Cardiovascular Systems—CSI—has announced the first in-human experience with Propel, its first-generation percutaneous ventricular assist device (pVAD), offering haemodynamic support for patients undergoing high-risk percutaneous coronary intervention (HR-PCI).
The first series of patients was treated by David Kandzari (Piedmont Heart Institute and Cardiovascular Services, Atlanta, USA), performed in Tbilisi, Georgia. Propel performed as intended, providing uninterrupted haemodynamic support leading to successful revascularisation, CSI said in a press release.
According to the company, Propel is designed to meet the needs of the HR-PCI patient by providing clinically meaningful haemodynamic support while minimising access site and procedural complications due to a small profile pump and smaller catheter body versus the current pVAD systems that are commercially available. Propel is percutaneously inserted, and the blood inlet portion of the device is positioned within the left ventricle below the aortic valve, and the outlet positioned above the aortic valve.
Propel was used at multiple support levels, with a hemodynamic power output and duration sufficient to maintain the stability of patients during their HR-PCI.
As one of the study investigators, Kandzari said: “This is a novel pVAD system that enables a 12Fr in-body pump with a 7Fr in-body catheter. This reduction in size may reduce the clinical complications associated with high-risk procedures while providing the clinically necessary cardiac support for the patient. The lower catheter profile may also increase the potential for use in patients with challenging anatomy that exclude treatment with current therapies.”
“Today’s announcement is another important milestone for CSI as we seek to develop an exciting pipeline of new products designed to improve the outcomes for patients with coronary artery disease,” said Scott Ward, chairman, president and chief executive officer of CSI. “We appreciate Dr Kandzari’s commitment and willingness to participate in these first cases. Conducting the first in-human cases outside the USA increases the confidence we have in Propel and furthers the development of this programme. We continue to work closely with FDA [US Food and Drug Administration], and the data from these cases will inform the design and conduct of an early feasibility study in the USA.”
