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Targeted Renal Therapy With FlowMedica's Benephit(TM) Delta Infusion System Improves Kidney Function in an Experimental Model of Congestive Heart Failure: Research Presented at TCT Symposium

Posted on: Wednesday, 19 October 2005, 12:00 CDT

FlowMedica:

At A Glance

-- Targeted Renal Therapy (TRT(TM)) via the Benephit(TM) Delta Infusion System improved renal function in a canine model of congestive heart failure (CHF).

-- TRT shows promise as a strategy for improving kidney function in CHF, a condition that affects 5 million Americans and is growing in prevalence as the population ages.

-- In TRT, medications or other therapeutic agents are delivered directly to the kidneys through the renal arteries, thus avoiding the potential side effects of systemic, intravenous infusion, the standard therapy for cardiorenal dysfunction (CRD).

-- CRD, also known as cardiorenal syndrome (CS), is a combination of kidney failure and heart failure that occurs in 20-30 percent of patients hospitalized with CHF. It is characterized by excess fluid accumulation in the body, resistance to conventional medical therapy, worsening kidney function and, in some cases, death.

A novel technique called Targeted Renal Therapy (TRT(TM)) delivered via the Benephit(TM) Delta Infusion System from FlowMedica, Inc., improved kidney function in laboratory animals induced with overt congestive heart failure (CHF), also known as heart failure, and renal dysfunction. Horng Chen, MD, Mayo Clinic, Rochester, Minn., reported the study at the Cardiovascular Research Foundation's (CRF) Seventeenth Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, in Washington, D.C.

CHF is the progressive inability of the heart to pump sufficient blood to vital organs, including the kidneys, placing many patients with CHF at risk for kidney failure.

The success of TRT in improving kidney function in this canine model, therefore, may have implications for improving health outcomes in humans with CHF. An estimated 5 million Americans suffer from CHF, and the incidence of the disease is growing as the population ages.

TRT is the delivery of certain medications and other therapeutic agents directly to the kidneys. It is a novel alternative to the standard delivery method of systemic intravenous (IV) infusions to treat kidney dysfunction related to a number of conditions, including cardiovascular and interventional procedures, diseases such as CHF, and conditions that may develop in connection with a medical treatment or diagnostic procedures. Unfortunately, systemic IV infusion of some drugs may result in significant side effects, including low blood pressure.

In the study, the use of TRT to improve kidney function in a canine model of cardiorenal dysfunction (CRD) was explored. CRD, also known as cardiorenal syndrome, or CS, is kidney failure that occurs in about 20 percent to 30 percent of patients hospitalized with CHF. It is characterized by excess fluid accumulation in the body, resistance to conventional medical therapy, worsening kidney function and, in some cases, death. Many of these patients require kidney dialysis, a process that mechanically removes waste products from the blood.

Numerous medical centers in the U.S. and Europe are currently assessing the novel premise that drug benefits to the kidneys will be maximized with TRT because the therapeutic dose of a drug is delivered directly to the kidneys. Furthermore, preliminary research suggests that side effects will be minimized with TRT because the kidneys eliminate most of the drug infused directly into the renal arteries, limiting the amount of medications reaching the rest of the body.

About FlowMedica

FlowMedica is a venture-backed, privately help commercial-stage medical device company founded in 2002 by Accelerated Technologies, Inc., in collaboration with leading cardiologists and surgeons. The company, located in Fremont, Calif., has raised a total of $15.3 million to date in three rounds of private equity financing. The Benephit Delta Infusion System, along with other members of FlowMedica's family of TRT solutions, has received FDA 510(k) clearance for the infusion of physician-specified agents in the peripheral vasculature including, but not limited to, the renal arteries.

Source: Business Wire

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