Part
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Part
01
Combination Therapies - Claims
The claims from the studies identified that are relevant to Solumba have been placed in additional column in the attached spreadsheet. As this was completed relatively quickly, additional research to identify articles with claims that could be used for commercial purposes for MEDtronic's Solitaire.
Claims for Commercial Purposes
- A 2020 study found:
- The Solumba technique has a recanalization rate of 86%.
- The Solumba technique requires fewer attempts to complete the MT procedure compared to ADAPT and SR.
- A 2018 study found:
- Patients treated with the combined technique were found to have better clinical outcomes and were less likely to die than patients undergoing SR.
- A 2016 study found:
- The Solumbra technique achieved recanalization of 88% at an average of 1.9 passes.
- The Solumbra technique has an average procedure time of 52.7 minutes.
- The Solumbra technique achieved a good functional outcome in 44% of cases.
- A 2018 study found:
- "The recanalizaton rate on first pass when using the Solumbra technique is 55.7% compared to 35.8% with SR and 34.4% with AD.
- The recanalizaton rate on first pass when using the Solumbra technique is 55.7% compared to 41.6% with SR and balloon catheter."
- A 2015 study found:
- The Solumbra technique has a lower rate of internal carotid thrombi (20%) when compared to the ADAPT technique (42.2%)..
- A 2018 study found:
- Using the Solitaire results in a QALY of 1.86 compared to 1.52 for the Trevo, 1.79 for the Penumbra, and 1.35 for the Solumbra.
- Using the Solitaire results in a net monetary benefit of $101,824, compared to $83,546 for the Trevo, $101,923 for the Penumbra, and $69,440 for the Solumbra.
- A 2017 study found:
- When treated using MEDtronic's Solitaire, patients at 12 months had improved functional dependence by 44% compared to 30% among those receiving medical therapy alone.
- When treated using MEDtronic's Solitaire, patients at 12 months had a health-related quality of life score of 0.46 compared to 0.33 among those receiving medical therapy alone.
- A 2015 study found:
- When treated using MEDtronic's Solitaire, patients had a functional dependence rate of 60% at 90 days compared to 35% among those receiving IV-tPA alone.
- When treated using MEDtronic's Solitaire, patients had a 90-day mortality rate of 9% compared to 12% among those receiving IV-tPA alone.
- When treated using MEDtronic's Solitaire, 0% of patients had a symptomatic intracranial hemorrhage compared to 3% of patients who received IV-tPA alone.
- A 2017 found:
- Treatment with Medtronic's Solitaire creates lifetime savings of $23,203 per patient when compared to treatment with IV-tPA alone.
- Treatment with MEDtronic's Solitaire resulted in increased QALY's of 0.131 compared to 0.105 among IV-tPA alone patients at 90 days.
- Treatment with MEDtronic's Solitaire resulted in increased QALY's of 6.79 compared to 5.05 among IV-tPA alone patients over a lifetime.