Abbott today announced the first global procedures conducted with its new Volt pulsed field ablation system. Volt treats patients battling common abnormal heart rhythms like AFib. It marks Abbott’s entry into the crowded pulsed field ablation (PFA) space alongside companies like Medtronic, Boston Scientific and Johnson & Johnson’s Biosense Webster. Last month, Medtronic became the […]
Clinical Trials
FastWave Medical kicks off first-in-human study of its IVL tech
FastWave Medical announced the successful completion of enrollment for its first-in-human study of its peripheral intravascular lithotripsy (IVL) system to treat calcified cardiovascular disease. Dr. Miguel Montero-Baker of Houston Methodist Hospital and the Hope Vascular & Podiatry Clinic and Dr. Venkatesh Ramaiah of HonorHealth Vascular Group and the Pulse Cardiovascular Institute successfully conducted the procedures […]
Gore enrolls first patients in expandable stent graft trial
W.L. Gore & Associates announced today that it enrolled the first patients in a trial evaluating its Viabahn VBX stent graft. The study compares Gore’s balloon-expandable endoprosthesis to bare metal stenting for patients with complex iliac occlusive disease. It aims to inform practice guidelines around the best modalities suited for patients with this condition. Dr. […]
Autonomix completes preclinical transvascular ablation study to treat pancreatic cancer
Autonomix Medical announced today that it completed an animal safety study evaluating its proprietary ablation technology. The Woodlands, Texas-based company designed its tissue ablation technology to address pancreatic cancer-related pain. Current approaches, like opioids or ethanol injections, may only provide limited relief and may lead to risky side effects. The company hopes its proof-of-concept effort […]
Study backs Smith+Nephew Regeneten bioinductive rotator cuff implant
Smith+Nephew today announced positive results for its Regeneten bioinductive implant from a randomized controlled trial. Data published online in Arthroscopy highlighted the success of Regeneten against the standard of care. One-year results found that medium and large full-thickness rotator cuff tears repaired and augmented with the implant had better tendon healing. Regeneten provides a patient-centric […]
BrainsWay initiates new studies of non-invasive neurostim
BrainsWay (Nasdaq:BWAY) announced plans for two new feasibility trials evaluating its neurostimulation technology. The studies both involve BrainsWay’s patented rotational field TMS (or Deep TMS 360°). The company’s transcranial magnetic stimulation (TMS) method of stimulation enables the activation of more neurons in the brain. With the new rotational field system under evaluation, two orthogonal TMS […]
Cala Health has positive essential tremor treatment data
Cala today announced results from multiple studies supporting positive outcomes for patients using its TAPS therapy for essential tremor (ET). San Mateo, California-based Cala develops multiple devices for treating essential tremor, including the Cala Trio and the kIQ. The company launched the kIQ wrist-worn device last year. They deliver transcutaneous afferent patterned stimulation (TAPS) therapy […]
Orchestra BioMed begins pivotal trial of cardiac neuromod tech
Orchestra BioMed (Nasdaq:OBIO) announced today that it randomized the first patient in a clinical trial of its AVIM therapy. The company’s BackBeat CNT atrioventricular interval modulation (AVIM) therapy treats pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications. New Hope, Pennsylvania-based Orchestra Biomed’s BACKBEAT pivotal study evaluates the efficacy and safety of AVIM […]
Glucotrack has positive data for implantable continuous blood glucose monitor
Glucotrack (Nasdaq:GCK) announced today that it completed the first preclinical study of its implantable continuous blood glucose monitor (CBGM). Rutherford, New Jersey-based Glucotrack aimed to assess the implant technique and device safety in the study. Additionally, the study used a small sample size of sensors to determine device functionality. Despite no intent to conduct an […]
Boston Scientific initiates new Farapulse trial, expects FDA approval in 2024
Boston Scientific announced today that it initiated the AVANT GUARD clinical trial to evaluate its Farapulse pulsed field ablation (PFA) system. The company also says it now anticipates FDA approval for Farapulse in the first quarter of 2024. AVANT GUARD looks at the safety and effectiveness of Farapulse as a first-line treatment for persistent AFib. […]
Microbot Medical meets objectives in preclinical surgical robot study, seeks FDA IDE
Microbot Medical (Nasdaq:MBOT) today announced the successful completion of its GLP pivotal preclinical surgical robot study. Braintree, Massachusetts-based Microbot completed the study using a porcine model. It operated under the guidelines of FDA-required levels of planning, controlling, monitoring and reporting. Microbot said earlier this month that the study used its Liberty endovascular surgical robotic system […]