Supira Medical announced today that it received FDA approval to initiate a new trial of its percutaneous ventricular assist device (pVAD).
The SUPPORT II pivotal trial evaluates the company’s next-generation pVAD in patients undergoing high-risk percutaneous coronary intervention (HRPCI). Los Gatos, California-based Supira plans to use findings to support a future FDA premarket approval (PMA) submission.
About a year ago, the company raised $120 million to support this trial. It follows an early feasibility study launched the year prior.
Supira said the FDA’s green light for the study marks a “critical step” toward U.S. market entry.
The company designed its pVAD technology with a high-flow from a low-profile catheter pump and real-time monitoring. It aims to minimize vascular complications.
Supira expects to enroll up to 385 patients at up to 40 U.S. sites. Dr. Ajay Kirtane and Dr. David Kandzari serve as national co-principal investigators. In a news release, Kandzari said the system could offer effective circulatory support while maintaining a smaller profile. He said it could potentially 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 randomized trial of a novel, lower-profile hemodynamic support device is an important step in advancing the care of some of our highest risk patients.”
Supira has other news beyond the trial milestone
Additionally, Supira Medical outlined new advances in cardiogenic shock. The company cited recent case experience outside the U.S., which includes the initial series of cardiogenic shock patients. It utilizes percutaneous axillary access to enable patient ambulation with an active 10Fr pVAD.
Supira also appointed medtech veteran D. Keith Grossman as independent board member. Grossman brings 40 years of leadership experience, including in the mechanical circulatory support space. He previously served as CEO of Nevro.
The company said that these milestones highlight the potential of its temporary mechanical circulatory support. Bringing the device to market could challenge the existing leader in the space, Johnson & Johnson’s Abiomed.
“Supira has established a compelling clinical and technological foundation that is uniquely positioned to change the growing and still under-penetrated pVAD landscape,” said Mr. 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.”
