Our Mission

RenalGuard Solutions, Inc. is a medical device company focused on innovative technologies for the cardiac and vascular markets. The company’s lead product is designed to protect patients from procedure-induced acute kidney injury (AKI) which may result from cardiac surgery and heart cath procedures, and may also be present in ICU patients. Our goal is to help improve morbidity and mortality rates in these patients, preserve quality of life, and reduce healthcare costs through the use of our technology.

Meet the Team

Scientific Advisory Board

Richard Solomon, MD

Richard Solomon, MD

Nephrologist, University of Vermont

David Leaf, MD

David Leaf, MD

Nephrologist, Harvard Medical School

Andrew Shaw, MD

Andrew Shaw, MD

Intensive Care & Anesthesiologist, Cleveland Clinic

Dan Engelman,MD

Dan Engelman,MD

Cardiothoracic Surgeon, Head of ERAS Society

Todd Rosengart, MD, FACS

Todd Rosengart, MD, FACS

Cardiothoracic Surgeon, Baylor College of Medicine

Prof. Alex Zarbock, MD

Prof. Alex Zarbock, MD

Anesthesiologist, University Hospital Münster

Intellectual Property

U.S. Patents
20200254178A1
Fluid therapy method
10,639,419B2
Fluid therapy method
10,881,774
Method and system to protect kidneys during cardiac surgery
10,045,734
Fluid replacement device – user interface
9,526,833
Patient hydration system with bolus function
8,444,623
Patient hydration method to prevent renal damage from any toxin
11,064,939,B2
Fluid replacement device
7,727,222
Patient hydration system with taper down feature
7,736,354
Patient hydration system with hydration state detection
7,758,562
Patient hydration system with a redundant monitoring of hydration fluid infusion
7,758,563
Patient hydration monitoring and maintenance system and method for use with administration of a diuretic
7,837,667
Patient hydration system with abnormal condition sensing
7,938,817
Patient hydration system and method
8,007,460
Patient hydration system and method
8,075,513
Patient connection system for a balance hydration unit
Canadian Patents
2,579,829
Patient Hydration System and Method
Japanese Patents
2007-53154
Patient Hydration System and Method
European Patents
EP3278833
Fluid Replacement Device- user interface and additional scale
EP3119284B1
Fluid therapy system
EP 2010251
Patient Hydration System with Abnormal Condition Sensing
EP2073887
Patient Connection System for a Balance Hydration Unit
EP1804889
Patient hydration system and method
2010268
Patient hydration system with a redundant monitoring of hydration fluid infusion

Clinical Investigations

Trial Principal Investigator Objective Summary
KIDNEY Heyman Luckraz, MD Assess the impact of the RenalGuard(r) system on the reduction of AKI in patients undergoing cardiac surgery In patients at-risk for AKI, undergoing cardiac surgery with the cardiac pulmonary bypass, the RenalGuard system significantly reduced the incidence of AKI. The RenalGuard system can be used safely and reproducibly in Cardiac Surgery.
REMEDIAL III Carlo Briguori, MD Evaluate the ability of the two most successful patient “tailored hydration regimens” to protect at-risk patients from CI-AKI by comparing RenalGuard Therapy with left ventricular end-diastolic pressure (LVEDP)-guided hydration (the “POSEIDON” method). The investigators concluded that RenalGuard Therapy is superior to the LVEDP-guided hydration regimen to prevent the composite of CI-AKI and/or acute pulmonary edema in high-risk patients.
PROTECT-TAVI 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.
AKIGuard 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.
MYTHOS 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.
REMEDIAL II 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.

Clinical Articles

The following papers and abstracts discuss the use of RenalGuard Therapy in the prevention of Contrast-Associated AKI (CA-AKI).

Author Title Source Detail
Luckraz, Heyman Reduction in acute kidney injury post cardiac surgery using balanced forced diuresis: a randomized, controlled trial European Journal of Cardio-Thoracic Surgery December 2020 European Journal of Cardio-Thoracic Surgery 0 (2020) 1–8 doi:10.1093/ejcts/ezaa395
Heyman Luckraz Balanced forced‐diuresis as a renal protective approach in cardiac surgery: Secondary outcomes of electrolyte changes Journal of Cardiac Surgery May 2021 Balanced forced‐diuresis as a renal protective approach in cardiac surgery: Secondary outcomes of electrolyte changes. J Card Surg. 2021;1‐7. https://doi.org/10.1111/jocs.15925
Heyman Luckraz Balanced forced-diuresis compared to control as a reno-protective approach in cardiac surgery: secondary outcome of a randomized controlled trial, assessment of neutrophil gelatinase-associated lipocalin levels Luckraz et al. J Cardiothorac Surg (2021) 16:240 https://doi.org/10.1186/s13019-021-01620-w Neutrophil gelatinase-associated lipocalin (NGAL) is a recognised biomarker for acute kidney injury (AKI).This study investigated the impact of balanced forced-diuresis using RenalGuard® system (RG), in reducing acute kidney injury (AKI) rates and the associated NGAL levels (6-h post-CPB plasma level) post adult cardiac surgery with cardiopulmonary bypass (CPB).
Heyman Luckraz, Ramesh Giri, and Benjamin Wrigley A new approach for the prevention of acute kidney injury in on-pump cardiac surgery Clinical Practice 2021 Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) is linked to significant patient morbidity and mortality. We assessed the use of instantaneous balanced forced diuresis provided by the RenalGuard® (RG) system in the perioperative phase and its impact on CSA-AKI.
Ilya Losin MD, Keren-Cohen Hagai MD , and David Pereg MD The treatment of coronary artery disease in patients with chronic kidney disease: gaps, challenges and solutions Karger: Kidney Diseases Kidney DOI: 10.1159/000533970 An in depth look into solutions for kidney complications during coronary procedures.
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
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
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
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
Briguori, Carlo, et al. Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II) Circulation Aug 2011; Online ISSN: 1524-4359

Videos

RenalGuard – Designed to Prevent AKI

RenalGuard and TAVI procedures

RenalGuard Interviews

Technical Manuals

English French  Italian German
The RenalGuard single Use Set Directions For Use (DFU) is available here.

Certifications

RenalGuard Solutions, Inc. is focused on meeting our customers’ requirements by delivering high quality products in compliance with all applicable standards.

 

Download our certifications below:

ISO 13485

Peristaltic Infusion Pump Controller and Sterile Administration Sets CE Certificate