Emboline™, Inc., developer of total embolic protection technology for transcatheter aortic valve replacement (TAVR), has announced completion of enrollment in its SafePass™ 2 clinical study of the Emboliner™ Embolic Protection Catheter.
Debris generation during TAVR has been associated with a range of negative neurological outcomes. These range from a major stroke rate of approximately six percent, overall stroke rates as high as 22 percent, and new cerebral lesions in as many as 94 percent of patients.
The novel Emboliner device is designed to provide total embolic protection of the brain and body during TAVR. The cylindrical Nitinol mesh device covers the entire arterial bed (all three cerebral branches and non-cerebral vessels) and contains an expandable access port through which TAVR devices are passed, enabling the device to capture and contain debris during the entire TAVR procedure. It requires no additional procedural access and minimal added procedural time.
SafePass 2 is a prospective, non-randomized, multicenter, open-label study at three centers in New Zealand to assess the safety and technical performance of the second-generation Emboliner device. Thirty-day results from the first 24 patients in which the Emboliner was used were presented at the most recent Transcatheter Cardiovascular Therapeutics (TCT) conference. The results were promising, with No device-related adverse events or access site complications, 100 percent technical performance, debris capture and removal in 100 percent of patients.
The study also examined the amount of debris collected from patients. An average of 250 particles of debris ≥150um in size was removed from each patient, with more than half of patients having debris ≥1mm in size, and one in four patients having debris ≥2mm in size. The amount of debris removed was more than five times the amount seen in the pivotal SENTINEL Trial of the Sentinel Cerebral Protection System.
Final data analysis is now underway for the full SafePass 2 study population, the data from which will be used to file for CE Mark for the Emboliner later this year.
“We were enthusiastic about participating in the SafePass 2 study, as the concept of full cerebral, renal and peripheral vascular protection is appealing,” said Dr. Mark Webster of Auckland City Hospital, principal investigator for the SafePass 2 study. “We found the learning curve for Emboliner to be relatively short, the device easy to use, and we were impressed by the captured debris.”
“The amount of debris captured and removed from TAVR patients using this device is several times greater than any first-generation cerebral protection device has shown to date,” said Emboline CEO Scott Russell. “Results from this study demonstrate the potential for Emboliner to significantly improve upon first-generation cerebral protection to protect both the brain and body, which is increasingly important as TAVR moves to younger and healthier patients. With these data we will begin the processes of securing CE Mark and seeking approval to begin our pivotal U.S. clinical study.”
Source: Emboline, Inc.