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The i-ED COIL System (i-ED COIL and EDG v4) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The i-ED COIL System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and venous embolizations in the peripheral vasculature.

i-ED COIL System is a neurovascular and vascular embolization device, which consists of two component devices, i-ED COIL Detachable Coil (hereafter i-ED COIL) and ELECTRO DETACH GENERATOR v4 Detachment System (hereafter EDG v4). The i-ED COIL is composed of a detach coil and a sheath adapter. Furthermore, the detach coil consists of a platinum coil (embolization material), to be placed at the site of vascular diseases, a pusher (delivery wire) to guide the platinum coil to the site and a PVA (polyvinyl alcohol) rod that connects the platinum coil and the pusher. The sheath adapter consists of a PP (polypropylene) sheath and an adapter. The i-ED COIL is designed for use with the EDG v4. The EDG v4 consists of a power source and connection cables attached with clips. EDG v4 is a medical electrical equipment to be used to detach the implantable platinum coil from the delivery wire of the i-ED COIL. It is intended for use in multiple coil detachments performed during a single procedure. The i-ED COIL and EDG v4 are provided sterile (EtO), and separately packaged and distributed in the U.S.

The Lacriflow CL is indicated in treatments of epiphora in patients 12 months and older, in cases of: - Canalicular pathologies (stenosis, obstruction, lacerations), - During Dacryocystorhinostomy (conventional or laser), - Congenital nasolacrimal duct obstruction.

The LACRIFLOW CL is intended for the treatment of epiphora due to conditions including the obstructions of lacrimal punctum, lacrimal canaliculus, or nasolacrimal duct. The LACRIFLOW CL consists of the Lacrimal duct tube and the Bougie. The Lacrimal duct tube is intended to be inserted and placed inside the lacrimal canaliculus or other sites to dilate the lacrimal duct, and the Bougie is intended to be used for the Lacrimal duct tube and removed after insertion of Lacrimal duct tube. Lacrimal duct is dilated by insertion of the Lacrimal duct tube into the obstructed site.

The Xpress-Way™ RX Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The Xpress-Way™ RX Extraction Catheter is not intended for use in the cerebral vasculature.

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The Xpress-Way RX catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system. The Xpress-Way RX is not intended for use in the cerebral vasculature.

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