The Melphalan Hepatic Delivery System (M-HDS; proposed U.S. name, Hepzato Kit) is a catheter-based drug delivery and chemofiltration kit for intra-arterial administration of melphalan chemotherapy directly to the liver followed by extracorporeal filtration of hepatic venous blood to reduce melphalan concentration before returning blood to systemic circulation. It is used to p…
Publications
Researched and Curated by Clinical and Scientific Experts.Every Hayes clinical evidence report is developed by experienced teams that have been trusted by healthcare decision makers since 1989. Here is a sampling of our content that is being used every day to inform defensible, evidence-based decisions by payers and providers.
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Atidarsagene Autotemcel for Metachromatic Leukodystrophy
Atidarsagene autotemcel is an investigational gene therapy administered by intravenous infusion for the treatment of metachromatic leukodystrophy.
Pulmonary Artery Denervation (PADN) Catheter (Pulnovo Medical) for Pulmonary Arterial Hypertension
The Pulnovo Pulmonary Artery Denervation (PADN) catheter is an investigational pulmonary artery catheter intended for radiofrequency ablation of pulmonary nerves to treat pulmonary arterial hypertension (PAH) in adults.
Therapeutic Intravascular Ultrasound (TIVUS) System (SoniVie) for Pulmonary Hypertension
The Therapeutic Intravascular Ultrasound System (TIVUS) is an intravascular ultrasound system under investigation for catheter-based pulmonary artery denervation to treat adult patients with pulmonary arterial hypertension.
WiSE Cardiac Resynchronization Therapy System
The WiSE CRT system is a wireless left ventricular pacing system that works with an implanted right ventricular pacemaker and/or defibrillator for patients in whom cardiac resynchronization therapy (CRT) is indicated.
Humacyl Acellular Vessel for Vascular Trauma
Humacyl is an off-the-shelf bioengineered human acellular vessel proposed for use in the repair of vascular trauma. This technology uses a process to decellularize donated human vascular smooth muscle cells, while preserving extracellular matrix proteins. This results in a tubular scaffold that is acellular at the time of implantation and becomes populated with the patient’s …
Minimally Invasive Lumbar Decompression Device Kit (Vertos Medical Inc.) for Treatment of Lumbar Spinal Stenosis
Focus of the Report: The focus of this Health Technology Assessment is to evaluate the effectiveness and safety of the minimally invasive lumbar decompression (mild) procedure, an approach that uses a proprietary surgical kit (mild; Vertos Medical Inc.) to treat lumbar spinal stenosis (LSS) in adult (≥ 18 years old) patients.
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Tofersen for Amyotrophic Lateral Sclerosis
Tofersen is an investigational antisense oligonucleotide proposed for the treatment of amyotrophic lateral sclerosis (ALS) caused by mutations in the SOD1 gene.
Tofersen for Amyotrophic Lateral Sclerosis
Tofersen is an investigational antisense oligonucleotide proposed for the treatment of amyotrophic lateral sclerosis (ALS) caused by mutations in the SOD1 gene.
Coolief Cooled RF System (Avanos Medical Inc.) for Pain due to Degenerative Hip Disease
This report addresses whether full-text clinical studies, systematic reviews, and clinical practice guidelines and position statements support the use of cooled radiofrequency ablation (CRFA) using the Coolief system (Avanos Medical Inc.) for relief of pain and improvement of function in adults with degenerative hip disease.