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.
Currently in development, FlowMedica's next platform, the Benephit® HF Infusion System, features a reduced profile and is available in a variety of lengths to allow access through sites that include the brachial and radial arteries. In addition, the system enables greater patient mobility and ease in providing therapy in settings outside the interventional laboratory such as the Intensive Care Unit (ICU) and Cardiac Care Unit (CCU).
The company's manufacturing system is compliant with Good Manufacturing Process (GMP) standards as well as ISO 9001 & 13485 to ensure quality design, manufacture, packaging, labeling, storage, installation and servicing of our products.