Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
Route 92 Medical, Inc.The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set is a device used to remove blood clots in patients suffering from acute ischemic stroke caused by large vessel blockages in the brain. It is used with a compatible vacuum pump to restore blood flow within 8 hours of stroke onset, helping patients who are not eligible for or have failed drug therapy. This system comprises catheters and tubing designed for safe and effective clot removal in neurovascular procedures.
Intended Use
The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, when used with a compatible 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 artery and middle cerebral artery M1 segment within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
Technology
The system includes an aspiration catheter with a single-lumen, coil-reinforced polymer distal shaft connected to a proximal control wire, a delivery catheter, a Base Camp Sheath System, and aspiration tubing. The catheters have hydrophilic coatings, and the aspiration tubing connects to an aspiration pump providing specific vacuum parameters to facilitate clot removal.
Performance
Non-clinical testing included simulated use, lumen patency under vacuum, dimensional verification, tensile strength, kink and torsion resistance, hydrophilic coating integrity, aspiration pressure, particulate evaluation, and animal studies demonstrating safety and performance under worst-case clinical conditions. Clinical testing was performed in a randomized controlled trial (SUMMIT MAX) showing non-inferior revascularization rates and safety compared to a predicate device, with detailed endpoints including reperfusion success and symptomatic intracranial hemorrhage.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/21/2024
5 months - 2
FDA Approval
5/19/2025
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