Search Results

The AZUR system is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, atteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

The Detachable AZUR HydroPack 18 Peripheral Coil System with a controlled detachable delivery method consists of an implantable coil, a delivery pusher, and a Detachment Controller (sold separately). The implantable coils are made of platinum alloy with a hydrogel inner core. The coil is attached to the delivery pusher via a polyolefin elastomer filament. The coil implant is delivered to the target treatment site through a microcatheter which has an inner dimension that is compatible with the selected AZUR HydroPack 18 Peripheral Coil System. The proximal end of the delivery pusher is inserted into the hand-held battery powered AZUR Detachment Controller. When the implantable coil has been successfully placed in the desired location, the AZUR Detachment Controller is activated and a flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implantable coil. The AZUR Detachment Controller is packaged and sold separately.

The ERIC Retrieval Device is indicated to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The ERIC™ (Embolus Retriever with Interlinked Cage) Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by removing clots from vasculature in patients suffering from acute ischemic stroke. The device consists of retrieval spheres secured on a pusher wire that are designed to capture and remove blood clots from the neurovasculature. The device is inserted into a microcatheter to navigate to the target location and retrieve the thrombus while the device is withdrawn from the vessel.

The Traxcess™ 14 SELECT Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.

The Traxcess™ 14 SELECT Guidewire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. The core wire proximal coated section is 0.014" stainless steel wire, and the distal coated section is tapered nitinol wire, contained within a 0.012" outer diameter wire coil. The wire coil is 400 mm in length. The distal 30 mm coil section is constructed of platinum/nickel for maximum radiopacity, and the balance, 370mm of the coil is constructed of stainless steel. The distal 14 mm section of the guidewire is shapeable by the physician. The coil section of the guidewire and the distal stainless-steel section is coated with a hydrophilic coating, while the proximal stainless-steel section is coated with PTFE. The purpose of these surface coatings is to provide lubricity when the Traxcess™ 14 SELECT guidewire is passed through percutaneous catheters. A shaping mandrel, torque device, and insertion tool are included with the device.

The AZUR Vascular Plug is indicated for use to reduce or block the rate of blood flow in arteries of the peripheral vasculature.

The AZUR Vascular Plug consists of an AZUR vascular occlusion plug implant that is attached to a delivery wire which is intended to be delivered to the treatment site through a microcatheter. The AZUR Vascular Plug implant is an embolization device consisting of a conformable, self-expanding nitinol braided wire frame surrounding a flexible, occlusive membrane. The implant comes in three sizes, small (5 mm), medium (8 mm) and large (10 mm). The implant is deployed in an appropriately sized vessel to reduce or block the flow of blood. The implant has radiopaque markers to provide visual confirmation of deployment location during the interventional treatment. The implant is delivered through a microcatheter on a detachable delivery system. The delivery wire attached to the AZUR Vascular Plug implant is 185cm in length and an outer diameter suitable for delivery through a 0.027" ID microcatheter. A detachment controller powers the delivery pusher to detach the implant. The microcatheter and the detachment controller are provided separately.

The Scepter Mini Occlusion Balloon Catheter is intended: For use in the peripheral and neuro vasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms. For use in the peripheral vasculature for the delivery of diagnostic agents, such as contrast media, that have been approved or cleared for use in the peripheral vasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter. For neurovascular use for the delivery of diagnostic agents, such as contrast media, and liquid embolic agents that have been approved or cleared for use in the neurovasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.

Scepter Mini Occlusion Balloon Catheter is a dual co-axial lumen balloon catheter. The catheter is designed to track over a steerable guidewire. The outer lumen is used for the inflation of the balloon independent of guidewire position. The inner lumen can be used to deliver diagnostic agents or liquid embolics to distal locations in tortuous anatomy. Radiopaque marker bands are located at each end of the balloon to facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories. The catheter is packaged sterile for single use only. The Scepter Mini has similar indications for use as the predicates, however, incorporates several minor design differences. The Scepter Mini has a slightly longer length and a slightly smaller diameter. The balloon of the Scepter Mini is slightly shorter. The distal tip of the Scepter Mini extends a shorter distance from the distal end of the balloon than that of the Scepter C and XC. For the Scepter Mini, the purge hole is covered by a semi-permeable membrane designed to allow air to escape while preventing liquids from passing. The predicate Scepter C and XC incorporate 3 radiopaque marker bands, while the design of the Scepter Mini allows for visualization under fluoroscopy with only 2 radiopaque marker bands (due to shorter distal tip segment). All Scepter catheters have a hydrophilic coating.