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Corindus Announces FDA Submission for Neurovascular Intervention Indicat...

Expansion of CorPath GRX into neurovascular intervention could mark first step in revolutionizing stroke treatmentWALTHAM, MA — February 14, 2019 — Corindus Vascular Robotics (“Corindus” or the “Company”) (NYSE American: CVRS), a leading developer of precision vascular robotics, announced today it is seeking premarket clearance from the U.S. Food and Drug Administration (FDA) to use the CorPath GRX System in neurovascular intervention. CorPath GRX, the second generation robotic platform, received FDA clearance for percutaneous coronary intervention (PCI) in 2016 and peripheral vascular intervention (PVI) in 2018. Upon successful FDA clearance, CorPath GRX would become the world’s first and only robotic platform indicated for use in PCI, PVI and neurovascular intervention (NVI).

PRESS RELEASE

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PRESS RELEASE

FDA expands indications for Medtronic’s Pipeline Flex embolization device

Medtronic said today it won expanded FDA approval for its Pipeline Flex embolization device.

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Sim&Size: 1500+ successful simulations in 2018!

 Sim&Cure is honoured and proud to announce that Sim&Size reached 1500 patient cases at the end of 2018! We are thankful to our clients and partners Medtronic, Microvention, Cerenovus, Balt, Phenox, Stryker and to each neurointerventionist that choose Sim&Size to support their interventional cases.Sim&Cure starts 2019 with a lot of excitement; working on new Sim&Size releases, waiting for the FDA approval, develop the use of Sim&Size in new countries and still more cases to come on the Asian, African, American and European continent! www.sim-and-cure.com

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PRESS RELEASE

FDA additionally clears RAPID imaging platform for use in selecting acut...

Approval Puts RAPID in a Class of Its Own for Diagnosing and Treating StrokeMENLO PARK, Calif. - iSchemaView, the worldwide leader in advanced imaging for stroke, today announced that the FDA has cleared the RAPID neuroimaging platform for use in selecting stroke patients who are likely to benefit from endovascular thrombectomy (clot removal). Specifically, this additional clearance means that RAPID CT-Perfusion and RAPID MR-Perfusion can be used by physicians to aid in the selection of acute stroke patients with known occlusion of the internal carotid artery or proximal middle cerebral artery for a clot removal procedure. RAPID is the only imaging platform approved for selecting stroke patients for clot removal.

PRESS RELEASE

Novel intrasaccular aneurysm treatment device receives FDA PMA approval

The WEB® Aneurysm Embolization System is the first intrasaccular flow disruptor PMA approved for the embolization of wide neck bifurcation aneurysmsAliso Viejo, CA. – January 7, 2019 – MicroVention, Inc., a U.S.-based subsidiary of Terumo and a global neurovascular company, announced today the FDA Premarket Approval (PMA) for the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. The WEB System is the first and only PMA approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. (The WEB System was developed by Sequent Medical, Inc. and Sequent was acquired by Terumo in 2016).

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