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Guidelines and Post-Market Surveillance of Flow Diverter for Intracranial Aneurysms

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Guidelines and Post-Market Surveillance of Flow Diverter for Intracranial Aneurysms Online March 9, 2017 Journal of Neuroendovascular Therapy 2017; 11: 173–179 DOI: 10.5797/jnet.ra-diverter.2016-0031 Guidelines and Post-market Surveillance of Flow Diverter for Intracranial Aneurysms Chiaki Sakai,1 Nobuyuki Sakai,2 Shigeki Kobayashi,3 Koji Iihara,4 Masayuki Ezura,5 and Haruko Yamamoto6 Flow diverter (FD) is stent-like fine-mesh device for the treatment of intracranial aneurysms, and endovascular therapy with FD has been developed for aneurysms difficult to be cured by standard treatment, and is already widely introduced in other countries. Japanese Society of Neuroendovascular Therapy (JSNET) submitted FD to the government committee as a priority device for the Japanese market in 2011. And, Pipeline Flex (Medtronic Neurovascular, Irvine, CA, USA) was approved in 2015, based on the result of an approving study in Japan and published data of pipeline for uncoilable or failed aneurysms (PUFS) study. At Pipeline Flex approval, three related medical societies, Japan Neurosurgical Society, Japan Stroke Society, and JSNET, established a clinical guideline, including clinical indication of FD, institute criteria, and operator criteria. Furthermore, these societies prepared to operate a clinical database of all cases where FD was used and post-market surveillance will be reported using this database. These activities may work for development of FD in Japan with support of the Ministry of Health, Labour and Welfare, Japan and Pharmaceuticals, and Medical Devices Agency. Keywords▶ flow diverter, clinical guideline, post-market surveillance Introduction the priority medical devices to introduction with high clinical needs along with Surpass NeuroEndoGraft (Stryker Neuro- Pipeline Flex (Medtronic Neurovascular, Irvine, CA, USA) vascular, Fremont, CA, USA) and gained approval through obtained approval in 2015 as the first flow diverter (FD), a domestic clinical trials. In its approval, the criteria for its therapeutic device for difficult-to-treat intracranial aneu- application and guidelines for its proper use were established rysms developed with a new concept, and reimbursement by related scientific societies similar to medical devices pre- from medical insurance began. Pipeline was designated as a viously approved in this framework, and post-marketing sur- medical device with high therapeutic usefulness by the Min- veillance (PMS) is made obligatory. However, the conditions istry of Health, Labour and Welfare (MHLW) committee on for the initiation of commercial distribution and clinical use of Pipeline differ widely from medical devices that have been 1Department of Neurosurgery, Hyogo College of Medicine, Nishi- applied to date. In its use, 1) stricter requirements concerning nomiya, Hyogo, Japan the operator and facility qualifications and training are 2Department of Neurosurgery, Kobe City Medical Center General imposed, and 2) the data of PMS obligated to business firms Hospital, Kobe, Hyogo, Japan are provided from the National Inventory Survey Concerning 3Chiba Emergency Medical Center, Chiba, Chiba, Japan the Efficacy and Safety of Flow Diverters based on industry- 4Department of Neurosurgery, Kyushu University Graduate School of Medicine, Fukuoka, Fukuoka, Japan government-academic collaboration registry led by related 5Department of Neurosurgery, Sendai Medical Center, Sendai, scientific societies. In this article, the background and process Miyagi, Japan that resulted in the present state are outlined. 6Center for Advancing Clinical and Translational Sciences, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan Unapproved Medical Devices with Received: February 29, 2016; Accepted: January 5, 2017 High Clinical Needs Corresponding author: Nobuyuki Sakai. Department of Neurosur- gery, Kobe City Medical Center General Hospital, 2-1-1 Minatojima- In 2006, the MHLW initiated a project to have scientific asso- minamimachi, Chuo, Kobe, Hyogo 650-0047, Japan Email: [email protected] ciations recommend unapproved medical devices, the early ©2017 The Editorial Committee of Journal of Neuroendovascular introduction of which is desired, and to select devices to be Therapy. All rights reserved. introduced through evaluation.1) In the field of neurovascular Journal of Neuroendovascular Therapy Vol. 11, No. 3 (2017) 173 Sakai C, et al. diseases, a carotid artery stent (Precise), an endovascular embolic material for embolization before surgical resec- embolic material (Onyx), an intracranial stent (Wingspan), tion for cerebral arteriovenous malformations Onyx in and vascular embolic beads (Embosphere) have been 2008 by four related societies (Japanese Society of Inter- selected and approved.2) Concerning FDs, the early intro- ventional Radiology, Japanese Society of Endovascular duction of Pipeline and Surpass was submitted in Septem- Intervention, Japan Neurosurgical Society, and JSNET), ber 2011 by the Japanese Society of Neuroendovascular and concerning the percutaneous transluminal cerebral Therapy (JSNET) as the requesting society and the Japan thrombectomy device MERCI Retriever in 2010 and the Neurosurgical Society and Japan Stroke Society as related stent for the treatment of intracranial atherosclerosis Wing- societies, and the FD was listed in February 2012 as span in 2012 by three related societies (Japan Stroke Soci- “self-expanding implants for the treatment of intracranial ety, Japan Neurosurgical Society, and JSNET). Concerning aneurysms” at the 18th meeting of the evaluation commit- the stent for supporting coil embolization of cerebral aneu- tee on the early introduction of medical devices with high rysms Enterprise VRD in 2010, also, criteria for applica- clinical needs. The committee judged, as FDs are “novel tion were established by three related societies (Japan devices, and as perforation of intracranial arteries by the Stroke Society, Japan Neurosurgical Society, and JSNET). guidewire has occurred overseas,3) it is necessary that the When Solitaire FR and Trevo ProVue were approved at educational system, including the training schemes the end of 2013 and early 2014, respectively, as stent-type and institutional criteria for their use, be evaluated primary thrombus retrieving devices to be used in percutaneous by the Japanese Society of Neuroendovascular Therapy, transluminal thrombectomy, three related societies com- which has an board certification system. Of the two devices piled the “Guidelines for the Proper Use of Percutaneous presently evaluated, i.e., Pipeline and Surpass, the clinical Transluminal Cerebral Thrombectomy Devices (April, trials of the latter are insufficient in the number of cases 2014)” describing the indications, implementation environ- and evaluation of the results compared with the former, ment, and points of attention in greater detail, following the and further evaluation of clinical results is considered nec- “Guidelines for Proper Implementation of Intravenous essary before its introduction.”4) rt-PA (alteplase) Therapy (October 2005)” compiled by the Receiving this reply, Covidien (presently Medtronic) initi- Japan Stroke Society at the approval of intravenous rt-PA ated a clinical trial to obtain approval in 2012. Details of the (alteplase) therapy in 2005.6) In the background of these trial are described elsewhere, but application for approval of developments were the circumstances in which deployment Pipeline was made in September 2014, Pipeline Flex obtained of stent-type thrombectomy devices became necessary after approval in April 2015, and the establishment of institutional the efficacy of endovascular recanalization therapy was criteria (so-called guidelines) became necessary. questioned in the previous year at the International Stroke Conference (ISC). It is still fresh in our memory that this Criteria for Application and guideline for the proper use was revised after 1 year to the Guideline for Proper Use 2nd edition of the “Guidelines for the Proper Use of Percu- taneous Transluminal Cerebral Thrombectomy Devices” For the medical devices for which the early introduction (April, 2015), following the report supporting the efficacy has been requested by related scientific societies and that of endovascular recanalization therapy at the ISC in 2015. were listed as “medical devices with high clinical needs,” For the approval of FDs, criteria for application have been the related scientific societies are expected to evaluate the established by three related societies similar to the previous preparation of requirements concerning the system of insti- cases (Table 1). Their contents nearly inherited the previous tution and skills to be acquired by the users, particularly, criteria for application of cerebral artery stenting to support concerning new medical devices that require particularly coil embolization, but a striking difference was that the high skill levels for use.5) Criteria for application regarding implementing facilities were prompted to register all patients the indications, implementing physicians, and implement- treated by the use of FDs. It was against this background that ing institutions were established concerning the carotid the “National Inventory Survey Concerning the Efficacy and artery stent Precise and distal thrombosis preventive device Safety of Flow Diverters,” which is explained later, was orga- Angioguard XP in 2008 by 12 related societies in the nized and put into effect. Also, guidelines for the proper use fields of not only neurovascular but also cardiovascular, were established by three related societies similar
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