Recross Cardio Reaches Milestone in PFO Sealing Clinical Program

The program includes 15 patients treated in the United States and 10 in Serbia, marking a significant expansion of the company’s clinical footprint. Unlike traditional closure devices, the Recross PFO Sealing System utilizes a membrane-based approach designed to provide a conformable, low-profile fit with minimal permanent material left in the heart. Dr. Carey Kimmelstiel, the study’s National Co-Principal Investigator, noted that the system balances effective closure with a familiar transcatheter workflow, a critical factor for long-term patient care. Dr. Mihajlo Farkic of the Dedinje Institute in Belgrade added that early results show the device can be implanted efficiently with promising acute sealing performance. CEO Tom Gerhardt stated that the company intends to use data from these procedures to refine its platform for broader applications, including atrial septal defects and iatrogenic septal management. The investigative nature of the study remains ongoing as the firm works to establish the clinical evidence required for future regulatory advancement.