Vasorum USA has announced that the US Food and Drug Administration (FDA) has granted approval for its Celt ACD PLUS System, a vascular closure device incorporating Blood Signal technology.
This device enhances the existing Celt ACD platform by providing a visual indicator to assist physicians in achieving precise placement and closure, a feature particularly useful when ultrasound imaging is unavailable.
The Celt ACD PLUS is available in 5F, 6F, and 7F sizes and is designed for the rapid closure of arterial punctures following percutaneous catheter-based vascular procedures. This new mechanism aims to decrease complications such as bleeding, haematomas, and pseudoaneurysms significantly.
According to Vasorum USA, clinical trials have shown notable reductions in time to achieve haemostasis, patient ambulation, and hospital discharge, suggesting improved efficiency and cost savings in post-anaesthesia care.
Vasorum USA sales and marketing vice president David Gunthe said: “The FDA approval of Celt ACD PLUS marks an exciting milestone for Vasorum and the physicians we serve.
“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.”
Initial commercial use of the Celt ACD PLUS device took place at Prime Vascular Institute in Florida under the supervision of Joseph Ricotta.
Ricotta said: “The Celt ACD PLUS represents a significant advancement in vascular closure.
“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.”
Celt ACD is designed to serve a broad range of interventional procedures.
Vasorum is based in Ireland and operates in the US as well. The company said that the transition towards outpatient care settings such as ambulatory surgical centres (ASCs) and office-based labs (OBLs) is boosting demand for efficient vascular closure solutions.
Although many hospitals have shifted coronary interventions to radial access, femoral access remains necessary for peripheral procedures. In these high-efficiency settings, quicker haemostasis allows for faster patient discharge, thereby increasing procedural throughput and optimising revenue, said the company.
As healthcare increasingly moves towards same-day discharge models and cost-effective care strategies, devices like the Celt ACD PLUS are pivotal in streamlining clinical workflows and enhancing patient care outcomes.
