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HeartPoint Global Implant System Proves Safety and Efficacy

HeartPoint Global, a leading medical device company dedicated to providing high-quality, minimally invasive cardiac care globally, announced another major milestone in the ongoing pre-clinical trials of the HeartPoint Global Implant System (HPGS), a first-of-its-kind patented, adjustable system that focuses on treating devastating left heart diseases, congestive heart failure, and structural pulmonary hypertension.

Landmark findings from a successful pre-clinical study recently completed in conjunction with Hadassah University Hospital at Lahav CRO, Israel’s largest contract research organization pre-clinical center specializing in large animal studies, included:

·        Long term data proving that the HeartPoint Implant System (HPIS) caused a significant restriction to blood flow and effectively maintained the reduced pressure gradient over the five-month period of the study.

·         Data proving that even a major reduction in the pressure gradient did not result in thrombus, blockages, or negative biological responses. The results of this pre-clinical trial for the HeartPoint Global Implant System go against the mainstream theory that reduction of the diameter in highly pressurized vessels to the extent reduced in the study would most likely result in thrombus formation and/or implant occlusion.

·        The observation of positive structural alterations to the hearts in echo and gross pathology. Maintaining the resulting gradient from the HeartPoint Global Implant System demonstrated septum shift and right ventricle enlargement. This significant pronounced structural change to the heart suggests the ability to target a lower gradient boosting safety margins for human patients.

Further exploring the unique placements of the Heartpoint Global Implant System, this newest trial also proved that the HPGS could navigate the most torturous curves in vivo, deliver successful deployments, and accomplish stent recapture. Previous successful pre-clinical tests of the implant system studied the direct placement of the device in the main pulmonary artery and the arterial branches and allowed for the adjustment of blood flow in the heart lung system. The interventions were performed by Dr. David Planer, Head of Interventional Cardiology, and Dr. Gabby Elbaz-Greener, both of Hadassah Medical Center.

 

“Providing a treatment for cardiovascular diseases that is both minimally invasive, adjustable at any time, and affordable is of paramount importance,” said Seth Bogner, Chairman & CEO of HeartPoint Global. “Throughout the pre-clinical testing process, our groundbreaking technology has demonstrated the ability to significantly improve the structure of the heart and the function of the heart-lung system. We are encouraged by the positive results we have seen thus far and look forward to starting our clinical trials imminently.”

This pre-clinical trial follows HeartPoint Global’s announcement of the successful exploration of the HPGS in the arterial branches that was announced in January. The innovative placement resulted in a septum shift and a reaction in the tricuspid valve, indicating that left heart diseases can also be treated with a Heartpoint Global intervention in the arterial branches. HeartPoint Global is scheduled to perform clinical trials in Europe shortly.

According to the World Health Organization, cardiovascular diseases are the world’s leading cause of death, with more than three-quarters of these deaths occurring in low- and middle-income countries. HeartPoint Global is addressing this issue by developing the first and only minimally invasive adjustable heart-lung system that brings affordability, accessibility, and the potential to save millions of lives in the developed and developing world.

In the U.S. and Western Europe, Heartpoint Global treats left heart issues, the largest subset of congestive heart failure, and the leading cause of mortality in the world. However, most of the market for HeartPoint Global’s flagship product, the HeartPoint Global Implant System, is in the developing world. Heartpoint Global will not only treat left heart issues but also children and adults who have developed various conditions due to undetected congenital defects. Heartpoint Global aims to serve both markets, the developed world through conventional well-established distribution systems, and the developing world through our Train the Doctor (TDP) program.

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Medical Device News Magazine, (division of PTM Healthcare Marketing, Inc., is a digital publication reporting the latest medical device, clinical trials, product launches, funding, mergers/acquisitions and biotech/diagnostic industry news.

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