#USA #TAVR #Santa Cruz #Emboline #Emboliner

Emboline, Inc. Completes Patient Enrollment in Pivotal IDE Trial

Emboline, Inc., a trailblazer in the field of embolic protection devices, has successfully concluded patient enrollment for its pivotal Investigational Device Exemption (IDE) trial titled Protect the Head to Head (ProtectH2H). This trial evaluates the effectiveness and safety of the Emboliner® Embolic Protection Catheter during Transcatheter Aortic Valve Replacement (TAVR) procedures. Initiated in May 2023, this trial marks a key milestone in the company's mission to safeguard patients from potential embolic injuries during transcatheter heart procedures.

Overview of the ProtectH2H Clinical Trial

The ProtectH2H trial is a multicenter, randomized, open-label study involving 500 subjects across 18 clinical sites in Brazil, Germany, and the United States. The primary endpoints set for this extensive trial include the occurrence of serious cardiac and cerebrovascular events within 30 days of the procedure, as well as the capture of acute embolic debris during treatment.

With patient enrollment finished, Emboline is on track to provide interventional cardiologists with an innovative device that significantly minimizes the risks associated with embolic debris that is commonly released during TAVR procedures—an occurrence that can lead to severe complications such as stroke.

Insights from the Medical Community

Dr. Tamim Nazif, Director of Clinical Research in Cardiology at Columbia University, expressed his enthusiasm upon the completion of the enrollment stage. He noted, "We are thrilled to have completed enrollment in this critical trial, which we believe will lead to comprehensive embolic protection for TAVR and similar heart procedures. The implementation of a full-body embolic filter with capability for debris capture demonstrates our commitment to patient safety."

This perspective is echoed by Scott Russell, the President and CEO of Emboline, who highlighted the collective effort of various researchers and the Emboline team in achieving this milestone. He stated that the support received from investigators across the participating countries reaffirms the confidence in the Emboliner device, which seems poised for wider application beyond TAVR.

The Emboliner® Device and Its Importance

The Emboliner® device holds the distinction of being the first to offer complete brain and bodily protection against ischemic events like stroke caused by embolic debris during heart procedures. While advancements in TAVR technology have made significant strides in reducing risks, the threat of a major stroke persists, highlighting the necessity for effective protective measures.

In addition to the IDE study, various investigators have also utilized the Emboliner® in compassionate-use and emergency cases, showcasing its versatility in high-embolism procedures—including thrombus extraction, valve-in-valve operations, and left atrial appendage occlusion. Presentations at TCT2025 in San Francisco are set to delve into several unique case studies demonstrating the device's efficacy.

Dr. Nazif is eager to present these findings, emphasizing the potential of the Emboliner to improve patient outcomes in challenging cases.

Moving Forward

As Emboline progresses towards submitting for regulatory approval in both the United States and Europe, the company remains optimistic about making the Emboliner available to all interventionalists, ultimately aiming to broaden its application in protecting patients from the dangers presented during heart procedures. Emboline, Inc. stands out as a pioneering entity dedicated to enhancing patient safety and outcomes in cardiology through innovative technological advancements.

As the company forges ahead, the insights and developments stemming from the ProtectH2H trial will be closely monitored by those invested in the health and safety of cardiac patients around the world.