Aortix is an investigational percutaneous mechanical circulatory support device in development for the treatment of chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure with worsening renal function.
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.
Sonpiretigene Isteparvovec (Nanoscope Therapeutics Inc.) for Retinitis Pigmentosa
Sonpiretigene isteparvovec is an investigational gene therapy for retinitis pigmentosa, administered as an intravitreal injection.
ADAMTS13, Recombinant-krhn (Adzynma; Takeda Pharmaceutical Co. Ltd.) for Congenital Thrombotic Thrombocytopenic Purpura
Adzynma (Takeda Pharmaceutical Co. Ltd.) is a human recombinant “A disintegrin and metalloproteinase with thrombospondin motifs 13” (rADAMTS13) indicated for prophylactic or on demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura.
Rebonuputemcel Injectable Discogenic Cell Therapy (IDCT; DiscGenics Inc.) for Degenerative Disc Disease
Rebonuputemcel Injectable Discogenic Cell Therapy (IDCT; DiscGenics Inc.) is an allogeneic progenitor cell therapy for the treatment of symptomatic early-to-moderate lumbar degenerative disc disease at a single level from L3 to S1.
Paradise Ultrasound Renal Denervation System (ReCor Medical Inc.) for Resistant Hypertension
The Paradise Ultrasound Renal Denervation (uRDN) System (ReCor Medical Inc.) uses ultrasound energy delivered via a balloon-cooled catheter to perform targeted circumferential denervation to the renal afferent and efferent sympathetic nerves. The system is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications an…
Nuvella System (Neuspera Medical Inc.) for Urinary Urge Incontinence
The Nuvella System (Neuspera Medical Inc.) is an investigational integrated sacral nerve stimulator system for treatment of urinary urge incontinence.
Aurora EV-ICD System (Medtronic Inc.) for Ventricular Tachyarrhythmias
The Aurora EV-ICD System (Medtronic Inc.) is an extravascular implantable cardioverter-defibrillator (ICD) indicated for the automated treatment of patients who have experienced, or are at significant risk of developing, life-threatening ventricular tachyarrhythmias through the delivery of antitachycardia pacing, cardioversion, and defibrillation therapies.
WiSE Cardiac Resynchronization Therapy System (EBR Systems Inc.)
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.
Genicular Artery Embolization With Embozene Microspheres (Varian, a Siemens Healthineers Company) for Symptomatic Knee Osteoarthritis
Embozene Microspheres (Varian, a Siemens Healthineers company) are biocompatible, nonresorbable, hydrogel particles under investigation for genicular artery embolization (GAE) to treat symptomatic knee osteoarthritis (KOA).
Edison System (HistoSonics) for Histotripsy of Liver Tumors
The Edison System (Histosonics Inc.) is a nonthermal focused ultrasound system with real-time image guidance intended for the noninvasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy.