Medtech

INTRODUCTION: Sternal dehiscence and other post-sternotomy complications, viz. superficial and deep sternal wound infection, mediastinitis, and sternal instability increase the risk of mortality. Sternotomy closure with steel sutures results in a low complication rate. Therefore, this study compared the clinical equivalence of Trusteel® (Healthium Medtech Limited, Bengaluru, India) and Ethisteel® (Ethicon, Johnson & Johnson, Cincinnati, USA) surgical steel sutures for sternal closure following median sternotomy...

Cardiovascular diseases remain a global health challenge, prompting continuous innovation in medical technology, particularly in Cardiovascular MedTech. This article provides a comprehensive exploration of the transformative landscape of Cardiovascular MedTech in the 21st century, focusing on interventions. The escalating prevalence of cardiovascular diseases and the demand for personalized care drive the evolving landscape, with technologies like wearables and AI reshaping patient-centric healthcare. Wearable devices offer real-time monitoring, enhancing procedural precision and patient outcomes...

BACKGROUND: Endovascular therapy (EVT) was demonstrated effective in acute large vessel occlusion (LVO) with large infarction. Revealing subgroups of patients who would or would not benefit from EVT will further inform patient selection for EVT. METHODS: This post-hoc analysis of the ANGEL-ASPECT trial, a randomised controlled trial of 456 adult patients with acute anterior-circulation LVO and large infarction, defined by ASPECTS 3-5 or infarct core volume 70-100 mL, enrolled from 46 centres across China, between October 2, 2020 and May 18, 2022...

PURPOSE: This study aims to describe and propose an effective strategy for an industrial cluster and investigates industrial cluster-promoted growth.Design/Methodology/Approach: A qualitative study was carried out within the Irish Medtech cluster with key stakeholders from the cluster. FINDINGS: The findings demonstrate significant opportunities for further cluster development and to potentially double the number of spin-outs and value of R&D investments while enhancing an entrepreneurial culture...

BACKGROUND: Incidence of sternal dehiscence, wound infection, and mortality are prevalent following sternotomy. Bone wax is widely used over the sternal edges for augmenting hemostasis. This study evaluated the clinical equivalence of Truwax® (Healthium Medtech Limited, Bengaluru, India) with Ethicon® (Johnson & Johnson, New Brunswick, New Jersey, United States) bone wax for sternal wound hemostasis in subjects undergoing surgical procedures by sternotomy. METHODS: The primary endpoint of this prospective (May 2022-April 2023), parallel-group, two-arm, randomized, single-blind, multicenter study was to evaluate the proportion of subjects having sternal dehiscence within 26 weeks of median sternotomy closure...

Artificial intelligence (AI)-enabled technologies in the MedTech sector hold the promise to transform healthcare delivery by improving access, quality, and outcomes. As the regulatory contours of these technologies are being defined, there is a notable lack of literature on the key stakeholders such as the organizations and interest groups that have a significant input in shaping the regulatory framework. This article explores the perspectives and contributions of these stakeholders in shaping the regulatory paradigm of AI-enabled medical technologies...

Neurodegenerative diseases (NDs) such as Alzheimer's Disease (AD) and Parkinson's Disease (PD) are devastating conditions that can develop without noticeable symptoms, causing irreversible damage to neurons before any signs become clinically evident. NDs are a major cause of disability and mortality worldwide. Currently, there are no cures or treatments to halt their progression. Therefore, the development of early detection methods is urgently needed to delay neuronal loss as soon as possible. Despite advancements in Medtech, the early diagnosis of NDs remains a challenge at the intersection of medical, IT, and regulatory fields...

UNLABELLED: Robot-assisted implantation of deep electrodes for stereo-EEG monitoring has become popular in recent years in patients with drug-resistant epilepsy. However, there are still few data on safety of this technique. OBJECTIVE: To assess the incidence of complications in patients with drug-resistant epilepsy undergoing robot-assisted implantation of stereo-EEG electrodes. MATERIAL AND METHODS: We retrospectively studied the results of implantation of stereo-EEG electrodes in 187 patients with drug-resistant epilepsy...

Introduction Incisional hernia is a common complication of midline laparotomy that may develop even after several years of surgery. Abdominal fascia closure with ideal suture material reduces the incidence of incisional hernia. This study compared the clinical equivalence of PD Synth (Healthium Medtech Limited) and PDS (Ethicon, Johnson & Johnson) slowly absorbed polydioxanone suture with respect to the occurrence of incisional hernia, following elective/emergency midline laparotomy. Methods Eighty-eight subjects undergoing elective/emergency midline laparotomy were randomized to PD Synth (n=45) and PDS (n=43) groups of this prospective, multicenter, randomized (1:1), single-blind, two-arm, parallel-group study (December 2020-May 2023)...

Background Surgical site infection (SSI) is considered as a healthcare-associated infection. Wound dressings play an imperative role in altering the risk of SSI. In this study, we compared the efficacy and safety of Trushield NXT Non-adherent dressing (Healthium Medtech Limited, Bangalore, India) to the traditional Tegaderm HP+ Pad Film Dressing with Non-Adherent Pad (3M, Bangalore, India) in post-operative wound management of obstetrics and gynecological surgeries. Methodology This was a single-centre, prospective, two-arm, parallel-group, randomized, single-blind study conducted between January 2022 and May 2022...

Transcatheter aortic valve implantation (TAVI) has become a therapeutic treatment for severe symptomatic patients with aortic stenosis. This study aimed to test a novel transcatheter aortic self-expandable bioprosthesis-the ScienCrown system (Lepu Medtech Inc., Beijing, China)-and evaluate the safety of the new device during TAVI. ScienCrown aortic valve implantation was performed on 10 patients. Clinical assessment was performed at baseline, post procedure, and after 1 year. Clinical outcomes and adverse events were assessed according to Valvular Academic Research Consortium-3 criteria...

BACKGROUND: The burden of communicable, non-communicable diseases and reproductive maternal, newborn, child & adolescent health in India, reflects the necessity to develop tailored solutions. The plethora of MedTech innovations has provided healthcare facilities with more effective, affordable and accessible healthcare for people across the country. However, in spite of the Make-in-India scheme in the country, the indigenously developed healthcare technology is far from making an impact on the healthcare system...

CONTEXT: Evaluation of visual quality in soft and rigid gas-permeable contact lens wearers, with an emphasis on twilight vision. PURPOSE: To assess the visual acuity and visual performance at dusk before and after soft and rigid gas-permeable contact lens (CL) correction in healthy subjects. SETTINGS AND DESIGN: This prospective study was conducted in a tertiary eye-care center. METHODS: Sixty eyes corrected with soft contact lenses (SCLs) and 30 eyes with rigid gas-permeable contact lenses (RGPCLs) were enrolled in this study...

BACKGROUND: Cryoballoon ablation (CBA) has emerged as an effective treatment for atrial fibrillation (AF). OBJECTIVES: This study sought to assess the performance of a novel liquid nitrogen-driven CBA system and evaluate its safety and efficacy in the treatment of drug-resistant paroxysmal atrial fibrillation (PAF). METHODS: This was a prospective multicenter single-arm clinical trial with 10 participating tertiary hospitals enrolling 176 patients with PAF...

As the health care landscape evolves toward value-based care and emphasizes health-related social needs, the importance of developing health policies and digital health solutions that foster health equity and risk-based reimbursement strategies has grown. Orthopaedic surgery, catering to a diverse patient population but challenged by a lack of workforce diversity, encounters distinct opportunities and obstacles in adopting digital health technologies for delivering equitable, high-value care. The integration of health-related social needs into the emerging value-based care model and risk-based reimbursement policies is important...

BACKGROUND: Rotator cuff tears are a common cause of disability in the shoulder of the aging population. Rotator cuff repair is performed to address disability arising from rotator cuff tears, which fails to improve by conservative treatment. The present retrospective study was undertaken to explore the efficacy, safety, clinical, and radiological outcomes of PEEK suture anchors (Ceptre® suture anchor and Viplok® knotless anchor; Sironix, Healthium MedTech, India) in the treatment of arthroscopic rotator cuff repairs...

Digital transformation in healthcare during the COVID-19 pandemic led to the development of new hybrid models integrating physical and virtual care. The ability to provide remote care by telemedicine technologies and the need to better manage and control hospitals' occupancy accelerated growth in hospital-at-home programs. The Sheba Medical Center restructured to create Sheba Beyond as the first virtual hospital in Israel. These transformations enabled them to deliver hybrid services in their internal medicine unit by managing inpatient hospital-care with remote home-care based on the patients' medical condition...

No abstract text is available yet for this article.

BACKGROUND: The circular economy reshapes the linear "take, make, and dispose" approach and evolves around minimizing waste and recapturing resources in a closed-loop system. The health sector accounts for 4.6% of global greenhouse gas emissions and has, over the decades, been built to rely on single-use devices and deal with high volumes of medical waste. With the increase in the adoption of digital health solutions in the health care industry, leading the industry into a new paradigm of how we provide health care, a focus must be put on the amount of waste that will follow...

Background Anterior cruciate ligament (ACL) injury is most common among athletes compared to the general population. ACL reconstruction is a clinical standard for restoring joint mechanical stability and enabling sports return. The purpose of the study is to evaluate the safety and functional outcomes after arthroscopic ACL reconstruction using the Sironix titanium button and the polyetheretherketone (PEEK) button. Methods A total of 31 subjects who have undergone arthroscopic ACL reconstruction using the Sironix titanium button and PEEK button between August 2022 and January 2023 were included in the study...