FDA Clears Next Generation HydroPICC from Access Vascular
Patented Biomaterial Platform Used in Peripherally Inserted Central Catheter (PICC) Designed to Virtually Eliminate Thrombus Accumulation
Bedford, MA – March 3, 2020 – Access Vascular, Inc. today announced it has received FDA clearance for the second generation of its HydroPICCTM peripherally inserted central catheter (PICC), which has demonstrated an average of 97% less thrombus accumulation on its surface compared to a standard polyurethane catheter1.
PICCs have become an increasingly popular choice over traditional central venous lines due to ease of use, decreased risk, reduced cost and ability to be placed by non-physicians;2 however, traditional PICCs are more than twice as likely to experience catheter-related thrombus leading to significant patient complications3 and associated costs. Standard PICCs are comprised of polyurethanes or silicones that absorb proteins,4 which attract thrombus. The inherent characteristics of these materials may also cause phlebitis and catheter-related infections, as well as other PICC line complications.5
HydroPICC is comprised of Access Vascular’s patented biomaterial platform that combines the superior mechanical properties of polyurethanes with the intrinsically low thrombogenicity of hydrogel. The lubricious and hydrophilic material is designed to repel protein and thrombus development, prevent catheter occlusion, reduce infections and add flexibility to the catheter. The company plans to develop a variety of thrombus-resistant venous catheters and devices from the biomaterial to address the $4.4 billion venous access market, including midlines, peripherally inserted venous catheters, ports, central venous catheters and dialysis catheters. The biomaterial also has the future potential to incorporate sustained delivery of such therapeutics as anti-infectives, analgesics/anesthetics or anti- inflammatories.
“The importance of improving the biocompatibility of materials that reside within the intravascular space cannot be overemphasized. Despite attention to optimal site choice and catheter to vein ratios, patients often develop fibrin sheaths that inhibit catheter functionality. They also commonly develop venous thrombus, sometimes with associated blood stream infections, that use these depositions as basecamps for biofilm formation,” said Gregory J. Schears, MD, a professor of anesthesiology in Rochester, Minnesota and medical advisor to Access Vascular. “A material that could combat these issues has the potential to significantly improve vascular access throughout the body.”
The second-generation device is easy to insert and integrates new features that streamline placement time based on clinician feedback gleaned from the commercial experience of the first-generation catheter.
The company will focus on generating clinical evidence at a limited number of commercial sites in the U.S. in 2020. Last year, the company was awarded a group purchasing agreement for a Breakthrough Technology contract with Premier, the leading improvement company uniting an alliance of approximately 4,000 U.S. hospitals and 165,000 other providers to
transform healthcare. The agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for HydroPICC.
“We are excited about the potential of our biomaterial to address significant and underserved clinical needs in venous access,” said Access Vascular CEO James Biggins. “Clinician response to HydroPICC has been strong and we look forward to working closely with key clinical leaders and centers to integrate the new technology into their practices to the betterment of both the care team and their patients.”
About Access Vascular
Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and are capable of long-term thrombus resistance and infection protection.
Medical advisors to the company include Gary M. Ansel, MD, with Ohio Health; Nadine Nakazawa, RN, with Stanford Health Care; Kenneth Rosenfield, MD, with Massachusetts General Hospital; Gregory Schears, MD, with Mayo Clinic; and Jeremy D. Schiller, MD with Mt. Auburn Hospital.
Data on file. Reduction of thrombus accumulation evaluated using in vitro and in vivo models. Pre-clinical in vitro/in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation
Moureau N, Chopra V. Indications for peripheral, midline, and central catheters: summary of the Michigan Appropriateness Guide for Intravenous Catheters recommendations. J Assoc Vasc Access. 2016;21:140–148.
Johansson E, Hammarskjöld F, Lundberg D, et al. Advantages and disadvantages of peripherally inserted central venous catheters (PICC) compared to other central venous lines: A systematic review of the literature. Acta Oncol. (Madr). 2013;52:886–892.
Andrade JD, Hlady V. Protein adsorption and materials biocompatibility: A tutorial review and suggested hypotheses. Berlin, Heidelberg: Springer Berlin Heidelberg; 1986. p. 1–63.
Seckold T, Walker S, Dwyer T. A comparison of silicone and polyurethane PICC lines and postinsertion complication rates: a systematic review. J. Vasc. Access. 2015;16(3):167-77.
MEDIA CONTACT:
Michelle McAdam
Chronic Communications, Inc.
michelle@chronic-comm.com
(310) 902-1274
