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Solitaire revascularization device

Manufactured by Medtronic
Sourced in United States, Ireland

The Solitaire revascularization device is a medical instrument used for the treatment of ischemic stroke. It is designed to remove blood clots from the brain's blood vessels, allowing for the restoration of blood flow.

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4 protocols using solitaire revascularization device

1

STRATIS Registry for AIS Thrombectomy

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STRATIS is a multicenter, non-randomized, observational registry for evaluating the use of the Solitaire revascularization device (Medtronic Inc., Irvine, California, USA) and Mindframe Capture low profile revascularization device (Medtronic) in patients with AIS due to intracranial large vessel occlusion (LVO). Informed consent was provided by patients or patients' legally authorized representatives, and the study was approved by the review boards of all participating institutions. All patients underwent stent retriever MT within 8 hours of the onset of stroke symptoms. The methodology and primary results have been published previously.3 (link) For this study, STRATIS patients were included if they: (1) had stroke onset at a location other than a hospital; (2) were transported by EMS first to a nECC and then transferred to a STRATIS-participating ECC; and (3) had study data available for their geographic location at the time of stroke onset and EMS field response. Patients transferred by ground ambulance (ground cohort) or air ambulance (aerial cohort) were included.
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2

STRATIS Registry: Solitaire Thrombectomy Outcomes

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The primary results of the STRATIS registry have been reported (16 (link)). STRATIS was a prospective, multicenter, non-randomized, observational registry evaluating the use of Solitaire Revascularization Device (Medtronic, Dublin, Ireland) in patients presenting with AIS in the setting of intracranial LVO. Inclusion criteria were: (1) any confirmed intracranial LVO with associated ischemic symptoms; (2) planned stent retriever-based thrombectomy; (3) treatment within 8 h of stroke onset; (4) modified Rankin Scale (mRS) score ≤1 prior to stroke onset; and (5) pre-treatment National Institutes of Health Stroke Scale (NIHSS) score ≥8 and ≤30. Written informed consent was obtained from patients before enrollment.
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3

Thrombectomy Devices for Acute Stroke

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Interventionalists were pre-approved based on training and post-training experience as previously described3 (link). Interventionalists could use any FDA approved device for thrombectomy (approved for use within an 8-hour window following stroke onset and used in the DEFUSE 3 study with an FDA investigational device exemption). The devices used were the Trevo Retriever (Stryker Neurovascular, Fremont CA), the Solitaire Revascularization Device (Medtronic, Irvine, CA), Covidien MindFrame Capture Revascularization Device (Medtronic), and the Penumbra Suction Thrombectomy system (Penumbra, Alameda, CA).
The interventionalist could utilize any device or combination of devices in the ICA or MCA M1 segment. They could also use the devices to remove thrombus from MCA M2 segments. If the interventionalists encountered severe common or proximal ICA stenosis or occlusion, they could also perform angioplasty or stenting with FDA approved devices. Adjuvant intraarterial thrombolytic agents were prohibited in DEFUSE 3.
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4

Mechanical Thrombectomy Bundle Cost Savings

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After receiving IRB approval from the University at Buffalo, we retrospectively analyzed the clinical and radiographic data of 45 consecutive patients undergoing me-chanical thrombectomy for acute ischemic stroke at our institution in whom a stroke bundle was used to purchase mechanical thrombectomy devices between December 1, 2018, and February 15, 2019. In the "bundle purchase program," there is a flat fee for the devices used to perform mechanical thrombectomy. Because the devices may be different depending on the thrombectomy strategy (e.g., stent retriever vs aspiration, radial vs femoral access), we developed several versions of the bundle (Table 1). The devices used in the "bundle purchase program" included the Avigo 0.014-inch microwire (Medtronic), Phenom 0.027inch or Marksman 0.027-inch microcatheter (Medtronic), React 0.068-inch aspiration catheter (Medtronic), Cello 8-Fr balloon guide catheter (Medtronic), and Solitaire revascularization device (Medtronic).
We evaluated the charges associated with the devices used to perform mechanical thrombectomy. We then compared the device-related costs of the procedure using the previous "à la carte charging" model (e.g., charging for each device individually) to the bundle cost to calculate a percentage of savings for each case.
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