Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
Imperative Care, Inc.The Zoom 7X Catheter, along with the Zoom Aspiration Tubing and Zoom POD Aspiration Tubing, is a sterile, single-use medical device designed to remove blood clots from large intracranial vessels in patients experiencing an acute ischemic stroke. It helps restore blood flow by aspirating the clot when connected to an aspiration pump, aiding clinicians in rapidly treating stroke and improving patient outcomes.
Intended Use
The Zoom 7X Catheter, with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing, and the Zoom Aspiration Pump (or equivalent vacuum pump), is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of last known well.
Technology
The Zoom 7X Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter with a hydrophilic coated distal tip and beveled edge for atraumatic navigation in neurovasculature. It connects to the Zoom Aspiration Pump via Zoom Aspiration Tubing or Zoom POD Aspiration Tubing, which includes flow control mechanisms. Accessories include a rotating hemostasis valve and introducer sheaths.
Performance
Non-clinical bench testing demonstrated the device meets ISO catheter standards (ISO 10555-1), including delivery, flexibility, bond strength, burst pressure, and clot retrieval. The Zoom POD tubing passed functional and vacuum tests. Biocompatibility testing was conducted per ISO 10993 standards. Animal and clinical studies were not required based on non-clinical testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/27/2024
8 months - 2
FDA Approval
5/28/2025
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