SmartTRAK Life Sciences New and Analysis Blog — November 22, 2019 — Novel Securement Device Making Inroads
Securement of both central line and peripheral catheters is critical as poor securement can lead to dislodgement, infection and/or phlebitis. The vast majority of products used today for securement include basic film (polyurethane) dressings, film dressings with stabilization and mechanical securement devices. 3M holds the leadership position in dressings with its Tegaderm line of products while BD leads the mechanical securement with its StatLock Stabilization Devices. However, a new class of product is emerging and making inroads in the market with impressive clinical and cost-effectiveness data.
Adhezion Biomedical’s SecurePortIV Catheter Securement Adhesive, a cyanoacrylate-based liquid adhesive, provides securement but also seals the insertion site from bacteria and was FDA cleared as a 510(k) Class II medical device in Sept 2017. The opportunity for SecurePortIV adhesive is impressive, at ~$6.00 per insertion site the total market opportunity for PIVs and central lines is estimated by SmartTRAK at $1.5B. With only a 20% adoption rate, a potential of $300MM exists. This opportunity may become a reality for Adhezion Biomedical as SecurePortIV has been the subject of numerous clinical trials demonstrating clinical benefit and cost effectiveness, with several having results presented at the recent AVA meeting.
The oncology/hematology department at the Mayo Clinic Arizona found securement and stabilization of its peripherally inserted central catheters (PICCs) needed improvement. Dr. Joan Ralph Webber, a clinical nurse specialist, reviewed alternative devices associated with securement and stabilization and was impressed with published results associated with tissue adhesive. Webber championed a clinical study to compare the use of SecurePortIV adhesive with a securement dressing to a retrospective cohort using an antimicrobial disc and an engineered stabilization device. One year later, the use of SecurePortIV adhesive demonstrated a decrease in migration rates to 1.4% from 19.35%, no CLABSI’s for 5 consecutive quarters and cost benefits of the tissue adhesive compared to the use of a chlorhexidine disc and engineered securement device. The facility is currently working towards approval for use of SecurePortIV adhesive across all catheter lines.
In another study, Jennifer Thompson, Vascular Access Manager at Texas Health Huguley Hospital Fort Worth South, presented results of four separate study protocols using a variety of products, that were tested to evaluate dressing adherence, moisture presence, skin integrity and average dwell time. The fourth and final protocol had only one item added to the standard protocol – use of SecurePortIV adhesive to the insertion site. Use of SecurePortIV adhesive in the dressing protocol demonstrated an impressive decrease in PIV disruption from 70% to 18% while achieving an 87% completion of therapy rate. A cost analysis determined use of SecurePortIV adhesive will save the hospital $407k of which $204k are material costs. Plans at this facility are to adopt SecurePortIV adhesive for use on all catheters.
Other impressive results were presented from several hospitals including many children’s hospital where benefits were seen in reduced dressing changes, decreased bleeding, lower infection rates and reduced dislodgement. With these impressive results, SmartTRAK talked with Adhezion Biomedical’s Chairman and CEO, Pete Molinaro about next steps moving forward.
Molinaro stated, “Our strategy is to continue to conduct meaningful clinical trials in an effort to expand SecurePortIV adhesive’s claims and further validate the already presented impressive results. We are grateful for the enthusiastic response shown by the vascular access clinical community for this product and gratified to hear that key opinion leaders view SecurePortIV adhesive as the next standard of care.”