Devices & Diagnostics

STERIS wins FDA clearance of System 1E accessory part

Medical device company STERIS (NYSE:STE) has received long-awaited U.S. Food and Drug Administration clearance on […]

Medical device company STERIS (NYSE:STE) has received long-awaited U.S. Food and Drug Administration clearance on an accessory part for its System 1E liquid chemical sterilization device.

The newly cleared product, the Verify Spore Test Strip, is an optional part that’s used to monitor the sterility of a chemical cleaning agent used in the system. The System 1E is used by hospitals, surgical centers and other healthcare facilities to sterilize heat-sensitive medical instruments.

Clearance of the accessory part was done through the FDA’s de novo process, which is generally used for devices that aren’t high risk, but don’t have a “substantially equivalent” counterpart on the market, according to an U.S. Securities and Exchange filing by Mentor, Ohio-based STERIS.

“With this de novo determination, the FDA has created a new category of device for use specifically with liquid chemical sterilants, and the Verify Spore Test Strip is the first product included in this new category, ” spokesman Steve Norton said.

Curiously, STERIS noted in the SEC filing that clearance of the test strip isn’t expected to have a material impact on System 1E sales and the company’s financial results.

That statement stands in stark contrast to comments from STERIS CEO Walt Rosebrough, who has repeatedly said during quarterly conference calls that the lack of clearance for the part was holding back System 1E sales.

For example, Rosebrough said in an August conference call that an inability to sell the test strip has had a “real impact” on System 1E sales, Crain’s Cleveland Business reported.

Here’s Norton’s explanation for the difference in outlook related to the test strip: “As the transition period progressed, the availability of a spore test strip became less relevant to customers as those that desired a sterility assurance accessory transitioned to an alternative. If a spore test strip were available earlier in the transition process, it would, as Walt stated clearly, have helped with sales and retention.”

System 1E sales have lagged the company’s projections. In February, company officials said they expected to sell 4,000 units of the device in fiscal 2012 after projecting as recently as August that the number could be as high as 8,000.

The System 1E is a replacement device for the System 1. The FDA is requiring customers transition away from the System 1 because it found in December 2009 that STERIS had made so many changes to the device over the years that the agency hadn’t cleared the modified version of the device. STERIS began shipping the System 1E in December 2010.

Nonetheless, the FDA’s decision on the spore test strip is welcome news for STERIS. “The clearance of this product is great news for our customers,” Norton said.

The company expects to begin shipping the newly cleared device in the next quarter.

 

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