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Nuwellis

Ownership
-
Employees
59
Market Cap
-
Website
Introduction

Nuwellis, Inc. operates as a medical device company. It engages in the provision of products for the treatment of fluid overload. The firm's products include Aquadex FlexFlow System, which provides an ultrafiltration for the removal of salt and water in patients with hypervolemia, or fluid overload. It operates through Cardiac and Coronary Disease Products segment. The company was founded by Crispin Marsh and William S. Peters in November 1999 and is headquartered in Eden Prairie, MN.

Clinical Trials

9

Active:0
Completed:3

Trial Phases

1 Phases

Not Applicable:7

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (7 trials with phase data)• Click on a phase to view related trials

Not Applicable
7 (100.0%)

Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

Not Applicable
Recruiting
Conditions
Heart Failure (for Example, Fluid Overload)
Heart Failure
Fluid Overload
Interventions
Device: Aquadex Smartflow® System
Drug: IV Loop Diuretics
First Posted Date
2022-04-08
Last Posted Date
2025-05-15
Lead Sponsor
Nuwellis, Inc.
Target Recruit Count
372
Registration Number
NCT05318105
Locations
🇺🇸

Banner Health, Tucson, Arizona, United States

🇺🇸

MemorialCare, Long Beach Medical Center, Long Beach, California, United States

🇺🇸

Sharp Memorial Hospital, San Diego Cardiac Center, San Diego, California, United States

and more 14 locations

Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)

Terminated
Conditions
Fluid Overload
First Posted Date
2020-11-25
Last Posted Date
2024-02-20
Lead Sponsor
Nuwellis, Inc.
Target Recruit Count
97
Registration Number
NCT04644731
Locations
🇺🇸

Children's of Alabama Hospital, Birmingham, Alabama, United States

🇺🇸

Lucile Packard Children's Hospital Stanford, Palo Alto, California, United States

🇺🇸

Joe DiMaggio Children's Hospital, Hollywood, Florida, United States

and more 4 locations

A Feasibility Study on Ultrafiltration and Blood Volume Measurements

Not Applicable
Terminated
Conditions
Acute Decompensated Heart Failure
Fluid Overload
First Posted Date
2020-01-27
Last Posted Date
2024-11-14
Lead Sponsor
Nuwellis, Inc.
Target Recruit Count
6
Registration Number
NCT04241718
Locations
🇺🇸

Midwest Cardiovascular Institute, Naperville, Illinois, United States

C-Pulse® System European Multicenter Study

Completed
Conditions
Heart Failure
First Posted Date
2013-06-07
Last Posted Date
2023-08-08
Lead Sponsor
Nuwellis, Inc.
Target Recruit Count
15
Registration Number
NCT01872949
Locations
🇦🇹

University Hospital, Innsbruck, Austria

🇩🇪

Evangelisches Krankenhaus Niederrhein, Duisburg, Northrhine-Westfalia, Germany

🇩🇪

Cardio-Centrum Berlin, Berlin, Germany

and more 5 locations

C-Pulse® System: A Heart Assist Device Clinical Study

Not Applicable
Terminated
Conditions
Heart Failure
First Posted Date
2012-12-04
Last Posted Date
2024-01-11
Lead Sponsor
Nuwellis, Inc.
Target Recruit Count
38
Registration Number
NCT01740596
Locations
🇺🇸

The University of Alabama at Birmingham Hospital, Birmingham, Alabama, United States

🇺🇸

University of Southern California Keck School of Medicine, Los Angeles, California, United States

🇺🇸

University of California San Francisco, San Francisco, California, United States

and more 25 locations
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News

Nuwellis Terminates REVERSE-HF Clinical Trial to Refocus on Outpatient Heart Failure Market

Nuwellis announced the termination of its REVERSE-HF clinical trial, which was evaluating ultrafiltration versus IV loop diuretic therapy for hospitalized heart failure patients.

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