WallabyPhenox Continues to Strengthen Its U.S. Product Portfolio as p17 XR Microcatheter Receives FDA Clearance

Irvine, California — March 20, 2026 — WallabyPhenox — On August 18, 2026, WallabyPhenox announced that its independently developed p17 XR Microcatheter has successfully received 510(k) clearance (K254071) from the U.S. Food and Drug Administration (FDA), authorizing the device for sale in the U.S. market. This clearance is a key milestone in WallabyPhenox’s continued effort to build out its U.S. neurointerventional product portfolio and represents the company’s 15th FDA registration certificate. With the p17 XR Microcatheter officially entering the U.S. market, WallabyPhenox further enriches its neurointerventional product matrix, injecting new momentum into the company’s ongoing globalization strategy, expansion into international markets, and development of integrated neurointerventional solutions.

As an important delivery platform in neurointerventional therapy, the p17 XR Microcatheter facilitates the precise delivery of diagnostic and therapeutic devices to target sites in neurovascular and peripheral vessels, providing stable and efficient delivery support for a wide range of neurointerventional procedures. The device features a 0.017-inch inner diameter, is offered in two working lengths (150 cm and 160 cm), and comes in two configurations with single or dual radiopaque marker bands to suit different procedural and clinical needs.

Designed for the complex vascular anatomy encountered in neurointervention, the p17 XR has been comprehensively optimized for delivery performance, stability, and compatibility. Its dual-layer metal reinforcement structure (a stainless steel coil combined with a nitinol braid) balances proximal support with distal flexibility, maintaining excellent stability through tortuous vascular pathways. A 60 cm hydrophilic coating, combined with a PTFE liner and a graduated Pebax structure, effectively reduces device delivery resistance and further enhances the catheter’s trackability and handling, providing reliable delivery support for complex neurointerventional procedures.

Notably, the p17 XR Microcatheter offers broad device compatibility. It is compatible with the p48 LT flow diverter, the pRESET LITE stent retriever, Avenir mechanically detachable coils and assist stents, as well as the DMSO/Onyx liquid embolic system. It can therefore cover a wide range of neurointerventional scenarios—including ischemic stroke, intracranial aneurysms, and cerebral vascular malformations—providing clinicians with a more flexible and efficient overall treatment solution.

To date, WallabyPhenox has 15 products cleared by the FDA, with a portfolio spanning the full continuum of neurointerventional care. These include the Avenir coil family for hemorrhagic stroke; the Esperance® aspiration catheter family (including Esperance®, Esperance® 3+, and Esperance® pHLO) and the pRESET stent retriever family (including pRESET and pRESET LITE) for ischemic stroke; as well as neurointerventional access products such as the pNOVUS® microcatheter, pORTAL® guidewire, Paragon balloon guide catheter, and Pilote™ distal access (support) catheter—continuously delivering integrated solutions that cover the full treatment pathway of cerebrovascular diseases for clinical practice worldwide.

Looking ahead, WallabyPhenox will continue to be guided by clinical needs, steadily advancing innovative product R&D and global market expansion, further enriching its neurointerventional product matrix, and strengthening its integrated solution capabilities. By empowering precision treatment through innovative technology, the company will provide safer, more efficient, and more accessible neurointerventional medical solutions for physicians and patients worldwide.