Cryocision flexible cryocatheter system is the first console-free and wholly single-use flexible cryosurgical system for bronchoscopic applications available in the US and Canada.
RT’s Three Key Takeaways:
- Console-Free Design: The portable system uses a miniaturized handheld refrigerant dispenser instead of bulky electromechanical consoles, allowing for use in various healthcare settings including intensive care units and emergency departments.
- Clinical Validation: Physicians successfully performed the first human cases in Quebec for various lung interventions, validating the technology’s safety and performance without device-related complications.
- Increased Accessibility: By eliminating the need for expensive capital equipment, the single-use platform aims to bring bronchoscopic cryobiopsy technology to more healthcare centers.
Endocision announced the successful completion of the first series of human clinical cases using its Cryocision flexible cryocatheter system at hospitals in Quebec. The clinical milestone follows clearance from the USFDA and approval from Health Canada.
The platform is the first console-free and wholly single-use flexible cryosurgical system for bronchoscopic applications available in the US and Canada, according to a news release. The design eliminates the need for bulky capital equipment, allowing for single-user procedures in multiple healthcare settings, including endoscopy suites, intensive care units, operating rooms, and emergency departments.
The system replaces traditional electromechanical consoles with a miniaturized refrigerant dispenser that can be handheld or attached to the handle of a flexible bronchoscope. This dispenser delivers pressurized CO2 to cool the tip of a flexible cryogenic catheter. According to the company, the 5Fr catheter offers improved flexibility to enhance accessibility in all lung lobes.
During the initial procedures, physicians used the catheter to navigate the bronchial tree and deliver controlled cryogenic interventions. Applications for the technology include cryobiopsy, debulking, tumor removal, mucus plug removal, and foreign body removal.
“This represents a major advancement in the field of interventional pulmonology,” said Dr Moishe Liberman, chief medical officer of Endocision, in a news release. “For decades, cryotechnology has played an important role in pulmonary medicine, but physicians have been limited by reusable systems, bulky and expensive capital equipment and stiff cryoprobes. Our platform introduces a new generation of handheld cryosurgical systems designed to simplify workflows, improve accessibility, and expand the possibilities of bronchoscopic diagnosis and treatment.”
Liberman also noted that bronchoscopic cryobiopsy can improve diagnostic yield compared to needle or forceps biopsy, and the system is intended to reach healthcare centers that cannot afford high capital expenditures.
The clinical cases demonstrated the device’s ability to perform cryoadhesion, cryoextraction, and cryodevitalization without device-related complications.
“The successful completion of these first human cases is the result of years of engineering, clinical collaboration, and regulatory work,” said Marc Chelala, chief executive officer of Endocision, in a news release. “Demonstrating successful clinical use following FDA clearance and Health Canada approval represents a transformational moment for our company.”
Endocision plans to expand clinical adoption of the system across additional centers in the US and Canada.
