When Michael Rosenberg, MD, was training for interventional radiology he noticed on the nights he was on call that he frequently was called because a patient's catheter, which was secured either by sutures or an adhesive device, such as tape, had become dislodged.
"He said, 'there's got to be a better way of strapping these things down on someone's skin,'" Jeff Killion, chief marketing officer for Interrad Medical (Plymouth, Minnesota), told Medical Device Daily.
Rosenberg soon began to wonder if there was a way to put some kind of anchor on the inside of the skin to hold the catheter in place. With that, the concept of the SecurAcath system was born and eventually, Interrad was founded.
The small private company recently received FDA 510(k) clearance for its SecurAcath PICC with Subcutaneous Securement System, which uses a small anchor that deploys in the subcutaneous tissue just beneath the skin to hold an indwelling catheter in place. Interrad says the device offers "significant advantages" over current securement methods, which include using sutures or adhesive on the surface of the patient's skin to hold the catheter in place. According to the company there are more than 12 million venous access catheters placed each year worldwide.
"Getting our first FDA approval is a very big deal," Killion said.
Interrad said the SecurAcath system is designed to improve catheter securement by decreasing catheter maintenance time and related costs, reducing catheter-related infections by improving cleaning of catheter exit site and minimizing catheter motion, decreasing skin surface issues, and eliminating needle stick injuries that may occur when suturing catheters.
"The first placements of the SecurAcath PICC will begin shortly followed by worldwide commercialization," Joe Goldberger, Interrad's president/CEO, said in a statement.
The company says the SecurAcath system has the potential to become the next standard of care for catheter securement.
Killion told MDD that Interrad is developing a stand-alone version of the SecurAcath, which would be just the anchor itself that could be attached to virtually any indwelling catheter. That device is being designed to work with all PICC, CVC, dialysis and drainage catheters, and Interrad expects it to be ready for commercialization sometime next year.
"We think that's the product we could actually make some headway with because we don't have to convince customers to switch the catheter they are using now," Killion said. "We think that is going to be the home-run product for us."
But first, the company has to go out and prove, in a clinical study, that the SecurAcath system does work.
"We are absolutely unaware of anyone else [making a similar device] and we believe we have staked out the entire territory of subcutaneous catheter securement," Killion said. He said the company has shown its device to larger catheter makers and that those companies seem to think it is a "very clever" device.
The only company that has even come close to developing anything similar, that Interrad is aware of, is Venetec, a California company that was scooped up by C. R. Bard (Murray Hill, New Jersey) in 2006 for $166 million. Venetec developed a line of adhesive catheter securement products as an alternative to sutures (Medical Device Daily, April 11, 2006), which are used on the surface of the patient's skin.
Killion said Interrad considered that deal to be validation for itself, especially given the $166 million purchase price, should Interrad ever look toward acquisition as an exit strategy.
"The idea is we'd like to stick around, we do have those other product ideas, so first we have to go out and prove to the world that this new technology does work," Killion said.
Then, eventually, he said, getting a larger company in the catheter realm to acquire Interrad could be an option.