The Car study is being done to collect real-world evidence of how commercially available MicroVention intracranial aneurysm treatment devices function and look at safety outcomes over a year when used per standard of care. The treating physician will use the device they think is most appropriate for each patient. The study will also be used to develop a full database in an effort to inform future studies and further the understanding of the safety and performance of these devices across a wide range of patient populations and disease characteristics.
This study aims to create a long-term Ehlers-Danlos syndrome (EDS) biorepository and clinical research database to support gene and biomolecular discovery. The repository will serve as a sustainable resource for advancing EDS-related research by collecting both clinical data and biological samples. Participants who consent will be included in the EDS registry, which stores demographic and operative information, contact details, and biological specimens for current and future studies. Enrolled patients may also choose to be recontacted for future research opportunities. The database will link participants across specialties using identifiers such as name, date of birth, and medical record number. Data collected will include information from electronic health records, such as clinical notes, diagnoses, medications, labs, imaging, anthropometric measures, and procedure reports.
This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.
To evaluate the performance of the Merit Medical WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY device). The WRAPSODY device is used to treat a blocked or narrowed vein you have in your dialysis access circuit that affects your blood flow during dialysis (treatment that removes waste and excess fluid from your blood).
This study is designed to assess the 10-year post-surgery implant survivorship of Total Knee Arthroplasty (TKA) procedures performed using the LEGION Medial stabilized insert, which is FDA approved. Implant survivorship is defined as all of the knee-implanted components without a need for a revision. Questionnaires will be used up to 10 years after surgery to find more about the safety and performance of the device.
The purpose of this research is to assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.
This is a prospective single-arm post-market multicenter study to evaluate
clinical outcomes of Cohealyx when used to manage full thickness wounds
post-surgical excision. Patients with a full thickness wound where autografting is clinically indicated will be considered for participation in this study. Patients will
undergo a staged surgical procedure for wound closure. In the first surgery, Cohealyx will be applied to the surgically excised wound bed within 5-days post-injury. Once Cohealyx has successfully integrated into the wound bed, the wound will be prepped and autografted per standard of care.
The study is a 48-week clinical study to compare study medication NTX-001 used intraoperatively to promote nerve regeneration compared to the standard of care on surgery for acute nerve damage in the hand on subjects between the ages of 18 to 80 years old. Subjects who present with sever nerve damage of the hand and need surgery to repair the nerve damage within 48 hours of injury. After surgery, subjects will complete 12 total study visits: 6 in person and 6 additional telehealth visits. During the in-person clinic visits, subjects will be assessed by physical examinations, vital signs, safety laboratory assessment and complete questionnaires. Subjects with motor/mixed motor injury will also complete an EMG and NCV assessments with an Occupational Therapist at 2 of the in-person visits. During the telehealth visits, subjects will complete questionnaires.
The objective of the study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3™ (HM3) LVAS (Abbott) when used for the treatment of advanced, refractory, left ventricular heart failure.