Early Results from First 24 Patients Show Excellent Safety Profile and Technical Performance, with Significant Debris Capture and Removal in All Patients
SANTA CRUZ, Calif. — January 15, 2020 — Emboline™, Inc., developer of total embolic protection technology for transcatheter aortic valve replacement (TAVR), today announced completion of enrollment in its SafePass™ 2 clinical study of the Emboliner™ Embolic Protection Catheter.
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 showing:
- No device-related adverse events
- No device-related access site complications
- 100 percent 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 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.”
Debris generation during TAVR has been associated with a range of negative neurological outcomes for patients, ranging from a major stroke rate of approximately six percent,1 overall stroke rates as high as 22 percent,2 and new cerebral lesions in as many as 94 percent of patients.3
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.
A video demonstrating use of the Emboliner is available to view here.
About Emboline, Inc.
Emboline, Inc., is a privately-held, emerging medical device company that has developed the Emboliner™ Embolic Protection Catheter, expected to be the first total embolic protection technology commercialized for TAVR and other interventional procedures with embolic risk. The novel Emboliner device is intended to more reliably protect the cerebral system, while also capturing non-cerebral debris. Emboline’s technologies are derived from intellectual property invented by Amir Belson, MD, founder of Neoguide Systems, Vascular Pathways, Zipline Medical, Qool Therapeutics, and other medical device companies.
CAUTION: Investigational Device. Limited by United States law to investigational use. Emboline, Emboliner and SafePass are trademarks of Emboline, Inc.
1. Pelligrini C, Rheude T, Trenkwalder T et al. One year VARC-2-defined clinical outcomes after transcatheter aortic valve implantation with the SAPIEN 3. Clin Res Cardiol 2019: 108(11);1258-1265.
2. van Mieghem N, et al. Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised MISTRAL-C trial. EuroIntervention 2016: 12;498-507.
3. Kapadia SR, Kodali S, Makkar R et al. Protection against cerebral embolism during transcatheter aortic valve replacement. J Am Coll Cardiol 2017: 69(4);367-377.