The confirmatory trial, a multicenter effort, evaluates the safety and efficacy of the device in patients suffering from severe aortic stenosis. Unlike current platforms, Venus-PowerX allows for 100% retrieval even after full deployment, a feature surgeons describe as a shift from partially to fully controllable interventions. The system integrates proprietary dry tissue technology with anti-calcification treatments and a self-adaptive skirt designed to minimize paravalvular leaks.

Venus Medtech is leveraging real-world evidence from early commercial adoption in Argentina, Chile, and Venezuela to bolster its international expansion. Chief Technology Officer Ma Renzheng noted that the successful enrollment confirms the device’s potential to improve procedural safety. By moving toward simultaneous filings with the NMPA and European regulators, the company is positioning its Chinese-developed structural heart technology to compete directly in major global markets.