Imperative Care, Inc. has announced that its Zoom System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This milestone marks the first comprehensive stroke thrombectomy system to feature large-bore .088” catheters designed for both access and aspiration when used in conjunction with a Zoom Catheter. With this clearance, Imperative Care expands its existing range of .035” to .071” aspiration catheters to include the new Zoom .088” catheters—Zoom 88, Zoom 88 Support, and TracStar—as part of the broader Zoom System for aspiration procedures.
This FDA clearance was supported by robust clinical evidence from the Imperative Trial, a prospective, multi-center clinical study conducted across 26 institutions in the United States. The trial evaluated the performance and benefits of the Zoom System in treating patients with stroke. The analyzed data included 211 patients who underwent aspiration thrombectomy using two catheters, providing comprehensive insights into the system’s efficacy and safety.
Ariel Sutton, Executive Vice President and General Manager of Imperative Care’s Stroke business, emphasized the company’s commitment to delivering a patient-focused and clinically validated stroke solution. “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,” Sutton said. “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 maximizes 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 Findings from the Imperative Trial
The clinical results submitted to the FDA highlighted several key benefits of the Zoom System:
- Fast Reperfusion Times:
- The median time from groin puncture to achieving mTICI ≥2B reperfusion was just 19 minutes, making it the fastest among referenced thrombectomy trials.
- High Reperfusion Success Rates:
- A core-lab adjudicated rate of mTICI ≥2B reperfusion was achieved in 84% of patients within three passes or fewer without requiring additional thrombectomy devices as rescue therapy. This success rate aligns closely with prior trials, which reported 82%.
- Minimal Use of Stent Retriever Rescue Therapy:
- Stent retriever rescue therapy was employed in only 4.7% of cases to achieve mTICI ≥2B reperfusion.
- Low Rates of Intracranial Hemorrhage and Vessel Injury:
- The rate of core-lab adjudicated symptomatic intracranial hemorrhage was just 0.9%, significantly lower than the 4.7% rate reported in previous trials.
- Instances of independently adjudicated dissection and vessel perforation were reported at 0.5%, also lower than the 1.3% reported in prior studies.
Dr. William Mack, M.D., Professor of Neurosurgery at the Keck School of Medicine, University of Southern California, and Co-Principal Investigator of the Imperative Trial, expressed his confidence in the Zoom System. “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,” Dr. Mack stated. “Even more impressive was the 0.9% rate of symptomatic intracranial hemorrhage. 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.”
The Zoom System: A Comprehensive Solution for Stroke Treatment
The Zoom System is designed to address the critical need for fast and effective treatment of ischemic stroke, where time is of the essence. The system’s innovative design provides physicians with versatile tools to navigate diverse patient anatomies and perform aspiration thrombectomy procedures efficiently. By including large-bore .088” catheters for both access and aspiration, the Zoom System enhances the ability to remove clots rapidly and safely.
The inclusion of the Zoom 88, Zoom 88 Support, and TracStar catheters into the system underscores Imperative Care’s commitment to advancing stroke care technology. These catheters are specifically engineered to provide superior aspiration power, enabling effective clot removal and reducing the need for additional devices or procedures. Furthermore, the system’s performance in the Imperative Trial demonstrates its potential to improve clinical outcomes for patients suffering from acute ischemic stroke.
Clinical Impact and Future Implications
The FDA clearance of the Zoom System not only validates its clinical efficacy and safety but also highlights its potential to set a new standard for stroke thrombectomy procedures. The findings from the Imperative Trial provide a compelling case for adopting this system in clinical practice, particularly given its demonstrated ability to achieve rapid reperfusion, high success rates, and a favorable safety profile.
Moreover, the addition of large-bore .088” catheters to the system equips physicians with enhanced tools to manage complex stroke cases. By minimizing the need for stent retriever rescue therapy and reducing complications such as intracranial hemorrhage and vessel injury, the Zoom System represents a significant advancement in the field of neurovascular care.
The success of the Imperative Trial and the subsequent FDA clearance would not have been possible without the dedication of the physicians, patients, and families who participated in the study. Their contributions have been instrumental in advancing stroke care and providing valuable insights into the clinical benefits of the Zoom System.
As Imperative Care continues to innovate in the field of stroke treatment, the company remains committed to improving patient outcomes and addressing the unmet needs of those affected by ischemic stroke. The FDA clearance of the Zoom System marks an important step forward in achieving these goals, paving the way for broader adoption of this groundbreaking technology in healthcare settings across the United States.
In summary, the Zoom System’s FDA clearance reaffirms Imperative Care’s leadership in stroke care innovation. With its comprehensive and clinically validated design, the system is poised to make a meaningful impact on the treatment of ischemic stroke, offering new hope to patients and their families.
About the Zoom Stroke Solution
The Zoom Stroke Solution is a complete stroke system from access through reperfusion designed for fast and effective clot removal in patients presenting with acute ischemic stroke. The comprehensive system includes the Zoom 6F Insert Catheters, Zoom 88 and Zoom 88 Support Large Distal Platform, and Zoom RDL Radial Access Platform, the Zoom 35, 45, 55 and 71 Catheters, Zoom Pump, Zoom POD and accessories. All Zoom Catheters are designed with the unique TRX™ Tip, which provides 15% greater clot engagement area at the tip of the catheter5 and are designed to enable smooth tracking through challenging vasculature. For complete product information, including indications, contraindications, warnings, precautions and adverse events, visit: https://bit.ly/3yWkfEJ.
About Imperative Care, Inc.
Imperative Care is a commercial-stage medical technology company researching and developing connected innovations to elevate care for people affected by devastating vascular diseases such as stroke and pulmonary embolism. The company is focused on addressing specific gaps in treatment and care to make an impact across the entire patient journey. Imperative Care is based in Campbell, Calif. https://imperativecare.com.
