Expert Review of Medical Devices

Introduction: The field of cardiac surgery continues to evolve significantly and one such example of advancement is aortic root replacement. In the setting of prior cardiac surgery, operative complexity increases due to adhesions, surgically-altered anatomy, and previously implanted prosthetic graft material. Device choice plays a significant role in balancing operative complexity with achieving simplicity and optimal clinical outcomes. Areas covered: This review explores the critical considerations necessary in performing redo aortic root surgery and the impact that device selection can have on the procedural complexity and clinical outcomes. This review was formulated by a systematic identification of published and unpublished laboratory and clinical studies evaluating these technologies. Expert opinion: Redo aortic root surgery represents one of the most challenging procedures in cardiac surgery, and the choice of both surgical technique and prosthetic device used are critical factors which influence the clinical success of the operation and the long-term outcomes for patients. By understanding the unique challenges of root replacement in a reoperative setting and the characteristics of different prosthetic devices, a tailored approach must be employed toward the best possible outcomes.

Introduction: This systematic review and proportional meta-analysis aims to evaluate the postoperative complication rate (CR%) of ceramic-based 3D-printed bone grafts based on the reported scientific articles conducted with human individuals. Methods: MEDLINE and SCOPUS were used as information sources. The synthesis of the study was carried out from studies with human individuals and the use of 3D-printed bone graft-ceramic as inclusion criteria. Cohen's kappa (κ) was calculated for interrater reliability. Qualitative analysis was performed based on the characteristics and outcomes of the individual study, and quantitative analysis was performed using proportional meta-analysis for CR%. Results: A total of 1352 records were identified through databases and resulted in 11 included studies (κ = 0.81-1.00) consisting of prospective clinical trials (64.63%), case series (16.67%), and case reports (18.18%). The overall postoperative complication rate was 14.3% (95% Cl: 0.19-53.6). The postoperative complication rate for studies conducted on the cranial defect, the maxillofacial-zygomatic defect, and the tibial-femoral defect was 2.7%, 11.1%, and 15.6%, respectively. This review also highlights common 3D printing techniques, materials, and grafs' characteristics, as well as their clinical applications. Conclusions: Ceramic-based 3D-printed bone grafts show potential as alternatives for bone tissue reconstruction.

Introduction: Diabetes is a chronic disease with high prevalence, necessitating advanced technology to achieve glycemic targets and reduce complications. Continuous glucose monitoring (CGM) has become a cornerstone in diabetes management, with the Freestyle Libre (FSL) systems being some of the most widely used devices. Areas covered: This review focuses on FSL systems, each including an all-in-one sensor and transmitter, a handheld reader and a Mobile Medical App (MMA). Glucose data are uploaded to a dedicated cloud-based platform for analysis. Over the years, FSL has evolved with new features offering valuable support for individuals with diabetes, caregivers, and healthcare providers. Clinical trials and real-world studies have demonstrated efficacy and safety across diverse populations, including individuals with type 1 and type 2 diabetes, adolescents, and pregnant women with diabetes. Expert opinion: FSL is a user-friendly system that meets the needs of patients and healthcare providers. The MMA allows a review of glucose metrics and pattern identification, and supports educational strategies and patient-tailored treatment. Future advancements, including ketone monitoring, integration with wearables and other devices, and telemedicine applications, will further optimize diabetes care and prevention.

Introduction: Magnetic resonance-guided focused ultrasound (MRgFUS) has emerged as a leading noninvasive therapy for tremor, offering a precise, lesion-based alternative to deep brain stimulation (DBS) and traditional lesioning techniques. By using phased ultrasound arrays to focus energy at intracranial targets, MRgFUS allows for real-time visualization and monitoring, improving safety and efficacy. Initially developed for essential tremor (ET), MRgFUS-VIM-thalamotomy has gained widespread acceptance and is now a first-line option for tremor-dominant Parkinson's disease (TDPD) and other tremor syndromes. Areas covered: This review discusses the fundamental physics of focused ultrasound, key anatomical targets, and the clinical application of MRgFUS thalamotomy, pallidotomy, and subthalamotomy. Skull density ratio (SDR) and energy efficiency are highlighted as crucial factors affecting treatment outcomes. The evolution of MRgFUS as a bilateral treatment, along with the exploration of novel targets such as the pallidothalamic tract, is examined. Additionally, we discuss advancements in FUS neuromodulation, which could complement lesioning by providing temporary or reversible symptom relief. Expert opinion: MRgFUS is poised to further revolutionize tremor treatment with frameless technology, staged bilateral procedures, and the integration of neuromodulation. Future developments may allow for precise, adaptive therapies that enhance both efficacy and patient experience.