Demonstrating rapid hemorrhage control and improved patient outcomes
RIVERDALE, Md., April 7, 2021 /PRNewswire/ — Medcura, Inc., a commercial-stage medical device company, announced today that it has published the results of a peer-reviewed clinical study at the University of Chicago in this month’s Cardiovascular Catheterization and Interventions (CCI)
This first-in-human study evaluated the clinical use of the Company’s FDA cleared R³ device for radial closure after routine angiography. Fifty (50) consecutive subjects undergoing a diagnostic catheter-based cardiac procedure were enrolled in the study where the Medcura device was used to enhance radial closure. The R³ device facilitated hemostasis, on average, in 41 minutes while causing no adverse events defined as clinically arterial occlusions, re-bleeding, re-admission, cutaneous discomfort or inflammation, or meaningful hematomas either on the day of the procedure or after follow-ups at seven (7) and thirty (30) days. The study also required the use of post-procedural ultrasound to confirm that 100% of the enrolled subjects had full radial artery patency prior to a same-day discharge. The current standard of care used for radial closure are either pneumatically or mechanically actuated wristbands that do not use hemostatic material, but instead use only compression, to achieve arterial closure. In comparison to the current study, the time to hemostasis reported when using these wristbands is over 2 hours see https://pubmed.ncbi.nlm.nih.gov/29769165/ with adverse event rates of up to 14% see https://pubmed.ncbi.nlm.nih.gov/22230148/.
“Achieving predictable, rapid hemostasis with preservation of radial patency, remains a challenge. Medcura’s R³ device can provide a simple, elegant solution that will reduce recovery time and should improve workflow efficiencies” said Dr. Sandeep Nathan, Medical Director of the Cardiac Intensive Care Unit, Co-Director of the Cardiac Catheterization Laboratory at the University of Chicago and Principal Investigator of the first-in-human study. “I’m pleased with both the hemostatic performance and the positive patient outcomes attributed to using this advanced materials approach. The almost “Velcro-like” removal without clot disruption and slight integration of some of the R³’s material into the clot provided an easy-to-use process and durable seal.”
This qualitative feedback from UCM aligns with recent published mechanistic results https://www.medcurainc.com/publications/biomaterialsGel.pdf. In this study, Medcura undertook a series of optical microscopy-based in vitro analyses that demonstrated how blood cells aggregate in response to varying hydrophobic designs along a polysaccharide backbone. This work was key to optimize the R³’s hemostatic performance for the clinic.
Reported analysis, see https://pubmed.ncbi.nlm.nih.gov/22740010/, suggests that reducing the time to hemostasis after routine angiography is one of the most important factors that can impact the total procedural cost. In combination with improved patient outcomes (e.g., the reduction of adverse events) more rapid hemostasis can reduce the time to discharge while improving patient satisfaction. This is just the first offering from Medcura’s vascular closure program, which includes other development candidates for distal radial closure and more complex femoral cases.
Medcura’s proven platform and recent expansion into new corporate headquarters, permits the Company to manufacture products like R³ while developing implantable products, like our breakthrough device LifeFoam. To better understand our growing product line, please visit our new web site at http://www.medcurainc.com.
About the Company
Medcura is a commercial-stage medical device company developing versatile hemostatic products for surgical, medical, and consumer applications. The Company combines the use of safe, inert ingredients with proprietary chemistry across a broad spectrum of clinical applications, with our Breakthrough Device, LifeFoam™, now leading the expansion into internal and surgical procedures.
SOURCE Medcura, Inc.