The AGENT Drug-Coated Balloon (Boston Scientific Corp.) is a paclitaxel-coated balloon catheter indicated for treatment of coronary in-stent restenosis (ISR). It is intended to be used after appropriate vessel preparation in adult patients undergoing percutaneous coronary intervention (PCI) in coronary arteries 2.0 millimeters (mm) to 4.0 mm in diameter and lesions up to 26 m…
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.
dNerva Lung Denervation System (Nuvaira Inc.) for Chronic Obstructive Pulmonary Disease
The dNerva Lung Denervation System (Nuvaira Inc.) is an investigational, bronchoscopic catheter-based pulmonary nerve ablation system proposed to reduce the frequency and severity of chronic obstructive pulmonary disease (COPD) exacerbations.
aXess Vascular Conduit (Xeltis) for Dialysis Access
The aXess graft (Xeltis) is a synthetic bioresorbable vascular conduit under investigation to establish arteriovenous access for hemodialysis in patients with end-stage renal disease.
Prademagene Zamikeracel (Abeona Therapeutics Inc.) for Recessive Dystrophic Epidermolysis Bullosa
Prademagene zamikeracel (pz-cel; formerly EB-101) (Abeona Therapeutics Inc.) is a gene-corrected epidermal sheet under investigation for the treatment recessive dystrophic epidermolysis bullosa.
CYB003 (Cybin Inc.) Deuterated Psilocybin Analogue for Major Depressive Disorder
CYB003 (Cybin Inc.) is an oral deuterated psilocybin analogue proposed for use in conjunction with supportive psychotherapy for treatment of patients with moderate to severe major depressive disorder who have had an inadequate response to an antidepressant medication.
Fidanacogene Elaparvovec-dzkt (Beqvez; Pfizer Inc.) for Hemophilia B
Fidanacogene elaparvovec-dzkt (Beqvez; Pfizer Inc.) is a single-infusion gene therapy for the treatment of adults with moderate to severe hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated vi…
Ventura Interatrial Shunt (V-Wave Ltd.) for Heart Failure
The Ventura Interatrial Shunt (V-Wave Ltd.) is an investigational transcatheter interatrial shunt proposed for treatment of chronic heart failure.
Rusfertide (Protagonist Therapeutics Inc./Takeda Pharmaceutical Co. Ltd.) for Polycythemia Vera
Rusfertide (formerly PTG-300; Protagonist Therapeutics Inc./Takeda Pharmaceutical Co. Ltd.) is a subcutaneously injected hepcidin mimetic for the treatment of erythrocytosis associated with polycythemia vera.
Varipulse Pulsed Field Ablation (Biosense Webster Inc.) for Atrial Fibrillation
Varipulse is an investigational pulsed-field ablation system in development for treatment of paroxysmal atrial fibrillation.
Letetresgene Autoleucel (Adaptimmune Therapeutics PLC) for Advanced Synovial Sarcoma
Letetresgene autoleucel is an investigational autologous engineered T-cell therapy for the treatment of HLA-A*02 positive patients with advanced synovial sarcoma expressing the NY-ESO-1 antigen.