The US Food and Drug Administration (FDA) has granted 510(k) clearance for Imperative Care’s Zoom System, marking an advancement in stroke thrombectomy procedures.
The clearance marks it as the first stroke thrombectomy system to feature large-bore 0.088in catheters, designed for access and aspiration when used with the Zoom Catheter.
Related: The FDA clears Instylla’s Tembo Embolic System
With the clearance, the company’s current portfolio of 0.035in – 0.071in aspiration catheters expands to include the Zoom 0.088in catheters – Zoom 88, Zoom 88 Support, and TracStar.
Clinical evidence from the final data of the multi-centre, prospective Imperative Trial conducted across 26 US institutions in the US underpinned the FDA clearance.
The trial involved 211 subjects and focused on the clinical benefits of the system, with a particular emphasis on the use of concomitant aspiration thrombectomy with two catheters.
Key findings from the trial showed a median time from groin puncture to modified treatment in cerebral infarction (mTICI) ≥2B reperfusion of 19 minutes.
Furthermore, the trial showed that 84% of subjects achieved core-lab adjudicated rate of mTICI ≥2B reperfusion in three passes or less eliminating the need for additional thrombectomy devices as rescue therapy.
The rate of symptomatic intracranial haemorrhage was 0.9%, and the dissection and vessel perforation rate was 0.5%, both lower than in previous trials.
Zoom Stroke offers a full system for stroke treatment, including the Zoom 88, Zoom 88 Support Large Distal Platform, and Zoom 6F Insert Catheters, among other components.
All Zoom catheters feature the TRX Tip to enhance clot engagement and navigate challenging vasculature smoothly.
Imperative Care Stroke business general manager and executive vice-president Ariel Sutton said: “At Imperative Care, we are focused on developing a patient-centric and well-studied comprehensive stroke system for physicians to best care for their patients based on their specific needs and anatomy.”
Imperative Care develops solutions for vascular conditions such as stroke and pulmonary embolism.
In July 2021, the company raised $260m in a Series D funding round led by D1 Capital Partners, aimed at advancing stroke care technologies.
