The OCS Heart is a portable extracorporeal heart perfusion and monitoring system indicated for the preservation of donor-after-brain-death (DBD) donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e.g., > 4 hours of cross-clamp time).
Emerging Technology Reports
The Emerging Technology Report provides regular updates about emerging and potentially disruptive technologies that are likely to have a significant impact in healthcare. This “early warning” report monitors new health technologies from 6 months to 2 years within a regulatory submission and tracks those as they go through clinical trial development and the regulatory approval process.
For each emerging technology, our analysts describe the technology and intended use, its prospects relative to the regulatory process and FDA information, competing technologies, relevant clinical guidelines, high-level look at the evidence such as published abstracts in the medical literature and available meeting abstracts, and available clinical trials.
Kerendia (finerenone) is a nonsteroidal mineralocorticoid receptor antagonist indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes.
The Vivistim Paired VNS System is an implanted neurostimulator system intended to be used to stimulate the vagus nerve during rehabilitation therapy in order to reduce upper extremity motor deficits and improve motor function in chronic ischemic stroke patients with moderate to severe arm impairment.
Mitapivat is an investigational oral drug designed to increase the activity of the pyruvate kinase (PK) enzyme in red blood cells. It is proposed for the treatment adults with PK deficiency.
Donanemab is an intravenously administered amyloid beta-directed antibody proposed for the treatment of Alzheimer disease.
The HistoSonics System is an ultrasound histotripsy system intended for noninvasive mechanical destruction of malignant cells via acoustic cavitation. It is under investigation for the treatment of primary or metastatic hepatocellular tumors.
Oportuzumab monatox is an antibody-drug conjugate that targets epithelial cell-adhesion molecule (EpCAM) in development for the treatment of bacillus Calmette-Guerin-unresponsive non-muscle invasive bladder cancer. It is an intravesical treatment, administered through a catheter directly into the bladder.
Elivaldogene autotemcel (eli-cel) is a lentiviral-based gene therapy for treatment cerebral adrenoleukodystrophy (CALD).
The WiSE CRT system is a wireless left ventricular pacing system that works with an implanted right ventricular pacemaker and/or defibrillator for patients in whom cardiac resynchronization therapy (CRT) is indicated.
The Viveve System is a cryogen-cooled monopolar radiofrequency device proposed for treatment of stress urinary incontinence in premenopausal women.