The Benephit® CV Infusion System is an FDA 510(k)-cleared, CE Marked, novel, proprietary selective infusion catheter system designed for implementing Targeted Renal Therapy (TRT™) - the direct delivery of physician-specified medications and other therapeutic agents to the kidneys via the renal arteries.

The device delivers physician-specified therapeutic agents directly into the renal arteries through a dedicated infusion catheter while allowing simultaneous coronary procedures through a single vessel access site in the femoral artery. There are no other commercially available products that can simultaneously infuse drugs into both renal arteries using a single catheter system.



About the System
The Benephit CV System consists of two components:

1. The CV (Coronary Vascular) Bifurcated Infusion Catheter
2. The 8 Fr Introducer Sheath

The CV bifurcated infusion catheter features two identical branches to allow the infusion of physician-specified medications and other therapeutic agents into both renal arteries simultaneously.



These atraumatic branches can be placed in the renal arteries easily, rapidly and safely with minimal radiocontrast media, and without the use of guide wires. Each branch contains two microports for infusion.



The introducer sheath enables two different catheters to be introduced through a single access site in the femoral artery. This approach allows concurrent coronary diagnostic and interventional procedures while infusing the renal arteries.



The family of Benephit CV Systems:

• Deploys easily and rapidly. Most cannulations are completed in less than one minute.
• Safely accesses renal vasculature. Atraumatic infusion branch tip is similar in diameter and profile to a 0.035" guide wire.
• Accommodates anatomic variations. Unique bifurcated design provides bilateral renal artery cannulation in 94% of anatomy despite a variety of take-off angles and different levels of aortic origin.
• Provides TRT in a variety of settings. Numerous sheath and catheter options allow TRT as a stand-alone or concomitant therapy in interventional, surgical, or critical care settings.

The Benephit CV System received 510(k) clearance from the U.S. Food and Drug Administration in January 2004 and CE Marking in February 2005 for the infusion of physician-specified agents in the peripheral vasculature including, but not limited to, the renal arteries.

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.

Animation and Images
The unique bifurcated design of the Benephit CV Infusion System accommodates a wide variety of anatomic variations.

Angiographic images: Renal Cannulations













Cannulation: Benephit CV Infusion System
Click on the links below to view a live case cannulation of the Benephit CV Infusion System at the Summer in Seattle conference in 2005.  These are .mpg files. You may need Windows Media Player or QuickTime Player to view them.

CV Cannulation - high resolution (45 sec duration, 26.9 MB)

CV Cannulation - low resolution (45 sec duration, 7.44 MB)