Supira Medical Enrolls First Patient in U.S. Early Feasibility Study of Novel pVAD for High-Risk PCI and Cardiogenic Shock

Supira Medical Announces Initiation and Successful Patient Enrollment in the Company’s U.S. Early Feasibility Study (EFS).

This multicenter, prospective, single-arm clinical study will evaluate the safety and feasibility of Supira Medical's low-profile, high-flow percutaneous ventricular assist device (pVAD) in patients undergoing high-risk percutaneous coronary intervention (HRPCI) and cardiogenic shock (CS). The Supira system, with a 10F profile, is designed to minimize vascular complications and provides real-time pressure measurements through multiple sensors. On November 21, 2023, the system received FDA Breakthrough Device Designation and completed a $40 million Series D financing round.

Patients with coronary artery disease (CAD) often require interventions such as angioplasty or stent placement. Many patients with advanced disease or complex comorbidities cannot undergo percutaneous coronary intervention (PCI) surgery without the temporary support of pVAD.

Percutaneous Ventricular Assist Device (pVAD) provides temporary mechanical support to assist the heart’s natural pumping function, enabling patients to undergo necessary interventional procedures. The U.S. EFS study is being conducted by the National Principal Investigator, David Kandzari (Piedmont Heart Institute, Atlanta, USA). He stated, “The U.S. EFS for Supira, starting with its first successful enrollment, has fueled the researchers’ enthusiasm to bring this program to the U.S. The Supira pump delivers impressive flow rates with a very small profile and comes with a console that supports simplified workflow. This unique combination holds promise to address the limitations of currently available options while enhancing the efficiency of the catheterization lab.”

Supira President and CEO Nitin Salunke stated, "We believe the Supira system is a transformative innovation, and we look forward to expanding critical evidence from our experience with 70 patients in South America. With these U.S. cases, we are one step closer to reshaping patient outcomes while creating value for physicians and healthcare systems."

pVAD is important for supporting cardiovascular function during high-risk PCI, especially for patients with complex coronary anatomy, hemodynamic impairment, and multiple comorbidities. They are also used in cardiogenic shock (CS), a high-mortality condition where the heart is too weak to pump sufficient blood to vital organs, often caused by a heart attack or heart failure.

Supira Medical is a privately held portfolio company of Shifamed. The company is dedicated to developing the next generation of percutaneous ventricular assist devices for high-risk patients undergoing interventional procedures. The historical financing situation is as follows:

This Issue's Planning: Shen Li

Editorial Responsibility: Chen Baolin

Author of this article: Yun Ye Xuan

Post-production:Ling Wujuan