According to Campbell, California–based Imperative Care, the Zoom system is the first such system to include large-bore .088-in. catheters indicated for both access and aspiration when used with one of the company’s Zoom catheters.
The FDA clearance expands Imperative Care’s present portfolio of .035 in. to .071 in. aspiration catheters to now include the Zoom .088 in. catheters for use with the Zoom system. The new .088 in. catheters are Zoom 88, Zoom 88 Support and TracStar.
“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,” Ariel Sutton, EVP and GM of Imperative Care’s Stroke business, said in a news release. “We know that with stroke, time is the most critical factor in driving positive patient outcomes.”
The 510(k) came after submission of final data from the company’s Imperative Trial.
“The Zoom system is the first purpose-built technology from access to aspiration that maximizes versatility for rapid and effective procedures as validated by the Imperative Trial and previous clinical studies of the Zoom stroke solution,” Sutton said.
According to the company, the prospective, multi-center clinical trial evaluated the clinical benefits of the Zoom system in patients across 26 U.S. healthcare institutions. The analyzed cohort included 211 patients treated with concomitant aspiration thrombectomy with two catheters. The study assessed reperfusion success using the modified Thrombolysis in Cerebral Infarction (mTICI) scores in the absence of any rescue therapy, reperfusion time, first-pass success, and functional independence, including a quality-of-life assessment.
Key results from the Imperative Trial included:
- The median time from groin puncture to mTICI was greater than or equal to 2B reperfusion of 19 minutes. (An mTICI greater than or equal to 2B is generally regarded as successful reperfusion.) The result was the fastest among the referenced thrombectomy trials.
- A core-lab adjudicated rate of mTICI greater than or equal to 2B reperfusion was achieved in 84% of patients within three passes or less without using additional thrombectomy devices as rescue therapy. The result was similar to similar to prior trials around 82%.
- Health providers needed stent retriever rescue therapy in only 4.7% of cases to achieve mTICI of greater than or equal to 2B reperfusion.
- There was a core-lab adjudicated rate of symptomatic intracranial hemorrhage of 0.9%, lower than the rate of prior trials (4.7%,). In addition, there was a rate of independently adjudicated dissection and vessel perforation of 0.5%, lower than prior trials (1.3%).
In total, the Zoom system includes the Zoom 6 Fr insert catheters, Zoom 88 and Zoom 88 support large distal platform, Zoom RDL radial access platform, the Zoom 35, 45, 55 and 71 Catheters, Zoom pump, Zoom POD and accessories. All Zoom catheters have what Imperative Care describes as its unique TRX tip, which the company says provides 15% greater clot engagement area at the tip of the catheter with a design enabling smooth tracking through challenging vasculature.
“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. Even more impressive was the 0.9% rate of symptomatic intracranial hemorrhage,” said Dr. William Mack, professor of neurosurgery at the Keck School of Medicine at the University of Southern California and co-principal investigator of the Imperative Trial.
“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.”
Mack — who is also a consultant for Imperative Care — later answered questions from MassDevice by email.
“This technology uses a family of different sized catheters to optimize delivery and clot aspiration,” he said. “The Imperative system allows for aspiration catheters that fit well in a large size range of target blood vessels. Specifically, the system incorporates the option for a super large bore aspiration catheter that facilitates navigation, support and aspiration.”
“We have come a long way with these measures in recent years and data from the Imperative trial adds to the body of research supporting the use of this kind of technology to treat acute stroke,” he continued. “Patients most benefit when physicians have access to devices that can quickly access occlusions in any of the large vessels in the brain.”
The 510(k) news comes about half a year after Imperative Care completed a $150 million round.
