#USA #TAVR #Santa Cruz #Emboline #Emboliner

Emboline, Inc. Achieves Milestone with Enrollment Completion in Pivotal IDE Trial

Emboline, Inc., a frontrunner in developing comprehensive embolic protection devices, has announced the successful completion of patient enrollment for its Protect the Head to Head (ProtectH2H) Clinical Trial. This pivotal trial, recognized under Investigational Device Exemption (IDE) NCT05684146, assesses the safety and efficiency of the Emboliner® Embolic Protection Catheter for patients undergoing Transcatheter Aortic Valve Replacement (TAVR) procedures. Enrollment kicked off in May 2023, and the study was meticulously executed across 18 leading clinical sites in Brazil, Germany, and the United States, involving a total of 500 subjects in a randomized and open-label format.

The ProtectH2H trial's primary endpoints encompass evaluating the occurrences of major adverse cardiac and cerebrovascular events (MACCE) within 30 days, along with assessing VARC-2 strokes and the debris captured during the procedure. This accomplishment signifies a pivotal step in Emboline's dedication to offering robust embolic protection during transcatheter procedures, particularly TAVR, which inherently generates substantial debris that poses risks to patient health.

Dr. Tamim Nazif, the Director of Clinical Research in Cardiology at Columbia University Irving Medical Center, co-principal investigator for the ProtectH2H trial, expressed enthusiasm about reaching this significant milestone. He emphasized the trial’s potential to deliver extensive embolic protection for TAVR and various structural heart procedures. The incorporation of a full-body embolic filter capable of capturing and eliminating harmful debris provides reassuring assurance to clinicians about enhancing patient safety against potential strokes and other embolic complications.

Scott Russell, President and CEO of Emboline, also shared his excitement regarding the trial's completion, highlighting the unwavering support from medical investigators across the US, Brazil, and Germany. He conveyed deep appreciation for the dedication demonstrated by Emboline’s clinical and product development teams that contributed to facilitating this pivotal study. With full enrollment achieved, Emboline is on the cusp of submitting for regulatory approval in the US and Europe, aiming to make the Emboliner accessible to interventional cardiologists keen on safeguarding their patients from the hazardous debris generated during transcatheter heart procedures.

In conjunction with the IDE study, the Emboliner® was utilized in approximately 20 compassionate-use and emergency-use cases amid other interventional procedures presenting high embolic risks. Such cases included thrombus and vegetation extraction, aortic and mitral valve-in-valve applications, leaflet modifications, and left atrial appendage occlusions. These instances not only illustrated the efficient full-body protection provided by the Emboliner but also demonstrated the trust physicians have placed in this investigational device. A recent analysis covering 10 of these unique instances is set for presentation at the upcoming TCT2025 conference in San Francisco on October 28.

Dr. Nazif reiterated the importance of this trial by expressing anticipation for showcasing pioneering examples of full-body embolic protection within high-risk patients undergoing TAVR and related structural heart procedures. He remains optimistic about further investigating the Emboliner's capabilities in elevating procedural safety for these challenging patient cohorts.

The Emboliner® stands out as the inaugural device delivering all-encompassing brain and body protection from ischemic incidents such as strokes caused by embolic debris during transcatheter heart interventions. Despite ongoing improvements in transcatheter valve technologies and methodologies over the years, the looming threat of suffering substantial debilitating strokes continues to be a real concern for patients, often overshadowing even the fear of mortality.

About Emboline

Emboline, Inc. operates as a privately held medical tech company located in Santa Cruz, California. They are pioneers in the development of the Emboliner® Embolic Protection Catheter, which represents the first-ever embolic protection device capable of fully capturing and removing surrounding debris generated during transcatheter procedures. This technology aims at effectively reducing the risk of strokes, cerebral ischemia, cognitive decline, and other negative outcomes associated with embolic events linked to medical procedures. The innovations derived from Emboline stem from patented intellectual property developed by Dr. Amir Belson. For further information, visit www.emboline.com.

Note: The Emboliner® is not yet commercially available and is intended for investigational purposes only.