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.
Horizon Scanning
It is a challenge for health plans and clinicians to know what emerging technologies are in the preapproval phase and what their clinical, financial, and risk impacts might be. This is where we come in.The Hayes Horizon Scanning Solution identifies innovative and potentially disruptive health technologies that are in various stages of the regulatory approval process. Our Research Analysts continually investigate new technologies that are on the horizon or in the early stages of clinical investigation, as well as the testing of existing technologies that may be seeking approval for new clinical applications. Hayes Horizon Scanning helps you track emerging technologies before you need to make decisions. Accessed through the Hayes Knowledge Center, Hayes Horizon Scanning addresses the following fundamental questions to help our clients forecast emerging technologies:
- Is this emerging technology new or replacing an existing technology?
- Where is this technology in the FDA regulatory process?
- When will this technology be commercially available in the market?
- What is the projected use, cost, and financial impact of this technology?
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.