P20: Development and Testing of an External Electro-pneumatic Device For Ambulatory Counterpulsation

Abstract

Purpose: The NuPulse iVAS is a minimally invasive, portable, counterpulsation platform technology that provides ambulatory circulatory support. iVAS successfully supported 81 patients in an FDA-approved feasibility trial. iVAS required implantation of a Skin Interface Device (SID 1.0, 69 mm diameter) with a large exit site (22 mm diameter) and subcutaneous ECG leads. SID 1.0 implantation required two incisions and creation of a large subcutaneous pocket (excluding small and pediatric patients) which could be obviated by an external SID. Methods: To reduce iVAS invasiveness and implant time, NuPulse redesigned the SID (SID 2.0) to be external (9.5 x 5.0 x 3.5 cm, 100 g) with surface ECG leads. The performance of SID 2.0 was compared to SID 1.0 through bench testing to regulatory standards. Results: SID 2.0 enables reduction in surgical time by 90 min, and atraumatic replacement. The pneumatic driveline exit site diameter was reduced to 5 mm (~500% reduction in area). SID 2.0 provided similar ECG microprocessing speed and results with surface ECG as the SID 1.0 with subcutaneous ECG leads. SID 2.0 is worn in a device belt, and passed human factors testing for surface ECG lead wire management and hand-free support for SID 2.0. Summary: Clinical trial experience with SID 1.0 drove design modifications to system components. The NuPulse portable counterpulsation platform will have an external SID 2.0 which improves patient safety and patient experience, while reducing surgical time and invasiveness.