The Sinuva implant is a steroid-eluting bioabsorbable sinus implant intended to be placed in the ethmoid sinuses during a physician office visit. It is proposed as a less invasive alternative to revision sinus surgery in patients with recurrent sinus polyps after sinus surgery. The Sinuva implant is composed of a bioabsorbable polymer and has a self-expanding, nonobstructive design; the implan…
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.
Propel Contour Bioabsorbable Steroid-Releasing Sinus Implant
The Propel Contour sinus implant (formerly called the Nova implant) is a second-generation, bioabsorbable steroid-releasing sinus implant developed by the manufacturer of the FDA-approved Propel and Propel Mini steroid-releasing implants. The Propel Contour sinus implant is comprised of a bioabsorbable co-polymer, and contains 370 µg of mometasone furoate, an anti-inflammatory steroid. The imp…
Sublocade (Buprenorphine Extended Release Injection) for Opioid Use Disorder
Sublocade (formerly RBP-6000) is an extended-release formulation of buprenorphine intended for the treatment of moderate-to-severe opioid use disorder in patients who have undergone induction with a transmucosal buprenorphine-containing product to suppress opioid withdrawal signs and symptoms. Sublocade utilizes the Atrigel Delivery System, which consists of a biodegradable polymer dissolved i…
Spinraza (Nusinersen)
Spinraza is ann intrathecally administered antisense oligonucleotide (ASO) for treatment of spinal muscular atrophy (SMA). SMA is caused by deletions or mutations in the survival motor neuron 1 (SMN1) gene; these gene alterations lead to a deficiency of survival motor neuron (SMN) protein, which is critical for the maintenance of motor neurons. Spinraza is designed to alter the splicing…
Soliris (Eculizumab) for Myasthenia Gravis
Soliris is an intravenous humanized monoclonal antibody for the treatment of acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis. Soliris was initially Food and Drug Administration (FDA) approved in 2007 for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. The approval was expanded in 2011 to include treatment of patients w…
Kevzara (Sarilumab)
Kevzara is an injectable fully human monoclonal antibody directed against the interleukin-6 (IL-6) receptor for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or are intolerant to 1 or more disease-modifying antirheumatic drugs (DMARDs). Proinflammatory cytokines such as IL-6 are linked to the disease process in RA and pla…
Remedē System for Central Sleep Apnea
The remedē system is a fully implanted neurostimulator intended for treatment of moderate-to-severe central sleep apnea in adults. The remedē system delivers unilateral transvenous phrenic nerve stimulation to cause diaphragmatic contraction that mimics a normal breathing pattern. The contraction of the diaphragm creates a negative intrathoracic pressure similar to that generated by normal bre…
Impella RP for Right Heart Failure
The Impella RP system is a minimally invasive, miniaturized percutaneous circulatory support system for the right ventricle. The intent of the therapy with the Impella RP System is to provide a percutaneous circulatory support system to restore normal right heart hemodynamics, reduce right ventricular work, and allow the right heart time to potentially recover adequate contractile function or …
Tecentriq (Atezolizumab) for Non-Small Cell Lung Cancer
Tecentriq is an intravenous humanized monoclonal antibody that targets PD-L1, an immune checkpoint protein expressed on certain tumor cells (TC) and tumor-infiltrating immune cells (IC). It inhibits interaction between PD-L1 and PD-1. Tecentriq is FDA-approved for second-line treatment of locally advanced or metastatic non-small cell lung cancer. Tecentriq is also approved to treate urot…
Q-Collar for Prevention of Mild Traumatic Brain Injury
The Q-Collar is a C-shaped, externally-worn device that applies mild jugular compression according to the principle of the Queckenstedt maneuver. This maneuver obstructs venous return from the head, increasing the venous blood volume in the cranial cavity and simultaneously reducing the space for cerebrospinal fluid, which in turn increases the intracranial pressure.This action is proposed to …