First Patients Treated With Cardiovascular Systems’ Propel pVAD

Cardiovascular Systems Inc. has kicked off clinical use of Propel, its first-generation percutaneous ventricular assist device (pVAD). The product offers hemodynamic support for patients undergoing high-risk percutaneous coronary interventions (HR-PCI).
 
The first patients were treated in Tbilsi, Ga., by Dr. David E. Kandzari, M.D., chief of Piedmont Heart Institute and Cardiovascular Services in Atlanta. Propel performed as intended, providing uninterrupted hemodynamic support leading to successful revascularization.
 
“This 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 R. Ward, chairman, president and CEO of CSI. “We appreciate Dr. Kandzari’s commitment and willingness to participate in these first cases. Conducting the first in-human cases outside the U.S. increases the confidence we have in Propel and furthers the development of this program. We continue to work closely with FDA, and the data from these cases will inform the design and conduct of an early feasibility study in the U.S.”

Propel is designed to meet the needs of the HR-PCI patient by providing clinically meaningful hemodynamic support while minimizing 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.
 
“This is a novel pVAD system that enables a 12 French in-body pump with a 7 French 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,” Kandzari said. 
 
CAD is a life-threatening condition and a leading cause of death in men and women globally. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the Centers for Disease Control and Prevention, 18 million people in the United States have CAD, the most common form of heart disease. Heart disease claims more than 650,000 lives in the United States each year. According to estimates, arterial calcium is present in 38 percent of patients undergoing a PCI. Significant calcium contributes to poor stent delivery, expansion and wall apposition leading to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events (MACE).
 
Cardiovascular Systems Inc., based in St. Paul, Minn., develops and commercializes solutions for treating vascular and coronary disease. The company’s orbital atherectomy system treats calcified and fibrotic plaque in arterial vessels throughout the leg and heart and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives.