Competitive Landscape

Only One Commercial Option Exists

RT Cardiac Systems

Only Commercial Option

Abiomed (ABMD) Impella family of products is only commercial acute, percutaneous blood pump system. The Impella CP (14 Fr) is the most widely used impella device providing ~80% usage. The device utilizes a rigid, mixed flow impeller coupled directly to an implantable motor. The performance is limited to the maximum length for implantation of the impeller-motor configuration.

The design configuration was first developed in the 1990’s. Abiomed has been driving market expansion through peer-reviewed journals and extensive training and clinical support. The recent earnings call stated an annual revenue of $841M.

Upcoming Competitive Technology

Several companies are pursuing balloon expanding pump configurations. The pumps are connected with an external motor via a semi-rigid drive shaft. The Abbott PHP is representative of this technology and is currently in US clinical trials. Feasibility data from presented in 2018 at TCT showed modest hemodynamic improvements. It is expected that balloon expanding impeller technology has the following limitations.

  • The advantage of increased pump size due to in-situ expansion appears to be negated by the large clearance between the impeller and housing, as shown in published PHP performance data. This likely also causes a disadvantage in hemolysis compared to the commercially available, rigid impeller device.

  • Semi-rigid driveline utilizes small diameter access but may have higher access site bleeding due to the high driveline stiffness.

  • The larger, expandable pump may also have more Aortic Valve insufficiency.

  • The advantages and disadvantages of expanding pump technology class will be known once the PHP clinical data is published, expected in 2021.