Q'Apel Medical's Zebra Neurovascular Access System Gets FDA Clearance for U.S. Market Launch

Q'Apel Medical's Zebra Neurovascular Access System Achieves FDA Clearance



Q'Apel Medical has made headlines with its recent announcement of receiving U.S. Food and Drug Administration (FDA) clearance for the Zebra Neurovascular Access System. This innovative medical device is set to transform the field of neurovascular interventions, providing healthcare professionals with advanced tools for critical procedures. The clearance opens the door for the commercial launch of the Zebra system in the U.S., highlighting the company's commitment to improving patient care in these complex medical scenarios.

A Growing Demand for Neurovascular Solutions



As an increasing number of neurovascular conditions such as strokes and cerebral aneurysms emerge, the need for reliable access solutions in the field is becoming more critical. Medical professionals are consequently in search of devices that facilitate safe and effective interventions. Dr. Jan-Karl Burkhardt, head of Cerebrovascular Surgery at Penn Medicine, emphasized the importance of flexibility and support in access catheters. He noted that many existing options fall short in navigating the intricate anatomy often involved in neurovascular cases.

The Zebra Neurovascular Access System is available in both 6F and 7F sizes and is specifically designed for introducing interventional devices into the peripheral and neurovascular systems. One significant feature of the Zebra system is its unique inner diameter (ID) to outer diameter (OD) ratio, which aims to maximize the inner lumen for optimal support during device delivery, eliminating ledges that can impede performance.

Innovative Design and Performance



Crafted from a single full-length hypotube, the Zebra system incorporates a distinctive pattern of laser-cut stripes, a design that allows for enhanced dynamic flexibility and stability throughout various procedures. Its advanced engineering enables the catheter to efficiently track through tight anatomical bends while maintaining lumen integrity, offering a reliable solution for clinicians in challenging neurovascular environments.

Jeff Krolik, Chief Technology Officer at Q'Apel Medical, said, "The Zebra Neurovascular Access System was engineered to easily navigate the complexities of the neurovascular anatomy. I am proud of our team's dedication and ingenuity in reaching this important milestone." The engineering team at Q'Apel Medical played an essential role in the conception of the Zebra system, ensuring the product not only addresses current clinical challenges but also positions itself for future innovations in neurovascular medicine.

Clinical Applications and Versatility



The 7F version of the Zebra system accommodates 0.072" aspiration catheters, providing significant procedural versatility that is vital for today's complex neurovascular interventions. Such features are essential for enhancing the efficacy of interventions and improving overall patient outcomes. The introduction of the Zebra Neurovascular Access System is expected to serve as a game-changer for medical professionals across the United States as they seek to deliver high-quality care in neurovascular procedures.

Dr. Burkhardt anticipates that the versatility of the Zebra design will lead to its widespread adoption in the field, allowing for improved procedural outcomes. As they prepare for the full U.S. launch, Q'Apel Medical will showcase the Zebra Neurovascular Access System at the Society for Neurointerventional Surgery (SNIS) convention in Nashville, Tennessee from July 14-18.

About Q'Apel Medical



Headquartered in Fremont, California, Q'Apel Medical is on a mission to revolutionize neurovascular interventions. By focusing on the evolving needs of healthcare providers, the company develops novel solutions and products engineered in collaboration with neurovascular specialists. Their commitment to quality and innovation ensures that they are well-equipped to address the complexities of modern medical treatments. For more information about Q'Apel Medical and the Zebra Neurovascular Access System, visit Q'Apel Medical's website.

Topics Health)

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