Supira Medical’s Next-Generation pVAD System Used in FIH Procedures

September 16, 2022—Supira Medical, Inc., a Shifamed portfolio company focused on developing a next-generation solution for mechanical circulatory support, announced it has initiated its first-in-human (FIH) clinical study of Supira’s low-profile, high-flow percutaneous ventricular assist device (pVAD).

The prospective, single-arm, single-center study will evaluate the safety and performance of the Supira pVAD to support cardiovascular hemodynamics in patients undergoing high-risk percutaneous coronary intervention (PCI).

The initial FIH procedures were performed by Principal Investigator, Adrian Ebner, MD, Head of the Cardiovascular Department at Italian Hospital Asuncion in Asuncion, Paraguay.

Gagan Singh, MD, Susheel Kodali, MD, and Azeem Latib, MD, were present with Dr. Ebner to observe the procedures.

“I am pleased to be a part of the initial cases and remain impressed by the performance of Supira’s pump,” commented Dr. Singh in Supira’s press release. “Unlike other pVADs, this system has the power to deliver high flow through a small profile. The combination of a low-profile/high-flow system is extremely attractive as we look to address the risks of vascular complications associated with currently available devices.”

Dr. Kodali added, “Achieving high-flow rates has typically required larger devices, which can be challenging from both an access and positioning perspective. In my opinion, Supira’s technology was easily placed and performed well. This is a meaningful advancement that will allow more operators to confidently perform high-risk PCI procedures.”

Finally, Dr. Latib remarked, “Mechanical support is critical for high-risk cases, and it is exciting to see this space continue to evolve. I am impressed with Supira’s technology, and I am confident it will be a game-changer for both physicians and patients undergoing high-risk procedures.”

Dr. Singh is Director of Clinical Cardiovascular Research at UC Davis Health in Sacramento, California. Dr. Kodali is Director of the Structural Heart and Valve Center at NewYork-Presbyterian/Columbia University Medical Center in New York, New York. Dr. Latib is Section Head of Interventional Cardiology and Director of Structural Heart Interventions at Montefiore Health Systems in New York, New York.