Supira’s pVAD for High-Risk PCI Evaluated in FIH Study

May 18, 2023—The Society for Cardiovascular Angiography & Interventions (SCAI) announced that initial results of a first-in-human (FIH) trial of a novel percutaneous ventricular assist device (pVAD) demonstrated that Supira Medical’s low-profile, high–continuous flow device allowed for successful procedure completion for patients undergoing high-risk percutaneous coronary intervention (PCI).

Lead investigator Gagan Singh, MD, presented the findings as late-breaking clinical research at the SCAI 2023 Scientific Sessions held May 18-20 in Phoenix, Arizona.

The prospective, single-arm, single-center FIH study aimed to demonstrate the safety and performance of the Supira system for cardiovascular hemodynamic support during high-risk PCI.

In the study, six patients underwent high-risk PCI with the Supira system. Patients were aged 58 ± 9 years, 83% male, and had a body mass index of 30 ± 2. Comorbid conditions consisted of previous heart attack (66%), diabetes (50%), tobacco use (50%), and pulmonary hypertension (50%). The ejection fraction ranged from 30% to 60% with at least two vessels treated in 66% of the patients. The device support time ranged from 42 to 96 minutes.

Primary endpoints included procedural and safety outcomes. Procedural success was defined as safe implantation of the device, hemodynamic support during the PCI, and successful withdrawal of the device. Safety assessment was defined as freedom from device-related major adverse events, including vascular complications (access and central), aortic valve injury, mitral valve injury, and systemic embolization.

As summarized by SCAI, procedural success was 100% and none of the patients treated with the Supira system experienced periprocedural device-related adverse events. Additionally, no early indicators of clinically significant hemolysis were reported.

“Initial safety results of the Supira’s pump performance are promising and point to a meaningful advancement which could allow more operators to confidently perform high-risk PCI procedures while avoiding vascular complications,” commented Dr. Singh in the SCAI press release.

Dr. Singh, who is Director of Clinical Cardiovascular Research at University of California, Davis, in Davis, California, continued, “This system features a unique combination of low profile and high continuous flow that offers the potential to minimize vascular complications and hemolysis while aiming to provide operators with a single device for multiple pVAD indications.”

According to SCAI, current FDA-approved pVAD devices typically have large profiles and are associated with high rates of morbidity and vascular complications such as vessel injury requiring surgical repair, loss of limb, hematoma, and/or acute limb ischemia.

The SCAI press release noted that Supira’s low-profile system aims to support cardiovascular hemodynamics with minimal hemolysis and a low risk of vascular complications for patients undergoing high-risk PCI and those in cardiogenic shock.

The Supira system is currently in its research and development phase and is not available for sale in any market. The company is currently planning additional studies outside the United States that will be followed by the initiation of an early feasibility study in the United States planned for Q4 2023, advised SCAI.