Second Heart Assist has announced the successful conclusion of its second set of case studies to assess the safety and effectiveness of its Whisper percutaneous mechanical circulatory support device.
These non-randomised case studies of six patients were conducted and lead by principal investigator, Adrian Ebner, head of the Cardiovascular Department at the Sanatorio Italiano Hospital in Asuncion, Paraguay and his team.
The Whisper device is designed to enhance cardiac function and renal perfusion in patients suffering from acute decompensated heart failure (ADHF). The series of cases focused on the safety and efficacy of the Whisper device in supporting cardiovascular haemodynamics during high-risk percutaneous coronary interventions (PCI).
“The Whisper device stands out for its ability to mobilise a significant volume of fluids, showcasing its superior design compared to conventional micro-axial pumps,” commented Alex Richardson, chief technology officer of Second Heart Assist. “Micro-axial pumps require extremely high rotations per minute (RPMs) to generate enough flow to reach the renal arteries. However, such high RPMs also lead to increased haemolysis, which can adversely affect kidney health. In contrast, the Whisper device efficiently supports high flow with low RPMs providing less risk to the kidneys, underscoring its advanced engineering.”
Percutaneous circulatory assist devices play a role in cardiovascular interventions, primarily by providing mechanical support to patients undergoing high-risk percutaneous catheter interventions. These devices are used during instances of acute myocardial ischaemia, where they help maintain cardiac output and ensure sufficient oxygen reaches the heart muscle, thus stabilising the patient’s condition.
Additionally, in the treatment of cardiogenic shock, which often occurs after a significant heart attack they support the weakened heart’s ability to pump blood, enhancing blood flow to vital organs and preventing multi-organ failure, thereby reducing the risk of mortality in such critical situations.
“Having done many trials with a multitude of mechanical circulatory devices, I am very impressed with how quick and simple the device is to deploy. The performance and flow the pump creates at low RPMs is amazing,” said Ebner.
Leslie Miller, chief medical officer of Second Heart Assist, said: “We are immensely grateful to Dr Adrian Ebner and the entire team at Sanatorio Italiano Hospital for their diligent work in successfully completing this six-patient study. Their expertise and commitment were crucial to this achievement. Thanks to their efforts, our team is now ready to expand initiatives to the USA.”
“Participating in clinical trials where the Whisper device demonstrates its life-saving capabilities is immensely gratifying,” adds Richardson. “Observing its dramatic impact on patient outcomes reinforces the importance of continued innovation and improvement in medical device technology.”
