Stellarex is a low-dose paclitaxel-coated balloon angioplasty catheter. It consists of an over-the-wire dual lumen catheter with a distally mounted semicompliant inflatable balloon and a tapered tip. The balloon is coated with a proprietary coating containing paclitaxel; the paclitaxel coating covers the working length of the balloon body. Stellarex delivers 2 μg/mm2 of paclitaxel w…
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.
SomnaPatch Sleep Apnea Test
The SomnaPatch is a home sleep apnea testing device that consists of a forehead-worn disposable adhesive patch connected to a nosepiece. It uses integrated sensors to measure and record nasal pressure, blood oxygen saturation, heart rate, respiratory effort, sleep duration, and changes in body position. The patch weighs less than 1 ounce.
Alfapump System for Treatment of Refractory Ascites
The alfapump is a fully implantable pump system that collects ascitic fluid from the peritoneal cavity and moves it into the urinary bladder, where it is passed naturally from the body through normal urination. It is proposed for management of refractory ascites in patients with cirrhosis of the liver who would otherwise require frequent large-volume paracentesis.
Micra Transcatheter Pacing System
The Micra Transcatheter Pacing System (TPS) is a single-chamber right ventricular (RV) pacing device with an estimated battery life of 7 to 15 years.The Micra TPS is self-contained and does not require a surgical incision in the chest or intravascular leads. It is inserted via a catheter placed in the femoral vein and held in place within the right ventricle of the heart via tines that attach …
Dupixent (Dupilumab)
Dupixent is a novel monoclonal antibody that inhibits signaling of interleukin-4 and interleukin-13, key T-helper cell 2 cytokines involved in the inflammatory process. The therapy is supplied in pre-filled syringes for self-administration by subcutaneous injection. Dupixent is the first FDA-approved biologic therapy for atopic dermatitis (AD). The FDA approved Dupixent in March 2017 for the t…
Radicava (Edaravone)
Radicava is a newly FDA-approved intravenously administered free radical scavenger for the treatment of amyotrophic lateral sclerosis (ALS). Oxidative stress has been considered to be involved in the onset and progression of ALS; it’s postulated that elimination of free radicals might protect motor neurons from oxidative stress and free radical damage in ALS patients. However, the FDA label fo…
Imfinzi (Durvalumab) for Urothelial Bladder Cancer
Imfinzi is an intravenous programmed death ligand-1 checkpoint inhibitor for the treatment of locally advanced or metastatic urothelial cancer in patients who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The interaction between the progra…
TrueTear Intranasal Tear Neurostimulator (Formerly Oculeve)
The TrueTear Intranasal Tear Neurostimulator is a nonsurgical, intranasally applied device that consists of a rechargeable handheld stimulator that is used with a disposable 2-pronged hydrogel tip assembly. The prongs are inserted into both nasal passages; the device then stimulates a nerve that innervates the lacrimal glands, increasing tear production.
Ingrezza (Valbenazine)
Ingrezza is a vesicular monoamine transporter 2 (VMAT2) inhibitor for the treatment of TD. VMAT2 has been identified as a pharmacological target for hyperkinetic movement disorders; Ingrezza causes reversible reduction of dopamine release by selectively inhibiting presynaptic VMAT2. Ingrezza is an oral medication that is taken once daily.
Ocrevus (Ocrelizumab) for Multiple Sclerosis
Ocrevus is a second-generation humanized anti-CD20 monoclonal antibody for the treatment of primary progressive and relapsing-remitting multiple sclerosis. Ocrevus selectively binds to the CD20 surface antigen on B cells and depletes them from the circulation. Ocrevus is administered by intravenous (IV) infusion.