Fistula

Exclusive license agreement secured with Erganeo for EVerGel, EVerZom's first drug candidate, a breakthrough treatment for fistulas and fibrosis of the digestive tract.

Retrieved on: 
Tuesday, March 5, 2024

Exclusive license agreement secured with Erganeo for EVerGel, EVerZom's first drug candidate, a breakthrough treatment for fistulas and fibrosis of the digestive tract.

Key Points: 
  • Exclusive license agreement secured with Erganeo for EVerGel, EVerZom's first drug candidate, a breakthrough treatment for fistulas and fibrosis of the digestive tract.
  • This new worldwide license marks a significant step forward in EVerZom's mission to bring innovative exosome-based therapeutic solutions to patients suffering from serious digestive diseases.
  • Paris, March 5, 2024 - EVerZom, a CNRS/Université Paris Cité spin-off specializing in exosomes, has announced the signature of a second exclusive license agreement with Erganeo for the development of EVerGel ™, a drug candidate tailored for the healing of digestive tissues.
  • EVerZom's first clinical application focuses on digestive tissue regeneration using naive exosomes derived from stem cells encapsulated in a gel called EVerGel ™.

Axena Health study shows incontinence is a major burden for women in Kenya and Nigeria

Retrieved on: 
Friday, March 8, 2024

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, unveiled the findings from a landmark study to understand the impact of urinary incontinence (UI) on women in sub-Saharan Africa.

Key Points: 
  • Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, unveiled the findings from a landmark study to understand the impact of urinary incontinence (UI) on women in sub-Saharan Africa.
  • Through conversations, focus groups and quantitative surveys, women and clinicians expressed a strong desire for education and treatment.
  • Axena Health will conduct a second study in Nigeria to test the feasibility of implementing clinic-based treatment that leverages Leva’s technology.
  • “We believe this is the first large-scale qualitative study to document the significant burden of incontinence among women in Kenya and Nigeria,” said Oliver Muchiri, co-author of the report and Practice Lead, Service and Systems Design Unit at ThinkPlace Kenya.

PatenSee and Fresenius Medical Care Sign Clinical Collaboration Agreement

Retrieved on: 
Tuesday, February 13, 2024

OR YEHUDA, Israel and RAANANA, Israel, Feb. 13, 2024 /PRNewswire/ -- PatenSee, developer of a fistula monitoring system for dialysis patients, has entered into an agreement with Fresenius Medical Care, a leading global provider of dialysis services.

Key Points: 
  • OR YEHUDA, Israel and RAANANA, Israel, Feb. 13, 2024 /PRNewswire/ -- PatenSee, developer of a fistula monitoring system for dialysis patients, has entered into an agreement with Fresenius Medical Care, a leading global provider of dialysis services.
  • Under the agreement, the parties will first collaborate in a joint, multi-center, pilot trial of PatenSee's contactless monitoring system in Fresenius Medical Care's dialysis clinics in Israel.
  • "Timely monitoring and analysis of the fistula status of hemodialysis patients are major clinical unmet needs and PatenSee's contactless, rapid monitoring has the potential to make a significant impact in dialysis patients," said Adi Shaked, Venture Innovation Manager-Israel at Fresenius Medical Care, which is leading the collaboration from the Fresenius Medical Care Ventures team, along with Dr. Alon Antebi, country medical director at Fresenius Medical Care, Israel.
  • We are happy to start this new phase of implementing PatenSee's contactless monitoring technology and even happier to perform this study in collaboration with Fresenius Medical Care with its wealth of experience and clinical expertise," said Shai Policker, chairman of PatenSee.

InventHelp Inventor Develops New Garment Line for Patients with IVs & Ports (CHK-952)

Retrieved on: 
Wednesday, January 24, 2024

Key Points: 
  • I wanted to create attire that outpatients could wear to dialysis and other treatments," said an inventor, from Blue Island, Ill., "so I invented GRAY'S ACCESS.
  • My design would provide added comfort while ensuring access to the anterior arm for ports, fistulas, or catheters."
  • The invention provides a new garment specifically designed for patients with IVs.
  • It also increases comfort and warmth for the patient and it eliminates the need to remove or reposition clothing items.

First Implantation of VasQ External Support Device in Greece

Retrieved on: 
Tuesday, January 23, 2024

ATHENS, Greece, Jan. 23, 2024 /PRNewswire/ -- The first implantation of the VasQ™ external support device in Greece was successfully performed by Dr. Alexandros Mallios at Henry Dunant Hospital Center in Athens, Greece.

Key Points: 
  • ATHENS, Greece, Jan. 23, 2024 /PRNewswire/ -- The first implantation of the VasQ™ external support device in Greece was successfully performed by Dr. Alexandros Mallios at Henry Dunant Hospital Center in Athens, Greece.
  • As a visiting surgeon, Dr. Mallios worked with the center's physicians to introduce VasQ to patients served by the Henry Dunant Hospital Center.
  • The device is unique in that it is implanted around the artery-vein connection to provide permanent external support to the mobilized venous segment, which is the typical site of early fistula failure.
  • Laminate CEO Tammy Gilon expressed her enthusiasm for the successful inaugural VasQ case in Greece.

First U.S. Implantation of VasQ™ Since FDA De Novo was Granted

Retrieved on: 
Tuesday, January 16, 2024

SPARTANBURG, S.C., Jan. 16, 2024 /PRNewswire/ -- The first U.S. implantation of VasQ™ since FDA De Novo was granted was successfully performed by Dr. Ari Kramer, Director and principal surgeon of Vascular Access Surgery at Spartanburg Regional Hospital in Spartanburg, SC.

Key Points: 
  • SPARTANBURG, S.C., Jan. 16, 2024 /PRNewswire/ -- The first U.S. implantation of VasQ™ since FDA De Novo was granted was successfully performed by Dr. Ari Kramer, Director and principal surgeon of Vascular Access Surgery at Spartanburg Regional Hospital in Spartanburg, SC.
  • VasQ is a nitinol-based external support device for the artery and vein anastomosis during the surgical creation of an arteriovenous fistula to promote maturation into a functional access for hemodialysis.
  • The device was designed to provide structural reinforcement of the mobilized vessels and guides a more stable arterial flow profile as it transitions into the vein.
  • Creating more functional fistulas with the assistance of a device like VasQ should help to reduce the CVC exposure for this patient population.

EVerZom: Therapeutic Ambition in Exosome Biotherapies

Retrieved on: 
Wednesday, December 13, 2023

Paris, December 13, 2023 - EverZom, a CNRS/University Paris Cité spin-off specializing in exosomes, today unveils its proprietary pipeline of exosome biotherapies developed thanks to its proprietary innovation platform.

Key Points: 
  • Paris, December 13, 2023 - EverZom, a CNRS/University Paris Cité spin-off specializing in exosomes, today unveils its proprietary pipeline of exosome biotherapies developed thanks to its proprietary innovation platform.
  • This revolutionary drug modality constitutes a new therapeutic era for acellular off the shelf therapeutics, opening up new opportunities in cell and gene therapy.
  • This platform addresses the entire technological value chain, from cell to patient: cell sourcing, exosome generation, engineering and formulation.
  • Leveraging its innovation platform, EVerZom’s ambition is to develop its pipeline of proprietary biotherapies in regenerative medicine, while building partnerships in several other indications.

Outstanding 12-month first-in-human data from Xeltis’ aXess hemodialysis vascular conduit trial presented at VEITHsymposium 2023

Retrieved on: 
Friday, November 17, 2023

The data was presented yesterday by Prof. Dr. Frans Moll at the 50th Annual VEITHsymposium in New York.

Key Points: 
  • The data was presented yesterday by Prof. Dr. Frans Moll at the 50th Annual VEITHsymposium in New York.
  • At 12 months, 100% secondary patency, 78% primary assisted patency and 0% infections were observed in data from 20 patients implanted with the aXess conduit.
  • This performance builds on the very encouraging 6-month data presented in April 2023 at the Vascular Access Society Congress in Porto, Portugal.
  • aXess is a restorative conduit which enables the creation of a new, long-term living vessel for hemodialysis vascular access.

Oral Presentation at American Heart Association’s Scientific Sessions Highlights the Need for Esophageal Protection During Ablation

Retrieved on: 
Monday, November 13, 2023

An oral presentation at the American Heart Association’s Scientific Sessions examined recent reporting rates of esophageal injury after left atrial ablation for the treatment of atrial fibrillation and found that the rates have not decreased in the last four years.

Key Points: 
  • An oral presentation at the American Heart Association’s Scientific Sessions examined recent reporting rates of esophageal injury after left atrial ablation for the treatment of atrial fibrillation and found that the rates have not decreased in the last four years.
  • The presentation at AHA by Christopher Joseph, MD (University of Texas, Southwestern Medical Center, Dallas, TX, USA) during the session Rapid Fire: More Sessions on Atrial Fibrillation Ablation.. Get Ready!!
  • reviewed data from the Manufacturer and User Facility Device Experience (MAUDE) database.
  • Reported fatality rates remain high at 41 percent.

VEGZELMA® (bevacizumab-adcd) receives preferred formulary status with Ventegra® for commercially insured patients

Retrieved on: 
Monday, December 11, 2023

Ventegra's proprietary formulary program (which includes Formulary Shield and the Ventegra Specialty Inclusion Program) is available for access by more than 400 clients and 13 million members/patients that are enrolled with Ventegra.

Key Points: 
  • Ventegra's proprietary formulary program (which includes Formulary Shield and the Ventegra Specialty Inclusion Program) is available for access by more than 400 clients and 13 million members/patients that are enrolled with Ventegra.
  • Gastrointestinal Perforations and Fistula: Discontinue for gastrointestinal perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ.
  • Surgery and Wound Healing Complications: In patients who experience wound healing complications during VEGZELMA treatment, withhold VEGZELMA until adequate wound healing.
  • Do not administer VEGZELMA for at least 28 days following a major surgery, and until adequate wound healing.