Q'Apel Medical Announces U.S. FDA Clearance for the Zebra Neurovascular Access System and Prepares for Full U.S. Launch
- Increasing rates of neurovascular interventions spark a need for reliable access and procedural versatility
- Company expands portfolio with a novel access catheter featuring a unique ID/OD ratio
- Purpose-built laser cut technology enables balanced delivery performance and stable support
FREMONT, Calif., July 8, 2025 /PRNewswire/ -- Q'Apel Medical (Q'Apel), a private medical device company focused on revolutionizing neurovascular interventions, today announced it has received U.S. Food and Drug Administration (FDA) clearance for its Zebra Neurovascular Access System. Available in 6F and 7F sizes, Zebra is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
"Fueled by an aging population and environmental factors, we continue to see an increase in neurovascular conditions, such as stroke and cerebral aneurysms, that require delicate interventions. The tortuous anatomy can be challenging to access, requiring a balance of flexibility and support, which many traditional access catheters fail to deliver," commented Jan-Karl Burkhardt, MD, Division Head, Cerebrovascular Surgery, Penn Medicine in Philadelphia, PA. "I continue to be impressed by Zebra's dynamic flexibility with each additional case. Its hallmark stripes provided stable support and maintained pushability throughout my procedures. I look forward to the versatility this novel design offers and expect it to become a mainstay for my neurovascular access cases."
Purpose-built from a single full-length hypotube, the Zebra Neurovascular Access System features a distinctive pattern of laser-cut stripes. This pattern is designed to deliver high-performance catheter construction with greater dynamic flexibility from tip to tail, providing support and flexibility where needed. The unique inner diameter (ID) to outer diameter (OD) ratio maximizes the inner lumen, without ledges, to provide optimal support during device delivery. Zebra's 7F accommodates 0.072" aspiration catheters, and the 6F design expands intraprocedural options and product compatibility to maximize procedural versatility for the complexity of today's neurovascular interventions.
"The Zebra Neurovascular Access System was engineered to easily track through the tight bends of this delicate anatomy while maintaining lumen integrity, allowing for atraumatic deliverability in neurovascular applications," stated Jeff Krolik, Chief Technology Officer for Q'Apel Medical. "I applaud our talented team for their commitment to this milestone and their continued passion to deliver meaningful clinical advancements for our customers and their patients."
The Zebra Neurovascular Access System will be on display in Booth 409 during the Society for Neurointerventional Surgery (SNIS), July 14th through 18th in Nashville, Tennessee.
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About Q'Apel Medical:
Q'Apel Medical is revolutionizing neurovascular interventions. Inspired by the evolving needs of our customers, our novel approach allows us to solve clinical challenges where others fall short. We are up for the task, the more complex the better. Our team thrives on creating high quality uniquely engineered products, designed in partnership with neurovascular specialists, that address what is needed right now, yet with the versatility to focus on what is coming next. For more information, visit www.qapelmedical.com.
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SOURCE Q'Apel Medical Inc.
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