Second Heart Assist Announces Completion of High-Risk PCI Case Studies in South America with its Whisper™ Device

SALT LAKE CITY, Nov. 19, 2024 /PRNewswire/ -- Utah-based Second Heart Assist Inc., announced today 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-randomized case studies of 6 patients were conducted and lead by Principal Investigator, Dr Adrian Ebner, Head of the Cardiovascular Department at the Sanatorio Italiano Hospital in Asuncion, Paraguay and his expert team. This device is designed to enhance cardiac function and renal perfusion in patients suffering from acute decompensated heart failure (ADHF). The series of single arm focused on the safety and efficacy of the Whisper™ device in supporting cardiovascular hemodynamics during high-risk percutaneous coronary interventions (HRPCI).

"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," commented Alex Richardson, Chief Technology Officer of Second Heart Assist, Inc., "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 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," added Richardson.

Percutaneous circulatory assist devices play a crucial role in cardiovascular interventions, primarily by providing mechanical support to patients undergoing high-risk percutaneous catheter interventions. These devices are indispensable during instances of acute myocardial ischemia, where they help maintain cardiac output and ensure sufficient oxygen reaches the heart muscle, thus stabilizing the patient's condition. Additionally, in the treatment of cardiogenic shock, which often occurs after a significant heart attack, these devices are life-saving. They support the weakened heart's ability to pump blood, enhancing blood flow to vital organs and preventing multi-organ failure, thereby significantly 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," expressed Dr. Ebner.

Dr. Leslie Miller, Chief Medical Officer of Second Heart Assist, Inc., expressed deep appreciation for their recent collaborative efforts: "We are immensely grateful to Dr. Adrian Ebner and the entire team at Sanatorio Italiano Hospital for their diligent work in successfully completing this 6-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." This step marks a significant advancement in Second Heart Assist's clinical development pathway and underscores the company's commitment to enhancing cardiac care on a global scale.

"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," closed Richardson who was present onsite at the hospital supporting all these cases.

About Second Heart Assist Inc.

Second Heart Assist Inc. (www.secondheartinc.com) is developing a temporary mechanical circulatory support (MCS) system that utilizes a stent cage fitted with a motorized impeller to aid in providing circulatory support throughout a patient's body. The system is intended for use in patients hospitalized with acute decompensated heart failure (ADHF) and who develop diuretic resistance with persistent congestion (cardio-renal syndrome (CRS), and/or cardiogenic shock (CS), and those in need of prophylactic hemodynamic support during high-risk percutaneous coronary intervention (PCI).

Caution: the Whisper™ device is not approved and not for sale in any geography.

For more information, please contact Jeff Donofrio, CEO ([email protected]) or Dr. Leslie Miller, CMO ([email protected]).

SOURCE Second Heart Assist Inc.