Read the untranslated law here: http://www.boe.es/buscar/doc.php?id=BOE-A-2015-7629
The Royal Decree 1030 / 2006, of 15 September, which establishes the portfolio of common services of the national system of health and the procedure for its updating, establishes in its annexes the contents of each of the portfolios of services, development of regulated in law 16/2003, 28 of may, cohesion and quality of the national health system.
He article 6 of said Royal Decree establishes that by order of the Ministry of health, services social e equality, prior agreement of the Council inter-territorial of the system national of health, may realize is and detail is the content of them different paragraphs of it portfolio of services common collected in their annexes.
Moreover, article 7 of the Royal Decree States that the portfolio of common services of the national system of health contained in its annexes will be updated through order of the Ministry of health, social services and equality, consent of the Interterritorial Council of the national health system. Article 8 indicates that portfolio update proposals will be agreed in the Committee on benefits, insurance and financing and that final approval of these proposals will be up to the Ministry of health, social services and equality agreement of the Interterritorial Council of the national health system.
As a result of these forecasts, the order SCO/3422/2007, of 21 November, which develops the procedure of updating of the portfolio of common services of the national health system, established the mechanism by which updated the portfolio of services on different occasions through the corresponding orders.
He Real Decree-Law 16 / 2012, of 20 of April, of measures urgent for ensure the sustainability of the system national of health and improve the quality and security of their benefits, was a change substantial in it portfolio common of services of the system national of health to the modify the article 8 of the law 16 / 2003, of 28 of mayo, differentiating a portfolio common basic of services welfare a supplementary common portfolio and a common portfolio of accessories services. In the case of the provision of prosthetics, surgical implants are part of basic common welfare services portfolio, while the rest of the allowance is considered part of the additional common portfolio.
He Council inter-territorial of the system national of health created the 29 of February of 2012 a group of work of development of the portfolio common basic of services care of the system national of health, with the objective of review it cited portfolio to identify and prioritize them benefits whose content would be precise detail, clarify or realize.
To address each of the areas prioritized basic welfare services common portfolio created expert groups, which involved professionals designated by the autonomous communities and the Ministry of health, social services and equality, scientific societies involved, as well as the Spanish network of evaluation agencies of health technologies and benefits of the national system of health that provides information based on scientific evidence about those cases in which there are doubts about the effectiveness, safety and efficiency.
For them implants, them works of concretion and update of the portfolio common basic of services welfare is have led to out in the breast of the Group of implants surgical, dependent of the Committee Advisor for the provision prosthetics, that has followed a scheme similar of work, creating groups of experts in each an of them eleven areas that configured the portfolio common basic of implants surgical.
As result of them works of these groups of experts, is have made proposals of concretion and update of the portfolio common basic of implants surgical, so is breaks down the content of many headings, is specify them conditions of use of some implants, is eliminate those that is considered obsolete and is include those others that have shown security effectiveness and efficiency. The final proposals were drafted taking into account the criterion of the experts and the content of evaluation reports provided by the aforementioned Spanish network of agencies. These proposals were submitted to the Advisory Committee for the provision of prosthetics on May 22, 2014, to in turn, raised them to the Commission's performance, assurance and financing of 29 may 2014, which subsequently ratified changes to the procedure for hearing at the meeting of November 25, 2014.
This order seeks, on the one hand, give effect to the realization and updating of annex VI to the Royal Decree 1030 / 2006, of 15 September, in relation to surgical, implants in order to clarify its scope, homogenizing and updating its indications in the light of the available scientific evidence, so that helps to maintain cohesion in the national health system and are guaranteed more effective and safe performance and a greater equity in access for all citizens, avoiding differences between benefits that users receive in each of the autonomous communities, which will be achieved a greater homogeneity and a rationalization of the health expenditure.
This portfolio common basic of implants surgical, whose update and concretion is collects in the annex I of this order, will be a first step that will allow advance in the establishment of amounts maximum of financing, in accordance with it planned in the Real Decree 1506 / 2012, of 2 of November, by which is regulates the portfolio common supplementary of provision prosthetics of the system national of health and is set the bases for the establishment of them amounts maximum of funding in providing prosthetics, because it is essential to have a more detailed common portfolio to bring products with characteristics similar to those that may apply you similar amounts.
Moreover, after the publication of the Real Decree 207 / 2010, of 26 of February, by which is set them conditions of the use protected of technical, technologies and procedures health and is modifies the Real Decree 1207 / 2006, of 20 of October, by which is regulates the management of the Fund of cohesion health, is put underway the use protected of the treatment surgical of the lipoatrophy facial associated to HIV-AIDS. During three years is has proceeded to collect them data about them results of the application of such treatments to them patients following a protocol established to the effect, coming is to the conclusion of that them treatments with fat autologous are safe and effective and require reoperation with less frequency that with them remaining materials. Also, the Group of experts of implants repairers not considered appropriate, to the view of the evidence available, include in the portfolio common basic of services care them materials synthetic for this indication. This led the Committee on benefits, insurance and financing of 29 may 2014 to propose the inclusion of surgical treatment with autogenic fat in the basic common portfolio of healthcare services for patients with HIV-related lipoatrophy. However, it is planned that in exceptional cases, which cannot be used grease, the competent health authorities may authorize expressly its realization with other materials.
Finally, the Royal Decree 1030 / 2006, of 15 September, points out in his article 7.5, which carry out the updating of the common portfolio of services most appropriate assessment procedure should be used in each case that allows to know the efficacy, efficiency, effectiveness, cost, safety or health utility technique, technology or procedure , as reports of evaluation, criteria of experts, records evaluation, uses mentored or others.
One of these assessment procedures are the studies of monitoring, whose regulation is carried out in this standard. To difference of the use protected, is expected as studies observational for rating technical, technologies or procedures in phase of post-introduction in portfolio by its need health, but exists any uncertainty on its effectiveness in the practice clinical usual or its efficiency, or are of foreseeable high impact economic u organizational or is unknown its behavior in groups of population specific (by age) Comorbidities, etc.).
Therefore, necessary regulate the mechanism by which studies monitoring techniques, technologies and procedures, will be developed so that they allow to obtain the necessary information to support future decisions on the common services portfolio update. This process gives a role to the Spanish network of agencies of health technology and benefits of the national health system evaluation.
This standard regulates the General conditions of the studies of monitoring techniques, technologies and procedures. In the annex II is collected those implants surgical that is introduced in it portfolio common basic of services care subject to study of monitoring, since is requires greater information on them, to proposed of the Commission of performance, assurance and funding, to the view of them respective reports of evaluation. Thus, once each of the studies, there will be the necessary information allowing to assess their situation in the basic common portfolio of healthcare services of the national health system, as established by the order SCO/3422/2007, of 21 November.
Since the object of them studies of monitoring are technical, technologies or procedures included in the portfolio common of services, in them conditions established in the corresponding study, proceeds, therefore, the compensation of the attention of patients in a community autonomous different to it of his residence through the Fund of cohesion health.
In the future, by resolution of the titular person of the General Directorate of basic services of the national system of health and pharmacy portfolio, prior agreement of the Interterritorial Council, other techniques, technologies or procedures on which there are uncertainties may be monitoring research.
This order has been informed by the Commission of performance, assurance and financing, the Committee consultative of the Council inter-territorial of the system national of health, the Council inter-territorial of the system national of health and the Agency Spanish of protection of data. He has also been subject to consultation by the autonomous communities, the National Institute of health management, the cities of Ceuta and Melilla and the mutualities of officials as well as the National Council on disability and the different sectors concerned have been heard.
The present order is dictates in use of the powers conferred upon them by the available end second of the Real Decree 1030 / 2006, of 15 of September.
By virtue, with the prior approval of the Minister of finance and public administration, and in accordance with the Council of State, I have: article 1. Object.
(He object of this order is: to) realize and update the content of the portfolio common basic of services care of the system national of health regulated by the Real Decree 1030 / 2006, of 15 of September, by which is sets the portfolio of services common of the system national of health and the procedure for its update, in it reference to them treatments surgical of the lipoatrophy facial associated to HIV-AIDS and to them implants surgical collected in the annex I. b) Regular conditions of the realization of studies of monitoring techniques, technologies and procedures, noting in annex II surgical implants undergoing monitoring research by this order.
Article 2. Modification of the Real Decree 1030 / 2006, of 15 of September, by which is sets the portfolio of services common of the system national's health and the procedure for its update.
The Royal Decree 1030 / 2006, of 15 September, which establishes the portfolio of common services of the national system of health and the procedure for its updating, is to be re-worded as follows: one. The section 9.5.5 annex II is worded in the following way: «9.5.5 implants dental, except as provided for in division RP implant repair of section 6 of annex VI. '
Two. The paragraph 5.1.1 of annex III is drawn up in the following way: «5.1.1 infectious and parasitic diseases: intestinal infectious diseases, tuberculosis, bacterial zoonotic diseases, other bacterial diseases, virus infection of the human immunodeficiency (including surgical treatment of facial lipoatrophy associated with HIV-AIDS made with autogenic fat, while the competent health authorities may exceptionally authorize the realization of this treatment by synthetic materials in patients» (, as them hemophiliacs, in which, prior justification clinical, not can use is the FAT), polio and other diseases viral of the system nervous central not transmitted by arthropods, diseases viral accompanied of Exanthema, diseases viral covers by arthropods, other diseases due to virus and chlamydiae, rickettsiosis and others diseases covers by arthropods, syphilis and other diseases venereal, others diseases espiroquetales, Mycosis, helminthiasis «, other diseases infectious and parasitic and effects late of the diseases infectious and parasitic.»
Four. A new section 4.3 is added to annex VI: «3. health authorities responsible for the management of surgical implants shall establish the procedure for the acquisition by the means deemed most appropriate in each case to guarantee its supply patients with maximum efficiency.»
5. Paragraph 6 of annex VI is replaced by the contents of the annex I to this order.
Article 3. Concept, purpose and characteristics of the studies of monitoring techniques, technologies and procedures.
1 studies of monitoring techniques, technologies and procedures (hereinafter referred to as the monitoring studies) are observational and part of the evaluation mechanisms foreseen in article 7.5 of the Royal Decree 1030 / 2006 of 15 September.
2 monitoring studies are aimed to follow up the results of a technique, technology or procedure introduced in common portfolio of the national system of health services for their health needs, so as to obtain information that will allow later assess its situation in the common services portfolio. Its purpose is: to) determine the effectiveness or the efficiency of the technique, technology or procedure, when there is some uncertainty about his behavior to make it in the clinical practice of generally or in specific population groups.
(b) obtain information about the results of the application of a technique, technology, or foreseeable high impact health care, organizational or economic procedure.
3. each monitoring study will be technically coordinated by an agency of assessment or evaluation unit (hereinafter assessment) of the Spanish network of evaluation of health technologies and features of the national system of health, included in the annual Plan of health technology assessment. To perform these duties of technical coordination Evaluation Agency will follow standard operating procedures in the methodological framework of common quality of the Spanish network of evaluation of health technologies and features of the national system of health, in accordance with the order SSI/1833/2013, October 2, which creates and regulates the Council network Spanish of agencies of assessment of health technologies and features of the national system of Bless you.
4. the study will take place following a Protocol and will be held for a period of time proposed by the corresponding assessment depending on the characteristics of technique, technology or procedure, the information that is desired and the periodicity of follow-ups that provision, that it will be ratified at the heart of the Commission's performance Quality assurance and financing prior to the collection of information.
5 you can perform only a technique, technology or procedure subject to monitoring research as part of the common portfolio of services in centres proposed for that purpose by the autonomous communities.
6. all patients who meet the criteria for inclusion set out in the Protocol shall be entitled to access techniques, technologies and procedures subject to monitoring research centres proposed for this study. To do this, the autonomous communities that have not proposed centers will facilitate transfer of patients requiring the use of any of these techniques, technologies or procedures, similar to the rest of the common portfolio of services and ensuring the accessibility of people with disabilities.
7. them studies of monitoring is adapted to them requirements of the legislation that les is of application depending on the technical, technology or procedure of that is try, by what, when so it available the normative specific existing, is subject to the authorization of the corresponding Committee of ethics.
Article 4. Submission of a technical, technology or procedure to study of monitoring.
1. the application of realization of a study of monitoring will be carried out by the Ministry of health, services social e equality, them administrations health of them communities autonomous or them mutual of officials or to request reasoned of third interested. The Committee on benefits, insurance and financing, taking into account the suitability of the study in response to the existing uncertainties about the technique, technology or procedure and its feasibility, will assess this application and develop, where appropriate, the proposal of the monitoring study.
2. the Commission may carry out a prioritization of monitoring studies to be performed, if it considers it necessary in the light of the applications received, taking into account the degree of uncertainty, your health need, its clinical utility, the population target and its cost.
3. the Ministry of health, social services and equality, in the light of this proposal, rule the subjugation of a technique, technology or procedure to study of monitoring by a resolution of the titular person of the General Directorate of basic services of the national system of health and pharmacy portfolio.
4 the resolution will establish the specific technical requirements of each monitoring, proposed by the Committee on benefits, insurance and funding research, and be determined, counting, in his case, with the favorable report of the corresponding Autonomous Community, the agency that is responsible for the technical coordination of the study.
Article 5. The study of monitoring protocol.
1. with prior to the implementation of the monitoring research, drawn up a selection of patients and data collection Protocol so that to ensure the safety, equity in access, including patients with disabilities, respect to bioethics and the achievement of results relevant for knowledge. In case the monitoring of patients is required to assess the results of the technique, technology or procedure, establish the periodicity of such monitoring and the data collected in each of them.
(2. the Protocol of the study of monitoring will consist of two parts: to) it first, that it shall draw up the Agency of evaluation responsible of the coordination technical of the study based on the information available, will pick up them following aspects: 1 description of the technical, technology or procedure.
2nd objective and justification of the study.
3rd indications subject to study.
4th initial conditions of use of the technique, technology or procedure: material, human and training requirements for its proper use, requirements that have to meet centers that is used, quality controls, as well as requirements that have meeting facilities that apply technology in accordance with the specific regulations that will be of application.
A time informed of these conditions initial, and based on the same, them communities autonomous propose provisionally to the address General of portfolio basic of services of the system national of health and pharmacy of the Ministry of health, services social e equality them centers of their respective areas that will participate in the consensus and elaboration of the second part of the Protocol.
(b) the second part will be elaborated by the assessment with the participation of experts appointed by the scientific societies involved and the affected units of the Ministry of health, social services and equality and centres proposed provisionally by the autonomous communities. Thus they will ratify or modify the conditions of use of technique, technology or procedure contained in the first part of the Protocol and the study design will be established specifying the methodology to be followed and the sample size required for the results of the study are significant. It will contain the following sections: 1 inclusion and exclusion criteria of patients that shape the information referred to in the portfolio of services.
2nd Variables that allow get information relevant for it takes of decisions relating to them patients and to the own technical, technology or procedure, referred to their results, them effects adverse and to them complications to short, medium and long term, as well as them variables that define subgroups of patients of special interest, and them relating to the use of resources.
3rd follow-up deemed that they should be made to patients and the same periodicity.
4th procedure of sending and receiving of data and monitoring of compliance with study protocol.
5 definition of alarms that allow the detection of problems relevant for it health that could arise during the realization of the study, as well as the mechanism of communication of them same to the Ministry of health, services social e equality, which will give transfer to the Commission of benefits, assurance and funding and, in his case, to them authorities sanitary competent.
3. the Protocol will be submitted to the Committee on benefits, insurance and financing for ratify it.
Article 6. Realization of monitoring studies.
1. a time ratified the Protocol by the Commission of benefits, assurance and funding, them communities autonomous checked that them centers of its field proposed provisionally have with them conditions of use of it technical, technology or procedure established in said Protocol, in line with it collected in the article 5, and will proceed to present the proposed final of participation in the study to the address General of portfolio basic of services of the system national of health and pharmacy of the Ministry of health, social services and equality. The unratified centers already not may continue to apply the technique, technology or procedure during the study period.
2. in the event that a technique, technology, or subject to monitoring research procedure is used for the care of a pathology or completion of a procedure for which to be designated centers, units or reference services of the national health system, centers proposed by the respective autonomous communities to participate in the study of monitoring must be previously designated in accordance with regulated in the Real Decree 1302 / 2006 , of 10 of November, by which is established the bases of the procedure for the designation and accreditation of them centers, services and units of reference of the system national of health.
3. the mutualities of officials may determine, having the favorable report of the respective autonomous community, the centres that will be held the technique, technology or procedure in its scope of management.
4. the centers that perform the technique, technology or procedure subject to monitoring research undertake to follow the corresponding protocol and to refer to the Agency's evaluation data referred to in the Protocol patients, in the form and time limits that are established in the same. In case of failure to do so, the Center will be excluded from the monitoring research, so may not apply, since that time and during the period the study, technique, technology or procedure as part of the common portfolio of services of the national health system.
5 during the course of the study of monitoring, Evaluation Agency will perform the following actions: to) you will receive and process data from the participating centres.
(b) it shall communicate immediately to the General Directorate of basic portfolio of services of the national system of health and pharmacy of the Ministry of health, social services and equality the serious adverse events that are detected in the application of the technique, technology or procedure subject to monitoring research, which could determine its stoppage or modification, without prejudice to the fulfilment of the obligations of communication required by the specific legislation in each case.
(c) it shall ensure that in the collection of data and its transmission meets the provisions of the organic law 15/1999, of 13 December, of protection of data of a Personal nature, and its implementing regulations.
(d) you will find that the informed consent of patients who will be applying the technique, technology or procedure collects that shown to the patient that it is subject to monitoring research and that the patient authorizes the treatment and transfer of the data derived from the study and its subsequent follow-up, and conforms to what is established in law 41/2002 , of 14 November, basic regulator of the autonomy of the patient and of rights and obligations in terms of information and clinical documentation.
Article 7. Completion of the monitoring studies.
1. Once completed the study period, the corresponding evaluation Agency will prepare a technical report.
2 the technical report, that in the event that the Agency deemed appropriate, may subject it to external review, shall include at least the following information: a) description of the technique, technology or procedure.
(b) regulatory requirements for its implementation in Spain.
(c) previous state of knowledge about its safety, efficacy and its degree of implementation in Spain.
(d) results obtained from the study of monitoring.
(e) conclusions on: 1 the efficacy, effectiveness and efficiency and, where appropriate, about their safety;
2nd its usefulness compared to other alternatives;
3rd the organizational impact of their introduction;
4th its economic impact, including the estimation of the cost of their use in the national system of health, 5 where appropriate, the recommendations on the conditions of use of the technique, technology or procedure.
3. in the course of studies of more than a year, in addition to the aforementioned report, monitoring evaluation Agency shall prepare annually to the Committee on benefits, insurance and finance, a report in which the evolution of the study, which will be presented in the first quarter of the next calendar year is collected.
4. the report technical is will present to the Commission of performance, assurance and funding for available of information objective on the technical, technology or procedure. Your analysis will allow put up, in your case, the resulting procedure of update of the portfolio common of services of the system national of health.
Article 8. Participation of the companies.
In monitoring studies which involve the use of a health product: 1. the companies may provide additional information that they believe that it can contribute both to the elaboration of the Protocol and of the technical report to corresponding evaluation Agency, through the General Directorate of basic services of the national system of health and pharmacy portfolio.
2. the companies will provide to it address General of portfolio basic of services of the system national of health and pharmacy it information that them request on the product that contribute to solve them uncertainties existing that have generated the need of perform a study of monitoring, whenever not is try of information confidential.
3. the General Directorate of basic portfolio of services of the national system of health and pharmacy, with the participation of the autonomous communities with centers involved in the study, agreed with the companies product to assess economic conditions thereof during the period of study within the framework of shared management of risks.
First additional provision. Requirements technical specific of them studies of monitoring.
Within a maximum period of two months from the entry into force of this order shall be established by resolution of the titular person of the General Directorate of basic services of the national system of health and pharmacy portfolio, the specific technical requirements referred to in article 4.4 of monitoring studies referred to in annex II of this standard , to proposal of the Commission of benefits, insurance and financing.
Provision additional second. Aspects General complementary of the studies of monitoring.
In the case that the Commission's performance, assurance and financing may deem it appropriate, he may propose complementary general aspects that facilitate implementation underway, development or the follow-up studies of monitoring, which will become effective by resolution of the titular person of the General Directorate of basic services of the national system of health and pharmacy portfolio.
Provision additional third. Adaptation of services portfolios.
The communities autonomous, the Institute national of management health and them mutual of officials adapted their respective portfolios of services to it willing in this order in the term maximum of six months from its entry in force.
Fourth additional provision. No increase in public spending.
The measures included in this order may not assume increased Endowment fees or other expenses of staff in the service of the public sector.
First final provision. Skill-related title.
This order is issued under cover of the provisions of article 149.1.16. ª of the Spanish Constitution, which attributes to the State the exclusive competence in bases and general coordination of the health.
Available to finish second. Entry into force.
This order shall enter into force the day following its publication in the "Official Gazette".
Madrid, 2 July 2015.-the Minister of health, social services and equality, Alfonso Alonso Aranegui.
ANNEX I 6. Implant surgical 6.1 therapeutic surgical implants: implants cardiac CA.
0 CA implants for cardioestimulacion. In case of using products that are marketed as with protection for 1.5 Tesla MR, resonance only should be done when it is only able to help diagnose image study and valuing the benefit exceed the risks. The resonance is held under strict measures of security (presence of professional qualified, monitoring continuous, pulse oximetry, control of frequency heart and equipment of resuscitation cardiopulmonary).
CA 0 0 pacemaker: CA 0 0 0 pacemaker who SSI with / without monitoring remote.
CA 0 0 1 pacemaker who SSIR (with response in frequency).
CA 0 0 1 0 pacemaker who SSIR without monitoring remote.
CA 0 0 1 1 pacemaker who SSIR with monitoring remote.
CA 0 0 2 pacemaker bicameral VDD / VDDR.
CA 0 0 2 0 pacemaker bicameral VDD / VDDR without monitoring remote.
0 0 2 1 dual-Chamber pacemaker VDD/VDDR AC with remote monitoring.
CA 0 0 3 DDD/DDDR pacing.
3 0 0 CA 0 dual-Chamber pacemaker DDD/DDDR without remote monitoring.
CA 0 0 3 1 DDD/DDDR pacing with remote monitoring.
CA 0 0 4 pacemaker with therapy of cardiac resynchronization (with frequency response).
0 4 0 0 CA pacemaker with without remote monitoring cardiac resynchronization therapy.
CA 0 0 4 1 pacemaker with with remote monitoring cardiac resynchronization therapy.
0 1 (DAI) implantable cardioverter-defibrillator CA: CA 0 1 0 serves DAI with frequency response.
CA. 0 1 0 0 serves DAI with without remote monitoring frequency response.
CA 0 1 0 1 DAI incidence response in frequency with remote monitoring.
CA 0 1 1 DAI bicameral with frequency response.
CA-0 1 1 0 bicameral DAI with without remote monitoring frequency response.
CA 0 1 1 1 DAI bicameral with remote monitoring frequency response.
0 1 2 DAI CA with frequency response with cardiac resynchronization therapy.
CA. 0 1 2 0 DAI with cardiac resynchronization therapy with frequency response without remote monitoring CA 0 1 2 1 DAI with cardiac resynchronization therapy with CA 0 1 3 subcutaneous defibrillator remote monitoring frequency response. Its use is contraindicated in patients with symptomatic bradycardia or ventricular tachycardia can be terminated with stimulation antitachycardia (ATP). When required a permanent stimulation it is not a valid alternative to the coronary system.
0 2 electrode AC: CA 0 2 0 endocardial stimulation electrode.
CA 0 2 1 electrode for coronary sinus stimulation.
CA 0 2 2 electrode for epicardial stimulation.
CA 0 2 3 electrode for defibrillation.
CA 1 implants Cardiology: CA 1 0 valve.
CA 1 0 0 valve mechanical.
CA 1 0 1 valve biological xenologa (them autologous is contemplated in the paragraph 5.2.16 of transplants of the annex III) CA 1 0 2 valve biological without suture, for patients with stenosis aortic serious symptomatic, > 75 years, with an expectation of life more of a year, operable, with high risk surgical due to Comorbidities or conditions anatomical that discouraged the implantation of prosthesis conventional , valued by a Committee multidisciplinary CA 1 0 2 0 self-expanding.
CA 1 0 2 1 expandable with ball.
CA 1 0 3 valve aortic transcatheter, for patients with stenosis aortic severe symptomatic, evaluated by a Committee multidisciplinary, in centers that have of a service of surgery heart and of a protocol written of selection of patients AC 1 0 3 0 self-expanding.
CA 1 0 3 1 expandable with ball.
CA 1 0 4 pulmonary valve transcatheter, for patients with congenital heart disease for which there is no other alternative therapy, in reference of the national system of health services.
CA 1 1 ring for valvuloplasty.
CA 1 1 0 ring for rigid valvuloplasty.
CA 1 1 1 ring for flexible valvuloplasty.
CA 1 1 2 ring for semi-rigid valvuloplasty.
CA 1 2 duct valving.
CA. 1 2 0 conduit valved with mechanical valve.
CA 1 2 1 duct valving with biological valve xenologa (the autologous contemplated in the section 5.2.16 transplant of annex III).
CA 1 3 substitute of the pericardium.
CA. 1 3 0 the pericardium synthetic substitute.
CA 1 3 1 substitute for biological xenologo pericardium (the autologous contemplated in the section 5.2.16 transplant of annex III).
CA 1 4 occlusion device cardiac and vascular.
CA 1 4 0 system for closing of communication atrial septal defect.
CA 1 4 1 device percutaneous for closure of Patent foramen oval, to the prevention secondary of the ACV cryptogenic.
CA 1 4 2 system for closing of communication Ventricular septal defect.
CA 1 4 3 system of closure of the ductus arteriosus.
CA 1 4 4 shut-off device (Occluder) of left atrial appendage LAA, for patients with atrial fibrillation, with the presence of other risk factors for stroke added and contraindication or intolerance to oral anticoagulation therapy or patients who are going to be undergoing a percutaneous mitral valve intervention and also have atrial fibrillation , high risk of stroke and contraindication or intolerance to oral anticoagulation therapy, subjected to monitoring research.
CA 1 5 in the following ventricular assist device:-as bridge to transplantation (temporary or short term) when the patient has a situation hemodynamic committed or refractory to drug therapy, - as a bridge to recovery in patients with acute heart failure who do not respond to conventional treatment and have possibility of myocardial recovery, cardiogenic shock and severe acute myocarditis and - as destination therapy (permanent or long-term) for patients who do not they are candidates for transplantation, with the left ventricle ≤25% ejection fraction, and a NYHA class IIIB/IV and peak VO2
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