Perfuze’s Zipline Access Catheters for Stroke Interventions Cleared by FDA

Perfuze advances stroke care with FDA 510(k) clearance for its new Zipline access catheters.

Designed to support the delivery of large aspiration catheters during neurointerventional procedures, the device aims to enhance physicians’ ability to quickly remove blood clots from patients suffering from acute ischemic stroke — a condition where every minute matters.

In stroke, as brain tissue rapidly loses function, millions of neurons can be lost in just a few minutes, making swift intervention essential.

Related: TNKase (Tenecteplase) Becomes First Stroke Medicine Approved by FDA in Almost 30 Years

The Zipline access catheter’s unique design improves navigational ease and trackability, making it easier for doctors to reach challenging clot locations, much like a precision-guided delivery system in emergency services.

The catheter works by providing enhanced support and a coil structure that facilitates the smooth passage of larger aspiration catheters. In practice, this means that during stroke interventions, physicians can navigate the intricate pathways of brain arteries with increased confidence and efficiency.

As the catheter works to clear clots faster, it has the potential to significantly improve procedural success rates and patient outcomes by reducing the time it takes to restore blood flow — achieving reperfusion more rapidly.

Adding to this breakthrough, Perfuze has secured nearly $24 million in additional funding from existing investors. The fresh capital will accelerate both the limited market release of the Zipline access catheters and ongoing clinical research and development efforts.

Early plans include expanding availability in select US Comprehensive Stroke Centers for further evaluation and adoption.

Focusing on reducing intervention times and improving outcomes, the Zipline access catheters promise to address one of today’s most time-sensitive medical challenges.

Minimally invasive stroke care is on the rise — with the neurovascular intervention devices market projected to reach $6.21 billion by 2030 — thanks to advances in imaging, improved device technology and clinical evidence of reduced complications and faster recovery compared to traditional procedures.

Adding momentum to the neurovascular narrative, CereVasc — renowned for its minimally-invasive neurological medical devices — recently announced that the first patient in its STRIDE pivotal trial has been treated with the eShunt system, a trial designed to evaluate the system’s safety and effectiveness in optimizing cerebral perfusion during critical interventions.

Similarly, neurovascular leader Terumo Neuro recently showcased its range of devices — from advanced access catheters to revascularization tools — designed to streamline the stroke intervention process by covering every step, from vascular access to complete clot removal and blood flow restoration.