Medical Devices-Evidence and Research最新文献

Purpose: The purposes of the present research were to assess the accuracy and usability of the inertial navigation system (INS).

Materials and methods: The accuracy of the device navigation subsystem was assessed using benchtop testing. The usability was assessed through simulated use with surgeons. These results were compared to recent cadaveric results for the same system.

Results: The navigation subsystem had an overall mean absolute error of 1.21° and a maximum absolute error across all devices of 4.79°. The device was found to be usable and to add an estimated 7 minutes to surgery time.

Conclusion: The INS uses a novel approach to provide the surgeon with accurate and fast acetabular cup inclination and anteversion angles during THA.

The pulse wave velocity (PWV) threshold for hypertensive target organ damage is presently set at 10 meters per second. New 24-hour monitors (eg, BPLab® and Vasotens®) provide several PWV measurements over a period of 24-72 hours. A new parameter, ie, the Pulse Time Index of Norm (PTIN), can be calculated from these data. The PTIN is defined as the percentage of a 24-hour period during which the PWV does not exceed 10 meters per second. The aim of the present study was to test the new PTIN for clinical feasibility using day-to-day repeatability analysis. Oscillometrically generated waveform files (n=85), which were previously used for research studies, were reanalyzed using the new 2013 version software of the Vasotens technology program, which enables calculation of PTIN. The intraclass correlation coefficient was 0.98 and Cronbach's alpha was 0.97, indicating that the PTIN has excellent day-to-day repeatability and internal consistency. The present results show adequate repeatability, and PTIN assessment using the Vasotens technology appears to be feasible.

First-generation drug-eluting stents have raised concerns regarding the risk of late and very late stent thrombosis compared with bare metal stents and require prolonged dual antiplatelet therapy. Despite extensive investigations, the physiopathology of these late events remains incompletely understood. Aside from patient- and lesion-related risk factors, stent polymer has been cited as one of the potential causes. In fact, the persistence of durable polymer after complete drug release has been shown to be responsible for local hypersensitivity and inflammatory reactions. Third-generation drug-eluting stents with more biocompatible or biodegradable polymers have subsequently been developed to address this problem. In this article, we evaluate and discuss the concept and clinical results (safety and efficacy) of a third-generation drug-eluting stent with biodegradable polymer: the Nobori® stent.

This review describes issues for the estimation of pulse wave velocity (PWV) under ambulatory conditions using oscillometric systems. The difference between the principles of measuring the PWV by the standard method and by oscillometry is shown, and information on device validation studies is summarized. It was concluded that currently oscillometry is a method that is very convenient to use in the 24-hour monitoring of the PWV, is relatively accurate, and is reasonably comfortable for the patient. Several indices with the same principles as those in the analysis of blood pressure in ambulatory monitoring of blood pressure, namely the assessment of load, variability, and circadian rhythm, are proposed.

Even if the performance of a given ventilator has been evaluated in the laboratory under very well controlled conditions, inappropriate maintenance and lack of long-term stability and accuracy of the ventilator sensors may lead to ventilation errors in actual clinical practice. The aim of this study was to evaluate the actual performances of ventilators during clinical routines. A resistance (7.69 cmH(2)O/L/s) - elastance (100 mL/cmH(2)O) test lung equipped with pressure, flow, and oxygen concentration sensors was connected to the Y-piece of all the mechanical ventilators available for patients in four intensive care units (ICUs; n = 66). Ventilators were set to volume-controlled ventilation with tidal volume = 600 mL, respiratory rate = 20 breaths/minute, positive end-expiratory pressure (PEEP) = 8 cmH(2)O, and oxygen fraction = 0.5. The signals from the sensors were recorded to compute the ventilation parameters. The average ± standard deviation and range (min-max) of the ventilatory parameters were the following: inspired tidal volume = 607 ± 36 (530-723) mL, expired tidal volume = 608 ± 36 (530-728) mL, peak pressure = 20.8 ± 2.3 (17.2-25.9) cmH(2)O, respiratory rate = 20.09 ± 0.35 (19.5-21.6) breaths/minute, PEEP = 8.43 ± 0.57 (7.26-10.8) cmH(2)O, oxygen fraction = 0.49 ± 0.014 (0.41-0.53). The more error-prone parameters were the ones related to the measure of flow. In several cases, the actual delivered mechanical ventilation was considerably different from the set one, suggesting the need for improving quality control procedures for these machines.

The somatostatin analogs (SSAs) lanreotide Autogel/Depot and octreotide long-acting release are used to treat acromegaly and neuroendocrine tumors. The present study evaluated opinions on SSA injection devices, including a recently approved lanreotide new device (lanreotide-ND), among nurses in Europe and the USA. Nurses injecting SSAs for at least three patients per year (n = 77) were interviewed regarding SSA devices. Device attributes were rated via questionnaire; nurses were then timed administering test injections with lanreotide-ND and octreotide long-acting release. The most important delivery system attributes were easy/convenient preparation and injection (ranked in the top five by 70% of nurses), low clogging risk (58%), and high product efficacy (55%). Compared with the octreotide long-acting release device, lanreotide-ND scored higher on 15/16 attributes, had shorter mean preparation and administration time (329 versus 66 seconds, respectively; P ≤ 0.01) and a higher overall preference score (70 versus 114, respectively; P ≤ 0.01). The five most important lanreotide-ND attributes were: prefilled device, confidence a full dose was delivered, low clogging risk, easy/convenient preparation and injection, and fast administration. These device features could lead to improvements in clinical practice and benefit patients/caregivers who administer SSAs at home.

Background: There is insufficient evidence to determine whether intra-articular injections may be effective for treatment of glenohumeral osteoarthritis. Euflexxa(®) (high molecular weight hyaluronate), a bioengineered high molecular weight hyaluronan, has been shown to be a safe and effective treatment for patients with knee osteoarthritis. There is also support for the use of hyaluronate injection for the treatment of chronic shoulder pain associated with osteoarthritis or rotator cuff damage. This small-scale exploratory study was conducted to evaluate the safety and efficacy of high molecular weight hyaluronate for the treatment of chronic shoulder pain associated with osteoarthritis.

Methods: Subjects with glenohumeral osteoarthritis and chronic pain (n = 27) received one injection per week for 3 weeks of high molecular weight hyaluronate and were assessed for changes in pain (100 mm visual analog scale [VAS]), range of motion, and the subject's and physician's global assessment over 26 weeks. Subjects were also assessed for pain, stiffness, and physical functioning using the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Finally, responses were evaluated using modified Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT)-Osteoarthritis Research Society International (OARSI) Proposition D criteria. Safety was assessed by recording adverse events.

Results: High molecular weight hyaluronate significantly improved pain (VAS, WOMAC), range of motion, stiffness, and physical functioning scores; 77.8% of subjects were rated as having an OMERACT-OARSI Proposition D high response. There were no serious adverse events, and none were considered to be related to treatment.

Conclusion: Treatment with high molecular weight hyaluronate improves pain, stiffness, and range of motion, and may have an acceptable safety and tolerability profile. A randomized, double-blind, placebo-controlled clinical trial may be warranted to investigate further the efficacy and safety of intra-articular high molecular weight hyaluronate for treatment of chronic shoulder pain in patients with glenohumeral osteoarthritis.

From its introduction, the antibiotic tobramycin has been an important tool in the management of persons with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa lung infections. Initially an intravenous rescue treatment for pulmonary exacerbations, tobramycin delivered by inhalation has become a mainstay of chronic suppressive CF infection management. Platforms for tobramycin aerosol delivery have steadily improved, with increased lung deposition complimented by decreased device complexities, loaded tobramycin doses, delivery times, and treatment burdens. Most recently, a unique tobramycin inhalation powder (TIP) formulation with a portable delivery system, the TOBI(®) Podhaler(®) (Novartis AG, Basel, Switzerland) has been developed and approved in Europe, Canada, and Chile. Four capsules, each containing 28 mg of TIP are successively pierced and inhaled via the T-326 Dry Powder Inhaler Device (Novartis AG, Basel, Switzerland). No external power source is required to deliver an efficacious tobramycin dose in minutes. By comparison, tobramycin inhalation solution (TIS) (TOBI(®); Novartis), is delivered by LC(®) Plus (PARI Respiratory Equipment Inc, Midlothian, VA) jet nebulizer powered by an air compressor over 15-20 minutes. Comparative pharmacokinetics, safety, and efficacy studies of TIS and TIP in CF subjects with P. aeruginosa ≥ 6 years old demonstrate that: tobramycin lung deposition with 112 mg TIP is comparable to that attained with 300 mg TIS, TIP is more effective than placebo and not inferior to TIS with respect to pulmonary function benefit, and TIP has significantly faster treatment times and achieves higher patient satisfaction than TIS. TIP is associated with an increased frequency of mild to moderate local adverse events (cough, dysphonia, and dysgeusia) compared with TIS, however, these become less frequent as subjects gain TIP experience. These results suggest that the TOBI Podhaler may better meet the needs of many CF patients and families by reducing treatment time and complexity and improving patient satisfaction compared with TIS.

Purpose: The purpose of this study was to assess the preventive effect of cilostazol on in-stent restenosis in patients after superficial femoral artery (SFA) stent placement.

Materials and methods: Of 28 patients with peripheral arterial disease, who had successfully undergone stent implantation, 15 received cilostazol and 13 received ticlopidine. Primary patency rates were retrospectively analyzed by means of Kaplan-Meier survival curves, with differences between the two medication groups compared by log-rank test. A multivariate Cox proportional hazards model was applied to assess the effect of cilostazol versus ticlopidine on primary patency.

Results: The cilostazol group had significantly better primary patency rates than the ticlopidine group. Cumulative primary patency rates at 12 and 24 months after stent placement were, respectively, 100% and 75% in the cilostazol group versus 39% and 30% in the ticlopidine group (P = 0.0073, log-rank test). In a multivariate Cox proportional hazards model with adjustment for potentially confounding factors, including history of diabetes, cumulative stent length, and poor runoff, patients receiving cilostazol had significantly reduced risk of restenosis (hazard ratio 5.4; P = 0.042).

Conclusion: This retrospective study showed that cilostazol significantly reduces in-stent stenosis after SFA stent placement compared with ticlopidine.

The root cause of coronary artery disease is atherosclerosis, ie, intraluminal narrowing (stenosis) of the arteries that supply blood to tissues of the heart. The introduction of the drug-eluting stent over the past decade has revolutionized the field of interventional cardiology. It is used extensively in clinical practice for the treatment of coronary artery disease. The first drug-eluting stent to receive US Food and Drug Administration approval was the sirolimus-eluting stent. Recently, two other stent analogs of sirolimus were approved, ie, the zotarolimus-eluting stent and the everolimus-eluting stent. However, concern has arisen in recent years about the long-term safety and efficacy of drug-eluting stents, due to the occurrence of late adverse clinical events, such as stent thrombosis. This review focuses on clinical studies that have been performed with the sirolimus-eluting stent or its analogs. We discuss the pharmacology, safety, and various therapeutic options that exist when choosing stents for coronary artery disease. Our aim is to provide a thorough review of the long-term efficacy and safety of sirolimus drug-eluting stents, and also to discuss currently approved and promising investigational drug-eluting stents, in an effort to provide insight into how these stents are currently evolving and generate further investigation in this area.