The Evoque Tricuspid Valve Replacement System (Edwards Lifesciences Corp.) is indicated for the improvement of health status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, for whom tricuspid valve replacement is deemed appropriate by a heart team.
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?
Etripamil (Milestone Pharmaceuticals) for Paroxysmal Supraventricular Tachycardia
Etripamil is an investigational, self-administered, calcium-channel blocker, nasal spray for rapid termination of paroxysmal supraventricular tachycardia outside of the healthcare setting.
Farapulse Pulsed Field Ablation System (Boston Scientific Corporation) for Atrial Fibrillation
The Farapulse Pulsed Field Ablation System (Boston Scientific Corporation) is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
LuX-Valve Plus (Jenscare Scientific Co. Ltd.) Transcatheter Tricuspid Valve Replacement for Tricuspid Regurgitation
LuX-Valve Plus (Jenscare Scientific Co. Ltd.) is an investigational transcatheter tricuspid valve replacement system for treatment of tricuspid regurgitation.
ProTractX3 Drug-Coated Balloon (GIE Medical Inc.) for Benign Esophageal Stricture
The ProTractX3 (GIE Medical Inc.) is an investigational drug-coated balloon for endoscopic dilation of symptomatic recurrent benign esophageal strictures in adults.
Exagamglogene Autotemcel (Casgevy; Vertex/CRISPR) for Transfusion-dependent Beta Thalassemia
Exagamglogene autotemcel (Casgevy; Vertex Pharmaceuticals and CRISPR Therapeutics) is an autologous genome-edited hematopoietic stem cell-based gene therapy indicated for the treatment of patients aged 12 years and older with transfusion-dependent beta thalassemia.
Automated Low-Flow Ascites Pump (alfapump; Sequana Medical NV) for Refractory Ascites
The automated low-flow ascites pump (alfapump; Sequana Medical NV) is an implantable wireless battery-powered pump for treatment of recurrent or refractory ascites due to liver cirrhosis.
Edison System (HistoSonics) for Histotripsy of Renal Tumors
The Edison System (HistoSonics) is a nonthermal focused ultrasound system with real-time image guidance under investigation for the noninvasive mechanical destruction of stage I primary solid renal tumors via histotripsy.
Eplontersen (Wainua; Ionis Pharmaceuticals Inc./AstraZeneca) for Hereditary Transthyretin-mediated Amyloid Polyneuropathy
Eplontersen (Wainua; Ionis Pharmaceuticals Inc./AstraZeneca) is an injectable transthyretin-directed antisense oligonucleotide indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Filsuvez (Birch Triterpenes) Topical Gel (Chiesi Global Rare Diseases) for Epidermolysis Bullosa
Filsuvez (birch triterpenes) topical gel (formerly Oleogel-S10; Chiesi Global Rare Diseases) is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older.