FDA clearance sought for Access Vascular’s HydroPICC Catheter

Medical device company reinventing venous access using proprietary material technology designed to reduce thrombus accumulation, Access Vascular asserted that the Company has sought 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its lead product, the HydroPICC, a peripherally inserted central catheter, intended for long-term use. In pre-clinical testing, the HydroPICC demonstrated a 30x reduction in platelet count when compared with current market-leading PICC.

James Biggins, founder, president and CEO of Access Vascular Inc said “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”

According to one study, 34 percent of PICCs placed will experience complications.These potential complications could significantly increase morbidity, hospital stay and overall cost of care. Venous access devices are ubiquitous within the healthcare system. In the U.S., over 3 million PICCs are placed every year to deliver drugs or nutrition to patients. Along with the benefits comes the significant potential of complications arising from the placement of a long-term catheter into a small caliber peripheral vein with multi-week indwell time.