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Emboline Announces That First 100 Patients Have Been Treated in IDE Study of Emboliner Full-Body Embolic Protection Catheter to Minimize Stroke Risk From TAVR
SANTA CRUZ, Calif.-- Emboline, Inc., a privately held medical technology company focused on reducing stroke and ischemic damage during structural heart procedures such as transcatheter aortic valve replacement (TAVR), marked a key milestone with the enrollment of the 100th patient in the Protect the Head to Head investigational device exemption (IDE) clinical trial (NCT05684146).
The Emboliner is the first device to provide full brain and body protection from ischemic events such as stroke caused by embolic debris released into the bloodstream during transcatheter heart procedures. Further, Emboline has the earliest and most comprehensive patent portfolio for aortic embolic protection, including aortic deflection and full-body debris capture-and-removal filter technologies.
The Protect the Head to Head IDE trial is a prospective, randomized, open label, multicenter, 2-arm study to demonstrate safety and effectiveness of the Emboliner Embolic Protection Catheter compared to a control device (Sentinel CPS) for patients undergoing TAVR. 500 patients will be enrolled in the study at up to 20 centers worldwide. Study endpoints include 30-day major adverse cardiac and cerebrovascular events (MACCE), 30-day VARC-2 stroke and acute embolic debris captured.
"We are excited to be participating in the pivotal trial of the Emboliner, which represents the next generation in embolic protection," 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 Emboliner device is easy to use, integrates well into the TAVR procedure, and offers the potential for full body embolic protection. We look forward to the study results and the opportunity to routinely offer this device to all our TAVR patients."
"Despite refinements made to the TAVR procedure, stroke remains a clear and present threat to patients," said Scott Russell, President and CEO of Emboline. "The embolic protection device currently available to physicians has significant limitations, and the Emboliner was designed to address those limitations. The Emboliner provides full brain and body protection, which gives added confidence to the physician that debris produced during the valve implant will be less likely to result in critical post-procedural complications."
"We are grateful for the enthusiastic support of our investigators and their research teams at each study site to help us achieve this important milestone," said Laura Brenton, Senior Vice President of Clinical and Medical Affairs at Emboline. "I would also like to thank our entire clinical team at Emboline for their seamless execution in the critical launch phase of our study, and also our physician advisors and core labs for their expertise and guidance in designing and supporting this critical study. We look forward to completing the study and presenting the results."
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. 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.
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