Access Vascular said today that its HydroPICC catheter has won 510(k) clearance from the FDA.
The peripherally-inserted central catheter is designed with Access Vascular’s proprietary bulk-hydrophilic material, which the company touted as “the ideal material for long-term implantable vascular access devices.”
“The FDA clearance of the HydroPICC catheter is an important milestone for Access Vascular and a critical step forward on our pathway to commercialization,” founder, president & CEO, James Biggins, said in prepared remarks. “Today’s news is a validation of our team’s commitment to innovation and to addressing critical unmet needs in venous access. Our proprietary, unique technology does not flake or elude, and in vitro study results demonstrate our device’s ability to reduce thrombus accumulation as compared to currently available technologies. The reduction in thrombosis demonstrated in testing could have a significant and profound impact on the lives of millions of patients.”
“The risk of catheter thrombosis is significant and can often trigger a cascade of events leading to further complications,” Dr. Gary Ansel, a member of Access Vascular’s medical advisory board, added.
“The proprietary technology used in HydroPICC addresses many of the issues that arise with current venous access devices. By reducing thrombosis on the catheter, we may be able to lessen the risk of complications associated with blood clots, potentially improve outcomes and lead to improved ‘valued care’ by positively impacting healthcare costs.”
To support the commercialization of its HydroPICC device and to boost the development of its pipeline, Access Vascular also announced today that it plans to expand its manufacturing and testing site with a 4,000-square foot lab, and add new members to its commercial and manufacturing teams.