Potrero wins FDA 510(k) for Accuryn system

Potrero Medical said today it won FDA 510(k) clearance for its Accuryn monitoring system designed to turn urinary catheters into diagnostic tools.

San Francisco-based Potrero’s Accuryn critical care monitoring system uses a urinary catheter to deliver real-time, actionable data on urine output, core temperature and intraabdominal pressure, the company said.

“Sepsis and acute kidney injury accounted for over $25 billion in U.S. healthcare costs in 2011 and these costs are growing unsustainably. The Accuryn device will provide actionable data to clinicians which will enable them to improve patient outcomes and to reduce the financial burden of these critical illnesses,” CEO Dr. Daniel Burnett said in a press release.

The company said it is engaged in a multicenter randomized clinical study of its Accuryn system to detect sepsis and critical illness, which is slated to enroll 100 patients in the U.S.

“Urine output monitoring is a very important field that has stagnated for decades. Based on my personal experience using Accuryn in our burn unit, I can say that this device establishes a new state of the art Accuryn is able to eliminate urinary outflow obstruction that is ubiquitous in current urine drainage systems.  Solving this problem significantly improves the accuracy and diagnostic value of urine output monitoring and also prevents urinary retention- a major risk factor for CAUTI,” Bruce Friedman of the Joseph M. Still Burn Center said in preapred remarks.

In February, Potrero Medical said the National Institute of Health is sponsoring the Prescient study, which will examine the company’s Accuryn monitoring system designed to detect physiological signatures of critical illness, including sepsis.

The company said it received $2.25 million in Small Business Innovation Research grants from the NIH’s National Institute of General Medical Sciences to run the study.

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