The Emboliner “Protect the Head to Head” investigational device exemption (IDE) clinical trial has seen its one hundredth patient enrolled. Emboline, Inc. focuses on reducing stroke and ischemic damage during structural heart procedures such as transcatheter aortic valve replacement (TAVR).
Background
The Emboliner device provides full brain and body embolic protection by capturing and removing all debris from transcatheter procedures. This debris could otherwise travel to the brain, kidneys and other critical organs. Moreover the goal is ultimately to reduce the incidence of stroke, cerebral ischemia, cognitive decline and other adverse outcomes associated with procedure-related emboli. Emboline describes its Emboliner® as the first such device to provide full brain and body protection from these ischemic events.
Emboliner IDE study
The Protect the Head to Head IDE trial is a prospective, randomized, open label, multicenter, 2-arm study. It aims to demonstrate safety and effectiveness of the Emboliner Embolic Protection Catheter. The study features a control device (Sentinel CPS) for patients undergoing TAVR. Indeed it will ultimately enrol 500 patients 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.
Investigator comments
“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. Indeed it 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.”
Company comments
Scott Russell, President and CEO of Emboline comments as follows:
“Despite refinements made to the TAVR procedure, stroke remains a clear and present threat to patients.”
“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. As a result this gives added confidence to the physician that debris produced during the valve implant will be less likely to result in critical post-procedural complications.”
Laura Brenton, Senior Vice President of Clinical and Medical Affairs at Emboline comments:
“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.”
“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.”
The Emboliner® is not commercially available and is intended for investigational use only. Emboliner is a registered trademark of Emboline, Inc.
Source: PR Newswire
published: March 12, 2024 in: Cardio, Clinical Studies/Trials, Companies, News, Regulatory, USA
