Nelson lobelo hospital infantil san jose, bogota, colombia 1. Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. Compared with the orbitgalaxy coils, our analysis suggests that the penumbra coil is more efficient and cost effective in the treatment of. Initial experience using the penumbra coil 400 comparison of aneurysm packing, cost effectiveness, and coil efflciency published online 15 march, 20. Approximately 2,000 patients with intracranial or peripheral aneurysms treated by the pc 400 system at up to 100 centers will be enrolled. Penumbra annual report 2020 annual reports stocklight. Aneurysm occlusion rates were similar in both groups.
Periprocedural safety of saccular aneurysm embolization. It can be safely scanned immediately after implantation under the following conditions. With its larger primary diameter, pc400 is designed to achieve higher packing densities using fewer coils, compared to conventional 10system coils. All aneurysm embolizations were performed by two interventionalists ap and hm utilizing the same endpoint of maximum safe packing of the aneurysm. Accessgudid penumbra coil 400 00814548019338 coil 400 standard, 16x60. Relationship of packing density to recurrence rate in cerebral. Comparison of penumbra coil 400 with a 10system coil in a 7. Pdf format download opens in new window word format download opens in new window excel format download opens in new. Penumbra coil detachment handle catalog number description dh1 detachment handle dh5 detachment. Other neurovascular abnormalities such as arteriovenous malformations and.
Jul 06, 2018 accessgudid penumbra coil 400 m4244004c150 pc400 cplx xsft, 11x35. It can be scanned safely under the following conditions. Find out all of the information about the penumbra product. Contact a supplier or the parent company directly to get a quote or to find out a price or your closest point of sale. Dec 31, 2018 penumbra smart coil penumbra coil 400. The purpose of this study was to examine the frequency of adjunctive stent usage when coiling widenecked intracranial. This is a case which has been successfully treated using a stentassisted coiling with both small and large coils i. Penumbra coil 400 reliability currently no lawsuits were filed because most recalled units were recovered before use.
When placing the fifth coil in the aneurysm, the coil tore a hole in the back of the aneurysm when the coil as about 25% in the aneurysm. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. May 05, 2011 may 3, 2011 a class 1 recall has been issued for the penumbra coil 400 system used in patients suffering from brain aneurysms to help prevent blood vessel rupture or leakage. Mar 09, 2016 the penumbra coil 400 system consists of 0. This is a retrospective single operator experience of. To accomplish coil embolization, coils are placed into the aneurysm, and in this study the newly produced penumbra 400tm coils pc 400 were compared with. Prior to use, please refer to the instructions for use for complete product indications, contraindications. The pc 400 coils are a new generation of platinum embolic coils designed specifically to enhance filling. While physician was attempting to place penumbra coil 400 6x15 complex soft finishing coil the catheter backed out of the aneurysm.
Mar 04, 2011 penumbra brand penumbra coil system, penumbra coil 400, product is manufactured and distributed by penumbra inc. Study of the penumbra coil 400 system to treat aneurysm. Accessgudid penumbra coil 400 00814548019048 coil 400 soft, 15x45. Penumbra coil 400 is a family of detachable coils developed to offer an improved alternative for the. The penumbra coil 400tm embolization system coil comparison. The penumbra coil system penumbra coil 400, subject of this 510k, has the same technological characteristics as the predicate device, and the change is limited to revised product labeling. Penumbra pc400 coil was then advanced through pxslim45 catheter. Original research initial experience with penumbra coil. Contact a supplier or the parent company directly to get a quote or to find out a. Regulatory specialist iii one penumbra place tradedevice. Study of the penumbra coil 400 system to treat aneurysm full. Reported herein are the results of a comparison study to assess the pc 400 s filling advantage in the treatment of cerebral aneurysms as compared to conventional embolic coils controls. Purpose the penumbra coil 400 system pc 400 are the newly introduced platinum coils designed specifically to enhance filling efficiency by increasing coil diameter. Penumbra coil 400 gained food and drug administration approval and was introduced to the market in april 2011, and early reports demonstrated safety and periprocedural efficacy.
Pac400 is a soft shapeless coil designed to pack densely as it seeks space like liquid metal. System pc 400 is the newly introduced platinum coil system designed specifically to. Such features can be found in the new generation of penumbra 400 p400 coils that was first introduced in 2011. Fda recalls penumbra coil 400 used for brain aneurysms. The penumbra coil 400 system for treatment of widenecked. Patient was undergoing elective left ica aneurysm embolization treatment. The penumbra coil 400 system will show no significant benefits in embolization cases compared to the conventional coils. Accessgudid penumbra coil 400 m4244006c04100 pc400 cplx xsft, 4x10. Initial experience with penumbra coil 400 versus standard coils in embolization of cerebral aneurysms. Due to the largest primary diameter, amounting to 0. The pc400 system features an instant, singleclick mechanical detachment system for ease of use.
Introduction penumbra coil 400 gained fda approval and was introduced to the market april 2011. The patient was undergoing a coil embolization procedure using penumbra coil 400s pc400s. On march 4 th 267 affected lots were recalled by the fda and penumbra, inc. Penumbra, together with its exclusive distribution partner, medicos hirata, inc. E021 initial experience using the penumbra coil 400. When this happens, it can cause serious injuries, including stroke and even death. Initial experience with penumbra coil 400 versus standard. The penumbra coil 400 system will achieve a higher packing density as compared to conventional coils h 2. Nov 06, 2011 this is a prospective, multicenter study of patients with intracranial or peripheral aneurysms who are treated by the pc 400 system. Initial experience using the penumbra coil 400 comparison of aneurysm packing, cost effectiveness, and coil ef. 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.
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. Improvements the malfunctioning products were only in a few lots. Penumbra coil detachment handle large middle cerebral artery aneurysm dr. Contraindications warnings the penumbra delivery microcatheters should only be.
Multicenter analysis of radiation exposure in large and giant aneurysms with the penumbra coil 400 system. Then it was decided to embolize with 7 penumbra 400. Ruby coil lp is deliverable through low profile microcatheters. More efficient coiling may result in shorter catheter in vessel time and less radiation exposure for the patient and healthcare team.
Penumbra coil system penumbra coil 400 and ruby coil system pod system. Pdf format download opens in new window word format download opens in new window excel format download opens in new window date february 23, 2021 filing type form 4 filing description statement of changes in beneficial ownership download. The embolization system is composed of three unique coil technologies. The goal of this multicenter case study care is to compare such exposure in patients treated with the novel penumbra coil 400 system pc 400 vs. Baltimore medical malpractice lawyer device blamed for. Relationship of packing density to recurrence rate in. Request pdf initial experience with penumbra coil 400 versus standard coils in embolization of cerebral aneurysms.
Jul 07, 2020 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. The penumbra delivery microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils to the peripheral and neuro vasculature. The companys specialized catheter has been linked to the deaths of stroke patients, and it was a target of stock short sellers in 2020. The physician then attempted to slide the pxslim microcatheter over the coil several times. Packing density and longterm occlusion after transcatheter vessel. In 2016 a lawsuit claimed the penumbra coil 400 caused brain damage after surgery. Because the problem was with the insertion device, the coil given to patients were not replaced. During the procedure, the physician successfully deployed and detached a pc400 using a px slim delivery microcatheter px slim. Criticism of penumbra has followed various aspects of its products and business practices. Our goal was to study the packing and treatment advantage of the pc 400s unique geometric configuration compared with conventional coils controls. The penumbra coil 400 pc400 is a largevolume platinum embolisation device. Penumbra coil system penumbra coil 400 and ruby coil system pod system indications for use describe penumbra coil 400 the penumbra coil 400 is indicated for the embolization of.
Baltimore medical malpractice lawyer device blamed for stroke. The primary objective is to gather post market data on the penumbra coil 400 pc 400. Jul 01, 2017 the above encourages works on developing coils of greater softness and volume. The penumbra coil 400 system for treatment of widenecked intracranial aneurysms. Original research initial experience with penumbra coil 400. This resulted in a major subarachnoid hemorrhage in the patient. Initial experience with penumbra coil 400 versus standard coils in. The penumbra coil 400 system will take a shorter procedural time while using fewer coils on average h 0. Study protocol and statistical analysis plan pdf november 10, 2011. The effectiveness of penumbra 400 microcoils in the. Periprocedural safety of saccular aneurysm embolization with the. 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. Mr conditional nonclinical testing has demonstrated the penumbra coil system is mr conditional. Initial experience using the penumbra coil 400 citeseerx.
Given its larger primary diameter, pc400 can achieve higher packing densities using fewer coils, compared to conventional 10system coils. Class 1 device recall penumbra brand penumbra coil system. The penumbra coil 400 pc400 is a largevolume platinum embolization device. Stentassisted embolization of a giant aneurysm of the. First four coils were introduced into aneurysm without incident. The pc400 coil within a coil design features a stretch resistant member that is designed to resist coil compaction. Prior to use, please refer to the instructions for use for ruby coil system, pod system, and penumbra delivery microcatheters for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. The penumbra coil 400 tm embolization system total. Accessgudid penumbra coil 400 m4244002c10400 pc400 cplx std, 10x40. Predicate and reference device comparison attributes predicate device reference device subject devices general.
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. Angiocalc cerebral and peripheral aneurysm calculator. Dec 18, 2020 penumbra smart coil penumbra coil 400. Penumbra coil 400 conventional 10system coil packing density. Ruby coil lp is the newest addition to the peripheral embolization platform and offers the same technology as penumbra s large volume devices. Federal usa law restricts this device to sale by or on the order of a physician. Mr conditional nonclinical testing has demonstrated the penumbra coil 400 is mr conditional. Nov 20, 2019 k151572 july 10, 2015 penumbra smart coil penumbra, inc. 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. Ruby coil system ordering information penumbra inc. The penumbra coil 400 tm embolization system m exceptionally. May 16, 2016 in 2011, the food and drug administration began a class i recall of approximately 267 lots of penumbra coil 400 products, citing the pull wire on the delivery system could slip, causing the coil 400 to detach too soon. Brain aneurism treatment device penumbra coil 400 recalled. Compared with conventional coils, the pc 400 is more efficient in the embolization of cerebral aneurysms, achieving greater packing density.
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