Imperative Care has today announced the receipt of US Food and Drug Administration (FDA) 510(k) clearance of the company’s Zoom system, making it the first comprehensive stroke thrombectomy system to include large-bore 0.088-inch catheters indicated for both access and aspiration when used with a Zoom catheter.
As per an Imperative press release, this clearance expands the company’s current portfolio of 0.035-inch to 0.071-inch aspiration catheters to now include the Zoom 0.088-inch catheters—Zoom 88, Zoom 88 Support and TracStar—for aspiration as part of the Zoom system.
Clinical evidence submitted to the US FDA to support the clearance included final data from the Imperative trial. This prospective, multicentre trial evaluated the clinical benefits of the Zoom system in patients treated across 26 US institutions. The analysed cohort included 211 patients who were treated with concomitant aspiration thrombectomy using two catheters.
“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,” said Ariel Sutton, executive vice president and general manager of Imperative’s Stroke business. “We know that, with stroke, time is the most critical factor in driving positive patient outcomes. The Zoom system is the first purpose-built technology from access to aspiration that maximises versatility for rapid and effective procedures—as validated by the Imperative trial and previous clinical studies of the Zoom stroke solution. Thank you to all the physicians, patients and their families who participated in this landmark trial, and placed their trust in our technology.”
Key results from the Imperative trial, submitted to the FDA to support clearance, demonstrated:
- Median time from groin puncture to modified thrombolysis in cerebral infarction (mTICI) ≥2b reperfusion of 19 minutes; fastest among prior thrombectomy trials including ARISE II, TIGER, Penumbra 3D and PROST, according to Imperative
- A core lab-adjudicated rate of mTICI ≥2b reperfusion was achieved in 84% of patients within three passes or less without the use of any additional thrombectomy devices as rescue therapy—similar to prior trials (82%), including SWIFT PRIME, Penumbra 3D, ARISE II, TIGER, ETIS and PROST
- Stent-retriever rescue therapy used in only 4.7% of cases to achieve mTICI ≥2b reperfusion
- A core lab-adjudicated rate of symptomatic intracranial haemorrhage of 0.9%, lower than the rate of prior trials (4.7% [SWIFT PRIME, Penumbra 3D, ARISE II, ETIS and MR CLEAN De Novo 510(k) data]); and a rate of independently adjudicated dissection and vessel perforation of 0.5%, lower than prior trials (1.3% [SWIFT PRIME, Penumbra 3D, ARISE II, PROST and MR CLEAN De Novo 510(k) data])
“In addition to the remarkable efficacy of the Zoom system, I was impressed by the demonstrated safety profile as evidenced by a 0.5% instance of serious vessel injury reported in the study,” said William Mack (University of Southern California, Los Angeles, USA), co-principal investigator of the Imperative trial. “Even more impressive was the 0.9% rate of symptomatic intracranial haemorrhage. These data, combined with our extensive experience with the Zoom system, reinforce our confidence in the technology and its clinical benefits for our practice, and the patients we treat.”
