Stereotaxis Corp. reported positive results showing its robotic magnetic navigation (RMN) system significantly reduces the incidence of silent cerebral embolism (SCE) in patients undergoing atrial fibrillation (AF) ablation vs. hand-held catheters. The prospective, multicenter study is believed to be the first to compare AF ablation using RMN with manual control and to highlight the benefit in lowering SCE risk.
TORONTO – Opsens Inc. has successfully treated 20 patients in the first-in-human study employing a new surgical guidewire to improve procedural workflow during transcatheter aortic valve replacement (TAVR). According to Opsens CEO Louis Laflamme, the Savvywire will be the first guidewire to deliver a valvular prosthesis while allowing continuous hemodynamic pressure measurement during the procedure.
Prelude Corp. (dba Preludedx) reported positive results from the SweDCIS randomized trial showing its DCISionrt test predicts radiation benefit for lowering 10-year local invasive breast cancer risk. The prognostic, artificial intelligence (AI)-based tool assesses and predicts the benefit of radiotherapy for women with ductal carcinoma in situ (DCIS) following breast-conserving surgery (BCS).
Nextsense Inc. reported partnerships with global biopharma company UCB SA, Heraus Holding GmbH, the University of California San Diego and Emory University at its first public appearance at the American Epilepsy Society Annual Meeting in Chicago this past weekend. The Nextsense platform uses biosensing earbuds to perform ongoing electroencephalograms (EEGs).
Delcath Systems Inc.’s phase III FOCUS trial of its Hepzato Kit for metastatic hepatic dominant ocular melanoma (mOM) posted positive results for this challenging and aggressive cancer. Nearly a third of patients responded to the therapy – more than three times the rate seen in those receiving the best available choice – and just under 7% had a complete response. The treatment, known as Chemosat in Europe, isolates the liver for treatment then purifies the blood exiting the liver before it returns to circulation to reduce systemic effects.
Wave Neuroscience Inc.’s study of the use of electromagnetic stimulation to treat post-traumatic stress disorder (PTSD) entered its second phase, building on the positive outcomes seen in the phase I collaboration with the U.S. military. Texas A&M University Health Science Center is directing the trial, which will expand the study to civilians.
Restore Medical Ltd. is implanting the first patients with its Contraband technology for congestive heart failure (CHF). The minimally invasive, catheter-delivered implant is being assessed in patients with chronic left ventricular failure. The Or Yehuda, Israel-based startup is carrying out the trial at the ZNA medical center in Antwerp, Belgium, followed by the Kaplan medical center in Israel. The goal of the implant is to enable the right ventricle to strengthen the left ventricle and improve ejection fraction, reduce mitral regurgitation and restore a favorable ventricular geometry.
Memed Diagnostics Ltd. has published new data from an EU Commission funded clinical trial evaluating its blood test for differentiating bacterial and viral infections. The prospective, multicenter cohort study, titled “AutoPilot-Dx,” was carried out in emergency wards in Italy and Germany. The goals of the study were to validate the performance of Memed’s BV test in a broad pediatric population with respiratory tract infections or fever without source and estimate its potential to impact antibiotic use.
Medical science has not yet convincingly duplicated the remarkable properties of cartilage, an omission that sustains an epidemic of life-altering knee replacement surgeries. Anthony Ratcliffe, CEO of Synthasome Inc., of Del Mar, Calif., said on a recent FDA webinar that companies might want to consider the lowly goat as the animal model of choice in preclinical studies of cartilage products because “the cost, ease of management, and the social aspects were all manageable” with goats.
Pulse Medical Imaging Technology Co. Ltd.’s latest trial showed its quantitative flow ratio (QFR) guidance provided a 35% risk reduction in the one-year rate of major adverse cardiac events, compared to standard angiography guidance. QFR, developed by Pulse, could be used to guide the strategy and optimization of percutaneous coronary intervention.