News | August 23, 2011

Results Published for REMEDIAL II Italian Trial of RenalGuard Therapy

 RenalGuard

August 23, 2011 — PLC Systems Inc. said the final results from the REMEDIAL II investigator-sponsored clinical trial have been published online in Circulation, a peer-reviewed journal of the American Heart Association. It will appear in the September 2011 issue of the publication. REMEDIAL II is an Italian trial of the company’s RenalGuard device.

Results showed RenalGuard is superior to current methods at preventing contrast-induced nephropathy (CIN) and in-hospital dialysis in high-risk patients undergoing computed tomography (CT) and angiography imaging procedures. All patients also received injections of iodine-based contrast agents.

Investigators discovered patients treated with RenalGuard and N-acetylcysteine (NAC) developed CIN, a serious and potentially fatal condition, at a much lower rate than patients in the control group. The second group was treated with an infusion of sodium bicarbonate and NAC. Sodium bicarbonate plus NAC remains the current standard-of-care for the prevention of CIN in many healthcare institutions worldwide.

The results provided strong scientific data that RenalGuard therapy is superior to sodium bicarbonate and N-acetylcysteine in preventing contrast-induced acute kidney injury (CI-AKI) in high-risk patients.

Carlo Briguori, M.D., Ph.D., chief of laboratory of interventional cardiology, Clinica Mediterranea, Naples, Italy, reported on data from 294 patients with chronic kidney disease (CKD). All patients also underwent elective catheterization procedures for diagnostic imaging.

The primary endpoint for the study used a definition of CIN as a rise in serum creatinine (SCr) of 0.3 mg/dl over the patient's baseline reading. The RenalGuard group had a CIN incidence rate 46 percent lower than the control group using this definition of CIN. He also reported on a number of secondary endpoints. There was a 60 percent reduction in CIN in the RenalGuard group compared to the control group when defining CIN as a 0.5 mg/dl absolute rise in SCr. There was an 80 percent reduction of CIN in the RenalGuard-treated group over the control group when defining CIN as a 25 percent rise over baseline SCr.

The development of CIN has been found to lead to a range of serious and potentially deadly outcomes in patients who already have compromised kidney function. Notably the trial also found RenalGuard therapy significantly reduced the need for in-hospital dialysis in high-risk patients. In the control group, seven (or 4.8 percent) of these patients required some level of dialysis. Only one patient (0.7 percent), or 85 percent fewer, in the RenalGuard-treated group required dialysis.

The Circulation article can be accessed at the following link: http://circ.ahajournals.org/content/early/2011/08/13/CIRCULATIONAHA.111.030759.abstract

For more information: www.plcmed.com

Related Content

Video Plus Brochure Helps Patients Make Lung Cancer Scan Decision

Image courtesy of the American Thoracic Society

News | Lung Cancer | April 19, 2019
A short video describing the potential benefits and risks of low-dose computed tomography (CT) screening for lung...
FDA Clears GE's Deep Learning Image Reconstruction Engine
Technology | Computed Tomography (CT) | April 19, 2019
GE Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) of its Deep Learning Image...
Surgically Guided Brachytherapy Improves Outcomes for Intracranial Neoplasms
News | Brachytherapy Systems | April 18, 2019
Peter Nakaji, M.D., FAANS, general practice neurosurgeon at Barrow Neurological Institute, presented new research on...
Check-Cap Initiates U.S. Pilot Study of C-Scan for Colorectal Cancer Screening
News | Colonoscopy Systems | April 15, 2019
Check-Cap Ltd. has initiated its U.S. pilot study of the C-Scan system for prevention of colorectal cancer through...
Example of full-dose, 10 percent low-dose and algorithm-enhanced low-dose. Image courtesy of Enhao Gong, Ph.D.

Example of full-dose, 10 percent low-dose and algorithm-enhanced low-dose. Image courtesy of Enhao Gong, Ph.D.

Feature | Contrast Media Injectors | April 11, 2019 | By Jeff Zagoudis
One of the most controversial issues in radiology in recent years has been the use of...
Deep Lens Closes Series A Financing for Digital AI Pathology Platform
News | Digital Pathology | April 09, 2019
Digital pathology company Deep Lens Inc. announced the closing of a $14 million Series A financing that will further...
Uterine Fibroid Embolization Safer and as Effective as Surgical Treatment
News | Interventional Radiology | April 05, 2019
Uterine fibroid embolization (UFE) effectively treats uterine fibroids with fewer post-procedure complications compared...
Videos | RSNA | April 03, 2019
ITN Editor Dave Fornell takes a tour of some of the most interesting new medical imaging technologies displa
News | Biopsy Systems | March 29, 2019
Dune Medical Devices has just completed the first in-man cases for Smart Biopsy, its percutaneous soft tissue biopsy...
Artificial Intelligence Can Improve Emergency X-ray Identification of Pacemakers
News | X-Ray | March 29, 2019
A research team from Imperial College London believes a new software could speed up the diagnosis and treatment of...