Clinical Investigations

Trial Principal Investigator Objective Summary
REMEDIAL II (Complete) Carlo Briguori, MD Study the efficacy of RenalGuard Therapy compared to the current standard of care. RenalGuard Therapy is superior to sodium bicarbonate and N-acetylcysteine in preventing contrast-induced acute kidney injury in high-risk patients.
MYTHOS (Complete) Antonio Bartorelli, MD
Giancarlo Marenzi, MD
Compare the rates of CIN in at-risk patient who receive induced diuresis with automated matched hydration therapy utilizing RenalGuard, compared to patients who receive standard overnight hydration. Patients who were at higher risk for renal failure and who were treated with RenalGuard while undergoing imaging procedures developed CIN at a rate 74% lower than those who were treated with overnight hydration.
AKIGuard (Complete) Tullio Usmiani, MD Compare sodium bicarbonate/isotonic saline/N-acetylcysteine/vitamin C prophylaxis (BS-NAC) against high-volume forced diuresis with matched hydration in CI-AKI prevention in patients with chronic kidney disease undergoing coronary angiography or percutaneous coronary intervention. Demonstrated significant improvement in long-term outcomes when using RenalGuard vs. standard therapy.
PROTECT-TAVI (Complete) Marco Barbanti, MD Investigate the effect of the RenalGuard System on prevention of acute kidney injury (AKI) in patients undergoing transcatheter aortic valve replacement (TAVR). Furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVR.
High urine rates may reduce the incidence of Contrast-Induced Nephropathy via a combination of known physiological factors, including:

More rapid transit of contrast through the kidneys

Less overall exposure to toxic contrast

Reduced oxygen consumption in the medulla of the kidney

RenalGuard Therapy entails the use of a physician-prescribed loop diuretic which may induce the required high urine output. The system is designed to measure urine output and replaces it in real-time with an equal volume of sterile saline. This matched fluid replacement aims to minimize the risk of over- or under-hydration which can lead to increased patient risks.

RenalGuard has been shown in two investigator sponsored studies to significantly reduce the incidence of CIN when compared to the standard of care. The device is comprised of a Console and a RenalGuard Single Use Set for infusion and urine collection. The Single Use Set contains a urine collection set which connects to a patient’s Foley catheter and an infusion set which connects to a standard IV catheter. The Console measures the volume of urine in the collection set and infuses an equal volume of hydration fluid to match the patient’s urine output. The Console relies on proprietary, patented software and electronic weight measurements to control the rate at which fluid is infused and to monitor urine volume.

In addition to urine volume replacement, a user can set the RenalGuard System to achieve a net fluid gain over and above matched hydration or to achieve a net fluid loss. RenalGuard allows infusion of a bolus of fluid at the user’s request. In addition, the device is capable of adjusting matched hydration to take into account other fluid sources.

1 Stevens, MA, McCullough, PA et al. A prospective randomized trial of prevention measures in patients at high risk for contrast nephropathy. JACC 1999;33:403-11
RenalGuard is CE-marked for the intended use of temporary (up to 14 days) replacement of urine output by infusion of a matched volume of sterile replacement solution to maintain a patient’s intravascular fluid volume. The RenalGuard System is not intended for infusion of blood, blood components, medications, or nutritional fluids. All treatments administered via The RenalGuard System must be prescribed by a physician. RenalGuard Solutions, Inc. reserves the right to modify the specifications and features described herein, or discontinue manufacture of the product described at any time without prior notice or obligation.  Caution – Investigational Device, Limited By United States Law to Investigational Use.

Clinical Articles

The following papers and abstracts discuss the use of RenalGuard Therapy in the prevention of Contrast-Induced Kidney Injury (CIN).

Author Title Source Detail
Barbanti, Marco Optimization and simplification of transcatheter aortic valve implantation therapy. Expert Review of Cardiovascular Therapy 2018 Mar 9:1-10. doi: 10.1080/14779072.2018.1449644
Luckraz, Heyman The use of the RenalGuard system in cardiac surgery with cardiopulmonary bypass: a first in man prospective, observational, feasibility pilot study openheart 10 October 2017; Vol. 2, Issue 4
Prasad, Anand Use of the RenalGuard system to prevent contrast-induced AKI: A meta-analysis Journal of Interventional Cardiology 4 Sept. 2017; 10.1111/joic.12417
Bartorelli, Antonio L, Marenzi, Giancarlo High Urine Output With Matched Hydration for CI-AKI Prevention “Salus Per Aquam” (Health Through Water) JACC: Cardiovascular Interventions Volume 10, Issue 4, February 2017; 364-366
Putzu et al. Prevention of Contrast-Induced Acute Kidney Injury by Furosemide With Matched Hydration in Patients Undergoing Interventional Procedures JACC: Cardiovascular Interventions Volume 10, Issue 4, February 2017; 355-363
Banai, Shmuel Prevention of post procedural acute kidney injury in the catheterization laboratory in a real-world population International Journal of Cardiology 226 (2017) 42–47
Visconti, Gabriella RenalGuard System for the prevention of acute kidney injury in patients undergoing transcatheter aortic valve implantation EuroIntervention 2016;11:e1658-e1661
Briguori, Carlo RenalGuard system in high-risk patients for contrast-induced Acute Kidney Injury American Heart Journal 173; March 2016; 67-76
Barbanti et al. Acute Kidney Injury With the RenalGuard System in Patients Undergoing Transcatheter Aortic Valve Replacement JACC Cardiovascular Interventions 2015;8(12):1595-1604.
T. Usmiani AKIGUARD (acute kidney injury guarding device) independent, randomized and controlled trial on contrast-induced acute kidney injury prevention in the cath lab: in-hospital and one year outcomes European Heart Journal ( 2014 ) 35 ( Abstract Supplement ), 142
Marenzi, Giancarlo, Bartorelli, Antonio, et al. Prevention of Contrast Nephropathy by Furosemide with Matched Hydration: The MYTHOS Trial JACC: Cardiovascular Interventions Volume 5, Issue 1, January 2012, Pages 90-97
Halpert, Andrew RenalGuard – an old idea with a modern twist: preventing contrast-induced nephropathy through induced diuresis with matched replacement EuroPCR 2012 Cardiovascular Innovation Pipeline Poster Session
Bertelli, Luca, et al. Comparison Of Renalguard System, Continuous Venovenous Hemofiltration And Hydration In High-Risk Patients For Contrast-Induced Nephropathy Journal of the American College of Cardiology Volume 59, Issue 13 Suppl S, March 27, 2012
Briguori, Carlo, et al. Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II) Circulation Aug 2011; Online ISSN: 1524-4359
Dorval, Jean-Frarncois, et al. Feasibility study of the RenalGuard™ balanced hydration system: A novel strategy for the prevention of contrast-induced nephropathy in high risk patients International Journal of Cardiology Int J Cardiol (2011), 10.1016/j.ijcard.2011.11.035 December 29, 2011

Videos

RenalGuard – Designed to Prevent AKI

RenalGuard and TAVI

Protecting Patients From Kidney Injury

Distributor Lookup

RenalGuard is sold through a select network of distributors.

Med Glories

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Torque Medical

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Zerberg Medical

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Fax: +903 124471937
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Turkey

Technoline Ltd.

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Phone: +356 2134 4345, Ext. 137
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Servicing:
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Sante International S.A.

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Phone: +40 215250401
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Salipharm GmbH

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Phone: +41 43 495 6343
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Sedeer Medical Services

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Medimen Healthcare Ltd.

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IZASA S.A.

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Girlow USA LLC

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Aquilant Ltd.

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Al Emara Trading & Contracting Co.

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PLC Systemas Medicos Internacionais

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