Carotid News
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Revacept protects during carotid artery surgery
Good news from vascular medicine: the innovative drug Revacept can protect people with narrowed carotid arteries from both further strokes and dangerous bleeding. Thanks to this completely new dual efficacy, Revacept is ideal for preventing complications after stroke prevention surgery on narrowed carotid arteries. This is the result of an international study conducted according to the highest ...
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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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CVRx Launches new Barostlm NE02 Implantable Pulse Generator
The new Borostim NE02 Implantable Pulse Generator (IPG) launches in the U.S., improving the patient experience while on therapy and simplifying the implant procedure for physicians MINNEAPOLIS, Nov. 3, 2022 - CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), developer of the world's first FDA-approved neuromodulation device to treat the symptoms of heart failure, has launched its new Barostim NE02™ IPG. ...
By CVRx
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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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Enalare Therapeutics Receives Orphan Drug Designation From the U.S. FDA on ENA-001 for the Treatment of Apnea of Prematurity (AoP)
ENA-001, a New Chemical Entity (NCE) with a novel mechanism of action as an agnostic respiratory stimulant, has previously been granted Rare Pediatric Disease designation for the Treatment of AoP by the FDA, with eligibility for a priority review voucher (PRV). The compound is also being developed by Enalare for the treatment of post-operative respiratory depression and community drug overdose. ...
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Enalare Therapeutics Receives an Additional Award Worth Up to $50 Million From BARDA, Expanding Its Partnership in Development of ENA-001
The Funding Will Accelerate Development of an Intramuscular Formulation of ENA-001, a Novel Agnostic Respiratory Stimulant, for the Potential Treatment of Community Drug Overdose and as a Medical Countermeasure for Mass Casualty Events. The Funding Supports Development of an Intramuscular ENA-001 From Pre-Clinical Toxicology Through Filing for Approval in the United States Enalare Therapeutics ...
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Silk Road Medical Strengthens Leadership Team
Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that it is strengthening its leadership team with two appointments. William Whealon, Ph.D. has joined the company as Executive Vice President of Research and Development, effective immediately. Silk Road Medical has also named Lucas Buchanan, the company’s ...
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Eagle Pharmaceuticals Takes Equity Stake in, with Option to Acquire, Enalare Therapeutics to Advance Global Development of ENA-001, a Novel Agnostic Respiratory Stimulant
ENA-001 is currently in development for: post-operative respiratory depression, community drug overdose, and Apnea of Prematurity Approval for post-operative respiratory depression expected in 2026 and community drug overdose thereafter ENA-001 works peripherally by inhibiting Big Potassium (BK) ion channels in the carotid bodies, which are located in the neck. By inhibiting these channels, ...
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CVRx Launches a new Barostim Programmer
MINNEAPOLIS, July 12, 2022 - CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), developer of the world's first FDA-approved neuromodulation device to treat the symptoms of heart failure, has launched its new Barostim Programmer, which was approved by the U.S. Food and Drug Administration (FDA) earlier this year. The second-generation programmer has a modernized design, operates on an upgraded cellular network ...
By CVRx
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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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Enalare Therapeutics Receives a National Institutes of Health (NIH) Grant Award
Enalare Therapeutics Inc., a biopharmaceutical company dedicated to developing novel therapies for patients suffering from life-threatening critical care conditions, announced today that it has been awarded a grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). Funding from the grant will be used to further the development of ENA001, Enalare's ...
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£1.1 million project to develop new biodegradable stents
A £1.1 million project to develop biodegradable stents for patients with severe vascular disease, which affects around one million people in the UK, has started thanks to Innovate UK funding. The unique project, a collaboration between the UK-based medical device company Arterius and the Translational Biomedical Research Centre (TBRC) at the University of Bristol, will develop a new type of ...
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CVRx Announces First Clinical Procedure with a New Ultrasound-Guided Implant Approach, the Latest Advancement in Barostim™ for the Treatment of Heart Failure Symptoms
MINNEAPOLIS, June 10, 2021 - CVRx©. developer of the world's first FDA-approved neuromodulation device to treat the symptoms of heart failure (HF). announced the completion of the first clinical procedure with the company's new lead implantation approach. The novel ultrasound-guided technique is the latest advancement of CVRx's Barostim™ Baroreflex Activation Therapy (BAT™) to ...
By CVRx
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Enalare Therapeutics Announces Positive Topline Results With ENA001 in a Propofol Induced Respiratory Depression Study
Enalare Therapeutics Inc., a biopharmaceutical company dedicated to developing novel therapies for patients suffering from life-threatening critical care conditions, announced today that it has completed a propofol induced respiratory depression study with its lead compound ENA001, having achieved the targeted primary endpoint. The objective of the study was to demonstrate the ability of ENA001 ...
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Sonia Madigan of the Market Herald interviews CEO Wayne Paterson on the progress of Anteris Technologies
Anteris Technologies (AVR) pauses trading as it plans for an upcoming capital raise On Thursday, the company entered a trading halt, pausing shares until Monday, August 2 It is unknown how much the company is planning to raise or where the funds will be spent On the market, Anteris last traded at $8.59 per share Anteris Technologies (AVR) has paused trading as it plans for an upcoming ...
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electroCore, Inc. Announces gammaCore Non-Invasive Vagus Nerve Stimulator Available Through National Spine and Pain Centers
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that the gammaCore Sapphire™ non-invasive vagus nerve stimulator (nVNS) will be available for purchase through many of the more than 130 National Spine and Pain Centers (NSPC) affiliated locations across the United States for patients suffering from pain associated with different forms of ...
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CVRx Receives MR-Conditional Labeling Approval for its Barostim Heart Failure System
MINNEAPOLIS, MAY 9,2022 - CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), developer of the world's first FDA-approved neuromodulation device to treat the symptoms of heart failure, has received U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR) conditional labeling for its Barostim System. The Barostim System now includes instructions to allow for safe MRI scans of the head and ...
By CVRx
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Silk Road Medical Announces FDA Approval of Expanded Indications for the ENROUTE Transcarotid Stent System
Silk Road Medical, Inc.?(Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that that the U.S. Food and Drug Administration (FDA) approved expanded indications for the ENROUTE stent to include patients at standard risk for adverse events from carotid endarterectomy (CEA). Previously, the stent was approved for use only in patients with ...
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Enalare Files Additional Patent Application for Lead Compound ENA-001 - Enhancing Potential Global Exclusivity Through 2042
Enalare Therapeutics Inc., a biopharmaceutical company dedicated to developing novel therapies for patients suffering from life-threatening critical care conditions, announced today that it has filed a Provisional Patent Application with the United States Patent and Trademark Office directed to parenteral formulations of ENA-001 and related compounds. The patent application encompasses the ...
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Elucid announces American Medical Association (AMA) instates CPT Code for Lipid-Rich Necrotic Core Quantification to Assess Atherosclerotic Plaque Stability
BOSTON – December 17, 2021 – Elucid, a Boston-based medical technology company harnessing scientific imaging and artificial intelligence to enable the precise diagnosis and treatment of the world’s leading cause of death announced a new CPT code unique to its Plaque IQ technology for CT angiography. Plaque composition, specifically lipid-rich necrotic core, has been identified ...
By Elucid
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