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FLOWer - Education for Healthcare Professionals

Key Features of FLOWer: Elevating TAVI Procedure Safety

Uncover the unique features of FLOWer, our advanced Embolic Protection Device, and understand how each element contributes to safer, more effective Transcatheter Aortic Valve Implantation (TAVI) procedures for aortic valve stenosis.

FLOWer is more than just a cerebral embolic protection device. It represents a comprehensive approach to protect both the brain and peripheral organs during TAVI procedures
  • Customizable Fit: Adjustable distal structure ensure a perfect fit against the aortic walls, enhancing system stability.
  • Precision Filtering: FLOWer's unique pore size coupled with its ability to trap even the tiniest debris, distinguishes it from other EPDs.
  • Proven Efficacy: In vitro studies using a human circulation model showcased FLOWer's performance, preventing over 99% of microspheres from reaching the brain and capturing 74% of them preventing them to enter the peripherical circulation.

With all the advancements in transcatheter heart valve design and TAVI techniques, the persistent 2-4% [ see sources(3) ] risk of overt stroke post-TAVI underscores the need for groundbreaking solutions like FLOWer.

  • User-Friendly: Simple to deploy, use, and retrieve.

In the world of  TAVI, time and ease of use are of the essence.  We designed FLOWer, our cerebral embolic protection device, to be the model of user-friendliness. Here’s how FLOWer streamlines your TAVI procedures:

  • Efficient Deployment: With FLOWer, adding safety doesn't mean adding time. Our device integrates into your workflow with a minimal impact on procedure time – adding at most three minutes.
  • Intuitive Control: The handle of FLOWer speaks the language of simplicity. Its intuitive design means you spend less time guessing and more time focusing on what matters – the patient.
  • Engagement Made Easy: The distal structures of FLOWer is designed for effortless engagement, ensuring a secure and reliable fit every time.
  • Mastering Complexity: FLOWer navigates with ease, ensuring protection is delivered precisely where it's needed.
  • Harmonious Integration: We understand the importance of compatibility. FLOWer is crafted to work seamlessly with all TAVI delivery systems, ensuring minimal to no interaction and preserving the integrity of your procedure.

FLOWer is the next step in TAVI procedure evolution. Experience the difference with FLOWer – where user-friendly design meets clinical excellence.

  • Safety First: Harmless with proven safety records.

Prioritizing Patient Safety with FLOWer EPD in TAVI Procedures

 

Here’s how FLOWer is setting new standards for patient safety:

  • Gentle on Access Sites: FLOWer is designed to minimize its impact on the vascular access site, reducing the likelihood of complications and ensuring a smoother recovery.
  • Seamless Closure: We've made vascular access closure a breeze with compatibility for pre-implanted suture-based devices, enhancing the safety profile of the procedure.
  • Atraumatic Design: The stability of FLOWer is matched by its gentle nature, remaining non-traumatic against the aortic wall even during the most complex procedures.
  • Uninterrupted Blood Flow: Long procedures come with their challenges, but with FLOWer, blood flow is meticulously preserved, safeguarding patient well-being from start to finish.

With a proven safety record, FLOWer stands as a testament to our dedication to patient care in TAVI procedures. Experience the peace of mind that comes with FLOWer, where safety and innovation go hand in hand.

  • Efficiency: Effective against both small and large emboli.

FLOWer EPD: Setting New Standards in Embolic Protection Efficiency

 

FLOWer stands out with its proven ability to tackle both small and large emboli, ensuring comprehensive protection for patients.

  • Proven in Pre-Clinical Studies: Our in vitro studies, simulating human circulation, FLOWer successfully prevented over 99% of microspheres, from reaching the brain and captured 74% of them. This level of precision in embolic protection marks a significant advancement in patient care.
  • Clinical Trial Insights:. In clinical trials, an average of 420 particles were captured per filter. Intriguingly, more than half of these particles were smaller than 150 µm, highlighting FLOWer's capability to intercept even the smallest of threats.
    Efficiency in embolic protection isn't just about capturing debris; it's also about ensuring a seamless and safe experience for both patients and medical professionals.
  • Tailored Fit and Ease of Use: FLOWer’s design allows for an easy choice of the appropriate size based on preprocedural CT scans, ensuring a perfect fit for all patient anatomies. Additionally, its user-friendly nature facilitates easy positioning and retrieval, including safe and straightforward repositioning when necessary.

Discover the difference with FLOWer – where efficiency meets excellence in embolic protection.

  • Embracing Universal Design for All Anatomies in TAVI Procedures

FLOWer has been meticulously designed to cater to every patient’s unique anatomy.

  • One Design, 3 Sizes: FLOWer's innovative design comes in three distinct sizes yet maintains the same access dimension. This versatility ensures that every patient receives the most suitable protection, tailored to their specific needs.
  • Efficient Sizing with Pre-Procedural CT Scans: Time is of the essence in TAVI procedures. With FLOWer, the sizing process is streamlined. The perfect fit is determined during the pre-procedural CT scan, eliminating any additional steps and ensuring a seamless integration into the procedure.
  • Adjustable for Precision: The adjustable distal structures of FLOWer are a game-changer. They ensure a perfect fit against the aortic walls, enhancing system stability and providing reliable protection regardless of the patient's anatomy.

FLOWer’s universal design principle is a commitment to patient-centered care, ensuring that every TAVI procedure is as safe and effective as possible.

  • Seamless Integration: Minimal to no interference with TAVI delivery systems.

FLOWer EPD: Ensuring Seamless Integration in TAVI Procedures

 

In the world of TAVI, the compatibility of an embolic protection device with delivery systems is crucial. FLOWer EPD excels in this aspect, demonstrating minimal to no interference with various TAVI delivery systems.

  • Tested with All Market-Leading TAVI Devices: In both pre-clinical settings and during the Nautilus clinical trial, FLOWer was tested with most TAVI devices available on the market. This extensive testing ensures that FLOWer integrates smoothly with any chosen TAVI system.
  • Clinical Validation: The efficacy and compatibility of FLOWer have been validated in a real-world clinical setting. With 75 patients enrolled across 7 sites in Europe, FLOWer has demonstrated its reliability and ease of integration in diverse clinical scenarios.

FLOWer’s design and performance are tailored to complement the TAVI procedure, not complicate it. Its seamless integration with delivery systems means that clinicians can focus on the procedure, confident in the knowledge that FLOWer will perform as expected, every time.

  • Clear Visualization: Easily visible under fluoroscopy.
  • Nitinol - The Key to Visibility: At the heart of FLOWer's design is Nitinol, a metal known for its excellent visibility under fluoroscopy. This choice of material is no coincidence. It's a deliberate decision to ensure that every movement, every placement of FLOWer is clearly visible and precisely executed.
  • Precision in Positioning: The visibility offered by Nitinol is not just about seeing where the device is. It's about providing the confidence to place and evaluate the FLOWer device accurately at each step of the TAVI procedure. This clarity is vital for both the safety and success of the procedure.
  • Real-Time Evaluation: With FLOWer, the ability to assess the device's position in real-time under fluoroscopy means adjustments can be made on the fly, ensuring optimal placement and protection throughout the procedure.

Clear visualization is more than a convenience; it’s a necessity in the delicate and precise world of TAVI procedures. FLOWer embraces this necessity, offering unparalleled visibility that leads to better outcomes and enhanced patient safety.

  • Stable Performance: Remains stable throughout the procedure.

FLOWer EPD: A Model of Stability in TAVI Procedures

 

FLOWer  is designed to deliver consistent stability from the beginning to the end of TAVI procedures.

  • Adjustable Distal Structure for Optimal Fit: The foundation of FLOWer's stability is its adjustable distal structure, expertly designed to fit precisely against the aortic walls. This perfect fit not only ensures a secure placement but also significantly enhances the system's stability during the procedure.
  • Adaptive Spine Design: The spine of the FLOWer device is a dynamic feature that adjusts to the unique anatomy of the aortic wall. This adaptation allows for close contact with the aortic wall, further boosting the device's stability.

With FLOWer, you can trust that the device will maintain its position, providing consistent protection throughout the TAVI procedure. This stability is not just reassuring; it’s essential for the success of the procedure and the safety of the patient.

  • Minimal Thrombogenicity: Low propensity to cause blood clots.

FLOWer EPD: Championing Safety with Minimal Thrombogenicity and Low Propensity to Cause Blood Clots in TAVI Procedures

 

FLOWer EPD stands out for its exceptionally low propensity to cause blood clots, ensuring patient safety and procedure success.

  • Proven in Studies: Our in vitro studies have thoroughly examined FLOWer's thrombogenicity. The results are clear and reassuring: during procedures, FLOWer exhibited no thrombotic complications, highlighting its safe design and reliable performance.
  • Preserving Blood Flow: The design of FLOWer is not just about blocking debris; it's also about maintaining healthy blood flow. The mesh of the device is engineered to allow blood to pass through seamlessly, reducing the risk of clot formation.
  • Simplified Anticoagulation Protocol: With FLOWer, there's no need for device-specific adjustments to the Activated Clotting Time (ACT). Regular ACT monitoring, as is standard for TAVI procedures, is all that's required. This simplification not only makes the process more straightforward but also aligns with standard procedural protocols.

FLOWer’s minimal thrombogenicity is a testament to our commitment to patient safety and procedural excellence. With FLOWer, clinicians can focus on the procedure, reassured by the device’s inherent safety features.

  • Low risk of causing dissections or displacing/rupturing plaques during deployment, positioning, retrieval, or when the TAVI delivery system passes through the aortic valve and ascending aorta.

In TAVI procedures, the deployment phase of an embolic protection device is critical. FLOWer EPD is engineered with an unwavering focus on safety during this crucial stage.

  • Safety-Centric Deployment Process:
    - Tailored Device Sizing: FLOWer's sizing is determined accurately using pre-procedural CT scans, ensuring a custom fit for each patient's unique anatomy.
    - Enhanced Visual Monitoring: Thanks to Nitinol, FLOWer is highly visible under fluoroscopy, providing clear visual feedback. This allows for precise and controlled deployment, significantly reducing the risk of dissections or plaque displacement.
    - Enhanced Tactile Sensitivity: FLOWer provides operators with intuitive tactile feedback throughout the deployment process. This critical feature enables a deeper understanding of how the device interacts with the body's structures, facilitating real-time adjustments for precise and secure positioning
  • Stability: A Key to Safe Deployment: The design of FLOWer, with its adjustable distal structures and adaptive spine, ensures that the device remains stable during deployment. This stability is vital in preventing unwanted movement that could lead to complications, especially when navigating through sensitive areas like the aortic valve and ascending aorta.

At every step of the deployment phase, FLOWer is designed to minimize risks and ensure a safe, smooth procedure. Safety isn’t just a goal; it’s a built-in feature of every FLOWer device.

In TAVI procedures, optimal management of the femoral access site is key to patient safety and procedural efficiency. FLOWer EPD brings notable improvements to this critical aspect.

  • 12 Fr Introducer Compatibility: Designed to fit the diameter of femoral arteries, FLOWer is compatible with a 12 Fr introducer. This ensures a smooth and safe insertion, aligning with standard procedural practices.
  • Simplified Vascular Access: FLOWer stands out by eliminating the need for additional vascular access points, unlike systems that require a separate access for pigtail catheters. This simplification reduces potential complications and streamlines the procedure.
  • Effortless Closure Management: Managing the femoral access site is more efficient with FLOWer, thanks to its compatibility with standard, pre-mounted suture-based closure devices. This makes the closure process less invasive and more straightforward.
  • Solid Safety Record: The Nautilus Study highlighted FLOWer's safety, showing no instances of bleeding or vascular complications. This underscores its reliability and commitment to patient safety.

With FLOWer EPD, femoral access in TAVI procedures is not just about cerebral protection; it’s about enhancing the entire procedural experience, focusing on safety and efficiency from start to finish.

  • Thorough Debris Removal: Captures and eliminates both cerebral and non-cerebral debris.

In transcatheter aortic valve implantation (TAVI), the challenge isn’t just protecting the brain; it’s about ensuring comprehensive debris removal, both cerebral and non-cerebral. FLOWer EPD stands at the forefront of this challenge, offering unparalleled debris elimination capabilities.

  • Comprehensive Cerebral Protection: FLOWer is meticulously designed to safeguard the cerebral circulation. Its advanced filtering technology is capable of capturing a wide range of debris sizes, significantly reducing the risk of cerebral complications.
  • Efficiency Against All Debris Sizes: FLOWer's efficiency isn't limited to large particles. It excels in trapping both small and large emboli. In vitro studies have shown that FLOWer prevents over 99% of microspheres from reaching the brain. Clinical trials have demonstrated its ability to capture an average of 420 particles per filter, more than half of which are smaller than 150 µm.
  • Beyond the Brain: Non-Cerebral Debris Removal: FLOWer's capabilities extend beyond cerebral protection. Its design ensures effective capture of non-cerebral debris as well, providing a comprehensive safety net throughout the TAVI procedure.

The FLOWer EPD is a guardian against a wide spectrum of embolic risks. With its thorough debris removal system, FLOWer ensures a safer TAVI experience, protecting patients from potential complications associated with both cerebral and non-cerebral debris.

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