San Fernando

Researchers are evaluating the safety and performance of the PRESERFLO17 MicroShunt XI device in patients with primary open angle glaucoma whose intraocular pressure IOP remains above 18 mmHg and up to 35 mmHg despite maximum tolerated medical therapy, or in cases where glaucoma progression requires surgery. This prospective, multicenter, single-arm post-market follow-up study focuses on this device, which is designed to help lower eye pressure by creating a channel for fluid to flow from the front chamber of the eye to a bleb under the conjunctiva. The PRESERFLO17 MicroShunt XI is implanted surgically by trained ophthalmologists or surgeons. The device works by shunting aqueous humor from the anterior chamber to a lower pressure bleb under the conjunctiva and Tenons capsule, helping to reduce IOP. This study does not include a control group or collect biospecimens. Participants receive the MicroShunt XI implant as part of their glaucoma treatment. Participants will be involved in assessments to monitor the safety and performance of the device, including measuring changes in intraocular pressure from screening through 12 months after implantation. The research team will track the proportion of eyes showing changes in IOP at 12 months. The study does not involve genetic or tissue sample collection. Total participation lasts up to one year, during which safety and performance data will be collected and evaluated.

Researchers are evaluating the safety and performance of the WhiteSwell eLym System for treating fluid overload or congestion in adults hospitalized with Acute Decompensated Heart Failure ADHF. This feasibility study focuses on assessing both acute and chronic device safety, as well as the technical success and patient treatment outcomes related to this device. The WhiteSwell eLym System is a device designed to reduce congestion by creating a low-pressure zone at the thoracic duct outflow, which helps move fluid from the lymphatic system back into the bloodstream. The device consists of a catheter and sheath used with a console and is temporarily placed for up to 60 hours via the left internal jugular vein while patients continue receiving intravenous diuretics. This treatment occurs during hospitalization, with the device placed in a heart catheterization laboratory. Participants will be monitored during their hospital stay and followed up at 30, 60, 90, and 180 days after discharge. Researchers will assess safety by tracking serious adverse events related to the device and treatment, technical success of device placement and removal, as well as changes in body weight, fluid levels, kidney function, lung water, and heart failure therapy needs. Additionally, quality of life and biomarker levels will be evaluated to understand long-term outcomes, including the time to rehospitalization for heart failure.