FDA clears portfolio expansion for Imperative Care stroke treatment

August 2, 2023 By Sean Whooley

The announcement for the study results comes just a week after the FDA cleared an expansion to the Zoom portfolio. Imperative Care will discuss its Zoom platform and its efforts to build next-generation devices at DeviceTalks West in October. Check out the agenda and register HERE.

Campbell, California-based Imperative Care develops connected technology to treat stroke and other ischemic diseases. The Zoom stroke solution product platform aims to usher in a new era of stroke thrombectomy. It enables fast and consistent treatment, plus improved procedure outcomes. Through reperfusion, physicians can perform fast, effective clot removal in patients with ischemic stroke.

The company presented data from its Neurovascular Quality Initiative-Quality Outcome Database (NVQI-QOD) at the Society of NeuroInterventional Surgery (SNIS) 2023 20th Annual Meeting in San Diego.

Imperative Care set the primary goals for NVQI-QOD as providing a platform for driving stroke care improvement while meeting demands set by regulatory agencies. The company also sought to evaluate the safety and clinical performance of medical devices used to treat acute ischemic stroke.

“We are excited about the opportunity to collaborate with NVQI-QOD to reinforce the safety and effectiveness of our unique angled-tip aspiration catheters for treating patients with ischemic stroke,” said Ariel Sutton, GM of Imperative Care’s stroke business. “Continuing to add to our growing body of evidence with the Zoom stroke solution is a priority for Imperative Care. These data further demonstrate the positive association between the use of the Zoom aspiration catheters with procedure times and successful final reperfusion.”

Imperative Care evaluated safety and clinical performance data from 211 patients. These patients had large or medium-sized vessel occlusions and received Zoom aspiration catheter treatment. Just over two-thirds (67.8%) received an aspiration-first technique. The remainder (32.2%) underwent a combined technique of aspiration with a stent-retriever. Additionally, 9% received adjunctive therapies, including intra- or extra-cranial angioplasty and/or stenting.

Results demonstrated a 22-minute median time from arterial puncture to recanalization. TICI≥2B reperfusion was achieved in 91.9% of patients, and in 59% of patients after the first pass. Overall 59.2% of patients achieved TICI≥2C reperfusion.

Among patients with 90-day follow-up data, 53.2% proved functionally independent. The overall rate of symptomatic intracranial hemorrhage came in at 2.8%.

Dr. Mahesh Jayaraman of Brown University presented the results.

“The angled-tip Zoom Aspiration Catheters have become a valuable tool for stroke thrombectomy procedures due to their proven trackability and ability to engage clot effectively,” said Jayaraman. “These real-world data demonstrate that treatment with the Zoom aspiration catheters led to high rates of successful reperfusion in patients with ischemic stroke, with no safety concerns. We look forward to future NVQI-QOD efforts to analyze valuable real-world data and evaluate the safety and effectiveness of new and promising technologies in the space.”

Imperative Care also recently announced that the FDA granted 510(k) clearance for its Zoom 88 large distal platform (LDP) support.

Zoom 88 LDP support is a portfolio expansion of the company’s Zoom 88 LDP platform. Imperative Care developed large-bore, .088″ intracranial access paired with angled-tip aspiration catheters. These enable better and faster reperfusion for stroke procedures. Zoom 88 support expands the intracranial access portfolio, Imperative Care says.

The new platform features a newly engineered support profile. It’s designed to maintain the capability of .088″ intracranial access with added stability. This gives physicians even more control over thrombectomy procedures in a greater patient population.

Dr. Harris Hawk completed the first successful cases using Zoom 88 support. Hawk serves as an interventional neuroradiologist at Erlanger Health System in Chattanooga, Tennessee.

“Zoom 88 Support was purposefully designed to meet the needs of more patients and deliver on the feedback we’ve received from physicians. Zoom 88 Support provides the same benefits of intracranial access found with Zoom 88 LDP, with the ability to treat more proximal or tandem occlusions,” Sutton said. “With the introduction of Zoom 88 Support, we continue to grow our patient-first portfolio to bring the benefits of large-bore intracranial access to more people.”

Filed Under: News Well Tagged With: DeviceTalks West, FDA, Imperative Care