Enrollment Completed in SafePass 2 Study of Emboline’s Embolic Protection Catheter for TAVR
January 15, 2020—Emboline, Inc. announced the completion of enrollment in the company’s SafePass 2 clinical study of the Emboliner embolic protection catheter for use with transcatheter aortic valve replacement (TAVR). Final data analysis is now underway for the full SafePass 2 study population.
The data will be used to file for European CE Mark approval for the Emboliner in 2020. Additionally, the company will be seeking FDA approval to begin the pivotal United States clinical study.
According to the company, the prospective, nonrandomized, multicenter, open-label SafePass 2 study is being conducted at three centers in New Zealand to assess the safety and technical performance of the second-generation Emboliner device.
Mark Webster, MD, of Auckland City Hospital, in Auckland, New Zealand, is the principal investigator for the SafePass 2 study. Dr. Webster commented in the company’s announcement, “We were enthusiastic about participating in the SafePass 2 study, as the concept of full cerebral, renal, and peripheral vascular protection is appealing. 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 30-day results from the first 24 patients treated using the Emboliner device were presented at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, held September 25–29 in San Francisco, California. The findings included:
- No device-related adverse events
- No device-related access site complications
- 100% technical performance (successful access of the aortic arch with the delivery catheter, positioning across the aortic arch, retrieval and removal of the device)
- Debris capture and removal in 100% of patients
The study also examined the amount of debris collected from patients. An average of 250 particles of debris ≥ 150 µm in size were removed from each patient, with more than half of patients having debris ≥ 1 mm in size, and one in four patients having debris ≥ 2 mm in size.
The company stated that the 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 noncerebral 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.