The Benephit® XT Infusion System is an FDA 510(k) cleared, 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 Benephit XT System is designed for patients who may benefit from TRT in conjunction with endovascular interventional/diagnostic procedures, complex surgical procedures or as the primary intervention.  The Benephit® XT provides the following additional features in cases where stand alone TRT administration may be necessary.

• Increased stability and security of the infusion catheter and sheath to accommodate continuous TRT in hospital settings such as the cardiac catheterization lab, radiology suite, operating room and intensive care unit.

• Depth markings on the introducer sheath as an added reference to confirm infusion system stability.

• Re-designed external components to improve the ease of catheter insertion and reduce procedure time.   Improved sheath hub design and hemostasis valve allows for the ease of infusion branches and catheter insertion without the need of a tear away.   Modified catheter lock design allows for use as a Touhy Borst valve and torque device; therefore allowing the removal of the torque device on the 35cm system only.

Similar to the Benephit® PV Infusion System, the Benephit® XT has been designed to infuse both renal arteries simultaneously through a single catheter as part of a 5Fr. System.  The 5Fr system may be introduced through a second arterial access site when TRT is used as an adjunct to endovascular procedures, or through a single access site during surgical intervention or when TRT is the primary intervention. 

In addition, the Benephit® XT System is offered in 35cm and 105cm system lengths, so as to facilitate entry from femoral and brachial artery access sites.

About the System

The Benephit® XT System consists of two components:

1. The Bifurcated Infusion Catheter

2. The 5 Fr Introducer Sheath

The XT bifurcated infusion catheter features two identical branches to allow the infusion of physician-specified medications and other therapeutic agents directly to both renal arteries simultaneously. These branches can be placed in the arteries easily, rapidly and safely with minimal radiocontrast media, and without the use of guide wires.   

The introducer sheath provides renal access through a single site, allowing a retrograde approach through the femoral artery, or antegrade access through the brachial artery.

The Benephit XT System:

• Deploys easily and rapidly. Many cannulations are achieved in less than one minute.
• Safely accesses renal vasculature. Atraumatic infusion branch tip is similar in diameter to a 0.035" guidewire.
• Accommodates anatomic variations. Unique bifurcated design provides bilateral renal artery cannulation in 96% 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 stand-alone or concomitant therapy in interventional, surgical, or critical care settings.

As of September 2007, the Benephit XT Infusion System is a 510(k) cleared device 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.

Cannulation: Benephit XT Infusion System
Click on the links below to view a live case cannulation of the Benephit XT Infusion System.  These are .mpg files. You may need Windows Media Player or QuickTime Player to view them.

XT Cannulation - high resolution (49 sec duration, 30.8 MB)

XT Cannulation - low resolution (49 sec duration, 8.23 MB)