Genesis MedTech announced today that it completed enrollment in its U.S. early feasibility study for its J-Valve transfemoral TAVR system. Developed by JC Medical, the U.S.-based Genesis subsidiary, J-Valve holds FDA breakthrough device designation. Its breakthrough designation covers the treatment of severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. Patients eligible for […]
Clinical Trials
Biosense Webster has positive Varipulse pulsed field ablation data
Biosense Webster announced positive one-year results from multiple studies evaluating its Varipulse pulsed field ablation (PFA) system. Johnson & Johnson MedTech’s electrophysiology unit shared results from its inspIRE and admIRE studies. The inspIRE study looked at pulmonary vein isolation using a variable loop catheter with 3D mapping integration. The admIRE study used a variable loop […]
Carthera enrolls first patient in ultrasound drug delivery trial
Carthera announced today that it enrolled the first patient in the SONOBIRD pivotal trial for its SonoCloud device. Paris, France-based Carthera designed SonoCloud to treat a wide range of brain disorders. The device emits ultrasound to temporarily increase the permeability of blood vessels in the brain, improving therapeutic molecule delivery. After implantation in the skull, […]
Study backs Biosense Webster low/zero fluoroscopy AFib ablation
Johnson & Johnson MedTech’s Biosense Webster announced positive findings from real-world data looking at its AFib ablation technology. The study evaluated the safety and effectiveness of low/zero fluoroscopy AFib ablation. Results supported the use of workflows to reduce radiation exposure during catheter ablation for treating paroxysmal AFib. Data also showed sustained safety, efficacy and long-term […]
Medtronic, Rijnstate enroll first patient in aneurysm repair trial
Medtronic , with Rijnstate, announced today that they enrolled the first patient in the Hercules trial comparing abdominal aortic aneurysm repair methods. Hercules compares endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR). It looks at these methods in patients who have an abdominal aortic aneurysm (AAA) with a wide, infrarenal neck diameter. Abdominal aortic aneurysms […]
Cortex initiates trial of mapping tech for AFib ablation
Cortex announced today that it began its RESOLVE-AF trial evaluating its Ablamap system with the newly released Ablacath mapping technology. Launched by Ajax Health in December 2023, the company already offers the FDA-cleared Ablamap with electrographic flow (EGF). It seeks to pair the system with the newly released Ablacath mapping catheter to identify extra-pulmonary vein […]
SoniVie completes enrollment in trial of ultrasound renal denervation for hypertension
SoniVie announced today that it treated the last patient in a pilot study of its Tivus technology for renal artery denervation to treat hypertension. Tel Aviv, Israel-based SoniVie develops Tivus (therapeutic intra-vascular ultrasound) to treat a variety of hypertensive disorders. It’s conducting the REDUCED-1 FDA investigational device exemption study to evaluate the renal denervation technology. […]
Neuralink completes first-in-human brain-computer interface implant
Elon Musk announced that his Neuralink brain-computer interface (BCI) venture completed its first-in-human implant this week. The entrepreneur posted on X (formerly Twitter) to confirm the implant, which took place on Jan. 28. “The first human received an implant from Neuralink yesterday and is recovering well,” Musk posted. “Initial results show promising neuron spike detection.” […]
CroíValve wins FDA IDE for tricuspid heart valve
CroíValve announced today that it began an early feasibility study for its Duo tricuspid coaptation valve system. The beginning of the study follows FDA investigational device (IDE) approval. Tandem II, a prospective, multi-center, non-randomized, single-arm study looks at the safety and performance of Duo in patients with severe or greater symptomatic tricuspid regurgitation (TR). Duo […]
Microbot Medical expands U.S. operations to prep for first in-human clinical study
Microbot Medical, the developer of the Liberty endovascular robotic surgical system, is building on the momentum from the positive results of its good laboratory practices (GLP) pre-clinical study. The company is adding a clinical research associate to support its pending investigational device exemption, or IDE, submission to commence its first-in-human clinical trial. The clinical research […]
Cognito Therapeutics enrolls first patient in sensory neurostim biomarker study
Cognito Therapeutics announced today that it enrolled the first patient in a biomarker study within its HOPE pivotal trial. HOPE evaluates a novel disease-modifying therapy that elicits gamma-frequency brain activity through non-invasive sensory stimulation. Cambridge, Massachusetts-based Cognito aims to slow the progression of Alzheimer’s disease from the comfort of a patient’s home. This evaluation looks […]