
  • Erythema migrans, a rash named for its ability to rapidly expand across the skin, is a hallmark of Lyme disease, a potentially severe bacterial illness.
  • This rash forms a classic target pattern, like a bullseye on a dartboard.

Purpura

  • Some rashes are given a colourful namesake – purpura is one such example.
  • Purpura refers to a rash of small purple or red dots.
  • Purpura signals an issue with either the walls of the tiny blood vessels that feed the skin or the blood within them.

Skin spiders


Skin rashes can also take on recognisable shapes. Spider naevi represent an issue within skin arterioles (small arteries which supply the skin with blood). Arterioles open and close to control the loss of heat from the body’s surface. But sometimes they can get stuck open – and a spider-like pattern will appear.

  • Crush the body under a fingertip and the whole thing disappears, as your touch temporarily stops the blood flow.
  • Treat the underlying cause, and the spiders often vanish with time – though they may persist or reappear later.

Black velvet

  • This “black velvet” skin appearance is more commonly seen in darker skins.
  • Usually, the condition is associated with disorders of the metabolism – namely type 2 diabetes and polycystic ovary syndrome.

Butterfly rashes

  • Cardiac valves have the important role of correctly directing the journey of blood through the heart and preventing backflow.
  • The body’s natural response is to preserve core blood volume, shutting off flow towards the skin.
  • The net effect can produce a purple-red rash, high across the cheeks and the bridge of the nose, like the outstretched wings of a butterfly.


Dan Baumgardt does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

Affluent Medical closes €3.5 million bridge via capital increase from key shareholders.

Retrieved on: 
Tuesday, January 30, 2024

Affluent Medical closes €3.5 million bridge via capital increase from key shareholders.

Key Points: 
  • Affluent Medical closes €3.5 million bridge via capital increase from key shareholders.
  • Key shareholders provide bridge to continue exploring options to secure long term financing.
  • Aix-en-Provence, 29 January 2024 - 5:45 pm - Affluent Medical (ISIN: FR0013333077 – Ticker: AFME), a French clinical-phase MedTech company specialising in the international development and industrialisation of innovative medical prostheses, today announced the closing of a €3.5 million bridge financing with its key existing shareholders.
  • Following this transaction, Affluent Medical share capital now consists of 33.145.236 shares, each with a nominal value of €0.10.

Affluent Medical : Pre-submission dossier for the 510(k) of medical device KaliosTM filed with FDA for review.

Retrieved on: 
Wednesday, January 17, 2024

Affluent Medical : Pre-submission dossier for the 510(k) of medical device KaliosTM filed with FDA for review.

Key Points: 
  • Affluent Medical : Pre-submission dossier for the 510(k) of medical device KaliosTM filed with FDA for review.
  • Assessments of the FDA review to be discussed in a meeting towards the end of the first quarter.
  • End of Q1 2024, Affluent Medical will schedule a meeting with the FDA to discuss their substantive feedback on the pre-submission dossier.
  • Affluent Medical believes that Kalios™ could avoid further interventions for potentially 30-40% of patients over five-years.

The Inner Circle Acknowledges, Divyakant B. Gandhi, MBBS, FRCS, FACS as a Distinguished Cardiothoracic Surgeon

Retrieved on: 
Monday, January 15, 2024

Divyakant B. Gandhi is an international physician, innovative thinker, and leader in cardiac care.

Key Points: 
  • Divyakant B. Gandhi is an international physician, innovative thinker, and leader in cardiac care.
  • He has been in practice as a Heart, Lung & Vascular surgeon for over 35 years.
  • As a leader in the clinical setting, Dr. Gandhi is the Chief of Staff, Medical Director, and Chief of Cardiovascular & Thoracic Surgery at McLaren Greater Lansing.
  • Dr. Gandhi practices his specialty under the auspices of the Center for Cardiovascular and Thoracic Surgery in Detroit, MI.

ReValve Solutions Announces Successful First-in-Human with Next Generation TMVR Technology

Retrieved on: 
Wednesday, November 29, 2023

ReValve Solutions Inc. (ReValve), which has developed a next generation technology for Transcatheter Mitral Valve Replacement (TMVR), announced that an 81-year-old male, with a history of heart failure, a series of failed surgical by-pass grafts and severe mitral regurgitation (MR 4+), was successfully treated with the Palmetto System.

Key Points: 
  • ReValve Solutions Inc. (ReValve), which has developed a next generation technology for Transcatheter Mitral Valve Replacement (TMVR), announced that an 81-year-old male, with a history of heart failure, a series of failed surgical by-pass grafts and severe mitral regurgitation (MR 4+), was successfully treated with the Palmetto System.
  • ReValve’s technology is designed to replace the Mitral Valve while also preserving the heart’s natural basal left ventricular function.
  • Our flexibility and four-point securement system provide a patent LVOT and maintains left ventricular function throughout recovery,” said Julie Logan Sands, Founder and CEO ReValve Solutions.
  • ReValve’s first-of-its-kind TMVR is thoughtfully designed to expand the treatable population of patients suffering from Mitral Valve Disease,” added Sands.

Foldax Completes Enrollment in India Clinical Trial Evaluating TRIA™ Polymer Surgical Mitral Heart Valve

Retrieved on: 
Monday, November 27, 2023

Foldax® , Inc., a leader in the development of innovative, polymer heart valves, today announced completion of enrollment in the Indian clinical trial of the TRIA™ polymer surgical mitral heart valve.

Key Points: 
  • Foldax® , Inc., a leader in the development of innovative, polymer heart valves, today announced completion of enrollment in the Indian clinical trial of the TRIA™ polymer surgical mitral heart valve.
  • The TRIA mitral valve is designed specifically for the anatomy and pressures of the mitral position.
  • “We are excited to see early promising results from the TRIA polymer mitral valve,” said Kaushal Pandey, MD, with P.D.
  • “The blood flow dynamics are excellent, and the polymer material properties are formulated to resist calcification, one of the main causes of tissue valve failure.”
    The Indian TRIA surgical mitral valve study is a prospective multicenter clinical trial.