The automated low-flow ascites pump (alfapump; Sequana Medical NV) is an implantable wireless battery-powered pump for treatment of recurrent or refractory ascites due to liver cirrhosis.
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.
Edison System (HistoSonics) for Histotripsy of Renal Tumors
The Edison System (HistoSonics) is a nonthermal focused ultrasound system with real-time image guidance under investigation for the noninvasive mechanical destruction of stage I primary solid renal tumors via histotripsy.
Eplontersen (Wainua; Ionis Pharmaceuticals Inc./AstraZeneca) for Hereditary Transthyretin-mediated Amyloid Polyneuropathy
Eplontersen (Wainua; Ionis Pharmaceuticals Inc./AstraZeneca) is an injectable transthyretin-directed antisense oligonucleotide indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Filsuvez (Birch Triterpenes) Topical Gel (Chiesi Global Rare Diseases) for Epidermolysis Bullosa
Filsuvez (birch triterpenes) topical gel (formerly Oleogel-S10; Chiesi Global Rare Diseases) is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older.
Globe Pulsed Field Mapping and Ablation System (Kardium Inc.) for Atrial Fibrillation
The Globe Pulsed Field Mapping and Ablation System is an investigational pulsed-field ablation system for treatment of atrial fibrillation.
PulseSelect Pulsed Field Ablation (PFA) System (Medtronic Inc.) for Atrial Fibrillation
The PulseSelect system (Medtronic Inc.) is a pulsed field ablation (PFA) system indicated for cardiac electrophysiological mapping (stimulation and recording) and for treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation or persistent atrial fibrillation (episode duration less than 1 year).
Lovotibeglogene Autotemcel (Lyfgenia; Bluebird Bio) for Sickle Cell Disease
Lovotibeglogene autotemcel (Lyfgenia; Bluebird Bio Inc.) is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events.
Aortix Percutaneous Mechanical Circulatory Support Device (Procyrion Inc.)
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.
Sonpiretigene Isteparvovec (Nanoscope Therapeutics Inc.) for Retinitis Pigmentosa
Sonpiretigene isteparvovec is an investigational gene therapy for retinitis pigmentosa, administered as an intravitreal injection.
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.