eV3 Solitaire™ Platinum Revascularization Device

Singapore - English - HSA (Health Sciences Authority)

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Available from:
COVIDIEN PRIVATE LIMITED
Class:
Class D medical device
Manufactured by:
Micro Therapeutics, Inc. d/b/a EV3 Neurovascular
Therapeutic area:
Neurology
Therapeutic indications:
The Solitaire™ Platinum Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset. The Solitaire™ Platinum Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients whoare ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Product summary:
Device System Info:[Sterile Medical Device], EO sterilized; Models: Solitaire™ Platinum Revascularization Device - SFR3-4-20-10, Solitaire™ Platinum Revascularization Device - SFR3-4-40-10, Solitaire™ Platinum Revascularization Device - SFR3-6-20-10, Solitaire™ Platinum Revascularization Device - SFR3-6-40-10, Solitaire™ Platinum Revascularization Device - SFR3-4-20-05, Solitaire™ Platinum Revascularization Device - SFR3-6-24-06
Authorization number:
DE0018727
Authorization date:
2016-11-10

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