The startup develops a medical device utilizing pulsating balloon technology to enhance blood flow to critical organs in patients with cardiovascular disease. This technology aims to prevent renal failure in individuals experiencing cardiac arrest, severe heart failure, stroke, diabetes, and low cardiac output acute kidney injury.
Funding
Funding not disclosed
Founders
Product
Problem
Patients undergoing cardiac surgery or experiencing cardiogenic shock are at risk of acute kidney injury (AKI) due to reduced blood flow to the kidneys. Current methods for preventing AKI in these patients are often limited by high cost, invasiveness, or lack of proven efficacy. AKI can lead to increased morbidity, mortality, prolonged hospital stays, and higher healthcare costs.
Solution
Pleioflow develops percutaneous flow-assist devices designed to augment blood flow to critical organs, specifically the kidneys, during high-risk cardiac procedures and in patients with compromised cardiac output. The Pleioflow-RF device, intended for use during cardiopulmonary bypass (CPB), features a self-expanding, one-way downstream valve and a pulsating balloon segment to enhance renal perfusion. The Pleioflow-HF device is designed for minimally invasive blood flow assistance in patients with cardiogenic shock or undergoing high-risk percutaneous coronary interventions (HR-PCI), supporting the left ventricle and improving coronary and end-organ perfusion. Both devices are designed to be easy to insert, even in unstable patients, and are intended to be cost-effective solutions for preventing AKI and improving outcomes in cardiovascular patients.
Target Audience
The primary target audience includes cardiac surgeons, interventional cardiologists, and hospitals seeking to reduce the incidence of acute kidney injury and improve outcomes in patients undergoing cardiac surgery or experiencing cardiogenic shock.
Features
- Percutaneous insertion for minimally invasive circulatory support.
- Pulsating balloon technology to augment blood flow.
- Self-expanding, one-way downstream valve (Pleioflow-RF) to direct flow towards the renal arteries.
- Catheter-mounted flow assist segment (Pleioflow-HF) for temporary left ventricular support.
- Low-profile design (8 French) for ease of insertion, even in acutely unstable patients.
- Designed for use with standard intra-aortic balloon pump (IABP) consoles.
- Intended to reduce left ventricular end-diastolic pressure and myocardial oxygen consumption (Pleioflow-HF).