pacemaker News
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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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BioTrace Medical Announces Key Events Featuring Tempo Lead at TVT 2018
The company’s Tempo® Temporary Pacing Lead will be featured in a New Technology Forum discussion titled “Improved Temporary Transvenous Pacers: The BioTrace Tempo Lead,” presented by Steven Yakubov, M.D., System Chief, Advanced Structural Heart Disease at Riverside Methodist Hospital/OhioHealth. The discussion will highlight the performance and benefits of the Tempo Lead ...
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Orchestra BioMed Announces Late-Breaking Clinical Results Showing BackBeat Cardiac Neuromodulation Therapy Drives Significant Reduction in Systolic Blood Pressure
Double-blind, randomized trial data demonstrates clinically meaningful and statistically significant difference of 8.1 mmHg in reduction of 24-hour ambulatory systolic blood pressure at 6 months vs. control High responder rate despite 88.5% of treated patients having isolated systolic hypertension (ISH) Primary safety endpoint achieved with no difference in major cardiac adverse events ...
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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 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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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 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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1 out of 10 survive cardiac arrest, a new device under FDA review hopes to change that
KEY POINTS Cardiac arrest is one of the leading causes of death in the U.S. and globally. It has a survival rate of 1 in 10 people with current treatment. The Neurescue device is designed to increase blood flow to the brain and heart during life-threatening emergencies such as cardiac arrest. Cardiac arrest is one of the leading causes of death around the world, ...
By Neurescue
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N8 Medical Announces NHLBI Grant to Develop Antimicrobial Pacemaker Envelope
N8 Medical, LLC (N8 Medical) today announced that the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) indicated its intent to fund N8 Medical’s STTR Phase I grant application for the development of a resorbable envelope to prevent surgical site infections associated with pacemaker implantation surgeries. N8 Medical will be working with researchers ...
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BioTrace Medical’s Tempo Lead Obtains CE Mark for Safe and Secure Temporary Intracardiac Pacing
BioTrace Medical, Inc., the leader in innovative temporary pacing technology, today announced the company’s Tempo Lead has obtained CE Mark certification in Europe for use in cardiac procedures requiring temporary intracardiac pacing. BioTrace Medical’s Tempo Temporary Pacing Lead is designed for safer, more secure and stable pacing to reduce intraprocedural complications, ...
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BioTrace Medical’s Tempo Lead Obtains CE Mark for Safe and Secure Temporary Intracardiac Pacing
BioTrace Medical, Inc., the leader in innovative temporary pacing technology, today announced the company’s Tempo Lead has obtained CE Mark certification in Europe for use in cardiac procedures requiring temporary intracardiac pacing. BioTrace Medical’s Tempo Temporary Pacing Lead is designed for safer, more secure and stable pacing to reduce intraprocedural complications, ...
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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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Orchestra BioMed to Present at the Innovation in Cardiovascular Interventions Meeting and the CSI Focus D-HF Congress
Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced upcoming presentations at the Innovation in Cardiovascular Interventions (ICI) Meeting in Tel-Aviv, Israel, taking place December 8-10, 2019 and the CSI Focus D-HF Congress in ...
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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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USPTO issues Patent for ground breaking polysaccharide technology platform to Endomedix.
Endomedix announced today that it received a patent of 30 issued claims for its PLEXimine™ Polysaccharide Technology platform for a new class of biomaterials. The patent, “Methods and Compositions for Achieving Hemostasis and Stable Clot Formation”, also covers design features and mechanisms of action for its first product based on the technology. This technology platform ...
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ReShape Lifesciences Technologies to be Featured at Minimally Invasive Surgery Symposium
ReShape Lifesciences Inc. (NASDAQ:RSLS), a developer of minimally invasive medical devices to treat obesity and metabolic diseases, announced today that the Company and its products will be discussed during the Metabolic and Bariatric Sessions of the Minimally Invasive Surgery Symposium (MISS) taking place in Las Vegas from March 6-9, 2018. Details of the presentations are as follows: Friday, ...
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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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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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Orchestra BioMed Strengthens Management Team with Appointments of Expert Product Development Leaders Juan A. Lorenzo and Paul V. Goode, Ph.D.
Orchestra BioMed, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced senior-level appointments to its product development teams. Juan Lorenzo, an expert in vascular devices, joins as vice president, product development, Focal Therapies and will ...
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