Global Electrophysiology Devices Market Could Exceed $12.2 Billion By 2026
A competitive process run by the Accelerated Access Collaborate (AAC) as part of the NHS AI LaB – in partnership with NHSX and the National Institute for Health Research (NIHR) – the award aims to benefit patients by combining the power of artificial intelligence with the expertise of the NHS to improve health and care outcomes. iRhythm will utilise the funding to trial its Zio service in selected sites – comprising trusts, CCG's and networks – across the UK. Throughout the three-year program, clinical, pathway and economic outcomes will be monitored and evaluated in order to inform any future commissioning decisions around the adoption of Zio within the NHS.
Acutus Medical, Inc. (NASDAQ: AFIB) recently announced pre-clinical experimental results of a novel diagnostic and therapeutic workflow utilizing the AcQMap® System along with tissue-selective, non-thermal pulse field ablation (PFA) via a proprietary Acutus ablation catheter. While Acutus has been known for its rapid imaging and mapping platform along with access and diagnostic products, the company is now aggressively pursuing the therapeutic commercial market.
Pulsed field ablation (also known as electroporation) is an emerging ablation modality that distinguishes itself from traditional thermal ablation, such as radiofrequency energy ablation and cryoablation, by delivering therapeutic energy faster and more selectively with minimal collateral damage. While not fully clinically proven or approved by regulatory authorities for use in cardiac tissue in humans, recent pre-clinical and clinical studies suggest that PFA may enable rapid targeted ablation of cardiac muscle while leaving adjacent tissue, such as nerves, blood vessels and the esophagus, completely unaffected. In addition, PFA does not rely on heat or extreme cold to ablate tissue. The application time required to create a lesion takes less than a second compared to thermal ablation which may take many seconds to minutes at each location.
Johnson & Johnson (NYSE: JNJ) New: Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson, recently announced results from the Phase 3b TRITON trial, the first randomised controlled study evaluating the efficacy and safety of initial triple oral combination therapy (UPTRAVI® [selexipag], OPSUMIT® [macitentan] and tadalafil) compared to initial double oral combination therapy (placebo, macitentan and tadalafil) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension (PAH). Study results were featured as an oral presentation as part of the digital European Society of Cardiology Congress held 29 August – 1 September 2020.
In the TRITON trial, both the initial triple oral therapy and initial double oral therapy arms demonstrated reductions in the primary endpoint, pulmonary vascular resistance, of 54 percent and 52 percent respectively, with no statistical difference observed between both groups. Improvements were observed in six-minute walk distance,1 N-terminal pro-brain natriuretic peptide (NT-proBNP) and clinical variables at week 26 in patients who were treated with either initial triple oral or initial double oral combination therapy, with no difference between treatment regimens.
Boston Scientific Corporation (NYSE: BSX) recently announced it has received CE Mark and initiated a limited market release of the fourth generation Vercise Genus™ Deep Brain Stimulation (DBS) System in Europe. Featuring full-body MRI conditional1and Bluetooth capabilities across the portfolio, the Vercise Genus System is indicated to treat the symptoms of Parkinson's disease (PD), essential tremor, and dystonia by delivering precisely targeted electrical stimulation in the brain designed to provide optimal symptom relief.
"With neurodegenerative movement disorders, the ability to deliver the right dose of stimulation where it is needed can make a remarkable difference in controlling an individual patient's symptoms," says Veerle Visser-Vandewalle, M.D., Ph.D., Cologne University Hospital, Germany. Vercise Genus adds features for patients, including a low-profile two-in-one extension with the option of abdominal placement. New clinician software optimizes programming with integrated visualization using patient imaging via the company's exclusive relationship with Brainlab.
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