Supira Medical Receives FDA Approval for SUPPORT II Pivotal Trial of Next-Generation Percutaneous Ventricular Assist Device
Key Insights
Supira Medical (search) received FDA approval to initiate the SUPPORT II pivotal trial, a randomized controlled study designed to assess the safety and efficacy of their next-generation percutaneous ventricular assist device (pVAD) in high-risk percutaneous coronary intervention patients.
The trial will enroll up to 385 patients at up to 40 U.S. sites and represents a critical step toward U.S. market entry through a future PMA submission.
The company has demonstrated advances in cardiogenic shock treatment with recent case experience utilizing percutaneous axillary access to enable patient ambulation with an active 10Fr pVAD.
Supira Medical (search), a clinical-stage company focused on transforming the percutaneous ventricular assist device (pVAD) market, announced FDA approval to initiate the SUPPORT II Pivotal Trial. The trial is designed to support a future PMA submission and represents a critical step toward U.S. market entry for the company's next-generation pVAD system.
SUPPORT II Trial Design and Leadership
SUPPORT II (SUpira System (search) in Patients Undergoing High-Risk Percutaneous COronaRy InTervention) is a prospective, randomized controlled study designed to assess the safety and efficacy of the company's next-generation pVAD in patients undergoing high-risk percutaneous coronary intervention (HRPCI). The study will enroll up to 385 patients at up to 40 U.S. sites.
The trial is led by national co-principal investigators Dr. Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons/New York-Presbyterian Hospital (search), and Dr. David Kandzari, Chief of the Piedmont Heart Institute (search) and Chief Scientific Officer for Piedmont Healthcare, Atlanta, GA.
"In HRPCI, the decision to use hemodynamic support is often influenced by access, deliverability, and the balance between support and procedural efficiency," said Dr. Kandzari. "A system that can provide effective circulatory support with a smaller profile has the potential to expand the available treatment population and improve effectiveness."
Dr. Kirtane emphasized the clinical significance of the device for complex procedures: "The appropriate use of a pVAD allows physicians to safely perform procedures of the highest complexity, offering HRPCI to patients who previously had limited options. The initiation of this pivotal randomized trial of a novel, lower-profile hemodynamic support device is an important step in advancing the care of some of our highest risk patients."
Advances in Cardiogenic Shock Treatment
Separately from SUPPORT II, Supira has been pursuing opportunities to improve treatment options for patients experiencing cardiogenic shock. Recent case experience outside the U.S. includes the initial series of cardiogenic shock patients, utilizing percutaneous axillary access to enable patient ambulation with an active 10Fr pVAD.
These developments highlight what the next generation of temporary mechanical circulatory support can potentially enable, including expanding access options, supporting mobility, and advancing how physicians manage critically ill patients. For interventional cardiologists and heart failure specialists, full hemodynamic support with flexibility in percutaneous access site and the potential for patient mobility during support represent important steps toward improving the overall care pathway for cardiogenic shock.
Strategic Board Appointment
In parallel with these clinical milestones, Supira announced the appointment of D. Keith Grossman to its Board of Directors. Mr. Grossman brings 40 years of leadership experience in the medical technology industry, including a foundational role in the mechanical circulatory support space.
"Keith brings a valuable combination of operational discipline, commercial insights, and strategic perspective," said Dr. Nitin Salunke, President and CEO of Supira Medical (search). "His addition as an independent member of our Board reflects our commitment to building an organization that is not only clinically differentiated but also positioned to execute at scale."
Mr. Grossman expressed confidence in the company's positioning: "Supira has established a compelling clinical and technological foundation that is uniquely positioned to change the growing and still under-penetrated pVAD landscape. I look forward to supporting the company as it advances its pivotal trial and prepares to become a leading presence among treatment options for high-risk PCI and cardiogenic shock patients."
Clinical Context and Device Status
To date, the Supira System (search) has been used in 99 patients. The device addresses critical needs in cardiovascular care, as pVADs are important for supporting cardiovascular function during HRPCI and in patients experiencing cardiogenic shock. HRPCI patients have complex coronary anatomy, compromised hemodynamics, and multiple comorbidities, while cardiogenic shock is a high-mortality condition where the heart is too weak to pump sufficient blood to vital organs, usually resulting from a heart attack or heart failure.
The Supira System (search) remains an investigational device and is not approved for sale in the U.S. or anywhere in the world. The device is limited by federal law to investigational use.