Allergan PLC - Xen Glaucoma Treatment System - Class 2 Recall

XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.
Source: Medical Device Recalls - Category: Medical Devices Source Type: alerts

Related Links:

XEN ® gel stent (Allergan, Dublin/Republic of Ireland) is a relatively new microinvasive glaucoma device providing an ab-interno approach to the subconjunctival space for aqueous drainage and reduction of intra...
Source: BMC Ophthalmology - Category: Opthalmology Authors: Tags: Case report Source Type: research
ConclusionPOAG surgical procedures with XEN® 45 Gel Stent implants are a safe and effective treatment approach.
Source: International Ophthalmology - Category: Opthalmology Source Type: research
Most cough/cold preparations contain sympathomimetic decongestants; many contain sedating antihistamines. Adverse effects, including death in children under 2, primarily from decongestants, but also from sedating antihistamines and dextromethorphan prompted FDA to recommend OTC cough and cold products not be used in this group. This, combined with manufacturer withdrawal under age 4, has created a cough and cold market void for young children in the US. Also, decongestant adverse effects in adults, including increased blood pressure, irregular heartbeat, and chest tightness resulted in contraindication in heart disease, hi...
Source: Annals of Allergy, Asthma and Immunology - Category: Allergy & Immunology Authors: Source Type: research
Micro-invasive glaucoma surgery (MIGS) stents are quickly becoming the norm. A new study from Market Scope titled “2019 Glaucoma Surgical Device Market Report,” shows that MIGS stents account for almost half of all glaucoma surgical device revenue in 2019. This is an even more impressive feat for the devices considering the loss of revenue that occurred from the Cypass Micro-Stent being recalled nearly a year ago. Alcon pulled Cypass off the market after five-year data revealed a higher rate of cell loss compared to patients who had cataract surgery alone. However, the report said Cypass...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news
This study confirms the safety and efficacy of XEN gel stents in the management of pseudoexfoliative glaucoma 2 years after implantation, with success rates similar to primary open-angle glaucoma regardless of the definition of success. Purpose: To compare the long-term safety and efficacy of XEN gel implant surgery (Allergan Inc., Irvine, CA) in patients with pseudoexfoliative glaucoma (PEXG) and primary open-angle glaucoma (POAG). Setting: Prospective, interventional study in a tertiary glaucoma center. Methods: A total of 110 eyes of 85 patients with POAG (57 eyes) or PEXG (53 eyes) and uncontrolled intraocular...
Source: Journal of Glaucoma - Category: Opthalmology Tags: Original Studies Source Type: research
Filing included data from the Phase 3 ARTEMIS studies, which demonstrated that the majority of patients remained treatment free for at least 1 year following 3 treatments with Bimatoprost Sustained-Release Allergan continues advancement in eye care inno... Biopharmaceuticals, Ophthalmology, FDA Allergan, Bimatoprost, intraocular pressure
Source: HSMN NewsFeed - Category: Pharmaceuticals Source Type: news
Conclusions: Corticosteroids, in combination with anti-infectives, could be a promising treatment option for acute conjunctivitis subject to development of further evidence on their effectiveness and safety in conjunctivitis treatment.
Source: Cornea - Category: Opthalmology Tags: Review Source Type: research
Conclusion This paper summarizes the current findings regarding the anti-colitis activity of plant-derived alkaloids and shows how these alkaloids exhibit significant and beneficial effects in alleviating colonic inflammation. These natural alkaloids are not only promising agents for IBD treatment but are also components for developing new wonder drugs. However, the underlying molecular mechanisms or toxicological evaluation of most plant-derived alkaloids still require much scientific research, and their actual efficacies for IBD patients have not been verified well in field research. Thus, further clinical trials to elu...
Source: Frontiers in Pharmacology - Category: Drugs & Pharmacology Source Type: research
Conditions:   Open-Angle Glaucoma;   Ocular Hypertension Intervention:   Drug: Bimatoprost SR Sponsor:   Allergan Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Condition:   Glaucoma Intervention:   Device: XEN Group Sponsor:   Allergan Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
More News: Allergy | Australia Health | Glaucoma | Medical Devices