BEDFORD, Mass., Feb. 22, 2018 /PRNewswire/ -- Access Vascular, a medical device company reinventing venous access using proprietary material technology designed to reduce thrombus accumulation, announced today that the Company has received 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.1
"The FDA clearance of the HydroPICC catheter is an important milestone for Access Vascular and a critical step forward on our pathway to commercialization," said James Biggins, founder, president and CEO of Access Vascular Inc. "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."
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. According to one study, 34 percent of PICCs placed will experience complications. 2,3 These potential complications could significantly increase morbidity, hospital stay and overall cost of care.
"The risk of catheter thrombosis is significant and can often trigger a cascade of events leading to further complications," added Dr. Gary M. Ansel, System Medical Chief, Vascular Services, Ohio Health Heart & Vascular Physicians and Access Vascular Medical Advisory Board Member. "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 meet the anticipated demand for the HydroPICC and to advance the development of a robust pipeline of venous access devices, Access Vascular is expanding its manufacturing and testing facility with an additional 4,000-square foot state-of-the-art lab and manufacturing space and growing the commercial and manufacturing teams.
ABOUT ACCESS VASCULAR'S PROPRIETARY BULK-HYDROPHILIC MATERIAL
Unlike current devices made from polyurethane, Access Vascular has developed a proprietary bulk-hydrophilic material that has a high-water content and a neutral surface charge, while meeting the performance needs for a power injectable catheter. These features make it the ideal material for long-term implantable vascular access devices that markedly reduce thrombus accumulation on the devices. The proprietary material had been demonstrated through testing not to initiate the thrombosis cascade and therefore does not trigger the body's thrombotic response.4
ABOUT ACCESS VASCULAR Access Vascular is reinventing venous access using our novel bulk-hydrophilic material platform to develop devices that address the key unmet need in the space—reducing catheter thrombus accumulation. Our technology has the potential to improve care, decrease complications and reduce costs by reducing complications resulting from thrombosis. The robust pipeline currently includes midlines, drug delivery catheters, dialysis catheter, and ports, all in various stages of development. More information is available at www.accessvascularinc.com.
1. Data on file at Access Vascular 2. Leroyer, C. et al. Prospective follow-up of complications related to peripherally inserted central catheters. Med. Mal. Infect. 43, 350–355 (2013). 3. Grau, D., Clarivet, B., Lotthé, A., Bommart, S. & Parer, S. Complications with peripherally inserted central catheters (PICCs) used in hospitalized patients and outpatients: a prospective cohort study. Antimicrob. Resist. Infect. Control 6, 18 (2017). 4. Data on file at Access Vascular