FDA Approves Vasorum's Celt ACD Plus Vascular Closure Device with Blood Signal Technology
核心洞察
Vasorum USA (搜索) has received FDA approval for its Celt ACD Plus (搜索) system, featuring innovative Blood Signal technology that provides visual indicators for precise arterial puncture closure following catheter-based procedures.
The next-generation small-bore closure device, available in 5F, 6F, and 7F sizes, reduces major vascular complications and demonstrates significant reductions in time to hemostasis, ambulation, and discharge.
First commercial cases were successfully completed by Dr. Joseph Ricotta at The Prime Vascular Institute (搜索), who noted the device shortens the learning curve for new users and ensures reliable closures across various clinical scenarios.
Vasorum USA (搜索) announced today that the U.S. Food and Drug Administration (FDA) has approved its Celt ACD Plus (搜索) vascular closure device, featuring the company's proprietary Blood Signal technology. The next-generation device enhances the proven Celt ACD platform by providing physicians with a visual indicator for precise placement and closure of arterial punctures following percutaneous catheter-based vascular procedures.
The Celt ACD Plus (搜索) is designed for rapid arterial puncture closure and is available in 5F, 6F, and 7F sizes. Its novel mechanism of action significantly reduces major vascular closure complications such as bleeding (搜索), hematomas (搜索), and pseudoaneurysms (搜索), according to the company.
Dr. Joseph Ricotta, Founder and Program Director of the Vascular Surgery Fellowship at Florida Atlantic University School of Medicine (搜索), performed the first commercial cases with the Celt ACD Plus (搜索) at The Prime Vascular Institute (搜索) in Delray Beach, Florida.
"The Celt ACD Plus (搜索) 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."
Clinical Benefits and Market Impact
Clinical data has demonstrated that the Celt ACD Plus (搜索) significantly reduces time to hemostasis, ambulation, and discharge, leading to improved efficiency and potential cost savings in post-anesthesia care. These benefits are particularly valuable as healthcare facilities increasingly prioritize same-day discharge and cost-effective care models.
David Gunther, Vice President of Sales and Marketing for Vasorum USA (搜索), emphasized the company's mission to transform vascular closure technology. "The FDA approval of Celt ACD Plus (搜索) 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."
Growing Market for Vascular Closure Devices
The U.S. small bore arterial vascular closure device market was valued at approximately $600 million in 2023 and is projected to reach $1 billion by 2032. This growth is driven by several factors, including the increasing prevalence of cardiovascular disease (搜索) (CVD), fueled by an aging population and rising rates of obesity (搜索), diabetes (搜索), and hypertension (搜索).
Additionally, the healthcare industry's 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 frequently require femoral access. In these high-efficiency environments, faster hemostasis enables quicker patient discharge, increasing procedural throughput and optimizing revenue.
About the Technology
The Celt ACD Plus (搜索) builds upon Vasorum's established closure platform with the addition of Blood Signal technology, which provides visual confirmation for proper device placement. This feature is especially valuable in clinical settings where ultrasound imaging might not be readily available, helping to ensure consistent and reliable arterial closures.
The device's mechanism of action is designed to provide immediate hemostasis while reducing the risk of complications that can occur with traditional closure methods. This advancement aligns with the growing emphasis on minimizing procedure-related complications and improving the overall patient experience.
Founded in 2007, Vasorum Ltd. (搜索) is headquartered in Dublin, Ireland, with operations in the United States. The company focuses on developing innovative solutions for vascular closure across a broad spectrum of interventional procedures.