Devices In France Research Articles

Early access programs for medical devices in France: Overview of recent reforms and outcomes (2015-2022)

The medical technology sector is characterised by a constant influx of innovations with the potential to revolutionise patient care. In France, there are several pathways for medical devices to enter the market, from diagnosis-related group tariffs to reimbursement lists. However, traditional regulatory pathways can delay market access for innovative technologies. In response, France has established Early Access Programs to expedite patient access to medical devices. This paper looks at three of these Early Access Programs for medical devices. Innovation Funding, introduced in its final version in 2015, provides temporary coverage for innovative devices and facilitates data collection for informed funding decisions. Transitional Coverage (PECT), established in 2021, targets CE-marked devices for rare or serious conditions. Transitional coverage for digital health applications (PECAN), introduced in 2022, covers digital medical devices, either therapeutic or for patient monitoring. Innovation funding has been granted to 16 technologies out of 35 applications (46%) since 2015. 6 technologies out of 11 (64%) applications benefit from PECT. PECAN, in its first year, has granted a telemonitoring solution with a favourable opinion. The French experience could provide valuable lessons for the development of a harmonised European framework to ensure that innovative medical technologies benefit those who need them, while maintaining high safety standards.

Paramedics and remote monitoring of cardiac implantable electronic devices in France

Paramedics and remote monitoring of cardiac implantable electronic devices in France

Registre REFORCE

Severe coronary artery calcification, too often underestimated, increases the complexity of percutaneous coronary interventions. Atherectomy is one of preferred approach for the preparation of calcified lesions before stent placement. Orbital atherectomy is a new method that has proven to be safe and effective in the preparation of calcium plaques (ORBIT I and ORBIT II studies). The recent introduction in France allows to perform a prospective registry named REFORCE. Its main objective is to include 300 patients in order to evaluate security and safety of the device in France during routine use.

Survey on the paramedical role in the remote monitoring of cardiac implantable electronic devices in France

Remote monitoring of cardiac implantable electronic devices (CIEDs) has become an expansive priority in many European countries, with nurses playing a central role in it. In France, a national survey for paramedics was set up to assess the organization of remote monitoring in the different institutions and to determine the paramedical role. A self-administered questionnaire (supplementary material), developed and validated by the College of Paramedics in partnership with the Working Group of Pacing and Electrophysiology of the French Society of Cardiology (SFC).

MT3 Comparison of Funding and Reimbursement Routes for Medical Devices in France, Germany, and Spain

MT3 Comparison of Funding and Reimbursement Routes for Medical Devices in France, Germany, and Spain

La « religion culturelle » en France et au Québec : quelques réflexions à partir de l’étude des Journées mondiales de la jeunesse

This article sheds light on the dynamics of ‘cultural Catholicism’ in France and Quebec, two French-speaking areas which were homogeneous Catholic societies and which are today affected by secularization and religious pluralization. To do this, it compares the reception of two World Youth Days (WYDs) : that of 1997 (Paris), and that of 2002 (Toronto). As they associate Catholicism with a global identity, WYDs weaken cultural religion, that aims to cement ethnic cohesion. The success of the device in France, and its relative failure in Quebec, reveal two regimes of religiosity at the turn of the millennium : In France, Catholicism only partially structures the national identity, which facilitates the adhesion to a globalist Catholic event. In Quebec, Catholicism remains an ambivalent pillar of the social imaginary, which hinders its celebration in a pan-Canadian and transnational frame.

Occlusal devices in France: An assessment of professional practice

Statement of problemWhether recommendations for the use of occlusal devices are made uniformly in terms of indications, designs, and wearing time is unclear. Different recommendations may lead to different clinical outcomes. PurposeThe purpose of this survey was to assess the professional practice of dental surgeons in France regarding the use of occlusal devices. Material and methodsA 26-question cross-sectional survey was sent to a panel of French dentists via the County Councils of the Dental Order. The questionnaire concerned the amount of occlusion-related treatment, the use of an anterior deprogramming device, stabilization splint, and anterior repositioning appliance, and the patient follow-up as well as the drawbacks of using an occlusal device as a therapeutic solution. The statistical tests used in the study were the chi-square test and the Yate correction for continuity. ResultsA total of 771 responses were received. Invasive options were still reported as being used as a first-line treatment for temporomandibular disorder, although a statistical difference was found between experienced and recently graduated practitioners, with recent graduates preferring noninvasive options as first-line treatment. Also, the results showed that anterior deprogramming devices were not used or that their application, particularly the length of treatment, was unfamiliar to practitioners. The anterior repositioning appliance seems to be used, but only a few practitioners integrate it into their practice. In general, about one-third of dentists appear to have a good knowledge of occlusion-related treatments, in particular, the use of occlusal devices. ConclusionsThe results indicated that only 20% to 30% of practitioners have good knowledge of contemporary occlusion-related practice. There is a need for the standardization of practice and improved education for practitioners in the use of occlusal devices.

Understanding acceptance of eHealthcare by IoT natives and IoT immigrants: An integrated model of UTAUT, perceived risk, and financial cost

The Internet of Things (IoT) is a modern disruptive technological approach that connects devices and people in a smart way at any time and at any place. The development of IoT is forecast to generate high economic value, improve efficiency of enterprises’ operational processes, and benefit the personal and professional lives of its end users. This new model of human–technology interaction is under-researched, especially with regard to eHealth. The current study aims to close this research gap by investigating IoT adoption in eHealthcare from the customer perspective and by including financial cost in the extended Unified Theory of Acceptance and Use of Technology (UTAUT) framework. The model is validated based on data collected from a randomly selected sample of 268 potential users of IoT-based healthcare devices in France. Structural modeling reveals that the cost of using IoT in eHealthcare is the key barrier to IoT adoption. Age is a significant mediator of customers’ intention to use IoT in eHealthcare and inspires the formulation of two new categories: IoT natives and IoT immigrants. The findings have practical application for IoT developers, policymakers, and potentially for marketers.

Temporary assist devices in France 2014–2018: intra-aortic balloon pump: is the technique really outdated?

Abstract Aims Intra-aortic balloon pump (IABP) utilization was expected to be quickly abandoned following the IABP-shock trial and its class III, level B of recommendation in the 2016 ESC guidelines. The aim of this study was to evaluate the use of IABP compared to other mechanical support devices in a nationwide approach. Methods We conducted a retrospective study based on the French national hospital discharge database. All patients implanted by an assist device either by IABP, extracorporeal membrane oxygenation (ECMO) or IMPELLA® from 2014 to 2018 (2 years before/2 years after the 2016 guidelines) were included. The primary endpoint was the incidence of IABP implantation over the years. Secondary endpoints were incidence of total assist devices implantations, ECMO and IMPELLA® implantation. Results From 2014 to 2018, a total of 18,872 patients benefited from mechanical support by IABP (n=6,637, 35.2%), ECMO (n=11,833, 62.7%) or IMPELLA® (n=402, 2.1%) in France. The incidence of total mechanical support implantations (ECMO and IABP) was constant over the years. IABP implantation decreased progressively from 1,725 implantations in 2014 to 976 in 2018 (−44%). By contrast, ECMO implantation increased progressively from 1,919 implantations in 2014 to 2,715 implantations in 2018 (+42%). IMPELLA® implantations remained stable over the years from 63 (1.7%) implantations in 2014 to 83 (2.1%) in 2018. Conclusion In this nationwide real-life study, despite a significant decline in IABP implantations over the years since the ESC guidelines, this device remained used in clinical practice with around 1,000 implantations in 2018. The size of the centers is not strictly correlated with this use, suggesting differential uses depending of the local background. Funding Acknowledgement Type of funding source: None

Modelling of five-point bending beam test for asphalt surfacing system on orthotropic steel deck bridges

ABSTRACT The orthotropic steel deck bridges (OSDBs) in the Netherlands consists mostly of multilayer system: top porous asphalt layer, guss asphalt layer, steel deck and two membrane layers. The five-point bending (5PB) beam test is the standard device in France for characterization of fatigue response of asphalt concrete surfacings used on orthotropic steel deck bridges. In this paper, an analytical solution for the 5PB beam test setup is presented first. In order to better understand the influence of geometrical, mechanical and structural parameters on the performance of the typical multilayer surfacing system of OSDBs, the 5PB test specimens with five structural layers have been investigated. The parametric study is performed at the numerical platform CAPA-3D that was developed at the Section of Structural Mechanics of TU Delft. The influences of the thickness of the asphalt layers and the mechanical properties of both top and bottom membrane layers are studied. The sensitivities of those influence factors are evaluated by the examination of the maximum tensile stress at the top surface of the porous asphalt layers and the strain distributions through the entire thickness of the specimen at two cross-sections.

PMD30 MEDICAL DEVICES MANAGED ENTRY AGREEMENTS IN FRANCE: A RETROSPECTIVE ANALYSIS (2018-2019)

In France, the price of medical devices included in the positive reimbursement list (LPPR) is negotiated between the manufacturer and the French Healthcare Products Pricing Committee (CEPS). The agreement leads to the list price publication. However, it can also include other elements which are not public as the managed entry agreement (MEA). MEA are confidential. This study aims to exhaustively review the MEA use for reimbursed medical devices in France. All the agreements signed between 2018 to May 2019 were reviewed to identify those including a MEA. Analyses considered the MEA type depending on the medical device characteristics (e.g. therapeutic area, HTA score, target population, budgetary impact). Statistical analysis was conducted. Among the 259 agreements analysed, 30% of them include a MEA. Confidential agreements are mostly associated to innovative devices (81% of them). While they are less frequent for medical devices with no added medical value (22%). Price-volume agreements are the most commonly used (71%), followed by simple discount (16%) and performance-based agreement (7%). When considering the distribution channel, inpatient medical devices are more entitled to be associated to a MEA than outpatient devices. In terms of therapeutic area, devices in cardiology and neurology ranks first in MEA use. CEPS increasingly uses MEA as a regulation tool to contain reimbursed medical devices expenditures.

Adverse events reported for Mirena levonorgestrel-releasing intrauterine device in France and impact of media coverage.

In 2017, concerns regarding adverse events (AEs) associated with the Mirena levonorgestrel intrauterine device were largely echoed in the media in France. This resulted in a tremendous reporting of AEs to pharmacovigilance centres. The aim of this study was to describe the reporting of AEs regarding Mirena in France and to study the impact of media coverage on this reporting. All cases reports involving Mirena recorded in the French national pharmacovigilance database from marketing (21 July 1995) until 04 August 2017 were extracted. To allow studying the influence of mediatisation, reports were described separately for the periods preceding and following the observed media coverage peak (15 May 2017). Overall, 3224 reports were considered, 510 (15.8%) recorded before the media coverage peak, and 2714 (84.2%) after. Before the peak, 76.5% of reports originated from health professionals; median time-to-report was of 5.5months (interquartile range: 1.7-18.6), and median number of AEs per report was 1 (range: 1-17). After the peak, 98.6% originated from patients; median time-to-report was 21months (interquartile range: 8.1-45.5), and median number of AEs per report was 6 (range: 1-37). After the peak, most reports mentioned anxio-depressive disorders (38.8 vs 10.6% before) or sexual disorders (47.3 vs 6.9%). Other emphasised AEs were weight increase (42.3 vs 10.2%) and pain (gastrointestinal, 19.1 vs 3.5%; musculoskeletal, 22.2 vs 4.5%). This study highlighted the importance of mediatisation impact on spontaneous reporting with changes concerning amounts of reports, type of reporter, and type of reported AEs. For Mirena, this led to generate signals regarding anxio-depressive and sexual disorders.

Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry.

Spinal cord stimulation (SCS) is an established therapy for refractory neuropathic pain. To ascertain the balance between treatment benefits and risks, the French National Authority for Health requested a post-market registry for real-world evaluation of the long-term effectiveness and safety of the therapy. A total of 402 patients undergoing implantation with a Medtronic SCS device as either a primo-implant (n=264) or replacement implant (n=138) were enrolled across 28 representative sites in France. Outcome measures at 2years included pain intensity, satisfaction with treatment, improvement of pain relief and daily life activity, willingness to undergo the treatment again and use of pain treatments. A patient was considered a responder if, compared to baseline, predominant pain reduction was ≥50%. At the 2-year follow-up visit, predominant pain intensity for primo-implant patients had decreased from baseline (p<0.001), with responder rates of 55%, 36% and 67% for the lower limbs, back and upper limbs, respectively. Most patients acknowledged an improvement in pain relief (89%) and daily life activity (82%) were satisfied with treatment (91%) and willing to undergo the treatment again (93%). A significant decrease (p<0.01) in the proportion of patients receiving pain treatment was observed for all drug and non-drug treatments. Reported adverse events were in line with the literature. Pain intensity at 2years was comparable for patients in the replacement group, supporting the long-term stability and effectiveness of SCS. Real-world evaluation of the use of spinal cord stimulation under the recommendations of the French Health Authority shows that two years after the first implantation of an SCS device close to 60% of the patients retain a significant pain reduction and 74% show improvement in pain scores [of at least 30%] with significant decreases in drug and non-drug pain treatments. This observational, prospective study in a real-life setting followed a large cohort of patients suffering from chronic pain and implanted with SCS devices in France. The study assessed the long-term effectiveness and safety of SCS therapy in a representative sample of implanting sites in France.

Remote monitoring of cardiovascular implantable electronic devices in France. The French Electra survey

Goal To evaluate routine Remote Monitoring (RM) of Cardiovascular Implantable Device (CID). A multiple choice questionnaire was e-mailed to 100 French physicians Implanters of CID in November 2017. A total of 73 answers were obtained (73%). Seventy five percent work in a public center, twenty three percent in a private center. The rate of Internal Cardiac Defibrillator implantation (ICD)/year per center is > 100 for 63%, 50–100 for 24,7%, < 50 for 6.8% and none for 5.5%. The number of patients followed with RM is > 1000 (9.6%), 500–1000 (27.4%), 200–500 (41.1%), < 200 (18%). 21.9% followed only ICD, 78.1% all type of CID; 80% declare proposing RM to almost all ICD implanted patients. A total of 75.3% of physicians are referent for RM, 23.3% receive information from referent RM team. Eighty five percent obtain systematic inform consent from patients before activation of RM. Onsite registration and transmitter delivery (or order card) is performed by paramedical staff (68%), engineer (25%), physician (4.1%) Follow-up is performed by paramedical staff collaborating with physicians (68.5%), physicians only (26%). A total of 71.3% communicate a phone number to patients but only 42.5% deliver opening office schedule. During programmed follow-up a specific report is systematically created by 42.5%; information is delivered only in case of significant alert by 30.1% and non-specific PDF report is sent by 8.2%. There are 76.7% archive data but only 43.8% are exhaustive. Remote monitoring of CID is a current practice in France especially for ICD follow up. Collaboration with paramedical staff is partial. Patients are informed but not systematically. Data are archived but partially. Absence of funding may explain incomplete and heterogeneous RM activity in France.

Hospital Engineering of Medical Devices in France

Biomedical engineering handles the organization and functioning of medical devices in the hospital. This is a strategic function of the hospital for its balance, development, and growth. This is a major focus in internal and external reports of the hospital. It's based on piloting of medical devices needs and the procedures of biomedical teams’ intervention. Multi-year projects of capital and operating expenditure in medical devices are planned as coherently as possible with the hospital's financial budgets. An information system is an essential tool for monitoring medical devices engineering and relationship with medical services.

Urinary artificial sphincter ZSI 375 for treatment of stress urinary incontinence in men: 5 and 7 years follow-up report.

This is a retrospective, non-randomised study. The aim of this study was to evaluate safety and efficacy of artificial urinary sphincter ZSI 375 inserted in male patients with stress urinary incontinence (SUI). Between May 2009 and January 2017, 45 men with SUI underwent ZSI 375 device insertion. Operations were performed in two French centres by one surgeon. Complications and pad used to manage continence were recorded. From May 2009 to January 2012, 45 patients with a mean age of 70.42 years underwent placement of the ZSI 375 device in France. The most common cause for incontinence was radical prostatectomy (RP, 33/45 -patients, 73.33%). The minimal period of incontinence was 6 months. Twenty-seven out of 45 patients (60.00%) had a severe incontinence (at least four pads per day), 13 patients (28.89%) had moderate incontinence (three pads per day) and five patients (11.11%) had two pads per day. With a long follow-up, the ZSI 375 device was considered to be successful in 73.33% patients after 5 years (60 months) and 72% of patients after 7 years (84months). The infection rate was 2.2 % affecting one in 45 patients. Six out of 45 patients presented a urethral erosion (13.33%). Mechanical failure with a revision occurred in three patients (6.67%). The ZSI 375 device is a safe and effective device to treat severe SUI in men.

Ion cyclotron emission studies: Retrospects and prospects

Ion cyclotron emission (ICE) studies emerged in part from the papers by A.B. Mikhailovskii published in the 1970s. Among the discussed subjects were electromagnetic compressional Alfvenic cyclotron instabilities with the linear growth rate ~ $\sqrt {n_\alpha /n_e } $ driven by fusion products, -particles which draw a lot of attention to energetic particle physics. The theory of ICE excited by energetic particles was significantly advanced at the end of the 20th century motivated by first DT experiments on TFTR and subsequent JET experimental studies which we highlight. More recently ICE theory was advanced by detailed theoretical and experimental studies on spherical torus (ST) fusion devices where the instability signals previously indistinguishable in high aspect ratio tokamaks due to high toroidal magnetic field became the subjects of experiments. We discuss further prospects of ICE theory applications for future burning plasma (BP) experiments such as those to be conducted in ITER device in France, where neutron and gamma rays escaping the plasma create extremely challenging conditions fusion alpha particle diagnostics.

Integration of Cost-Effectiveness Assessment in the Market Access Scheme of Drugs and Medical Devices In France.

Integration of Cost-Effectiveness Assessment in the Market Access Scheme of Drugs and Medical Devices In France.

Le cathéter veineux central à insertion périphérique en nutrition parentérale à domicile chez l’adulte

Peripherally inserted central catheter (PICC) is a new device in France, at least for home parenteral nutrition (HPN). As a central intravenous line entering the organism via a peripheral vein of the arm, it offers some advantages on classic tunneled catheter: mainly reduced risk of mechanical or anatomical complications during insertion. Infection rate is identical but thrombosis risk is higher. PICC is appropriate for short or medium duration HPN (less 6months), particularly in case of contra-indication to large vein puncture.

Hiérarchisation des programmes de soins par des étudiants en pharmacie de France et du Québec selon la perception de l’impact de la présence de pharmaciens dans les services de soins

Healthcare decision makers need to establish priorities and their decisions must be justified. However, few data is available on the prioritization process of the healthcare programs that should benefit from decentralized pharmacists. The main objective was to prioritize healthcare programs according to the perceived impact of a decentralized pharmacist for outpatient and inpatient clienteles. The secondary objective was to compare the prioritization made by pharmacy students from two Quebec universities and from one French university. Two different approaches were developed (perceived impact according to three indicators and according to the global impact). The majority of healthcare programs with a high evidence based literature quality score (5/6 outpatient programs and 5/8 inpatient programs) were highly prioritized by at least two out of three cohorts. The median rank that was attributed for each healthcare program was significantly different between the three cohorts for 8/17 (47%) of outpatient programs and for 10/18 (56%) of inpatient programs. A higher rank was attributed to healthcare programs when the evidence based literature quality score was high. The prioritization was also influenced by the difference in pharmaceutical practice between France and Quebec (e.g. sterilization and medical devices in France). This study presented two approaches for the prioritization of healthcare programs that should benefit from a decentralized pharmacist, according to students from France and from Quebec.