- Company expands clinical program beyond 70 patients already treated in South America FIH and Feasibility Studies.
- FDA acknowledged potential benefits of the Supira System by granting the company a review pathway under the Breakthrough Device Program.
- Results from EFS will be used to support submission to FDA for Supira’s pivotal study IDE.
LOS GATOS, Calif., Nov. 21, 2024 /PRNewswire/ -- Supira Medical, Inc. (Supira), a Shifamed portfolio company, announced today the initiation and successful patient enrollment in the company’s U.S. EFS. This multi-center prospective, single arm clinical study will evaluate the safety and feasibility of Supira’s innovative low-profile, high-flow percutaneous ventricular assist device (pVAD) in patients undergoing high-risk percutaneous coronary intervention (HRPCI). The U.S. EFS procedure was performed by the study national principal investigator, David Kandzari, MD, Chief of the Piedmont Heart Institute.
“I am pleased to share that Supira’s U.S. EFS began with its first successful enrollment, supporting the enthusiasm among investigators to bring this program to the U.S. The Supira pump delivers impressive flow rates through a remarkably small profile, with a console that supports simplified workflows. This unique combination promises to address limitations of presently available options while enhancing cath lab efficiency,” stated Dr. Kandzari.
“We believe the Supira System is a transformative innovation and look forward to expanding the significant body of evidence from our 70-patient South America experience. With these U.S. cases, we are one step closer to our goal of reshaping outcomes for patients while delivering value for physicians and the healthcare system,” commented Dr. Nitin Salunke, President and CEO of Supira. “I would like to thank our clinical advisors for their strong, continued support and our team for their tireless efforts to achieve this historic milestone.”
pVADs are important for supporting cardiovascular function during HRPCI, particularly in patients with complex coronary anatomy, compromised hemodynamics, 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, usually resulting from a heart attack or heart failure. The Supira System is an investigational device and is not approved for sale in the U.S. or anywhere in the world.
About Supira Medical, Inc.
Supira Medical, a privately held portfolio company of Shifamed, is focused on development of a next-generation pVAD for use in high-risk patients undergoing interventional procedures and cardiogenic shock. To learn more about Supira Medical, please visit www.supiramedical.com.
About Shifamed, LLC.
Founded by serial entrepreneur Amr Salahieh, Shifamed is a highly specialized medical innovation hub focused on developing solutions that accelerate time to market, reduce risk, increase impact, and forge a path toward a world where patients are able to live longer, healthier lives. To learn more about Shifamed, please visit www.shifamed.com.
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SOURCE Supira Medical, Inc.
