Be-RITe! (Benephit® System Renal Infusion Therapy) Registry

To assess general use of the family of Benephit Systems outside of formal investigator-sponsored clinical studies, FlowMedica has initiated the Be-RITe! 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.

The specific objectives of the Registry are as follows:

• To track post-marketing device safety.
• To evaluate customer satisfaction and collect user-interface information.
• To identify quality trends.
• To understand and quantify usage patterns of the Benephit Infusion Systems (CV and PV), including patient characteristics, adjunct procedures, and infusion times, rates, and infusion agents.

Several academic and community medical institutions are participating in the Registry to track usage associated with the delivery of Targeted Renal Therapy (TRT™) with either the Benephit CV or Benephit PV Infusion Systems at participating centers. Numerous physician participants have recently reported on data from the Be-RITe! Registry, most recently at  NCVH  (1,2).  A total of 501 patients, at 17 US and international centers, were enrolled and included in this most recently reported analysis.  The following are some of the highlights:

• Among patients enrolled, 90% had chronic renal disease, 58% had diabetes mellitus, 15% had congestive heart failure, and 6% suffered from acute renal failure, among other comorbidities and renal risk factors.
• Patients received TRT via the Benephit systems while undergoing diagnostic coronary angiography and/or intervention (40.5%), peripheral angiography and/or intervention (48.8%), or open cardiac or vascular surgery (10.3%) as their primary procedures, with 0.4% receiving TRT as a primary stand-alone therapy.  Interventional patients received an average of 148cc of contrast media.
• Despite significant vascular disease and a variety of renal anatomic variations, bilateral renal artery cannulation was accomplished in 96% of patients in approximately 2 minutes, requiring an average of only 8cc of contrast media for placement.
• Numerous agents were infused through the Benephit systems for TRT, including fenoldopam mesylate, sodium bicarbonate, alprostadil, and B-type natriuretic peptide. Median duration of TRT was 120 minutes.
• The Benephit devices were placed by interventional cardiologists, interventional radiologists, and cardiothoracic and vascular surgeons, and the settings in which they were used included the coronary and interventional radiology catheterization labs and surgical operating rooms.

As of August 29th , 2007, Be-RITe! enrollment has been completed and closed.. Contributing to the Be-RITe! Registry are 37 interventional cardiologists, interventional radiologists and vascular and cardiothoracic surgeons at 17 institutions worldwide.  Patient demographics and physicians’ cited reasons for using TRT remain similar to those previously presented (see below).

As well, the data demonstrate a continuing trend towards more use in the interventional peripheral vascular and surgical settings.

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1. B. Weinstock. “Contrast-Induced Nephropathy (CIN): Targeted Renal Therapy (TRT) as an Emerging Therapy in CIN”. Presented at New Cardiovascular Horizons – New Orleans, LA, Sept. 8, 2007.

2. D. Allie. “Targeted Renal Therapy (TRT): A Be-RITE Registry Update and Beyond”.  Presented at New Cardiovascular Horizons – New Orleans, LA, Sept. 7, 2007.