The Benephit® PV 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 Benephit PV System is designed for patients who may benefit from TRT in conjunction with endovascular interventional and diagnostic procedures. The system has also been used for stand-alone percutaneous therapy in patients undergoing complex surgical procedures.
Like the Benephit CV Infusion System, the Benephit PV is designed to infuse both renal arteries simultaneously through a single catheter. However, the Benephit PV System's reduced profile (5 Fr) allows facile introduction through a second arterial access site during a planned endovascular procedure or through a single access site during surgical procedures. In addition, the wide variety of system lengths allows physicians to provide TRT from a variety of access sites that include the femoral, brachial, or radial arteries.
About the System
The Benephit PV System consists of two components:
1. The PV (Peripheral Vascular) Bifurcated Infusion Catheter
2. The 5 Fr Introducer Sheath
The PV 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 or radial arteries.
The family of Benephit PV Systems:
- Deploys easily and rapidly. Most 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 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 stand-alone or concomitant therapy in interventional, surgical, or critical care settings.
The Benephit PV Infusion System received 510(k) clearance from the U.S. Food and Drug Administration in March 2005 and CE Marking in October 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 PV Infusion System accommodates a wide variety of anatomic variations.
Angiographic images: Renal Cannulations
Cannulation: Benephit PV Infusion System
Click on the links below to view a live case cannulation of the Benephit PV Infusion System at the Transcatheter Cardiovascular Therapeutics conference in 2006. These are .mpg files. You may need Windows Media Player or QuickTime Player to view them.
PV Cannulation - high resolution (49 sec duration, 30.8 MB)
PV Cannulation - low resolution (49 sec duration, 8.23 MB)
|
