The Benephit® Infusion Systems are FDA 510(k)-cleared and bear the CE Marking for the "infusion of physician-specified agents to the peripheral vasculature including, but not limited to, the renal arteries."  The systems have been studied by investigators for various applications, some or all of which may involve usage of the Benephit Infusion Systems that has not been evaluated by the FDA or EU regulatory authorities. Completed and on-going studies are summarized below.

Completed Investigator-Sponsored Studies:

Differential Effects Between Intravenous and Targeted Renal Delivery of Fenoldopam on Renal Function and Blood Pressure in Patients Undergoing Cardiac Catheterization. Am J Cardiol 2006;97(1):1076-1081. Teirstein P, Price M, Mathur V, Madyoon H, Sawhney N, Baim D.

This randomized, placebo-controlled, investigator-sponsored clinical trial evaluated the intra-renal delivery of fenoldopam using the Benephit CV Infusion System in patients at risk for CIN. Investigators found that patients receiving Targeted Renal Therapy (TRT™) showed significantly improved kidney function, while standard administration of the same medication via IV did not improve kidney function relative to the placebo. Furthermore, they discovered that blood levels of the medication and unwanted effects were significantly less with TRT compared to standard IV treatment. Download article (pdf).

Intra-Renal Fenoldopam Increases Renal Artery Flow Velocity and Causes Less Effects on Blood Pressure Lowering than Intravenous Fenoldopam. EuroInterv 2005;1:305-308. Grube E, Teirstein P, Baim D, Mueller R, Schmidt T, Burkhoff D.

This investigator-sponsored study concluded that, in patients with renal insufficiency, targeted local delivery of fenoldopam enhances renal vascular effects and reduces systemic effects vs. IV delivery. The investigators found that intra-renal fenoldopam demonstrated dose-related renal vascular effects through 0.4 mcg/kg/min. Download article (pdf).

Renal and Hemodynamic Effects of Intra-renal Nesiritide (B-type Natriuretic Peptide) in Heart Transplant Patients. J Am Soc Nephrol 2005;16:618A (abstract). Ho A, Kirger E, Mathur V, Heywood JT.

This investigator-sponsored study determined that intra-renal delivery of nesiritide with the Benephit CV Infusion System safely, rapidly, and significantly increases kidney function and decreases renal vascular resistance in stable heart transplant patients with renal insufficiency. In addition, intra-renal nesiritide infusion was not found to affect blood pressure. Investigators concluded that this finding is consistent with a renal first pass elimination effect. Download abstract (pdf). Download poster (pdf).

Significant Renal First Pass Elimination of Nesiritide (B-Type Natriuretic Peptide) in Man: Data from a Randomized, Controlled Trial.  Annual Scientific Meeting of the American Society of Nephrology, Philadelphia, PA, November 8-13, 2005, Abstract #SA-PO273.  Price MJ, Mathur VS, Guzman L, Teirstein PS. 

This investigator-sponsored, randomized, controlled trial evaluated the differential effects of intra-renal nesiritide, intravenous nesiritide, and standard of care hydration on glomerular filtration rate (GFR), aldosterone suppression, and the incidence of contrast-induced nephropathy (CIN) in patients with chronic kidney disease undergoing percutaneous diagnostic and/or interventional procedures.  In this small study of predominantly diabetic and hypertensive patients, the investigators reported that both intravenous and intra-renal nesiritide were able to increase GFR and suppress aldosterone, with intra-renal administration being associated with durable aldosterone suppression post d/c of the drug.  The investigators found no differences in the rates of CIN between study groups. Download poster (pdf).

Ongoing Investigator-Sponsored Studies:

Targeted Intra-renal Fenoldopam for Avoidance of Nephropathy (TIFFANY) Study.
A randomized, placebo-controlled investigator-sponsored U.S. clinical study is evaluating treatment with intra-renal (IR) fenoldopam using the Benephit Infusion System in patients at very high risk for CIN (diabetics with moderate or severe renal dysfunction). This study is comparing a placebo, IV, or IR administration of fenoldopam via clinical endpoints. The study is underway and is enrolling up to 64 patients. The principal investigator is Paul Teirstein, MD, FACC, director of interventional cardiology at Scripps Clinic, La Jolla, California. Initial results presented at TCT 2005. Download abstract (pdf). Download poster (pdf).

Peripheral Angiographers' Targeted Renal Infusion for Contrast Injury Avoidance (PATRICIA) Study.
A randomized, placebo-controlled investigator-sponsored U.S. clinical study is evaluating treatment with intra-renal (IR) fenoldopam using the Benephit PV Infusion System in patients at very high risk for CIN (those with moderate or severe renal dysfunction). This study is comparing a placebo or IR administration of fenoldopam using clinical endpoints. The study is underway and is enrolling up to 50 patients. The principal investigator is Barry Weinstock, MD, FACC, Orlando Regional Medical Center, Orlando, Florida.

Effect of Combined Intra-Arterial Infusion of Fenoldopam Mesylate and MESNA (2-mercaptoethane sulphonate) on Urinary F2 Isoprostane Levels in High Risk Patients Undergoing Coronary Angiographic Interventions.

This is a randomized, double blind, investigator-sponsored, placebo-controlled trial comparing intra-renal infusion of fenoldopam (FNP) mesylate versus FNP plus an IR continuous infusion of 2-mercaptoethane sulphonate (MESNA).  This study will be a “proof of hypothesis” to confirm the concept that administration of iodinated contrast agents generates direct tubular toxicity through the release of reactive oxygen species.  It also hopes to establish that parenteral vasodilators in combination with antioxidants can augment renal blood flow while minimizing oxidant injury. The study is underway and is enrolling up to 20 patients. The principal investigator is James A. Tumlin, MD, Southeast Renal Associates, Charlotte, NC.

To assess general use of the family of Benephit Systems outside of formal investigator-sponsored clinical studies, FlowMedica has initiated the Be-RITe! (Benephit® System Renal Infusion Therapy) Registry. The FlowMedica Be-RITe! Registry is an observational, retrospective data compilation tool in which post-marketing device use is formally tracked.  The Registry serves as part of a post-production monitoring process in which submitted case data are compiled for patient safety, customer satisfaction analysis, and clinical summary of the FlowMedica devices’ usage and performance. For additional Be-RITe! International Registry information, click here.