Therapeutic options for heart failure (HF) in the pediatric population are severely limited. Pediatric patients requiring mechanical circulatory support (MCS) have very high mortality and adverse event rates. Clinicians currently depend on the Berlin Heart EXCOR pediatric device, which severely limits ambulation and precludes hospital discharge, or adult MCS devices (used off-label), which require a complex and invasive implant/explant procedure (sternotomy with cardiopulmonary bypass) in pediatric anatomies. To overcome these limitations, NuPulseCV (Raleigh, NC) is developing a chronic counterpulsation device (PediPulse) for pediatric support. PediPulse can be implanted using minimally invasive surgical techniques without the need to enter the chest. The device is actuated by a small, wearable pneumatic driver through a percutaneous air-line and triggered by the patient's ECG via subcutaneous ECG leads. PediPulse has the advantages of being ambulatory, non-thrombogenic that enables the patient to turn their support 'on' or 'off' as needed, non-obstructive, low-cost with low adverse event rates, less invasive, and able to be implanted in a less sick pediatric HF population that may increase potential for myocardial recovery. In this proposal, we will fabricate PediPulse components and perform validation and verification testing for submission to the FDA for HDE trials in pediatric HF patients.
Menu
