Stenosis

Silk Road Medical Strengthens TCAR Portfolio with Launch of ENROUTE Transcarotid Neuroprotection System PLUS

Retrieved on: 
Tuesday, April 2, 2024
Neuroprotection, Risk, Stroke, FSVS, NPS, Workflow, Stenosis, FACS, SILK, Blood, Physician, TCAR

SUNNYVALE, Calif., April 02, 2024 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced the launch of its ENROUTE® Transcarotid Neuroprotection System PLUS (“NPS PLUS”), a key component of the TCAR® portfolio.

Key Points: 
  • SUNNYVALE, Calif., April 02, 2024 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced the launch of its ENROUTE® Transcarotid Neuroprotection System PLUS (“NPS PLUS”), a key component of the TCAR® portfolio.
  • This next generation device builds upon the prior ENROUTE Transcarotid Neuroprotection System to deliver smoother arterial sheath insertion, greater flow precision, and a simplified prep experience for surgical teams, all while maintaining unparalleled neuroprotection during the TCAR procedure.
  • “With the launch of the NPS PLUS, we're thrilled to empower our TCAR-trained physicians with a solution that addresses their insights and feedback to further strengthen and streamline the TCAR procedure,” shared Chas McKhann, Chief Executive Officer of Silk Road Medical.
  • During TCAR, the surgical team inserts a tube-like sheath into the carotid artery and connects it to the ENROUTE Neuroprotection System, which temporarily reverses blood flow.

Johnson & Johnson to Acquire Shockwave Medical

Retrieved on: 
Friday, April 5, 2024
Research, Medical Devices, Health Technology, Cardiology, Biotechnology, Other Health, Health, Pharmaceutical, Science, Cardiovascular disease, Worldwide, Growth, Peripheral artery disease, Coronary artery disease, Johnson & Johnson, Patient, PAD, JNJ, Perella Weinberg Partners, Acquisition, Electrophysiology, Death, IVL, Medtech, Ventricular fibrillation, European, PCI, Artery, Laminar, Stenosis, Hand, Physician, Percutaneous coronary intervention, CAD, Pharmaceutical industry

Johnson & Johnson (NYSE: JNJ) and Shockwave Medical, Inc. (Nasdaq: SWAV) (“Shockwave”) today announced that they have entered into a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Shockwave for $335.00 per share in cash, corresponding to an enterprise value of approximately $13.1 billion including cash acquired.

Key Points: 
  • Johnson & Johnson (NYSE: JNJ) and Shockwave Medical, Inc. (Nasdaq: SWAV) (“Shockwave”) today announced that they have entered into a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Shockwave for $335.00 per share in cash, corresponding to an enterprise value of approximately $13.1 billion including cash acquired.
  • The transaction is expected to accelerate revenue growth for both Johnson & Johnson and Johnson & Johnson MedTech.
  • Delivers immediate operational accretion: The transaction will be accretive to operating margin for both Johnson & Johnson and Johnson & Johnson MedTech.
  • Under the terms of the agreement, Johnson & Johnson will acquire all outstanding shares of Shockwave for $335.00 per share in cash through a merger of Shockwave with a wholly owned Johnson & Johnson subsidiary.

Cleerly® ISCHEMIA™ Demonstrates Robust Diagnostic Accuracy and Prognostic Utility in Analyses from Large Scale Clinical Trials

Retrieved on: 
Thursday, March 28, 2024
FDA, Health, Technology, Clinical Trials, Artificial Intelligence, Cardiology, Diagnosis, Coronary ischemia, Patient, Myocardial perfusion imaging, Journal, Ischemia, MD, American College, CCTA, Stenosis, Atherosclerosis, SPECT, Medical device

The study describes the validation of Cleerly's artificial intelligence-guided quantitative coronary CT angiography (AI-QCT) ISCHEMIA technology for diagnostic accuracy and prognostic risk stratification.

Key Points: 
  • The study describes the validation of Cleerly's artificial intelligence-guided quantitative coronary CT angiography (AI-QCT) ISCHEMIA technology for diagnostic accuracy and prognostic risk stratification.
  • For patients with an abnormal Cleerly AI-QCT ISCHEMIA finding, a positive result was associated with an approximately 7-fold increase of adverse cardiovascular events during an 8-year follow-up.
  • Collectively, this study shows that Cleerly AI-QCT ISCHEMIA, when used in conjunction with Cleerly LABS, can provide a 3-in-1 approach for the assessment of atherosclerosis, stenosis and ischemia.
  • These study results come after Cleerly announced that its Cleerly ISCHEMIA software device is billable using the new Category I CPT® code 75580.

Innovating "Treadmill Exercise Test AI-Assisted Interpretation System," CMUH(Taiwan) Timely Saves More Patients with Severe Myocardial Infarction

Retrieved on: 
Tuesday, April 2, 2024
Depression, Thrombosis, Myocardial infarction, Sudden death, Cardiovascular disease, Exercise, Survival, Coronary artery disease, ECG, Hyperlipidemia, Patient, Palpitations, Angina, Cancer, AI, Death, Moyamoya disease, Chronic pain, Plaque, Diet, Receiver, Smoking, Cardiac catheterization, Stenosis, Oxygen, Heart, Atherosclerosis, Rupture, Ministry, Duke, Vascular occlusion, CAD

To address this issue, China Medical University Hospital (CMUH) AI Center successfully developed the "Treadmill Exercise Test AI-Assisted Interpretation System" which was trained with nearly a thousand treadmill ECG, in patients with coronary arterystenosisover 70% shown on their coronary angiography.

Key Points: 
  • To address this issue, China Medical University Hospital (CMUH) AI Center successfully developed the "Treadmill Exercise Test AI-Assisted Interpretation System" which was trained with nearly a thousand treadmill ECG, in patients with coronary arterystenosisover 70% shown on their coronary angiography.
  • The program also utilizes ten measured features and two derived features including maximal work output and peak heart rate to determine the severity of coronary artery stenosis.
  • Generally, coronary heart disease in patients of middle or senior age is presented as angina or myocardial infarction and is one of the primary causes of sudden death."
  • Dr. Wu stated, "Coronary artery stenosis is a multi-factorial condition related to smoking, advanced age, diabetes hypertension and hyperlipidemia.

InspireMD Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, March 6, 2024
CMS, Pi, Growth, Radiology, IDE, State university system, CAD, Buffalo, PMA, MDR, TEL, Medical device regulation, Health, Stroke, CAS, TCAR, EPS, EFS, Thomas Jefferson University, European, Carotid artery stenosis, Myocardial infarction, CE marking, Vascular disease, Thrombectomy, Clinical trial, Medicaid, NPS, CEA, Good Samaritan Hospital, Stenosis, Risk, Blood vessel, Medicare, Death, Stent, Patient, Medicine, NSPR, Pharmaceutical industry

TEL AVIV, Israel and MIAMI, March 06, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced financial and operating results for the fourth quarter and full-year ended December 31, 2023.

Key Points: 
  • Fourth Quarter 2023 and Recent Developments:
    Generated record CGuard revenue in the fourth quarter 2023 of $1.76 million, a 71.6% increase over the fourth quarter of 2022.
  • Sold 3,107 CGuard EPS stent systems in the fourth quarter of 2023, as compared to 1,781 in the fourth quarter of 2022, an increase of 74.5%.
  • Financial Results for the Fourth Quarter Ended December 31, 2023
    For the fourth quarter of 2023, total revenue increased 71.6%, to $1,761,000, from $1,026,000 during the fourth quarter of 2022.
  • Total financial income for the fourth quarter of 2023 was $468,000, an increase of $349,000 or 293% compared to $119,000 for the third quarter of 2022.

Silk Road Medical Expands TCAR® Portfolio with Launch of Tapered ENROUTE® Transcarotid Stent System

Retrieved on: 
Tuesday, March 5, 2024
FACS, Hospital, MD, CEA, Professor, Physician, Vascular surgery, Stroke, Plaque, MBA, Risk, Cooper University Hospital, Silk, Patient, Anatomy, TCAR, Stenosis, SILK, Pharmaceutical industry

This launch expands upon the company’s prior ENROUTE Transcarotid Stent System, offering additional configurations to better tailor the Transcarotid Artery Revascularization (TCAR) procedure to patient anatomy.

Key Points: 
  • This launch expands upon the company’s prior ENROUTE Transcarotid Stent System, offering additional configurations to better tailor the Transcarotid Artery Revascularization (TCAR) procedure to patient anatomy.
  • “New tapered configurations for our ENROUTE Transcarotid Stent System build upon the robust portfolio of Silk Road’s carotid solutions.
  • The ENROUTE Transcarotid Stent System features an optimized cell design balancing lesion coverage and anatomical conformability for long-term plaque stabilization.
  • The stent system was purpose-built for TCAR with a short delivery system for ergonomic and precise stent delivery.

Exclusive license agreement secured with Erganeo for EVerGel, EVerZom's first drug candidate, a breakthrough treatment for fistulas and fibrosis of the digestive tract.

Retrieved on: 
Tuesday, March 5, 2024
CNRS, Regeneration, Crohn's disease, EIC, Exosome, Quality of life, Fistula, Stenosis, B cell, Patient, Fibrosis, Intellectual property, Congress, Research, ECCO, Pharmaceutical industry

Exclusive license agreement secured with Erganeo for EVerGel, EVerZom's first drug candidate, a breakthrough treatment for fistulas and fibrosis of the digestive tract.

Key Points: 
  • Exclusive license agreement secured with Erganeo for EVerGel, EVerZom's first drug candidate, a breakthrough treatment for fistulas and fibrosis of the digestive tract.
  • This new worldwide license marks a significant step forward in EVerZom's mission to bring innovative exosome-based therapeutic solutions to patients suffering from serious digestive diseases.
  • Paris, March 5, 2024 - EVerZom, a CNRS/Université Paris Cité spin-off specializing in exosomes, has announced the signature of a second exclusive license agreement with Erganeo for the development of EVerGel ™, a drug candidate tailored for the healing of digestive tissues.
  • EVerZom's first clinical application focuses on digestive tissue regeneration using naive exosomes derived from stem cells encapsulated in a gel called EVerGel ™.

Silk Road Medical Reports Fourth Quarter and Full Year 2023 Financial Results and Provides 2024 Financial Outlook

Retrieved on: 
Wednesday, February 28, 2024
Silk Road, CMS, Investment, Physician, Stroke, Adjustment, Risk, Growth, Webcast, Patient, TCAR, Stenosis, SILK, Video game

Gross profit for the fourth quarter of 2023 was $34.8 million compared to $29.1 million for the fourth quarter of 2022.

Key Points: 
  • Gross profit for the fourth quarter of 2023 was $34.8 million compared to $29.1 million for the fourth quarter of 2022.
  • Gross margin for the fourth quarter of 2023 increased to 74% compared to 73% for the fourth quarter of 2022, primarily due to an increase in production volumes.
  • Operating expenses were $49.2 million for the fourth quarter of 2023 compared to $41.7 million in the fourth quarter of 2022, which represents an increase of 18%.
  • ET on Wednesday, February 28, 2024, to discuss its fourth quarter and full year 2023 financial results.

NCLA Suit Challenges DOE’s Unlawful Attempt to Collect Cryptocurrency Miners’ Energy Use Data

Retrieved on: 
Friday, February 23, 2024
Court, EIA, Stenosis, Climate, Management, Data collection, Complaint, District court, OMB, Red, NCLA, TRO, Paperwork, Joe Biden, Administration, Electricity, Primary energy, Congress, Energy Information Administration, DOE, Ministry of Energy, Cryptocurrency

The Texas Blockchain Council v. Department of Energy suit is pending in the U.S. District Court for the Western District of Texas.

Key Points: 
  • The Texas Blockchain Council v. Department of Energy suit is pending in the U.S. District Court for the Western District of Texas.
  • OMB approved EIA’s slapdash Cryptocurrency Mining Facilities Survey request just two days after receiving it.
  • NCLA urges the Court to set aside this unlawful action and force DOE and OMB back to the drawing board.
  • DOE wants to get away with assuming the results of the very survey it hopes to conduct.”
    — Mark Chenoweth, President and Chief Legal Officer, NCLA

Cleerly® Receives FDA Breakthrough Device Designation for Heart Disease Risk Staging System

Retrieved on: 
Tuesday, March 5, 2024
Technology, Medical Devices, FDA, Clinical Trials, Health Technology, Cardiology, Software, Health, Artificial Intelligence, Diabetes, Prediabetes, Randomized controlled trial, Physician, Food, Stenosis, MACE, Coronary artery disease, Lung, Splenic infarction, Risk, TAP, CAD, Atherosclerosis, Ischemia, Risk assessment, Metabolic syndrome, Patient, MPH, Medicine, Diagnosis, Heart, CTS, Medical device

Cleerly , the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Coronary Artery Disease (CAD) Staging System.

Key Points: 
  • Cleerly , the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Coronary Artery Disease (CAD) Staging System.
  • The CAD Staging System is a noninvasive imaging-based investigational software device that analyzes important and actionable features of coronary atherosclerosis, stenosis and ischemia.
  • The FDA’s Breakthrough Device Designation is granted for technologies that have the possibility to encourage more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases.
  • “This designation from the FDA highlights the critical need for better heart disease risk assessment methods.