Emboline has announced that the first patient has been treated in the Protect the Head to Head investigational device exemption (IDE) clinical trial at New York-Presbyterian Hospital/Columbia University Medical Center in New York, USA.
Emboline received IDE approval for the study from the US Food and Drug Administration (FDA) in December 2022. The Emboliner is described by the company as the first device to provide full brain and body protection from ischaemic events such as stroke caused by embolic debris released into the bloodstream during transcatheter heart procedures.
The Protect the Head to Head IDE trial is a prospective, randomised, open label, multicentre, two-arm study to demonstrate safety and effectiveness of the Emboliner embolic protection catheter compared to the control device (Sentinel, Boston Scientific) for patients undergoing transcatheter aortic valve implantation (TAVI). Five hundred patients will be enrolled in the study at up to 20 centres worldwide. Study endpoints include 30-day major adverse cardiac and cerebrovascular events (MACCE), 30-day VARC-2 stroke and acute embolic debris captured.
“This is a major step towards US approval and commercialisation of the Emboliner,” said Scott Russell, president and CEO of Emboline. “Stroke remains both a significant risk and fear for patients undergoing TAVI. In our previous SafePass clinical studies, the Emboliner captured and removed more than five times the clinically relevant embolic particles compared to published data for a commercially available device offering partial brain protection. This is consistent with the predicted difference based on arterial blood flow and suggests a significant advantage for patients treated with the Emboliner. We are grateful for the support of our investors and principal investigators and look forward to working with the participating hospitals and investigators on this important trial.”
Tamim Nazif (Columbia University Irving Medical Center, New York, USA), co-principal investigator for the Protect the Head to Head study treated the first study patient. “The Emboliner represents a major advance in embolic protection for cardiovascular procedures by providing full brain and body protection, leaving no major artery to the brain, kidneys or lower body unprotected. The device has shown promising results in the smaller SafePass feasibility studies and we look forward to the results of this pivotal randomised trial as we seek to bring this exciting new technology to our patients.”
“The mounting body of evidence on embolic protection devices suggests that embolic protection is no longer considered controversial or optional, it is just the right thing to do to protect your patients from the very real risk of stroke,” said Alexandra J Lansky (Yale University School of Medicine, New Haven, USA), principal investigator for the trial. “The Emboliner represents a new generation in embolic protection devices by fulfilling an unmet need in providing full brain and body protection from stroke and other ischaemic events caused by debris released during TAVI. We look forward to the study results.”