Healthcare Industry News: vascular access
News Release - September 24, 2007
FlowMedica Inc. Launches the Benephit(R) XT Infusion SystemThe Next-Generation System for Targeted Renal Therapy (TRT(R))
FREMONT, Calif.--(HSMN NewsFeed)--FlowMedica Inc., a medical device company pioneering targeted renal therapy (TRTŪ), today announced the release of the BenephitŪ XT Infusion System, a next-generation infusion system designed for implementing TRT - the direct delivery of physician-specified medications and other therapeutic agents to the kidneys via the renal arteries. TRT is an alternative to the standard delivery method of systemic intravenous (IV) infusion of physician-specified agents. It may offer significant benefit via direct infusion of therapeutic levels of medications without the side effects that can be encountered with conventional IV delivery. Physicians are employing TRT to address major causes of kidney failure. These causes include contrast-induced nephropathy (CIN), cardiorenal syndrome and other forms of acute kidney injury (AKI).
The Benephit XT Infusion System 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 a new feature set that includes:
- 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 for infusion system stability.
- Re-designed external components to improve the ease of catheter insertion and reduce procedure time.
The Benephit XT is an FDA 510(k) cleared device intended for the infusion of physician-specified agents in the peripheral vasculature including, but not limited to, the renal arteries. The Benephit XT systems have not received clearance or approval to prevent or treat acute kidney injury or any other condition.
The proprietary infusion catheter system features two components: a bifurcated infusion catheter and a 5 Fr introducer sheath. The bifurcated infusion catheter features two identical branches (0.035" OD) that can be placed simultaneously into both of the renal arteries easily, rapidly and safely without the use of guidewires. The 5Fr introducer sheath provides access for the bifurcated infusion catheter, to allow bilateral renal artery infusion through a single vascular access site. The Benephit XT System is available in two different lengths - 35 cm and 105 cm - allowing the catheter to be placed from a retrograde approach through a femoral artery, or antegrade approach through a brachial artery.
FlowMedica, Inc., a privately held, commercial-stage medical device company located in Fremont, Calif., was founded in 2002, in collaboration with leading cardiologists and surgeons. Investors include: Forbion Capital Partners, De Novo Ventures, Medica Venture partners, Oxford Bioscience Partners and Palo Alto Investors. The company's initial products for TRT - the Benephit CV and PV Infusion Systems - have received U.S. 510(k) regulatory clearance and bear the CE Marking for the infusion of physician-specified agents in the peripheral vasculature including, but not limited to, the renal arteries. The Benephit XT does not yet bear the CE Marking. The company's products have not received regulatory clearance to prevent or treat acute kidney injury or any other condition.
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