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FlowMedica is a venture-backed, privately held commercial-stage medical device company located in Fremont, California. It was founded in 2002 in collaboration with leading cardiologists and surgeons to address a critical and underserved clinical need: the prevention and treatment of kidney dysfunction resulting from certain cardiovascular, endovascular, or surgical procedures and disease states. The company has developed novel, proprietary, minimally invasive intravascular systems for implementing Targeted Renal Therapy (TRT™) - the delivery of therapeutic agents to the kidneys via the renal arteries.

The company's initial product, the Benephit® CV Infusion System, is an FDA 510(k)-cleared, CE Marked, selective infusion catheter system for TRT. The device delivers therapeutic agents directly into both renal arteries through a dedicated infusion catheter while allowing simultaneous coronary procedures through a single vessel access site in the femoral artery.

FlowMedica's second platform, the Benephit PV Infusion System, is an FDA 510(k)-cleared, CE Marked system that has a reduced profile to allow TRT through an alternative arterial site during endovascular diagnostic and interventional procedures. The System comes in a variety of lengths to allow access through sites that include the femoral, brachial and radial arteries.  In addition to the traditional PV System, FlowMedica has developed the Benephit PVSolo Infusion System for selective infusion to a single kidney, as well as the Benephit PVMini Infusion System for patients with smaller vascular anatomies.  The PVSolo System is  commercially available in the US only.   

FlowMedica’s third platform, the Benephit XT Infusion System, is an FDA 510(k) cleared infusion system that represents the next-generation of the Benephit PV Infusion System.  The Benephit XT allows for local infusion of physician-specified agents into both renal arteries simultaneously through a single catheter.  The Benephit XT improves upon its predecessor, the Benephit PV, with redesigned feature sets and improved product performance.  The infusion system comes in two lengths (35cm and 105cm) to allow access through the femoral and brachial artery.  The Benephit XT is commercially available in the US only.  .

 

The company's manufacturing system is compliant with FDA’s Quality Systems Regulations (QSRs) and applicable Good Manufacturing Process (GMP) standards per 21 C.F.R. 820, as well as ISO 13485:2003, to ensure quality design, manufacture, packaging, labeling, storage, and distribution of our products.