Vasorum Secures FDA Approval for Celt ACD® PLUS Vascular Closure Device

Vasorum USA, Inc, a privately held, commercial-stage medical device company dedicated to redefining vascular closure, announced U.S. Food and Drug Administration (FDA) approval of the Celt ACD^® PLUS System, featuring Blood Signal technology. This next-generation device enhances the proven Celt ACD^® platform by providing physicians with a visual indicator for precise placement and closure, particularly beneficial in cases where ultrasound imaging is not available.

The Celt ACD^® PLUS is an innovative small-bore closure device available in 5F, 6F, and 7F sizes, designed for rapid arterial puncture closure following percutaneous catheter-based vascular procedures. Its novel mechanism of action reduces major vascular closure complications such as bleeding, hematomas, and pseudoaneurysms. Clinical data has demonstrated significant reductions in time to hemostasis, ambulation, and discharge, leading to improved efficiency and cost savings in post-anesthesia care.

First commercial cases with the Celt ACD^® PLUS device were successfully completed at The Prime Vascular Institute by Joseph Ricotta, MD, MS, FACS, Founder and Program Director of the Vascular Surgery Fellowship at Florida Atlantic University School of Medicine.

"The Celt ACD^® PLUS represents a significant advancement in vascular closure," said Dr. Ricotta. "By providing a visual indicator for accurate deployment, it shortens the learning curve for new users and expands access to the Celt ACD^® technology. This is particularly beneficial in settings where ultrasound guidance may not be available, ensuring consistent, reliable closures across a broader range of clinical scenarios."

David Gunther, Vice President of Sales and Marketing for Vasorum USA, Inc., emphasized the company's mission to transform vascular closure technology. "The FDA approval of Celt ACD^® PLUS marks an exciting milestone for Vasorum and the physicians we serve," stated Gunther. "By enhancing the safety and efficiency of arterial closure, we continue to build on our commitment to innovation and improving procedural outcomes for both physicians and patients."

The U.S. small bore arterial vascular closure device market, valued at $600 million in 2023, is projected to reach $1 billion by 2032. This growth is driven by the increasing prevalence of cardiovascular disease (CVD), fueled by an aging population and rising rates of obesity, diabetes, and hypertension.

Additionally, the shift toward outpatient settings, including ambulatory surgical centers (ASCs) and office-based labs (OBLs), is driving demand for efficient closure solutions. While many hospitals have transitioned coronary interventions to radial access, peripheral procedures still require femoral access. In these high-efficiency environments, faster hemostasis enables quicker discharge, increasing procedural throughput and optimizing revenue.

With healthcare increasingly favoring same-day discharge and cost-effective care models, vascular closure devices like the Celt ACD^® PLUS play a critical role in streamlining workflow and enhancing patient outcomes.