FLOWer Embolic Protection
The new frontier of Embolic Protection Device: to provide higher and complete level of protection from adverse events during Transcatheter Aortic Valve Implantation (TAVI) procedure.
Our innovative Embolic Protection Devices, FLOWer, featuring a 60 um mesh, maintains secure anchoring within the aortic arch, protecting the brain, kidneys, and peripheral circulation from the majority of debris during Transcatheter Aortic Value Implantation (TAVI) procedures. With its intuitive design, the device ensures rapid, straightforward, and firm placement within the aortic arch, a skill easily acquired by healthcare professionals.
By capturing debris and substantially diminishing the risk of embolic events, this device foster enhanced safety and effective execution, ultimately leading to improved patient outcomes.
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User-Friendly
- Engagement Made Easy: The distal structure of FLOWer® is designed for effortless engagement, ensuring a secure and reliable fit with the aorta
- Efficient Deployment and Intuitive Control: Adding at most 3 mins to deployment
- 12 Fr Introducer Compatibility: Effortless Closure Management compatible with standard, pre-mounted suture-based closure devices
- One Design, 3 Sizes: The different sizes guarantee a perfect fit with aortas ranging from 25 mm to 39 mm. The correct device size is determined during the pre-procedural CT scan analysis
Safe and Harmless
- Minimal to no interference with existing TAVI delivery systems and all other working catheters
- ACT adjustments as per standard cardiovascular transcatheter procedures
- Gentle on the vascular access site reducing complications and ensuring a smoother recovery
- Minimal thrombogenicity
- Enhanced tactile sensitivity throughout the deployment process facilitating real-time adjustments for precise and secure positioning
- Stability during deployment with adjustable distal structure and adaptive spine
- No need for a further access site thanks to the customized pigtail provided with the device
- Non-traumatic against the aortic wall even during the most complex procedures
High Clinical Efficiency (1)(2)
- Comprehensive Cerebral Protection: Advanced filtering technology can capture debris greater than 60 µm, significantly reducing the risk of stroke and cerebral complications
- Beyond the Brain: Non-cerebral debris capture and removal, protecting the brain and peripheral circulation
- Clinical Efficiency: In in vitro studies, simulating human circulation, FLOWer® prevented over 99% of microspheres from reaching the brain and captured 74% of them. In clinical trials, an average of 420 particles were captured per filter. More than half of these particles were smaller than 150 µm, highlighting FLOWer®'s capability to intercept even the smallest of threats. No access site vascular complication in the clinical trial of over 75 patients. Stroke rate within 72 hours in the Nautilus clinical trial (TAVI procedures): 1.5%.
Video Resources
References
- FLOWer - The Complete Embolic Protection Device – Nautilus Study, EuroPCR 2023.
- FLOWer® Instruction for Use.
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