Supira Medical has announced the initiation and successful patient enrolment in the company’s US early feasibility study (EFS).
The multicentre, prospective, single arm clinical study will evaluate the safety and feasibility of Supira’s low-profile, high-flow percutaneous ventricular assist device (pVAD) in patients undergoing high-risk percutaneous coronary intervention (PCI). The US EFS procedure was performed by the study national principal investigator, David Kandzari (Piedmont Heart Institute, Atlanta, USA).
“I am pleased to share that Supira’s US EFS began with its first successful enrolment, supporting the enthusiasm among investigators to bring this program to the USA. 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 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 US cases, we are one step closer to our goal of reshaping outcomes for patients while delivering value for physicians and the healthcare system,” commented 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 high-risk PCI, particularly in patients with complex coronary anatomy, compromised haemodynamics, 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 USA or anywhere in the world.
Supira Medical is a privately held portfolio company of Shifamed.
