The purpose of this study was to examine the frequency of adjunctive stent usage when coiling widenecked intracranial. Using the balloonassisted technique, we inserted 11 penumbra coil 400 coils, resulting in a packing attenuation of 37. Study of the reverse medical barrel vascular reconstruction device vrd for adjunctive treatment to embolic coils for wideneck, intracranial, bifurcatingbranching aneurysms of middle cerebral and basilar arteries. Pdf format download opens in new window word format download opens in new window. Penumbra coil detachment handle catalog number description dh1 detachment handle dh5 detachment handle 5 pack created date. Manual aspiration technique to retrieve a prematurely detached. Approximately 2,000 patients with intracranial or peripheral aneurysms treated by the pc 400. To stabilize the other microcatheter still inside the aneurysm, we placed a. Penumbra designs, develops, manufactures and markets innovative products and has a broad portfolio that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and vascular. An aneurysm coiling efficiency study of the penumbra coil 400 system 8. Penumbra coil detachment handle large middle cerebral artery aneurysm dr. After establishing our microcatheter position within the pseudoaneurysm, we deployed 11 individual penumbra coil 400 detachable 0.
Vesselpreserving stentassisted coil embolization of an. Penumbra coil 400 conventional 10system coil packing density. Penumbra have been or are currently being studied with respect to coil packing density. Data for each patient are collected in accordance with the standard of care at each participating hospital through oneyear followup. Safety information and recall for penumbra coil 400, penumbra inc safety information and recall of products concerning penumbra coil 400 by the manufacturer penumbra inc. The objective of this work is to analyze the effectiveness of penumbra 400. The primary objective is to gather post market data on the penumbra coil 400 pc 400 system in the acute treatment of intracranial and peripheral aneurysms. Nelson lobelo hospital infantil san jose, bogota, colombia 1. One example of such an innovation is the penumbra coil 400 pc 400.
Soly are both medical companies, but which is the superior business. Packing performance of helical guglielmi detachable coil. Coil herniation, premature deployment, and fracture are procedure. The penumbra smart coil system is comprised of complex and wave coils designed for framing, filling, and finishing intracranial aneurysms and. The penumbra logo, penumbra smart coil, ace and wave are registered trademarks or trademarks of penumbra, inc. Assessment of the embolization of neurovascular lesions.
Advisory notice is only available in german language. Stryker, fremont, california, and penumbra coil 400 0. It can be scanned safely under the following conditions. Given its larger primary diameter, pc400 can achieve higher packing. The penumbra coil 400 pc400 is a largevolume platinum embolization device. Penumbra inc, alameda, california, which has a larger diameter than standard coils 0.
Followup runs confirmed adequate packing density within the aneurysm. Bfarm field corrective actions safety information and. Background and purpose 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 physician then attempted to slide the pxslim microcatheter over the coil several times.
The penumbra coil 400 has attempted to increase the packing density with a bare platinum coil that is larger and requires a 0. Penumbra coil 400 is a novel endovascular coiling technology indicated for the treatment of intracranial aneurysms. The penumbra coil 400 system for treatment of widenecked. The company currently sells products to hospitals in the united states through a dedicated salesforce in their two major markets, neuro and peripheral vascular. Lawsuit claims medical device caused brain damage after. Pdf format download opens in new window word format download opens in new window excel format download opens in new window date may 12, 2020 filing type form 8k filing description current report filing download. The design features of the penumbra coil 400 used in the case. The penumbra logo, penumbra system, penumbra coil 400 and px slim are registered trademarks or trademarks of penumbra, inc. Penumbra coil 400 safe and effective in small aneurysms. Materials and methods 16 aneurysms embolized with the pc. The penumbra coil 400 was used to treat an aneurysm dennis montgomery suffered in 20, according to his lawyer, peter mullenix. While physician was attempting to place penumbra coil 400 6x15 complex soft finishing coil the catheter backed out of the aneurysm. Home home investor relations sec filings sec rss feed opens in new window. Patient was undergoing elective left ica aneurysm embolization treatment.
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. Initial experience using the penumbra coil 400 comparison of aneurysm packing, cost effectiveness, and coil efflciency published online 15 march, 20. Cureus stentassisted embolization of a giant aneurysm. Initial experience with penumbra coil 400 versus standard coils in. Ace registry pc 400 system coils ace study of the penumbra coil 400 system to treat aneurysm study director siu po sit, phd design prospective, multicenter registry aim to gather postmarket data on the pc 400 system subjects 2,000 patients with intracranial or peripheral aneurysms. Request pdf the penumbra coil 400 system for treatment of widenecked intracranial aneurysms. Request pdf initial experience with penumbra coil 400 versus standard coils in embolization of cerebral aneurysms. Specifically, penumbra coil 400 products are used for peripheral embolization in japan, and have received regulatory approval for that use in that market. Challenges to neuroendovascular care in developing. Mr conditional nonclinical testing has demonstrated the penumbra coil 400 is mr conditional. Despite the mass effect, an adequate revascularization has been reported.
He said during the surgery at overlake hospital in bellevue, the. The purpose of this study was to retrospectively compare the packing performance of helical guglielmi detachable coil gdc 18 thickness, 0. Penumbra is a global healthcare company focused on interventional therapies. We will compare the two businesses based on the strength of their analyst recommendations, valuation, institutional ownership, risk, profitability, dividends and earnings. Aditi kolla regulatory specialist iii one penumbra. Penumbra coil 400 stretchresistant bare platinum complex standard, complex soft, jsoft, curve extra soft instant, physiciancontrolled. Penumbra smart coil product categories demo request. The effectiveness of penumbra 400 microcoils in the. Penumbra coil 400, embolization coil penumbra, inc. Multicenter analysis of radiation exposure in large and giant aneurysms with the penumbra coil 400 system. Penumbra coil 400 pc400 system in treating intracranial aneurysms compared with standard diameter coils. An initial use of these coils is being reported in the current study.
The aim of this retrospective, singleoperator study was to compare the use of the pc400 with conventional 0. The penumbra coil 400 pc400 is designed to improve endovascular filling for intracranial aneurysms. The company offers aspiration based thrombectomy systems and accessory devices, including revascularization device for mechanical thrombectomy, such as penumbra system under the penumbra jet, ace, 3d revascularization device, and penumbra engine brands, as well as components and accessories. Detached penumbra coil detachment handle large middle cerebral artery aneurysm internal carotid artery sacrifice vein of galen transverse sinus embolization 2,10 2,3,4,5,6,7,8 1,10 1. This is a case which has been successfully treated using a stentassisted coiling with both small and large coils i. Study of the penumbra coil 400 system to treat aneurysm. Penumbra brand penumbra coil system, penumbra coil 400, product is manufactured and distributed by penumbra inc. Guglielmi detachable coil an overview sciencedirect topics. On february 19, 2016, a complaint for damages was filed on behalf of this claimant against penumbra and the hospital involved in the procedure montgomery v.
Penumbra coil 400 neurovascular embolization penumbra inc. The penumbra coil system is comprised of the penumbra coil 400, a. 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. Methods 40 aneurysms treated exclusively with orbit or galaxy coils and 18 aneurysms treated only with penumbra coils from 2010 to february 2012 were compared. The penumbra 5max ace catheter is safe, efficient, and. Initial singlecenter experience endovascular treatment. Next, we crossed the dissection flap with our microcatheter system. The penumbra 400 coil pc 400 has a larger diameter than conventional coils and is constructed completely of metal, a feature that increases the coil stability and may improve its ability to respect the aneurysm neck. We design, develop, manufacture and market innovative devices and have a broad portfolio of products that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral vascular. Initial experience using the penumbra coil 400 comparison of aneurysm packing, cost effectiveness, and coil ef. Request pdf the effectiveness of penumbra 400 microcoils in the embolization of large cerebral aneurysms background. Stentassisted embolization of a giant aneurysm of the. Coil type method of detachment comments us fda indicated use penumbra, inc.
Slim microcatheter penumbra and a synchro2 microwire stryker. The penumbra coil 400 tm embolization system total. Class 1 device recall penumbra brand penumbra coil system. Our goal was to study the packing and treatment advantage of the pc 400 s unique geometric configuration compared with conventional coils controls. Penumbra coil 400 stretchresistant bare platinum complex standard, complex soft, jsoft, curve extra soft instant, physiciancontrolled mechanical detachment optimized for framing, filling, and finishing. Backgroundobjective this was a retrospective single operator experience of aneurysm coiling at the ochsner clinic, comparing the penumbra coil 400 with the other most commonly used coil types, orbit and galaxy.
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