Penumbra coil 400 complex software

Daniel davis chief commercial officer cco penumbra. These coils have varying levels of softness designed to simplify complex cases. The initial experience with the large diameter penumbra coil 400 pc400 system has been positive regarding safety, efficacy, improved packing density and cost effectiveness, but followup data. The pc 400 system features an instant, singleclick mechanical detachment system for ease of use. The penumbra smart coil system is comprised of complex and wave coils designed for framing, filling, and finishing. Coil 400, penumbra p logos, penumbra system, penumbra smart coil, pod. For other countries, please contact your healthcare professional or local penumbra representative. Mri compatibility cards intended for us audience only. The penumbra coil 400 is a platinum detachable embolization coil system. The penumbra coil 400 pc 400 is a largevolume platinum embolisation device. Ruby coil is a largevolume coil that can be delivered through the lantern highflow microcatheter. The following penumbra products are associated with one or more patents identified below, and are marked pursuant to 35 u. A software designer is suing a california company, claiming its medical device used to treat aneurysms malfunctioned and caused him to suffer brain damage.

The penumbra coil systempenumbra coil 400, subject of this 510k, has the same technological. April 14, 2011 a total of 267 lots of the penumbra coil 400 are subject to a class 1 recall by the us food and drug administration fda a drug safety alert on the coil was sent yesterday. Solid state ignition module with cutoff wire kit replaces stihl 00004000. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and the related. Lawsuit claims medical device caused brain damage after. Penumbra coil 400 is a family of detachable coils, developed to offer an improved alternative for the treatment of larger aneurysms and other larger, more complex lesions. With its larger primary diameter, pc 400 is designed to achieve higher packing densities using fewer coils, compared to conventional 10system coils. The penumbra coil 400 is a platinum detachable embolization coil system, designed to resist coil compaction and aneurysm recurrence.

The penumbra coil 400 tm embolization system m complex soft complex standard 332 mm complex extra soft curve extra soft 24 mm j soft up to 25 cm framefill fill fillfinish. Standard complex coils attached to detachment pusher. The penumbra coil 400tm embolization system penumbra, inc. Exceptionally stable occlusion the penumbra coil 400 tm embolization system m complex soft complex standard 332 mm complex extra soft curve extra soft 24 mm. Initial experience with penumbra coil 400 versus standard coils in. The penumbra coil 400 system pc 400 is the newly introduced platinum coil system designed specifically to enhance filling efficiency by increasing coil diameter. The penumbra coil 400 system pc 400 is the newly introduced platinum coil system designed specifically to enhance filling. Daniel davis has 19 years of experience in sales, marketing, and business development with both early stage and fortune 500 companies in medical devices and before that in software and consumer. The ruby coil system is a largevolume coil that can be delivered through a high flow microcatheter, and can densely pack aneurysms and vessels. Breathing space free, confidential phone line service for those feeling down or depressed breathingspace. Penumbra coil 400 neurovascular embolization penumbra inc. The penumbra smart coil system is comprised of complex and wave coils designed for framing, filling, and finishing intracranial aneurysms and. Indicated for arterial and venous embolization in the peripheral vasculature, ruby coil s characteristic softness and 3d complex shape is designed to allow the coil to densely pack aneurysms and vessels in a variety of clinical applications.