Alydia Health Inc., of Menlo Park, Calif., has completed enrollment in the pivotal PEARLE investigational device exemption (IDE) study, which is assessing the safety and effectiveness of the Jada system to rapidly control and treat abnormal postpartum uterine bleeding and postpartum hemorrhage.
LONDON – The genomes of 38 different tumor types and the 47 million mutations that fostered their growth are revealed in unprecedented detail in 23 studies published in Nature and other journals on Feb. 6, 2020.
The advent of transcatheter aortic valve replacement (TAVR) changed the framework for dealing with aortic valve stenosis, but some clinicians might argue there was a corresponding and inappropriate rush away from surgical aortic valve replacement (SAVR).
Houston-based Nanospectra Biosciences Inc. has kicked off a pivotal U.S. study of its Aurolase therapy in the targeted destruction of prostate tumors using nanomedicine technology. The IDE study, with an estimated completion date of December 2022, will support a de novo 510(k) submission to the U.S. FDA. The first two patients were treated at the University of Michigan, which also participated in the first-in-human pilot study of Aurolase.
Soliton Inc., of Houston, unveiled positive proof-of-concept (POC) study results out to 12 weeks using its Rapid Acoustic Pulse (RAP) device for the treatment of fibrotic scars. Overall, the treatment of fibrotic scars using the device proved safe and tolerable during this POC study.
Lineage Cell Therapeutics Inc. CEO Brian Culley told BioWorld that concerns about the pace of the company’s dry age-related macular degeneration (AMD) phase I/IIa trial have been alleviated after an independent data safety monitoring board (DSMB) decreed that the study’s protocol-mandated treatment stagger can be removed.
Years after a setback to its clinical program, Medtronic plc‘s Symplicity brand renal denervation (RDN) system appears to be firing on all pistons. The Dublin-based company said this week that it will begin enrolling patients in a pilot study to assess the safety and efficacy of its newer-generation Symplicity Spyral using a targeted procedural approach with fewer radiofrequency (RF) ablations.
The U.S. FDA has given its nod for a new trial of Abbott Laboratories’ Amplatzer Amulet left atrial appendage (LAA) occluder for those with atrial fibrillation (AF) who are at risk of stroke. Known as the CATALYST trial, it is the first study comparing the effectiveness of a LAA closure device to non-vitamin K antagonist oral anticoagulant (NOAC) drugs, a newer class of blood thinners, the Abbott Park, Ill.-based company said.
GI Dynamics Inc.’s U.S. IDE trial of Endobarrier, which is designed for patients diagnosed with type 2 diabetes and obesity, is now underway with the first patient enrollment at Michigan Medicine in Ann Arbor, Mich. The FDA approved the pivotal STEP-1 clinical trial in August 2019 to evaluate the Endobarrier as a barrier between the small intestine and food to reduce calorie intake.
Abbott Laboratories had a winning week, scoring U.S. FDA approval of its Infinity directional deep brain stimulation (DBS) system in treating symptoms of Parkinson’s disease not adequately managed by medication. The company also reported new data underscoring the benefits of its Proclaim XR neuromodulation system in people living with chronic pain.
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