Supira Medical has announced US Food and Drug Administration (FDA) approval to initiate the SUPPORT II pivotal trial, designed to support a future premarket approval (PMA) submission for its percutaneous ventricular assist device (pVAD).
SUPPORT II is a prospective, randomised 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 enrol up to 385 patients at up to 40 US sites and is led by national co-principal investigators Ajay Kirtane (Columbia University, New York, USA) and David Kandzari (Piedmont Healthcare, Atlanta, USA).
“In HRPCI, the decision to use haemodynamic support is often influenced by access, deliverability, and the balance between support and procedural efficiency,” said 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.”
“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,” said Kirtane. “The initiation of this pivotal randomised trial of a novel, lower-profile haemodynamic support device is an important step in advancing the care of some of our highest risk patients.”
In parallel, Supira has announced the appointment of D Keith Grossman to its board of directors. Grossman’s 40-year leadership experience in the medical technology industry, including a foundational role in the mechanical circulatory support space, will reinforce the company’s focus on scaling toward market readiness and growth, the company said in a press release.
“Keith brings a valuable combination of operational discipline, commercial insights, and strategic perspective,” said Nitin Salunke, president and CEO of Supira Medical. “His addition as an independent member of our board reflects our commitment to building an organisation that is not only clinically differentiated but also positioned to execute at scale.”
“Supira has established a compelling clinical and technological foundation that is uniquely positioned to change the growing and still under-penetrated pVAD landscape,” said Grossman. “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.”
