First Patient Receives Targeted Renal Therapy with FlowMedica's Benephit(TM) Delta Infusion System.

FREMONT, Calif. -- Congestive Heart Failure Patient Avoids Kidney Failure 

AT A GLANCE

--The first human successfully received targeted renal therapy (TRT) with the Benephit(TM) Delta Infusion System, a new device designed to treat kidney dysfunction as a result of congestive heart failure (CHF) and other conditions.

--TRT is the delivery of certain medications and other therapeutic agents directly to the kidneys.

--Nearly 5 million Americans suffer from CHF. Patients with CHF, diabetes and impaired kidney function are at risk for developing radiocontrast nephropathy (RCN), a life-threatening condition caused by reaction to the dyes used in many coronary intervention procedures.

--Leading cardiologists estimate that 1 in 5 patients undergoing coronary interventions could benefit from TRT for RCN.

A patient undergoing treatment for clogged coronary arteries has become the first to successfully receive targeted renal therapy (TRT(TM)) with the Benephit(TM) Delta Infusion System, a new device designed to help prevent kidney dysfunction in certain patients undergoing certain coronary procedures, according to FlowMedica, Inc., the company that developed the system. In addition to chronic kidney disease, the patient suffers from congestive heart failure (CHF), a condition that affects nearly 5 million Americans. The combination of these conditions greatly increased the patient's risk of developing kidney failure from the dye (radiocontrast media) used during his angiography and stenting procedures.

The Benephit Delta system is a novel, catheter-based medical device that enables the administration of physician-specified medications and other therapeutic agents directly to the renal arteries. This system is designed to provide selective infusion to both renal arteries simultaneously, using a single catheter. It received 510(k) clearance from the U.S. Food and Drug Administration (FDA) earlier this year.

The Benephit Delta is designed to provide TRT, an alternative to systemic intravenous (IV) infusion of medications to treat kidney dysfunction that is related to a number of conditions, including cardiovascular procedures and diseases, for example, congestive heart failure. Systemic infusion is limited in many instances because it can cause serious side effects such as the lowering of blood pressure.

As the patient suffers from chronic kidney disease and CHF, doctors determined he was an appropriate candidate for TRT with the Benephit Delta system.

"This patient was at high risk for developing kidney failure following the coronary procedure, but we had a positive outcome and the patient was able to avoid a potential burdensome dialysis procedure," said the patient's interventional cardiologist, Giora Weisz, M.D., co-director of clinical services for the Center for Interventional Vascular Therapy (CIVT) at NewYork-Presbyterian Hospital, and Columbia University Medical Center, New York. "TRT with the Benephit Delta system now enables us to treat a substantial segment of patients whose treatment options may have been limited previously due to their increased risk of developing kidney failure."

The patient recently had angioplasty to treat two severely blocked coronary arteries. Five stents were placed in his coronary arteries during the technically complex procedure, which required large amounts of dye. The more dye used, the greater the risk of developing the potentially life-threatening condition known as radiocontrast nephropathy (RCN), especially in people with CHF, diabetes and already impaired kidney function. CHF is the progressive inability of the heart to pump sufficient blood to vital organs, including the kidneys.

The Benephit Delta system was used to deliver a medication (fenoldopam) directly into the patient's kidneys through the renal arteries. Fenoldopam increases blood flow inside the kidneys. The patient did not develop RCN.

Cardiologists have estimated that 20 percent of patients undergoing coronary interventions could benefit from TRT for RCN.

A number of strategies have been investigated to prevent RCN in at-risk patients, including administering medications and other therapeutic agents through systemic IV infusion. However, systemic infusion of pharmaceuticals often is associated with serious side effects such as hypotension, the lowering of blood pressure. Researchers believe that the amount of medication that reaches the kidneys often does not attain sufficient levels to be therapeutic and, therefore, the treatment may not be effective.

Physicians are assessing the premise that drug benefits to the kidneys will be maximized with TRT because the drug is delivered in a therapeutic dose directly to the kidneys. Furthermore, since medications and other therapeutic agents used for TRT are excreted by the kidneys, side effects are thought to be minimized because the kidneys eliminate most of the drug immediately and, therefore, limit the amount of drug reaching the rest of the body.

About FlowMedica

FlowMedica is a venture-backed, privately held 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. FlowMedica's family of Benephit Systems have received regulatory clearances in numerous countries throughout the world for the infusion of physician-specified agents in the peripheral vasculature including, but not limited to, the renal arteries.