The Superion Interspinous Spacer is an interspinous implant proposed to treat neurogenic claudication in patients with impaired physical function secondary to moderate lumbar spinal stenosis with or without grade 1 spondylolisthesis who have undergone at least 6 months of non-operative treatment.
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.
Cotellic (Cobimetinib) and Zelboraf (Vemurafenib) Combination Therapy
Cotellic (cobimetinib) and Zelboraf (vemurafenib) is an oral BRAF and MEK inhibitor combination therapy for the treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.
Imlygic (Talimogene Laherparepvec, T-Vec) for Treatment of Unresectable Melanoma
T-Vec is a first-in-class, injectable, intralesional oncolytic immunotherapy for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery.
Adjuvant Yervoy (Ipilimumab) for Patients with Resected Melanoma
An anti-cytotoxic T-lymphocyte-associated antigen-4 human monoclonal antibody for adjuvant therapy in patients with high-risk, resected stage III melanoma.
In.Pact Admiral Drug Coated Balloon (DCB) PTA Catheter
A drug-coated balloon percutaneous transluminal angioplasty catheter to treat obstructive de novo or restenotic lesions ≤ 18 cm in length in the superficial femoral or proximal popliteal arteries.
Prostvac (PSA-TRICOM; Rilimogene-Galvacirepvec)
A vector-based cancer vaccine for first-line treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
Reza Band
An externally worn upper esophageal sphincter compression device intended for reduction of symptoms associated with laryngopharyngeal reflux disease in adults.
Augment Bone Graft (rhPDGF-BB and beta-TCP)
An injectable synthetic graft substitute proposed as an alternative to autologous bone graft in hindfoot and/or ankle fusion procedures in adults.
Praluent (Alirocumab)
Praluent is a member of a new class of lipid-lowering agents known as PCSK9 inhibitors. It is self-administered as a subcutaneous injection in a single-use pre-filled pen or pre-filled syringe. It is indicated for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascula…
StimGuard Wireless Miniature Sacral Nerve Stimulator for Overactive Bladder
A wireless injectable sacral nerve stimulator for the relief of overactive bladder.