FlowMedica Inc. Receives FDA Clearance For New Indication For The Benephit® Infusion Systems

Main Category: Urology / Nephrology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 07 Dec 2008 - 1:00 PDT

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FlowMedica Inc., a medical device company pioneering targeted renal therapy (TRT®), announced today that it has received FDA clearance for a new labeling indication for the Benephit® Infusion Systems. The system can now facilitate TRT in patients who have demonstrated symptoms of or are at risk of developing Acute Kidney Injury (AKI).

TRT is the direct delivery of physician-specified medications and other therapeutic agents into the kidneys via the renal arteries. Since TRT facilitates direct infusion into both kidneys at the same time, it may offer significant benefit over IV infusion by allowing local delivery of therapeutic medications with reduced systemic side effects. Physicians can now use TRT to facilitate the treatment of patients with or at risk of developing acute kidney injury as caused by a number of conditions, including cardiovascular, endovascular, and surgical procedures and diseases. Target patient populations include CAD, PAD and CABG patients. Physicians generally capable of using the system immediately are interventionalists including cardiologists, vascular and thoracic surgeons, radiologists and the nephrologists. The new indication reads:

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.

"We are excited to apply this new indication to our existing, commercially available Benephit Infusion Systems," said Jeff Elkins, President and CEO of FlowMedica. "Working with thought leaders in this field, we were able to provide the FDA with post market registry data from 593 patients and rationale for a new indication that reflects the broad applicability of TRT in patients suffering from AKI and susceptible to CIN. Both are problems with few therapeutic alternatives."

The new indication applies to the Benephit CV and XT Infusion Systems, which are proprietary bifurcated selective infusion catheter systems designed for implementing TRT directly into both renal arteries through a single catheter. Each Benephit Infusion System consists of a bifurcated infusion catheter and a vascular introducer sheath with dilator. The bifurcated infusion catheter is a single-lumen infusion catheter with a bifurcated distal end that allows access to both renal arteries at the same time via one catheter insertion for simultaneous bilateral infusion.

"Building upon the currently available clinical data, this new indication further supports the application of TRT as an additional tool for use in facilitating treatment of patients at risk for contrast-induced acute kidney injury," said Barry Katzen M.D., Founder and Medical Director of Baptist Cardiac and Vascular Institute. "With the continued growth of interventional procedures and high-risk patient population, the prevention and treatment of acute kidney injury remains a growing area of concern with significant healthcare impact."

About FlowMedica

FlowMedica, Inc., a privately held, venture-funded, 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, Medica Venture partners, and Oxford Bioscience Partners. The commercially available Benephit Infusion Systems have received U.S. 510(k) clearance and bear the CE Marking.

http://www.flowmedica.com

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