Accelerating Innovation in Structural Heart Care: Bioforum’s Role in Pi-Cardia’s FDA Journey
Bioforum is proud to have supported Pi-Cardia in securing FDA clearance for ShortCut™—a first-of-its-kind solution in structural heart care. This collaboration demonstrates the value of expert data management and regulatory strategy in accelerating life-saving medical innovations.
ShortCut™: Transforming Valve-in-Valve Procedures
Pi-Cardia’s ShortCut™ is the only FDA-cleared leaflet modification device designed for transcatheter aortic valve replacement (TAVR). By modifying calcified valve leaflets during valve-in-valve procedures, ShortCut™ offers a safer, more effective solution for patients—earning FDA Breakthrough Device Designation for its potential to address critical unmet needs.
Meeting the Challenge: Regulatory Strategy & Data Excellence
To bring ShortCut™ to market, Pi-Cardia navigated a complex regulatory journey—shifting focus from European to U.S. approval, adapting trial protocols, and expanding to U.S. sites.
Through their partnership with Bioforum (formerly TechnoSTAT), Pi-Cardia ensured precision in trial execution, compliance, and data integrity. From automated edit checks and cross-site standardization to advanced statistical planning, Bioforum played a key role in delivering FDA-ready outputs that met the highest standards.
Outcome: FDA Clearance & Future Impact
Bioforum’s collaborative approach helped streamline Pi-Cardia’s path to FDA clearance. This case reflects our commitment to empowering innovative companies with the tools, technology, and expertise to bring meaningful medical advancements to market faster.
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Learn how Bioforum helped Pi-Cardia overcome regulatory hurdles and achieve FDA approval for a breakthrough structural heart device.