Regurgitation

Renexxion Ireland’s European Partner, Dr. Falk Pharma GmbH, has Elected PPI-non-responsive Symptomatic GERD as the Second Naronapride Indication to Develop and Commercialize in their Licensed Territories

Retrieved on: 
Wednesday, February 7, 2024

Falk Pharma”), has elected to advance the development of naronapride for patients with proton-pump inhibitor non-responsive symptomatic gastroesophageal reflux disease (PPI-nrsGERD) as the second indication in their licensed territories.

Key Points: 
  • Falk Pharma”), has elected to advance the development of naronapride for patients with proton-pump inhibitor non-responsive symptomatic gastroesophageal reflux disease (PPI-nrsGERD) as the second indication in their licensed territories.
  • In October 2021, Renexxion and Dr. Falk Pharma announced an exclusive Licensing and Collaboration Agreement to advance naronapride initially for gastroparesis in Greater Europe (including UK), Russia, Central Asian Republics, and certain Australasian countries.
  • Today, Renexxion is pleased to confirm that Dr. Falk Pharma will also advance naronapride for PPI-non-responsive symptomatic GERD in these regions.
  • This is a welcomed addition to our pipeline which includes naronapride for gastroparesis.”
    “We are very pleased that our European partner, Dr. Falk Pharma, chose PPI-nrsGERD as its next indication for development for naronapride in their territories.

The Surgical Clinic in Nashville, Tennessee, Offers the Minimally Invasive TIF® 2.0 Procedure for Patients with GERD

Retrieved on: 
Wednesday, June 14, 2023

Dr. Willie Melvin at The Surgical Clinic in Nashville, Tennessee, offers the Transoral Incisionless Fundoplication (TIF®) procedure for patients with gastroesophageal reflux disease (GERD).

Key Points: 
  • Dr. Willie Melvin at The Surgical Clinic in Nashville, Tennessee, offers the Transoral Incisionless Fundoplication (TIF®) procedure for patients with gastroesophageal reflux disease (GERD).
  • The TIF® 2.0 procedure is a minimally invasive, incisionless surgical solution for patients suffering from GERD and has been shown to improve patient outcomes and provide symptom relief.
  • Symptoms can be debilitating for those affected and can cause chronic heartburn, asthma, cough, regurgitation, and hoarse voice or chest pain.
  • “As an avid outdoors person, it was difficult not having enough energy due to my GERD symptoms interfering with my sleep.

Hoag Bringing Leading-Edge Mitral Valve Replacement Option to Orange County and Selected for the MOMENTIS Study

Retrieved on: 
Monday, April 17, 2023

NEWPORT BEACH, Calif., April 17, 2023 /PRNewswire/ -- Hoag is recruiting patients for a long-term study designed to collect real-world clinical outcomes for a new mitral valve replacement option.

Key Points: 
  • NEWPORT BEACH, Calif., April 17, 2023 /PRNewswire/ -- Hoag is recruiting patients for a long-term study designed to collect real-world clinical outcomes for a new mitral valve replacement option.
  • Because the valve has already received FDA approval, Hoag has already performed more than a dozen mitral valve replacements using this valve over the last eight months.
  • To qualify for the study, patients are required to be otherwise healthy and in need of a mitral valve replacement, rather than a valve repair procedure.
  • "More than 90% of mitral valve surgeries at Hoag are performed to repair the mitral valve.

EndoGastric Solutions, Inc.® Develops Reflux-Friendly Cookbook to Promote GERD Awareness Week

Retrieved on: 
Monday, November 21, 2022

EndoGastric Solutions, Inc. today announced the companies national campaign, GERD Gourmet; Recipes for Reflux, supporting GERD Awareness Week, November 20th-26th.

Key Points: 
  • EndoGastric Solutions, Inc. today announced the companies national campaign, GERD Gourmet; Recipes for Reflux, supporting GERD Awareness Week, November 20th-26th.
  • The International Federation for Gastrointestinal Diseases (IFFGD) designated Gerd Awareness Week as a time for encouraging individuals experiencing GERD symptoms to consult their physician and seek out information and support regarding the condition.
  • The first line of treatment for patients with GERD is often to make lifestyle changes, including diet and scheduled eating times.
  • GERD Awareness Week is the ideal time to remind patients that they should take their GERD symptoms seriously.

Affluent Medical : Pivotal study progresses to 24 patients successfully implanted with KaliosTM, an adjustable mitral ring that avoids complex re-interventions.

Retrieved on: 
Friday, October 28, 2022

Affluent Medical : Pivotal study progresses to 24 patients successfully implanted with KaliosTM, an adjustable mitral ring that avoids complex re-interventions.

Key Points: 
  • Affluent Medical : Pivotal study progresses to 24 patients successfully implanted with KaliosTM, an adjustable mitral ring that avoids complex re-interventions.
  • Pivotal study progresses to 24 patients successfully implanted with KaliosTM, an adjustable mitral ring
    Excellent results continue to confirm the efficacy of the KaliosTM adjustable mitral ring in the Optimise II pivotal study.
  • Sustained interest from the surgical community, for the KaliosTM adjustable mitral ring function performed on 5 patients.
  • After adjustment, the results in terms of reduction of mitral regurgitation were excellent with for these 5 patients, namely trivial mitral regurgitation (grade 1+).

EndoStim Receives FDA Breakthrough Device Designation for the EndoStim System for the Treatment of Drug Refractory GERD

Retrieved on: 
Tuesday, October 25, 2022

EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Companys EndoStim System.

Key Points: 
  • EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Companys EndoStim System.
  • "We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD, said Eric Goorno, Chief Executive Officer of EndoStim.
  • We look forward to working closely with the FDA to expedite the review of the EndoStim System.
  • EndoStim is a medical device company developing and commercializing a first-in-class neurostimulation treatment system for drug refractory gastroesophageal reflux disease (GERD).

Thubrikar Aortic Valve announces initial 30-day outcomes of CE Mark-enabling TAVI-1 Study

Retrieved on: 
Tuesday, August 2, 2022

Thubrikar Aortic Valve, Inc. , announced today successful 30-day outcomes in the first two patients receiving the Optimum Transcatheter Aortic Valve (Optimum TAV).

Key Points: 
  • Thubrikar Aortic Valve, Inc. , announced today successful 30-day outcomes in the first two patients receiving the Optimum Transcatheter Aortic Valve (Optimum TAV).
  • Williams and Kodali report disclosures with Thubrikar Aortic Valve, Inc.
    Thubrikar Aortic Valve, Inc. is a privately held medical device company based near Philadelphia, PA, that has developed a next-generation transcatheter aortic valve, the Optimum TAV, and delivery catheter, collectively called the Optimum TAVI System.
  • Optimum TAV was designed to mimic the natural aortic valve using 30 years of research by the companys Founder, Dr. Mano Thubrikar.
  • He is the author of The Aortic Valve, a leading textbook covering the fundamentals of valve structure and function.

Establishing TAVR for the Treatment of Aortic Regurgitation(1)

Retrieved on: 
Tuesday, June 15, 2021

This milestone includes patients enrolled in the multi-center prospective clinical trial, treating symptomatic, severe high surgical risk aortic regurgitation (AR) patients (The ALIGN-AR Clinical Trial).

Key Points: 
  • This milestone includes patients enrolled in the multi-center prospective clinical trial, treating symptomatic, severe high surgical risk aortic regurgitation (AR) patients (The ALIGN-AR Clinical Trial).
  • AR is a condition that occurs when a patients aortic valve does not close properly, resulting in reverse blood flow from the aorta back into the left ventricle.
  • The current treatment for high surgical risk patients who are not candidates for open-heart surgery is limited and consists of medical management.
  • JenaValve Technology, Inc., with locations in Irvine, California, Leeds, U.K., and Munich, Germany, develops and manufactures transcatheter aortic valve implantation (TAVR) systems to treat patients suffering from aortic valve disease.

Global Tricuspid Valve Repair Market (2021 to 2025) - Size & Forecast with Impact Analysis of COVID-19 - ResearchAndMarkets.com

Retrieved on: 
Friday, June 11, 2021

Tricuspid valve disease often transpires with other heart valve problems.

Key Points: 
  • Tricuspid valve disease often transpires with other heart valve problems.
  • There are primarily two types of tricuspid valve disease that are tricuspid regurgitation (TR) and tricuspid stenosis.
  • For the treatment of patient's with such kind of disease tricuspid valve repair and tricuspid valve replacement treatments are opted such treatment cure diseases affecting the tricuspid valve.
  • Though, the growth of global tricuspid valve repair market would be negatively impacted by various challenges.

FDA Grants Micro Interventional Devices, Inc. Breakthrough Device Designation for the MIA™-T Percutaneous Tricuspid Annuloplasty System

Retrieved on: 
Thursday, May 27, 2021

NEWTOWN, Pa., May 27, 2021 /PRNewswire/ -- Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA-T Percutaneous Tricuspid Annuloplasty System.

Key Points: 
  • NEWTOWN, Pa., May 27, 2021 /PRNewswire/ -- Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA-T Percutaneous Tricuspid Annuloplasty System.
  • The MIA-T system treats moderate-severe tricuspid regurgitation (TR) via a 12F catheter-based system.
  • The safety and performance of MIA-T has been demonstrated in the STTAR, Study of Transcatheter Tricuspid Annular Repair, conducted at 6 European clinical sites.
  • * We expect that breakthrough device designation will speed the process to commercialization so patients, physicians and the healthcare system can benefit from this technology."