Health Problem: Dry eye disease (DED) is a type of ocular surface disorder. Meibomian gland dysfunction (MGD) contributes to DED in approximately 60% of patients. The meibomian glands are present in the upper and lower eyelids and they secrete lipids that are an important component of tears. The oily lipids float to the surface of tear soluti…
Health Technology Assessments
Health Technology Assessments (HTAs) are a comprehensive systematic review and critical analysis of available evidence for A SINGLE medical technology for which there are several published clinical trials and a substantial body of evidence. This report details an entire technology class for which there are one or more indications or patient populations in use.
Our analysts evaluate clinical trial data, along with information regarding safety issues, coverage policies from the private and public sectors, regulatory approvals, consensus statements, and an overall projection of the potential clinical efficacy and economic impact of the technology. Reports are reviewed annually up to 5 years post publication to determine if there is new literature or evidence that would impact a change in rating and warrant an updated report.
Micra Transcatheter Pacing System (Medtronic Inc.) for Single-Chamber Pacemaker Indications
Health Problem: Bradycardia due to atrioventricular (AV) dysfunction or sinus node dysfunction may result in hemodynamic consequences. A permanent cardiac pacemaker (PM) is the definitive treatment for symptomatic bradycardia that is not caused by underlying disorders or medication. More than 600,000 PMs are implanted annually worldwide, with…
Cardiac Contractility Modulation in Heart Failure Patients Using the Optimizer Smart System (Impulse Dynamics)
Health Problem: Heart failure (HF) is a chronic condition that develops over time due to circumstances that overwork and damage the heart. The primary causes include coronary heart disease, high blood pressure, and diabetes. HF is characterized by the inability of the heart to pump blood efficiently. HF is estimated to affect approximately 5….
Sinuva (Intersect ENT Inc.) Steroid-Releasing Sinus Implant for the Treatment of Nasal Polyps After Ethmoid Sinus Surgery
Health Problem: Chronic rhinosinusitis (CRS), commonly known as chronic sinusitis, is a condition in which the paranasal sinuses are chronically inflamed, interfering with drainage and causing mucus buildup. Chronic inflammation in sinuses can lead to facial swelling, pain, tenderness, fever, fatigue, and difficulty breathing through the nose…
Thermal Pulsation for Chronic Dry Eye Syndrome and Meibomian Gland Dysfunction
Health Problem: Dry eye disease (DED) is a type of ocular surface disorder. Meibomian gland dysfunction (MGD) contributes to DED in approximately 60% of patients. The meibomian glands are present in the upper and lower eyelids and they secrete lipids that are an important component of tears. The oily lipids float to the surface of tear soluti…
Tumor Treating Fields (Optune) for Treatment of Glioblastoma
Health Problem: Glioblastoma (GBM) is the most prevalent primary malignant intracranial tumor, representing as much as 16% of primary brain tumors. GBM is a fast-growing glioma that develops from glial cells in the brain; it is also referred to as a grade IV astrocytoma. In the United States, the annual incidence of GBM ranges from 0.59 to 3….
DeNovo NT Natural Tissue Graft (Zimmer Inc.) for Articular Cartilage Repair of the Knee or Ankle
Health Problem: Articular cartilage is a resilient connective tissue that covers and lubricates joints at the interfaces of long bones to reduce friction during movement. Articular cartilage lesions have been reported in 4% to 6% of all knee arthroscopies (up to 36% in athletes). Chondral and osteochondral lesions of the ankle are commonly related to ankle sprain, affecting 1…
Reflectance Confocal Microscopy for Diagnosis of Cutaneous Melanoma
Health Problem: Melanoma is a malignant tumor of melanocytes, the pigment-producing cells of the skin that derive embryonically from the neural crest. This malignant cancer occurs primarily in adults and the most favorable prognoses are obtained when lesions are thin, minimally invasive, and confined to the primary site. Conversely, the proba…
Laparoscopic Radiofrequency Volumetric Thermal Ablation (Acessa System; Halt Medical Inc.) for Treatment of Uterine Fibroids
Health Problem: Uterine fibroids (UF) are benign tumors of the myometrium, the smooth muscle layer of the uterus. Approximately 25% of fibroids are symptomatic. Fibroids are the most common indication for hysterectomy and may be associated with infertility and adverse pregnancy outcomes.
Technology Description: The Acessa System is a minimally invasiv…
XEN Glaucoma Treatment System (Allergan) for Treatment of Open-Angle Glaucoma
Health Problem: Glaucoma is a disease of the optic nerve characterized by loss of retinal ganglion cells; remodeling of the lamina cribrosa; structural changes to the nerve; elevated intraocular pressure; and progressive, irreversible loss of vision, leading to blindness. Open-angle glaucoma (OAG) is associated with partial blockage of the fl…