Emboline, Inc. Completes Enrollment in U.S. Pivotal IDE Trial of the Emboliner® Embolic Protection Catheter Designed to Protect Patients from Embolic Injury During Transcatheter Aortic Valve Repla...
SANTA CRUZ, Calif., Oct. 23, 2025 /PRNewswire/ -- Emboline, Inc., a leading innovator in full-body embolic protection devices for transcatheter procedures, today announced completion of patient enrollment in its Protect the Head to Head (ProtectH2H) Clinical Trial, a pivotal Investigational Device Exemption (IDE) trial (NCT05684146) evaluating the safety and effectiveness of the Emboliner® Embolic Protection Catheter for patients undergoing Transcatheter Aortic Valve Replacement/Implant (TAVR / TAVI). Enrollment began in May 2023.
The ProtectH2H trial was a prospective, randomized, open label, multicenter, 500-subject, 2-arm study conducted at 18 prominent clinical sites in Brazil, Germany and the United States. Study endpoints include 30-day major adverse cardiac and cerebrovascular events (MACCE), 30-day VARC-2 stroke and acute embolic debris captured. This achievement represents a significant milestone in Emboline's mission to provide comprehensive, full-body embolic protection during transcatheter procedures such as TAVR where a shower of debris is produced in every procedure. With full enrollment completed, the company is one step closer to providing interventional cardiologists with a truly effective device to protect patients from injury due to embolic debris released during transcatheter heart procedures.
"We are very excited to have completed enrollment in this important trial, which we hope will bring us closer to being able to offer our patients comprehensive embolic protection for TAVR and other structural heart procedures," said Tamim Nazif, MD, Director of Clinical Research in Cardiology at Columbia University Irving Medical Center and Co-Principal Investigator for the Protect the Head to Head study. "The use of a full body embolic filter with debris capture and removal will provide a significant level of confidence that we are doing all we can to protect our patients from stroke and other embolic complications."
"This important milestone would not have been possible without the enthusiastic support of our investigators and their research teams in the United States, Brazil, and Germany. I am also quite proud of the effort and dedication of the entire Emboline team, especially the outstanding clinical, quality and product development teams who went above and beyond to support this study. We are excited to move towards submission for regulatory approval in the US and Europe, and finally having the Emboliner available to all interventionalists to protect their patients from the shower of debris released during transcatheter heart procedures." said Scott Russell, President and CEO of Emboline. "Additionally, the trust in our investigational device that we have seen from our investigators reinforces our confidence that the Emboliner is truly a universal protection device with the potential for much broader applicability beyond TAVR."
In addition to the IDE study, investigators in ProtectH2H also used the Emboliner® in approximately 20 compassionate-use and emergency-use cases in other interventional procedures that have extremely high embolic risk, including thrombus and vegetation extraction, aortic and mitral valve-in-valve, leaflet modification, and left atrial appendage occlusion, demonstrating the full-body protection of the Emboliner and the confidence physicians have in this investigational device. A review of 10 of these unique cases will be presented at TCT2025 in San Francisco on October 28 by Tamim Nazif and Emily Tat of Columbia University Irving Medical Center.
"We are excited to present some of the first examples of full body embolic protection in very high embolic risk patients undergoing TAVR and other structural heart procedures," said Dr. Nazif. "We look forward to further investigating the utility of the Emboliner for improving the safety of our procedures in these very challenging patient populations."
The Emboliner® is the first device to provide complete brain and body protection from ischemic events such as stroke caused by embolic debris released into the bloodstream during transcatheter heart procedures. While transcatheter valve technology and techniques have continued to be refined over the past two decades since the introduction of TAVR, suffering a major debilitating stroke remains a real and persistent threat, and is often cited by patients as being feared more than death.
About Emboline
Emboline, Inc., is a privately held medical technology company based in Santa Cruz, CA that has developed the Emboliner® Embolic Protection Catheter, the first embolic protection device to provide full brain and body embolic protection by capturing and removing all debris from transcatheter procedures that would otherwise travel to the brain, kidneys and other critical organs, and reducing the incidence of stroke, cerebral ischemia, cognitive decline and other adverse outcomes associated with procedure-related emboli. Emboline's technologies are derived from intellectual property invented by Amir Belson, MD. More information is available at www.emboline.com.
The Emboliner® is not commercially available and is intended for investigational use only. Emboliner is a registered trademark of Emboline, Inc.
Media Contact for Emboline: media@emboline.com
View original content:SOURCE Emboline, Inc.