Q’Apel Medical Wins FDA Nod for Zebra Neurovascular Access System

Q’Apel Medical, a neurovascular interventions company, has won U.S. Food and Drug Administration (FDA) clearance for its Zebra neurovascular access system.

The Zebra device is indicated to introduce interventional devices into the peripheral and neurovasculature. It’s available in 6F and 7F sizes.

The system, which is built from a single-length hypotube, features a distinctive pattern of laser-cut stripes. The pattern was engineered for high-performance catheter construction with better dynamic flexibility from tip to tail, the company said.

Zebra’s unique inner diameter (ID) to outer diameter (OD) ratio maximizes the inner lumen without ledges, creating support during delivery of the device. The 7F size accommodates 0.072″ aspiration catheters, and the 6F design expands intraprocedural options and product compatibility to maximize procedural versatility, Q’Apel said.

Jan-Karl Burkhardt, MD, Division Head, Cerebrovascular Surgery, Penn Medicine in Philadelphia said in neurovascular interventions, the tortuous anatomy can be challenging to access because it requires a balance of flexibility and support that many traditional catheters fail to deliver.

“I continue to be impressed by Zebra’s dynamic flexibility with each additional case,” Dr. Burkhardt told the press. “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.”

“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.”

Last week, the company revealed it had appointed former Haemonetics executive Stewart Strong as its new CEO.