Cardiac Pacemakers News
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EMI/RFI: Materials and Technologies - A Comprehensive Market Analysis by BCC Research
Boston: “According to the latest BCC Research study, the demand for EMI/RFI: Materials and Technologies is estimated to increase from $7.4 billion in 2023 to reach $9.2 billion by 2028, at a compound annual growth rate (CAGR) of 4.6% from 2023 through 2028.” This comprehensive report delves into the dynamic landscape of the EMI/RFI materials and technologies market, meticulously ...
By BCC Research
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Implicity Joins the AWS ISV Accelerate Program
Implicity, a leader in remote patient monitoring and cardiac data management solutions, announced it has joined the Amazon Web Services (AWS) Independent Software Vendor (ISV) Accelerate Program, a co-sell program for AWS partners that provide software solutions that run on or integrate with AWS. The program helps AWS partners drive new business by directly connecting participating ISCs with the ...
By Implicity
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The future of rehabilitation
Congratulations to the ONWARD team for the incredible progress they are making in the field of neuroengineering! In recent days, numerous media have reported the news of a great advance for science, and especially for all those people with spinal cord injury and their medical and caregiver teams. The ONWARD team has developed an epidural electrical stimulation system using electrodes placed ...
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gammaCore Sapphire Non-Invasive Vagus Nerve Stimulator (nVNS) Receives Unique National Product Code Number by the Belgian Pharmaceutical Association
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today announced that gammaCore Sapphire has been issued a National Code Number (CNK) in Belgium. CNK numbers are unique product code identifiers allocated by the Belgian Pharmaceutical Association (APB) for products and medicines commercially available from pharmacies throughout ...
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electroCore, Inc. Announces Distribution Agreement with Joerns Healthcare, LLC
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced today that gammaCore Sapphire™, the first and only FDA-cleared, non-invasive device to treat and prevent multiple types of headache pain via the vagus nerve, will be distributed and billed exclusively by Joerns Healthcare, LLC (Joerns) within selected managed care health systems. ...
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1st Successful Heart Tumor Removal Without Open Heart Surgery
EchoPixel has once again contributed to a pioneering procedure at CentraCare – St. Cloud Hospital with the first team to remove a heart tumor without invasive open heart surgery using the novel AlphaVac catheter. Previously CentraCare had been the first to use EchoPixel’s 4D hologram technology to conduct the WATCHMAN implant, which is a one-time, minimally invasive procedure ...
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ReShape Lifesciences Announces 2017 Weight Loss Contest Winner
ReShape Lifesciences Inc. (NASDAQ:RSLS), a developer of minimally invasive medical devices to treat obesity and metabolic diseases, today announced the winners of its 2017 weight loss contest, which recognizes patients for their successful weight loss with the ReShape Balloon™. The contest winner lost a total of 80 pounds, or 41% total weight loss (TWL), with 60 pounds, or 28% TWL, lost ...
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Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch Ventricular Restoration System
Santa Clara, Calif.– July 12, 2022 – Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch® Ventricular Restoration System. Currently being evaluated in the CORCINCH-HF pivotal clinical trial, the AccuCinch System ...
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electroCore, Inc. Announces Study of gammaCore Sapphire for the Treatment of Post-COVID Syndrome
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced Mayo Clinic is initiating an investigator-initiated study to assess the efficacy of gammaCore Sapphire non-invasive vagus nerve stimulation (nVNS) in patients with post-COVID syndrome. Post-COVID syndrome, also known as Long COVID, is a collection of symptoms that persist greater than 28 days ...
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EBR Systems Raises AU$110M in Initial Public Offering on the Australian Securities Exchange (ASX)
EBR Systems’ WiSE™ CRT System is world’s first and only wireless endocardial (inside the heart) left ventricle pacing system for heart failure EBR’s AU$110m ASX initial public offering today was strongly supported by new and existing institutional shareholders The new capital funds the completion of pivotal study, targeting FDA submission for approval in 2023 followed ...
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EBR Systems Appoints Dr Bronwyn Evans, Dr David Steinhaus and Ms Karen Drexler to the Board of Directors
Highlights: Dr Evans, Dr Steinhaus and Ms Drexler to join EBR Systems’ Board ahead of the planned A$110m IPO on the Australian Stock Exchange Board appointments follow the retirement of Mr Dave Stassen and Dr Leighton Read New EBR Systems’ Board consists of Mr Allan Will, Mr John McCutcheon, Dr Christopher Nave, Mr Trevor Moody, Dr Bronwyn Evans, Dr David Steinhaus and Ms ...
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Orchestra BioMed Announces Presentations at TCT 2021 of Positive Long-Term Clinical Results from the MODERATO II Study Showing the Significant Clinical Impact of BackBeat CNT on Isolated Systolic Hypertension and Pulse Pressure
BackBeat CNT treated patients experienced a mean reduction of 17.5 mmHg in office systolic blood pressure measured 24-months following therapy activation. Patients with Isolated Systolic Hypertension (ISH) treated with BackBeat CNT experienced clinically meaningful and statistically significant reductions of 7.4 mmHg in ambulatory systolic blood pressure and 9.4 mmHg in ambulatory Pulse ...
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EBR Systems’ WiSE CRT System Demonstrates Technical Feasibility of Leadless Left Bundle Branch Area Pacing for Cardiac Resynchronization
Published last month in the European Heart Journal, the case report details the successful deployment of the WiSE Electrode implanted in the LV septum of an 82-year-old male with tachyarrhythmia-induced cardiomyopathy. The patient exhibited improved electrical resynchronization on ECG and reported significant symptomatic improvement at six-month follow-up. This is the first reported case of ...
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FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System
EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the WiSE CRT System for the treatment of heart failure. The FDA created this designation and its associated program in 2017 for certain devices providing more effective treatment ...
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Orchestra BioMed Announces Peer-Reviewed Publication of MODERATO II Study Results Showing a Statistically Significant Reduction in Blood Pressure in Pacemaker-Indicated Patients Treated with BackBeat Cardiac Neuromodulation Therapy
Double-blind, randomized trial data show a clinically meaningful and statistically significant net reduction of 8.1 mmHg in 24-hour ambulatory systolic blood pressure at 6 months in treated vs. control patients Very high (85%) response rate to therapy despite 81% of treated patients having isolated systolic hypertension (ISH), a more dangerous and difficult to treat form of hypertension ...
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Diaphragm Pacemaker for Teen Featured on WSB-TV Atlanta
Fourteen year-old Sedarius was recently featured on WSB-TV Atlanta as the first pediatric patient to receive surgery to implant a diaphragm pacemaker in the state of Georgia. Sedarius was diagnosed with CCHS when he was eight years old, and required a tracheotomy and ventilator to breathe while he slept. The Avery Breathing Pacemaker will allow him to breathe without the need for a trach or ...
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Avery Biomedical Devices’ Nextgen Diaphragm Pacing Transmitter, Spirit, Earns FDA Approval – Now Available
Avery Biomedical Devices (Commack, NY), the global leader in high reliability diaphragm pacemakers, announced that its new diaphragm pacemaker transmitter, Spirit, has earned FDA approval and is now being offered to patients using its pacing system. This NextGen transmitter features a light-weight compact design with easy-to-use touch controls and offers precision-enhancing digital ...
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Avery Biomedical Letter to Medscape Regarding Diaphragm Pacing
Please find below a letter that our attorney sent to the editors of Medscape (parent company WebMD) who have published false information about our product. Medscape Letter Regarding Avery System Avery Biomedical Devices has an outstanding track record spanning over 45 years including an outstanding safety record, long term viability with some patients pacing for more than 35 years, and ...
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Orchestra BioMed Announces Clinical Data Demonstrating a Significant and Sustained Reduction in Blood Pressure in MODERATO II Control Patients After Crossover to BackBeat Cardiac Neuromodulation Therapy
Clinically meaningful and statistically significant reduction in systolic blood pressure is consistent with the decrease previously observed in the study treatment group during the same time period. Ambulatory Systolic Blood Pressure (aSBP) decreased by an average of 10.3 mmHg (p Office Systolic Blood Pressure (oSBP) decreased by an average of 13.1 and 20.9 mmHg at 6 and 12 months, ...
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Orchestra BioMed Announces Clinical Data Showing Significant and Sustained Reduction in Systolic Blood Pressure Out to Two Years with BackBeat Cardiac Neuromodulation Therapy
Clinically meaningful and statistically significant reduction of 16.6 mmHg in systolic blood pressure out to two years 88% of the treated patients had isolated systolic hypertension (ISH) 70.6% of all treated patients and 80% of treated ISH patients had their blood pressure under control at 24 months Orchestra BioMed™, Inc., (“Orchestra BioMed” or the ...
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