Expert Review of Medical Devices最新文献

Introduction: Spinal cord stimulation is considered a minor elective procedure. The inherent goal is to provide safe, reliable, effective treatment with mitigation of known potential risk of adverse events.

Areas covered: This is a comprehensive literature review evaluating the most prevalent complications encountered with SCS implantation.

Expert opinion: SCS-related complications are uncommon. The authors offer clinical insight and feel the best practice is to have strategies employed to avoid complications, and we assist clinicians and surgeons in appropriately identifying and treating potential complications. There is a focus on appropriate patient selection, adherence to evidence-based guidelines and best practice recommendations.

Introduction: Chronic heart failure (HF) is characterized by high hospital admission rates. The CardioMEMS^TM HF System is a pulmonary artery pressure sensor developed for remote hemodynamic monitoring to reduce HF hospitalizations. The device is FDA approved and CE marked, but clinical evidence for the CardioMEMS system is mainly based upon U.S. studies. Because of structural differences in HF care between the U.S. and Europe, it is important to study CardioMEMS efficacy in European setting on top of usual HF care and contemporary therapy. Several observational studies have been performed in Europe, but there is an unmet need for randomized clinical trials.

Areas covered: This review focuses on safety and efficacy data for CardioMEMS remote hemodynamic monitoring in European HF setting, and discusses important upcoming studies.

Expert opinion: For safety, data from European studies are in line with U.S. studies. Efficacy with regard to reduction of HF hospitalizations seems promising, but is merely based upon observational studies comparing pre- and post-implantation event rates. The first European randomized clinical trial (MONITOR HF) will provide efficacy data compared to actual standard care in a high-quality healthcare system with contemporary HF treatment and will provide important generalizable information to other European countries.

Introduction: The FlareHawk Interbody Fusion System is a family of lumbar interbody fusion devices (IBFDs) that include FlareHawk7, FlareHawk9, FlareHawk11, TiHawk7, TiHawk9, and TiHawk11. These IBFDs offer a new line of multi-planar expandable interbody devices designed to provide mechanical stability, promote arthrodesis, and allow for restoration of disc height and lordosis through a minimal insertion profile during standard open and minimally invasive posterior lumbar fusion procedures. The two-piece interbody cage design consists of a PEEK outer shell that expands in width, height, and lordosis with the insertion of a titanium shim. Once expanded, the open architecture design allows for ample graft delivery into the disc space.

Areas covered: The design and unique features of the FlareHawk family of expandable fusion cages are described. The indications for their use are discussed. Early clinical and radiographic outcome studies using the FlareHawk Interbody Fusion System are reviewed, and properties of competitor products are outlined.

Expert opinion: The FlareHawk multi-planar expandable interbody fusion cage is unique amongst the many lumbar fusion cages currently on the market. The multi-planar expansion, open architecture, and adaptive geometry set it apart from its competitors.

Introduction: The determinants of time to return to activity (RTA) and return to work (RTW) after carpal tunnel release (CTR) remain unclear.

Methods: We performed a systematic review of studies published from January 2000 to November 2022 involving patients treated with open (OCTR), mini-open (mOCTR), or endoscopic (ECTR) CTR and reporting RTA or RTW. The time to RTA and RTW were estimated using a random-effects meta-analysis model. Subgroup analysis and multivariable meta-regression explored sources of heterogeneity in outcomes.

Results: A total of 7386 patients in 48 studies (63 groups) were included, with 24 groups (4541 patients) treated with OCTR, 16 groups (1085 patients) treated with mOCTR, and 23 groups (1760 patients) treated with ECTR. Among 15 studies (20 groups) reporting RTA, the mean was 13.1 days (95% CI, 9.9-16.3; I²>99%). Shorter duration of postoperative activity restriction guidance was associated with faster RTA. Among 43 studies (58 groups) reporting RTW, the mean was 23.4 days (95% CI, 21.4-25.3; I²>99%). Procedure type (mOCTR and ECTR compared to OCTR), prospective study design, and smaller proportion of patients receiving disability benefit were associated with faster RTW.

Conclusions: The time to RTA and RTW after CTR are highly variable and influenced by study-, patient-, and physician-specific factors.

Introduction: Carotid artery angioplasty and stenting (CAS) is an established procedure to treat carotid artery stenosis for either primary or secondary prevention of stroke. Randomized clinical trials have shown an increased risk of periprocedural cerebrovascular events with CAS compared with carotid endarterectomy (CEA). Several strategies have been proposed to mitigate this risk, including alternative vascular access site, proximal/distal embolic protection devices, and dual-layer stents, among others.

Areas covered: This review provides a general overview of current embolic protection strategies for CAS. The phases of the procedure which can affect the early risk of stroke and how to reduce it with novel techniques and devices have been discussed.

Expert opinion: Innovations in device technologies have dramatically improved the safety and efficacy of CAS. To minimize the gap with surgery, a thorough, patient-oriented approach should be pursued. Endovascular technologies and techniques should be selected on an individual basis to address unique lesion characteristics and vascular anatomies. Meticulous pre-procedural planning, both clinical and anatomical, is needed to assess the embolic risk of each procedure. Only by having an in-depth understanding of the wide range of available endovascular devices and techniques, the operator will choose the most appropriate strategy to optimize CAS results.

Introduction: In recent decades, concerns about safety of synthetic non-absorbable materials transvaginally implanted emerged. We aim to define the actual role of synthetic non-absorbable transvaginal mesh (TVM) for pelvic organ prolapse (POP) and mid-urethral sling (MUS) for stress urinary incontinence (SUI), in relation with the worldwide legislative evolution.

Areas covered: While in the United Kingdom MUS is not considered the first-line surgical option, other countries adopt MUS as the main procedure. United States, United Kingdom, Australia, New Zealand, France banned or paused TVM use for POP repair. At the same time, Germany, Asian, and South American countries adopt TVM after adequate counseling for selected populations such as women affected by or at high risk of POP relapse and contraindication for other surgical routes.

Expert opinion: The worldwide evolution of recommendations determined deep modification of clinical practice, with native tissue repair returning to forefront when the vaginal route is indicated. A more careful evaluation of the safety and efficacy profile of meshes' materials and the assessment of the minimal surgeon's expertise in performing TVM procedures became crucial. A multidisciplinary approach and a high specialization of the hospitals both in performing mesh procedures and in managing complications are mandatory.

Introduction: Ureteral stents are commonly used in urology but are frequently associated with hematuria, abdominal discomfort, urinary tract infection, stent displacement, and stent encrustation. Surface modification of ureteral stents is beneficial to solve the problem, and these can be divided into coated stents and drug-eluting stents according to the modification method. Coated stents can be divided into hydrophilic coatings, antibacterial coatings, and anti-encrustation coatings. Drug-eluting stents can be divided into antimicrobial drug-eluting, antispasmodic analgesic drug-eluting, anti-ureteral stricture drug-eluting, and anti-tumor drug-eluting. Surface modification of ureteral stents can not only reduce complications related to ureteral stents but also strengthen the treatment of certain urologic diseases, which has a high clinical application value.

Areas covered: This review focuses on highlighting and summarizing the latest research progress about surface modification of ureteral stents, ureteral stent development history, classification, functions, and future development prospects.

Expert opinion: The purpose of this article is to discuss surface modification of ureteral stents to reduce stent-related complications and potential research directions for the treatment of urinary tract tumors are also briefly discussed, to help guide further innovation in ureteral stent coatings, which contribute to the future progress of ureteral stents surface modification.

Aim: The aim of the present study was to propose the clinical efficacy of the different dentin matrix obtained from three devices (BonMaker, Tooth Transformer, and Smart Dentin Grinder) and to show their morphological, physical, and biochemical characteristics using scanning electron microscopy (SEM), energy-dispersive X-ray (EDX) spectroscopy, and Raman spectroscopy.

Research design and methods: The study included 70 patients who underwent bone augmentation using the BonMaker, Tooth Transformer, and Smart Dentin Grinder devices. In addition, 84 implants were placed. Furthermore, four samples, one for each device and one non-demineralized control, were analyzed with scanning electron microscopy (SEM), energy-dispersive X-ray analysis, and Raman spectroscopy.

Results: In all patients, augmentation of bone defects with ground dentin matrix was successful, and implants showed correct osseointegration. The morphological organization, the chemical composition, and the presence of organic molecules in the dentin samples processed by the three different devices were demonstrated using SEM, energy-dispersive X-ray analysis, and Raman spectroscopy.

Conclusions: Comparing BonMaker, Tooth Transformer, and Smart Dentin Grinder devices in our practice, we concluded that these systems, even with different structural and chemical differences of the dentin granules, have a comparable potential for obtaining regenerative material from the patient's own teeth.

Introduction: Liver-dominant metastatic colorectal cancer is noted in approximately 20%-35% of the patients. Systemic chemotherapy remains the first-line treatment for mCRC, but the prognosis is poor due to liver failure. Novel minimally invasive technologies have enabled the optimization of locoregional treatment options.

Areas covered: This is a comprehensive review of novel locoregional treatment technologies, both percutaneous ablation and transcatheter arterial treatments, which can be used to decrease hepatic disease progression in patients with mCRC. Trans-arterial radioembolization is the most recently developed locoregional treatment for metastatic liver disease, and robust evidence has been accumulated over the past years.

Expert opinion: Image-guided techniques, endovascular and ablative, have gained wide acceptance for the treatment of liver malignancies, in selected patients with non-resectable disease. The optimization of dosimetry and microsphere technological advancement will certainly upgrade the role of liver radioembolization segmentectomy or lobectomy in the upcoming years, due to its curative intent. Also, ablative interventions provide local curative intent, offering significant and sustained local tumor control. Standardization protocols in terms of predictability and reliability using immediate treatment assessment and ablation zone software could further ameliorate clinical outcomes.

Introduction: The impact of robotic-assisted total knee arthroplasty (rTKA) vs. traditional, manual TKA (mTKA) on hospital costs is not well documented and is analyzed herein.

Research design and methods: Patients in the Premier billing Healthcare Database undergoing elective rTKA or mTKA ("index') in the in- or outpatient setting for knee osteoarthritis between Oct 1^st, 2015, to September 30th, 2021, were identified. Variables included patient demographics and comorbidities and hospital characteristics. Matched rTKA vs. mTKA cohorts were created using direct (on provider characteristics, age, gender, race and Elixhauser index) and propensity score matching (fixation type, comorbidities). Index and 90-day inflation-adjusted costs and healthcare utilization (HCU) were analyzed for both cohorts, using generalized linear models.

Results: 16,714 rTKA patients were matched to 51,199 mTKA patients. Average 90-day hospital cost reached $17,932 and were equivalent for both cohorts (rTKA vs. mTKA: $132 (95% confidence interval; -$19 to $284). There was a 2.7% (95%CI: 2.2%-3.3%) increase in home or home health discharge, and a 0.4% (95%CI: 0%-0.8%) decrease in 90-day hospital knee related re-visit in the rTKA vs. mTKA group.

Conclusions: Cost-neutrality of rTKA vs. mTKA was observed, with a potential for lowered immediate post-operative HCU in the rTKA vs. mTKA cohorts.