Recross Cardio has announced the treatment of the 25th subject in the PROTEA-PFO clinical programme evaluating the Recross PFO sealing system.
The programme, enrolling at sites in the USA and Europe, is designed to assess the initial safety and preliminary performance of the Recross PFO seal, a novel membrane-based approach to septal sealing, in subjects who have had a prior ischaemic stroke due to presumed paradoxical embolism.
Building on the first enrolment in the early feasibility study (EFS), Recross has expanded its clinical experience across multiple physicians and healthcare institutions. To date, the programme includes 15 subjects treated in the USA and 10 subjects treated in Serbia.
Carey Kimmelstiel, director of interventional cardiology at Tufts Medical Center and professor of medicine at Tufts University School of Medicine (Medford, USA), national co-principal investigator of the study, said: “As our experience with PFO [patent foramen ovale] closure evolves, we continue looking for technologies that not only achieve effective closure but also consider the subjects’ needs over their lifetime. The Recross system offers a novel approach while maintaining a familiar transcatheter workflow. Reaching 25 treated subjects across multiple centres is an important milestone in understanding the performance of this technology.”
“We are proud to have contributed to the continued progress of the study,” Mihajlo Farkic, principal investigator at the National Institute for Heart and Blood Vessels “Dedinje” in Belgrade, Serbia, commented. “Our early experience has demonstrated that the device can be implanted efficiently and has shown promising acute sealing performance. Continued clinical experience across multiple centres will be important to further understand the potential of this technology and the way we approach PFO closure.”
The Recross PFO sealing system is the first clinical application of Recross’ proprietary membrane-based septal sealing platform. The technology is designed to provide a conformable, low-profile approach to septal sealing with minimal permanent implant footprint.
