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The FlowMedica Benephit® Infusion Systems are intended to facilitate targeted renal therapy, or TRT®, the delivery of physician-specified agents to the kidneys via the renal arteries. The Benephit® Infusion Systems are indicated for use in patients undergoing medical, interventional, or surgical procedures, where the procedure carries an elevated risk of iatrogenic kidney injury for the patient. The Benephit® Infusion Systems are also indicated to facilitate TRT® in patients who have demonstrated symptoms of acute kidney injury, and in whom arterial catheterization for TRT® is feasible.

The Benephit® family of infusion systems comprises the Benephit® CV, Benephit® PV, Benephit® PVMini, Benephit® PVSolo, and Benephit® XT systems. Each system includes a bifurcated infusion catheter and a vascular introducer sheath with dilator. Each Benephit® Infusion System consists of a bifurcated infusion catheter and a vascular introducer sheath with dilator. The bifurcated infusion catheter in each of the Benephit® systems is a single-lumen infusion catheter with a bifurcated distal end that allows access to two locations (e.g., two renal arteries) for infusion simultaneously. Each system's introducer sheath is a PTFE-lined, coil reinforced polymer sheath with matching radiopaque dilator. The Benephit® CV system comprises a 2.4 Fr. bifurcated infusion catheter, utilizing a nitinol hypo tube shaft, and an 8 Fr. compatible introducer sheath with a unique Y-hub design. The Benephit® PV, PVMini, PVSolo, and XT systems comprise a 4.8 Fr. bifurcated catheter utilizing a braid reinforced polymer shaft and a 5 Fr. compatible introducer sheath with a standard single hemostasis valve configuration.

The FlowMedica Benephit™ △ Bifurcated Infusion Catheter is intended for the infusion of fluids into the peripheral vasculature including but not limited to the renal arteries. The FlowMedica Benephit™ Δ 5Fr. Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.

Benephit™ Δ Infusion System (Benephit™ Δ Bifurcated Infusion Catheter & Benephit™ Δ 5Fr. Introducer Sheath)

Infusion of physician-specified agents in the peripheral vasculature including but not limited to the renal arteries. The FlowMedica Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.

The FlowMedica Bifurcated Infusion System consists of the FlowMedica Bifurcated Infusion Catheter and the FlowMedica Introducer Sheath. The FlowMedica Bifurcated Infusion System consists of the Bifurcated Infusion Catheter and the Introducer Sheath. It is intended for single-use only and is sterilized using ethylene oxide gas. The Bifurcated Infusion Catheter functions by selectively delivering physician-specified agents directly to the peripheral vasculature. The Bifurcated Infusion Catheter contains a 77cm working length shaft/infusion lumen. It is bifurcated at the distal end, which is comprised of two identical metal-supported and braided polymer branches. The Introducer Sheath provides for the introduction of two interventional devices through a single vessel access site, allowing for the introduction of the Bifurcated Infusion Catheter and the introduction of a standard coronary guiding or diagnostic catheter as may be required for a catheterization procedure. The Introducer Sheath, available in four lengths, is a polymer and metal coil reinforced sheath with two insertion ports in its integral Y hub assembly. The ports contain a hemostasis valve, designed for a 6Fr diagnostic or guiding catheter, and Touhy Borst valve used for the Bifurcated Infusion Catheter. A vessel diffator is supplied with the Introducer Sheath. The FlowMedica Bifurcated Infusion Catheter is designed for use only with the FlowMedica Introducer Sheath. Each component is packaged separately and may be ordered and shipped separately; however, the Instructions for Use included with the Bifurcated Infusion Catheter specify exclusive usage with the FlowMedica Introducer Sheath.