UC Davis Health First in Western US to Use Novel Supira pVAD System in High-Risk Cardiac Procedures
Key Insights
UC Davis Health (search) is among the first in the nation to use the Supira percutaneous ventricular assist device (pVAD) system to improve blood flow during high-risk stenting procedures.
The Supira pVAD system (search) features a low-profile design with multiple sensors for real-time pressure monitoring, potentially reducing vascular complications.
The early feasibility study results will support a U.S. Food and Drug Administration (FDA) submission for a pivotal investigational device exemption study.
Cardiologists at UC Davis Health (search) are among the first in the United States to utilize the Supira percutaneous ventricular assist device (pVAD) system, a novel, low-profile device designed to enhance blood flow in cardiovascular patients undergoing complex, high-risk heart artery stenting procedures. This initiative is part of an early feasibility study conducted through the UC Davis Clinical Cardiovascular Research Unit.
UC Davis Medical Center stands as one of only four sites nationwide with early investigational access to the Supira pVAD System (search) and is the first hospital in the Western United States to implement it. The device offers a potential solution for patients with severe coronary artery disease (search) or comorbidities.
How the Supira pVAD System Differs
pVADs are employed during stent placement or angioplasty to provide circulatory support for high-risk patients facing severe coronary artery disease (search) or comorbidities. These devices are also crucial in treating cardiogenic shock (search), a life-threatening condition that can arise after a severe heart attack, where the heart's ability to pump blood to vital organs is compromised.
The Supira pVAD system (search) distinguishes itself with a smaller design compared to existing devices. It incorporates multiple sensors that gather real-time aortic and ventricular pressure data, aiding in clinical decision-making.
Addressing Vascular Complications
Tai Pham, assistant professor of cardiovascular medicine and co-principal investigator of the study, noted, "The combination of a low-profile and high-flow system is extremely attractive as we look to address the risks of vascular complications associated with currently available devices."
Garrett Wong, clinical professor of cardiovascular medicine and co-principal investigator of the study, stated, "We are excited to utilize this novel device for patients with complex coronary anatomy, problems with their blood flow and multiple diseases. This next-generation device may allow us to offer procedures to patients who otherwise would be too high risk."
Path to Regulatory Approval
The data collected from this early feasibility study will be included in the submission to the U.S. Food and Drug Administration (FDA) for a pivotal investigational device exemption study. This represents a crucial step toward potential widespread availability of the Supira pVAD System (search).
UC Davis Health: A Leader in Cardiovascular Clinical Trials
The Supira pVAD System (search) study is one of many clinical trials conducted by the Clinical Cardiovascular Research Unit. In the last 10 years, the unit has conducted studies and trials in many areas of cardiology, including heart valve disorders (search), congestive heart failure (search) and hypertension (search).