Subject: FDA
Q'Apel Medical Announces FDA Clearance for Walrus Balloon Guide Catheter
FREMONT, Calif., July 17, 2019 /PRNewswire/ -- Q'Apel Medical announced today that it received U.S. Food and Drug Administration clearance for its novel walrus Balloon Guide Catheter (BGC).
In the neurovascular space where speed, reliability and performance are so critical to patient outcomes, physicians and patients demand that innovative technologies are best-in-class. The walrus BGC, with its 087 ID, marks a big step forward in balloon guide catheter technology and for stroke patients worldwide.
"Catheter compatibility in the neurovascular space is critical to the treatment of stroke patients. Until now, widespread adoption of BGCs has been limited due to technical constraints. The walrus BGC was specifically designed to address these technical shortcomings with an 087 ID in a highly trackable catheter platform," said Raymond Turner MD, professor of neurosurgery at Prisma Health. "I expect its introduction will be welcomed by neurovascular physicians everywhere."
The walrus BGC represents the second FDA-cleared technology from Q'Apel in the past 12 months, joining the wahoo Access Catheter with Selectflex technology in Q'Apel's expanding product portfolio. Q'Apel has several more innovative products slated to come to market over the course of the next year.
About Q'Apel Medical LLC
Q'Apel Medical LLC is a medical device company founded with the sole purpose of developing best-in-class technology for neurovascular interventions. Learn more about Q'Apel at www.option3llc.com/portfolio.
For more information about Q'Apel and the walrus BGC, please email [email protected].
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SOURCE Q'Apel Medical
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