The U.S. FDA has granted Sonivie Ltd. IDE approval for a pilot study to treat resistant hypertension patients with renal artery denervation (RDN) using its Tivus ultrasound ablation system. The intravascular, catheter-based system uses high-frequency non-focused ultra-sound energy to ablate nerves in the renal artery and cause denervation of nerves in other structures such as the bronchus.
The U.S. FDA’s accelerated approval path is front burner these days, what with Congress looking to modernize the path through provisions added to the must-pass user fee legislation, the controversy still boiling over the FDA’s accelerated approval last year of Biogen Inc.’s Alzheimer’s drug, Aduhelm (aducanumab), and a number of recent withdrawals of drugs granted accelerated approval years ago.
At the ongoing Biomed Israel 2022 event, Magneto Thrombectomy Solutions Ltd. has shared successful first-in-human (FIH) results showing safety and feasibility of its Etrieve system, a novel catheter based on electric fields for removing blood clots, in patients with acute pulmonary embolism (PE).
Abbott Laboratories reported results from its PERSIST-END study demonstrating that close to nine in 10 patients treated for persistent atrial fibrillation (AF) with its Tacticath contact force ablation, sensor-enabled (Tacticath SE) were free of symptoms of their arrhythmia over 15 months of follow-up. The study’s findings, which supported a November 2021 FDA approval for persistent AF, also showed significant improvement in patients’ quality of life and a more than 50% cut in the use of health care resources, the company said.
Samsara Vision Inc. has received FDA approval to begin a U.S.-based PMA supplement trial to assess improvements in visual acuity and safety of its smaller-incision next-generation implantable miniature telescope, called SING IMT, in people with late-stage age-related macular degeneration (AMD). The device has been available in the EU since 2020.
Cefaly Technology sprl reported results from a phase III clinical trial showing that two-hour treatment with its Cefaly Dual external trigeminal nerve stimulation (e-TNS) device is a safe and effective nonpharmaceutical option for acute migraine treatment in a nonhospital setting.
Vivosense Inc. aims to improve clinical trial recruitment and outcomes by developing new digital biomarkers and clinical outcome assessments (COAs) that use data from wearable devices, a goal made a touch easier by its successful completion of a $25 million series A financing round. The company’s platform is designed to detect and rigorously interpret subtle shifts in physiology using body-worn sensors.
With an eye on promoting innovation in complex innovative trial designs, the U.S. FDA published a series of case study examples Jan. 18 from its CID Pilot Meeting Program.
Olga Torres, co-owner of Miami-based Unlimited Medical Research, pleaded guilty Jan. 12 to obstructing a 2017 FDA inspection in connection with an alleged scheme to falsify data in a clinical trial evaluating an asthma drug for children.
