Second Heart Assist’s Whisper Percutaneous MCS Device Evaluated in High-Risk PCI Cases

November 25, 2024—Second Heart Assist Inc. recently announced the conclusion of its second set of case studies to assess the safety and effectiveness of the company’s Whisper percutaneous mechanical circulatory support device.

These nonrandomized case studies of six patients were conducted by a team led by principal investigator Adrian Ebner, MD, Head of the Cardiovascular Department at the Sanatorio Italiano Hospital in Asuncion, Paraguay.

“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,” commented Dr. Ebner in the company’s press release. “The performance and flow the pump creates at low rotations per minute (RPMs) is amazing.”

Leslie Miller, MD, Chief Medical Officer of Second Heart Assist, stated in the press release. “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 United States.”

According to the Utah-based company, Whisper is designed to enhance cardiac function and renal perfusion in patients experiencing acute decompensated heart failure. The series focused on the safety and efficacy of the Whisper device in supporting cardiovascular hemodynamics during high-risk percutaneous coronary interventions.

Alex Richardson, Chief Technology Officer of the company and present at the hospital supporting all these cases, added, “The Whisper device stands out for its ability to mobilize a significant volume of fluids, showcasing its superior design compared to conventional micro-axial pumps.”

Richardson explained, “Micro-axial pumps require extremely high RPMs to generate enough flow to reach the renal arteries. However, such high RPMs also lead to increased hemolysis, 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.”

He concluded, “Participating in clinical trials where the Whisper device demonstrates its life-saving capabilities is immensely gratifying. Observing its dramatic impact on patient outcomes reinforces the importance of continued innovation and improvement in medical device technology.”