The Vibrant vibrating capsule is an electric swallowable capsule that naturally passes through the gastrointestinal tract. It is indicated for the treatment of adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least 1 month.
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.
Delandistrogene Moxeparvovec (Elevidys; Sarepta Therapeutics Inc.) for Duchenne Muscular Dystrophy
Delandistrogene moxeparvovec (Elevidys; Sarepta Therapeutics Inc.) is an adeno-associated virus vector-based gene therapy indicated for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.
TOPS System (Premia Spine) for Lumbar Spondylolisthesis With Spinal Stenosis
The TOPS System (Premia Spine) is a motion-preserving spinal implant indicated for patients between 35 and 80 years of age with symptomatic degenerative spondylolisthesis up to Grade I, with moderate to severe lumbar spinal stenosis and either the thickening of the ligamentum flavum and/or of the scarring facet joint capsule at one level from L3 to L5.
LimiFlex Dynamic Sagittal Tether (Empirical Spine Inc.) for Spondylolisthesis
The LimiFlex Dynamic Sagittal Tether is a minimally invasive spinal implant designed to stabilize the spine, without fusing it, and maintain motion after spinal decompression in patients with grade 1 lumbar degenerative spondylolisthesis with spinal stenosis.
Multichannel Vestibular Implant (MVI) System for Vestibular Dysfunction
The Multichannel Vestibular Implant (MVI) System (Labyrinth Devices LLC) is an investigational vestibular implant for treatment of vestibular dysfunction.
Detour System (Endologix LLC) for Percutaneous Femoropopliteal Bypass
The Detour System is an endovascular stent-graft bypass system indicated for percutaneous revascularization in patients with symptomatic long femoropopliteal lesions with chronic total occlusion or diffuse stenosis who are suboptimal candidates for surgical or other endovascular treatments.
Viaskin Epicutaneous Immunotherapy (EPIT) for Peanut Allergy
Viaskin Peanut is an investigational daily immunotherapy patch for treatment of peanut allergy in children aged 1 to 3 years.
Alleviant (ALV1) System (Alleviant Medical Inc.) for Heart Failure
The Alleviant (ALV1) System is a radiofrequency catheter used to create an implant-free interatrial shunt for the treatment of heart failure with preserved ejection fraction (HFpEF) or heart failure with mildly reduced ejection fraction (HFmrEF).
Beremagene Geperpavec-svdt (Vyjuvek; Krystal Biotech Inc.) for Dystrophic Epidermolysis Bullosa
Vyjuvek is a topical gene therapy indicated for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
Revivent TC Transcatheter Ventricular Enhancement System (BioVentrix Inc.)
The Revivent TC Transcatheter Ventricular Enhancement System is a micro-anchor and tether system intended for minimally invasive left ventricular (LV) restoration in patients with LV scar/aneurysm and heart failure.