LOS GATOS, Calif., April 8, 2026
Supira Medical has achieved a major regulatory milestone with the U.S. Food and Drug Administration granting approval to initiate its SUPPORT II pivotal clinical trial, a critical step toward advancing its next-generation percutaneous ventricular assist device (pVAD) for high-risk cardiac patients. This development marks a significant progression toward a future Premarket Approval (PMA) submission and potential U.S. market entry, positioning Supira at the forefront of innovation in mechanical circulatory support technologies.
Pivotal Trial to Evaluate Next-Generation pVAD
The SUPPORT II (SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention) trial is a prospective, randomized controlled study designed to assess the safety and efficacy of Supira’s investigational pVAD in patients undergoing high-risk percutaneous coronary intervention (HRPCI). The study is expected to enroll up to 385 patients across approximately 40 U.S. clinical sites, reflecting a robust and comprehensive evaluation strategy.
The trial is led by renowned interventional cardiology experts, including Dr. Ajay Kirtane of Columbia University and Dr. David Kandzari of Piedmont Heart Institute. Their leadership underscores the clinical importance of this study, which aims to address the growing need for effective hemodynamic support devices in complex cardiovascular procedures. The Supira System is designed with a lower-profile architecture, enabling improved deliverability and procedural efficiency while maintaining strong circulatory support, a balance that is critical in high-risk interventions.
Advancing Treatment in Cardiogenic Shock
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Beyond HRPCI applications, Supira is also advancing innovation in the management of cardiogenic shock, a life-threatening condition characterized by the heart’s inability to pump sufficient blood to vital organs. Early clinical experience outside the United States has demonstrated the feasibility of using the Supira System via percutaneous axillary access, allowing for patient mobility during mechanical support—a significant advancement over traditional immobilizing systems.
These developments highlight the potential of next-generation pVAD technologies to transform patient care pathways, offering physicians greater flexibility in access site selection and enabling improved patient outcomes through enhanced mobility and sustained hemodynamic stability. For clinicians, the ability to provide full circulatory support while maintaining procedural efficiency and patient comfort represents a critical evolution in cardiovascular intervention strategies.
The Supira System has already been utilized in 99 patients, generating valuable real-world insights that continue to inform its clinical development. While still investigational and not yet approved for commercial use, the device’s growing body of evidence supports its potential to address significant unmet needs in both interventional cardiology and heart failure management.
Strategic Leadership Strengthens Commercial Pathway
In parallel with its clinical advancements, Supira Medical has appointed D. Keith Grossman, a seasoned leader with over 40 years of experience in the medical technology industry, to its Board of Directors. His extensive background in mechanical circulatory support and medtech commercialization is expected to play a pivotal role in guiding the company’s transition from clinical development to market readiness.
This strategic addition reinforces Supira’s commitment to building a strong commercial foundation alongside its clinical progress. Leadership expertise in scaling operations, navigating regulatory pathways, and executing go-to-market strategies will be crucial as the company moves closer to PMA submission and eventual commercialization.
The convergence of regulatory progress, clinical innovation, and experienced leadership positions Supira Medical as a key emerging player in the evolving pVAD landscape. As cardiovascular disease continues to be a leading cause of mortality worldwide, innovations that enhance the safety and effectiveness of high-risk procedures are of paramount importance.
With the initiation of the SUPPORT II trial, Supira is advancing toward a future where next-generation mechanical circulatory support systems can expand treatment options, improve procedural outcomes, and ultimately save lives in critically ill cardiac patients. The coming years will be pivotal as clinical data from this trial shapes the trajectory of Supira’s technology and its potential impact on global cardiovascular care.
Source: Supira Medical press release
