Interventional heart procedures such as transcatheter aortic valve replacement (TAVR) have revolutionized cardiology, providing lower-risk alternatives to open-heart surgery. However, these procedures are performed on a beating heart and can cause a shower of embolic debris to be released into the bloodstream. If these emboli travel to the brain, they can cause acute ischaemic lesions and stroke, and can contribute to long-term neurologic impairment and dementia. According to recent TAVR studies, stroke rate from TAVR is approximately 3.1%1-10, with 94% of all TAVR patients suffering brain lesions, 25% of patients demonstrating neurologic impairment, and 40% showing cognitive decline one month after TAVR11.
The recently completed SafePass 2 clinical study demonstrated that embolic debris are released into the bloodstream during every TAVR procedure12,13. Particle counts can range from the hundreds to sometimes thousands of particles of varying types and sizes. The odds of a TAVR patient having a stroke are simply based on the chance of an embolic particle flowing to a vulnerable area of the brain. But it doesn’t have to be a roll of the dice. Embolic damage may be avoided if embolic debris are captured and removed before they can reach the brain or other organs.
This is our goal and passion.
The Emboliner® Total Embolic Protection Catheter is the only embolic protection device designed to provide complete protection of the brain and other critical organs by capturing and removing emboli produced during the procedure.
Emboline will begin IDE clinical studies in 2021. Stay tuned.
- Manoharan, et al., J Am Coll Cardiol Intv 2015; 8: 1359-67.
- Moellman, et al., presented at PCR London Valves 2015
- Linke, et al., presented at PCR London Valves 2015
- Kodali, et al., Eur Heart J 2016; doi:10.1093/eurheartj/ehw112
- Vahanian, et al., presented at EuroPCR 2015
- Webb, et. al. J Am Coll Cardiol Intv 2015; 8: 1797-806
- DeMarco, et al, presented at TCT 2015
- Meredith, et al., presented at PCR London Valves 2015
- Falk, et al., presented at EuroPCR 2016
- Kodali, presented at TCT 2016; Reardon, M Published in NEJM March 2017
- Lansky, et. al. Am J Cardiol. 2016; doi: 10.1016/j.amjcard.2016.08.013.
- Pasupati S. Clinical Performance of a Total Embolic Protection Device: Results of the Emboliner SafePass 2 Study [abstract]. In: TCT Connect. Oct 14-18, 2020; virtual conference. TCTMD: TCT458.
- Pasupati S. Capture and Analysis of Debris Generated During TAVR — Can it Inform our Treatment Decisions and Prognoses? [abstract]. In: TCT Connect. Oct 14-18, 2020; virtual conference. TCTMD: TCT454.
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