Paracentesis

New Case Series Demonstrates Potential of Aquadex Therapy for End-Stage Liver Disease Patients with Fluid Overload

Retrieved on: 
Tuesday, February 6, 2024

The publication, “Utilization of Aquapheresis Among Hospitalized Patients with End-Stage Liver Disease: A Case Series and Literature Review,” is a single-center retrospective case series featured in Clinical Transplantation .

Key Points: 
  • The publication, “Utilization of Aquapheresis Among Hospitalized Patients with End-Stage Liver Disease: A Case Series and Literature Review,” is a single-center retrospective case series featured in Clinical Transplantation .
  • The most common cause of liver disease was alcohol-related, with nine of the 14 patients presenting with alcohol-associated cirrhosis.
  • In this case series, Aquadex was shown to provide a potential additional solution to mitigate these clinical gaps.
  • Aquadex is proven to simply, safely, and precisely remove excess fluid from patients suffering from fluid overload who have not responded to conventional medical management, including diuretics.

Laborie Introduces the Next Generation RenovaRP Centesis System

Retrieved on: 
Monday, January 8, 2024

PORTSMOUTH, N.H., Jan. 8, 2024 /PRNewswire/ -- Laborie Medical Technologies, Inc. (Laborie), a leading diagnostic and therapeutic medical technology company, is proud to announce the launch of the RenovaRP™ Centesis System, an innovative fluid drainage device designed to advance patient care and improve efficiency for healthcare professionals.

Key Points: 
  • PORTSMOUTH, N.H., Jan. 8, 2024 /PRNewswire/ -- Laborie Medical Technologies, Inc. (Laborie), a leading diagnostic and therapeutic medical technology company, is proud to announce the launch of the RenovaRP™ Centesis System, an innovative fluid drainage device designed to advance patient care and improve efficiency for healthcare professionals.
  • The RenovaRP Centesis System builds upon the current RenovaRP paracentesis pump by providing an expanded indication for thoracentesis and design enhancements to the handle and nest of the device to improve the overall user experience.
  • "The RenovaRP Centesis System represents a significant milestone for Laborie, empowering healthcare professionals with a cutting-edge tool to enhance patient care during paracentesis and thoracentesis procedures," said Rhett Klein, Vice President of Sales and Global Marketing at Laborie.
  • The RenovaRP Centesis System offers a safe, efficient, and minimally invasive solution to address these medical conditions, improving patient comfort and reducing recovery times.

Sequana Medical submits Premarket Approval application to US FDA for alfapump® in recurrent or refractory ascites due to liver cirrhosis

Retrieved on: 
Thursday, December 28, 2023

The alfapump received breakthrough device designation from the US FDA in 2019.

Key Points: 
  • The alfapump received breakthrough device designation from the US FDA in 2019.
  • Recurrent or refractory ascites is a severe condition characterized by the accumulation of fluid in the abdomen.
  • The current standard treatment involves therapeutic paracentesis, an invasive and burdensome procedure that drains ascites from the abdomen using a large needle over an extended period.
  • Timur Resch, Global Vice President QM/QA/RA at Sequana Medical, commented: “The submission of our Premarket Approval application to the FDA is the result of an enormous team effort and a clear demonstration of our intensive preparation to fulfil US regulatory requirements.

Sequana Medical announces additional alfapump data supporting strong and durable clinical profile; PMA on track for year-end submission

Retrieved on: 
Thursday, October 19, 2023

We are greatly encouraged by our recent pre-PMA meeting with the FDA, where we discussed the reported clinical data from our alfapump studies and benefit-risk analysis for the submission package.

Key Points: 
  • We are greatly encouraged by our recent pre-PMA meeting with the FDA, where we discussed the reported clinical data from our alfapump studies and benefit-risk analysis for the submission package.
  • We look forward to submitting our PMA application by year end and continuing our preparations for launching the alfapump in the US and Canada."
  • These data show that the alfapump has a sustained effect on controlling ascites, virtually eliminating the need for therapeutic paracentesis.
  • Overall, these safety data indicate that the alfapump has a robust safety profile over long-term follow-up.

Focusing on the development of BsAbs in China, YZY Biopharma Announces Proposed Listing on the Main Board of SEHK

Retrieved on: 
Wednesday, September 13, 2023

The Company carefully selects potential targets for its BsAbs, and has adopted a differentiated clinical development strategy to maximize the clinical and commercial value of its drug candidates.

Key Points: 
  • The Company carefully selects potential targets for its BsAbs, and has adopted a differentiated clinical development strategy to maximize the clinical and commercial value of its drug candidates.
  • Since its establishment, YZY Biopharma focuses on the development of BsAbs in China.
  • In addition, the Company is also focusing on the development of the TME-targeted BsAbs, including Y101D and Y332.
  • Therefore, the execution of an appropriate CMC development strategy is vital to the success of the overall drug development program.

Sequana Medical announces additional data on safety, quality of life and survival from North American pivotal alfapump® study (POSEIDON)

Retrieved on: 
Wednesday, June 21, 2023

Together with the positive primary endpoint data reported previously, these results further support the clinical benefits of the alfapump and show a survival rate that compares favorably to literature.

Key Points: 
  • Together with the positive primary endpoint data reported previously, these results further support the clinical benefits of the alfapump and show a survival rate that compares favorably to literature.
  • Renal function is often impaired in patients with advanced cirrhosis and patients with evidence of renal failure were excluded from the study.
  • Sequana Medical management will host a conference call with a live webcast presentation today at 15:00 CEST / 09:00 am EST.
  • The webcast and conference call will be conducted in English and a replay will be available on Sequana Medical’s website shortly after.

Additional data from North American pivotal alfapump® study (POSEIDON) will be presented at EASL Congress 2023

Retrieved on: 
Monday, June 19, 2023

The poster will include primary and secondary endpoint data from Pivotal Cohort patients in the POSEIDON study1, including reduction in paracentesis requirement, safety, quality of life and survival.

Key Points: 
  • The poster will include primary and secondary endpoint data from Pivotal Cohort patients in the POSEIDON study1, including reduction in paracentesis requirement, safety, quality of life and survival.
  • Title: “The effects of alfapump on ascites control and quality of life in patients with cirrhosis and recurrent or refractory ascites: pivotal trial results”
    Sequana Medical management will attend the EASL Congress and is available to meet.
  • Sequana Medical management will host a conference call with a live webcast presentation on Wednesday, 21 June 2023 at 03:00 pm CEST / 09:00 am EST.
  • The webcast and conference call will be conducted in English and a replay will be available on Sequana Medical’s website shortly after.

BioVie Announces the Pausing of Patient Enrollment in Ascites Phase 2b Trial, Encouraging Efficacy Data is Announced, Initiating FDA Discussions to Conduct Pivotal Registrational Trial

Retrieved on: 
Monday, March 13, 2023

This improvement was significantly different from those treated with SOC only who experienced a mean increase in ascites fluid of 3.1% (BIV201 vs. SOC p=0.05).

Key Points: 
  • This improvement was significantly different from those treated with SOC only who experienced a mean increase in ascites fluid of 3.1% (BIV201 vs. SOC p=0.05).
  • Patients who completed the treatment with BIV201 experienced a 53% reduction in ascites fluid (p=0.001), which was significantly different from those treated with SOC (p=0.007).
  • The current trial (NCT04112199) evaluates the efficacy of BIV201 combined with standard-of-care (SOC), compared to SOC alone, for the treatment of refractory ascites.
  • “Compelling data from the first 15 patients led us to pause enrollment,” commented Cuong Do, BioVie’s President and CEO.

Sequana Medical announces positive top-line results from the North American pivotal alfapump® study (POSEIDON)

Retrieved on: 
Tuesday, October 25, 2022

Patients enrolled in the Pivotal Cohort entered into a three-month pre-implant observation period before they are implanted with the alfapump and will be used for primary endpoint analysis.

Key Points: 
  • Patients enrolled in the Pivotal Cohort entered into a three-month pre-implant observation period before they are implanted with the alfapump and will be used for primary endpoint analysis.
  • The study allowed to enrol additional patients in a Roll-In Cohort to ensure new centres were experienced with the alfapump implantation prior to enrolling patients in the Pivotal Cohort.
  • Sequana Medical NV is a pioneer in treating drug-resistant fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer.
  • There is no link between DSR therapy and ongoing investigations with the alfapump system in Europe, the United States or Canada.

BioVie to Present Data on Characterizing Hospitalization Burden of Ascites at AASLD Liver Meeting 2022

Retrieved on: 
Monday, October 24, 2022

The Liver Meeting 2022 will be held Washington, DC, from November 4-6, 2022.

Key Points: 
  • The Liver Meeting 2022 will be held Washington, DC, from November 4-6, 2022.
  • Hospitalization Burden of Patients with Cirrhosis and Ascites Receiving Paracentesis (Rika O. Mortimer, et al)
    BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative therapies to overcome unmet medical needs in chronic debilitating conditions.
  • A Phase 2 study of NE3107 in Parkinsons disease (NCT05083260) is fully enrolled and expects to have topline data readout in December 2022.
  • Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained.