Carotid artery stenosis

InspireMD Announces Abstract of One-Year Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial Accepted for Presentation at LINC 2024

Retrieved on: 
Tuesday, March 26, 2024
Neuroprotection, OhioHealth, VIVA, LINC, EPS, Stroke, NSPR, Carotid artery stenosis, Clinical trial, PMA, ITT, TEL

TEL AVIV, Israel and MIAMI, March 26, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that an abstract of the one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard™ Prime Carotid Stent System for the treatment of carotid artery stenosis has been accepted for presentation at the Leipzig Interventional Course (LINC) 2024, which is being held May 28-31, in Leipzig, Germany.

Key Points: 
  • TEL AVIV, Israel and MIAMI, March 26, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that an abstract of the one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard™ Prime Carotid Stent System for the treatment of carotid artery stenosis has been accepted for presentation at the Leipzig Interventional Course (LINC) 2024, which is being held May 28-31, in Leipzig, Germany.
  • Chris Metzger, M.D., System Vascular Chief at Ohio Health, and lead investigator of the C-Guardians trial
    Marvin Slosman, chief executive officer of InspireMD, stated, “At last year’s VIVA and VEITH conferences in November, Dr. Metzger, principal investigator for the C-GUARDIANS trial, presented positive 30-day follow-up data from the trial which demonstrated a DSMI1 rate of just 0.95% in the Intent-To-Treat (ITT) analysis population, and 0.63% in the per-protocol (PP) analysis population.
  • We are very excited to announce today that an abstract of the 12-month outcomes data from this important trial has been accepted for presentation at the upcoming LINC 2024 conference, which is among the most influential and widely attended meetings focused on vascular intervention.
  • We are optimistic that the results will show a similar level of neuroprotection, which may support a Premarket Approval Application (PMA) later this year and allow us to prepare for a commercial launch of CGuard Prime in the U.S. in the first half of 2025, if approved.”

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.

Advancing Healthcare Access: Genesis MedTech Teams Up with Silk Road Medical to Serve Patients affected by Carotid Artery Disease in China

Retrieved on: 
Friday, March 8, 2024
Chinese Medical Doctor Association, Stroke, Neck, CEA, Physician, Common carotid artery, Carotid artery stenosis, Plaque, Risk, Splenic infarction, Genesis, Disability, Death, CNI, Cranial nerves, Health, Patient, Atherosclerosis, TCAR, Stenosis, Mortality, Medtech, SILK, Brain, Pharmaceutical industry

TCAR (Transcarotid Artery Revascularization) is an innovative minimally invasive surgical procedure used to treat carotid artery disease, a condition characterized by the narrowing or blockage of the carotid arteries in the neck.

Key Points: 
  • TCAR (Transcarotid Artery Revascularization) is an innovative minimally invasive surgical procedure used to treat carotid artery disease, a condition characterized by the narrowing or blockage of the carotid arteries in the neck.
  • Since its establishment in 2019, Genesis MedTech Group has continuously strived to enhance its peripheral interventional portfolio, offering comprehensive solutions to both physicians and patients.
  • Before the introduction of TCAR, moderate to severe carotid artery disease was generally treated clinically with two surgical methods: Carotid Endarterectomy (CEA) and Transfemoral Carotid Artery Stenting (TFCAS).
  • Together with Silk Road Medical, we remain dedicated to make better healthcare more accessible, improving patient care and outcomes."

InspireMD Presents Positive 30-Day Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial at VIVA23

Retrieved on: 
Wednesday, November 1, 2023
Blood vessel, Stroke, FDA, Carotid artery stenosis, OH, Incidence, OhioHealth, TEL, Mortality, NSPR, PMA, IDE, EPS, A. C. Guards, Clinical trial, Myocardial infarction, VIVA, Safety, Stent, Patient, Death, Medical device, Pharmaceutical industry, EU

The presentation, which was accepted as a late-breaking abstract, was delivered by Dr. Chris Metzger, System Vascular Chief at OhioHealth in Columbus, OH and principal investigator of the C-GUARDIANS trial.

Key Points: 
  • The presentation, which was accepted as a late-breaking abstract, was delivered by Dr. Chris Metzger, System Vascular Chief at OhioHealth in Columbus, OH and principal investigator of the C-GUARDIANS trial.
  • From July 2021 to June 2023, 316 patients were prospectively enrolled in this single-arm carotid artery stenting study performed at 24 sites in the US and the EU.
  • Stenting with the C-Guard carotid stent system in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%, from procedure through 30 days follow-up.
  • We believe the neuroprotective qualities of C-Guard set it apart from competing stents on the market and should help accelerate the ongoing shift in carotid revascularizations from ‘surgery first’ to an endovascular ‘stent first’ approach.

Los Angeles Vascular Surgeon, Varicose & Spider Vein Treatment Specialist Dr. Rameen Moridzadeh Receives Castle Connolly's 2023 Top Doctor® Award

Retrieved on: 
Monday, October 2, 2023
Vein, Aneurysm, Varicose veins, University School, PAD, DVT, Castle Connolly Medical, Multimedia, Artery, Sclerotherapy, Carotid artery stenosis, Blood, Hospital, Patient, Division, Physician, New York University Grossman School of Medicine, Laser, Deep vein thrombosis, Castle, Diagnosis, LOS, Cedars-Sinai Medical Center, UCLA, Nursing, Medical device

LOS ANGELES, Oct. 2, 2023 /PRNewswire-PRWeb/ -- Rameen Moridzadeh, M.D. has been selected as a 2023 Top Doctor® by Castle Connolly. He has earned this impressive award for his expertise as one of the top vein specialists and vascular surgeons in Los Angeles, CA. Dr. Moridzadeh's medical education, training, hospital appointments and disciplinary history were rigorously screened by the Castle Connolly physician-led research team. Castle Connolly publishes its list of Top Doctors at http://www.castleconnolly.com and in a wide variety of partner publications, magazines and affiliate websites. Around 5% of the nation's licensed physicians have been selected as Castle Connolly Top Doctors in their regions for their specialties. Individuals do not and cannot pay to be selected as a Castle Connolly Top Doctor. Dr. Moridzadeh is a fellowship-trained and board-certified vascular and endovascular surgeon well-known for successfully treating conditions affecting veins, arteries and other blood vessels. He specializes in minimally invasive options and surgical procedures to improve vascular health and can offer an accurate diagnosis, delivering the best care possible. He has performed thousands of treatments for varicose veins, peripheral artery disease (PAD), carotid artery stenosis, aortic aneurysms, deep vein thrombosis (DVT), spider veins and chronic venous insufficiency at his clinics and hospitals. Dr. Moridzadeh offers RF ablation, sclerotherapy, laser therapy and vascular surgery for his patients, many of which require little to no downtime after the procedure.

Key Points: 
  • LOS ANGELES, Oct. 2, 2023 /PRNewswire-PRWeb/ -- Rameen Moridzadeh, M.D.
  • has been selected as a 2023 Top Doctor® by Castle Connolly.
  • He has earned this impressive award for his expertise as one of the top vein specialists and vascular surgeons in Los Angeles, CA.
  • Dr. Moridzadeh's medical education, training, hospital appointments and disciplinary history were rigorously screened by the Castle Connolly physician-led research team.

Endologix Announces that Lucas Buchanan Joins Board of Directors

Retrieved on: 
Thursday, August 24, 2023
General Health, Medical Devices, Other Health, Health, Cardiology, Duke University, University, Wharton School of the University of Pennsylvania, Cerebrovascular disease, Amneal Pharmaceuticals, Ernst & Young, PTAB, MBA, Carotid artery stenosis, Medtronic, MD, Patient, Vascular disease, Health administration, Pharmaceutical industry, Economics

Endologix LLC , a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, is pleased to announce that Lucas Buchanan has been appointed to the Endologix Board of Directors.

Key Points: 
  • Endologix LLC , a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, is pleased to announce that Lucas Buchanan has been appointed to the Endologix Board of Directors.
  • Lucas Buchanan is currently the Chief Financial Officer and Chief Operating Officer at Silk Road Medical, Inc.
  • Mr. Buchanan played a pivotal role in financing the company and scaling its operations, including leading Silk Road’s initial public offering in 2019, and his role has continued to expand.
  • “We are thrilled to welcome Lucas to our Board of Directors,” said Matt Thompson, MD, President, and CEO of Endologix.

Silk Road Medical Reports Second Quarter 2023 Financial Results

Retrieved on: 
Tuesday, August 1, 2023
SILK, TCAR, Stroke, Carotid artery stenosis, Patient, Investment, Risk, Growth, Webcast, Pharmaceutical industry, Video game, Cryptocurrency

“Silk Road is the leading force in stroke prevention for patients with severe carotid artery stenosis, and our second quarter results demonstrate the strong momentum behind TCAR as the gold standard in carotid stenting,” said Erica Rogers, CEO of Silk Road Medical.

Key Points: 
  • “Silk Road is the leading force in stroke prevention for patients with severe carotid artery stenosis, and our second quarter results demonstrate the strong momentum behind TCAR as the gold standard in carotid stenting,” said Erica Rogers, CEO of Silk Road Medical.
  • Gross profit for the second quarter of 2023 was $32.3 million compared to $24.2 million for the second quarter of 2022.
  • Gross margin was 71% for the second quarter of 2023 compared to 73% for the second quarter of 2022.
  • ET on Tuesday, August 1, 2023, to discuss its second quarter 2023 financial results.

InspireMD Announces Completion of Enrollment in C-Guardians U.S. Investigational Device Exemption (IDE) Clinical Trial

Retrieved on: 
Monday, June 26, 2023
Myocardial infarction, TCAR, Marketing, Stroke, Clinical trial, Carotid artery stenosis, TEL, Incidence, NSPR, PMA, Patient, CAS, Mortality, EPS, IDE, Neuro, FDA, Death, CEC, Safety, Pharmaceutical industry

TEL AVIV, Israel, June 26, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it completed enrollment of its ongoing C-Guardians U.S. Investigational Device Exemption (IDE) clinical trial, designed to support potential U.S. marketing approval of the CGuard Prime EPS stent system.

Key Points: 
  • Marvin Slosman, chief executive officer of InspireMD, stated, “The completion of enrollment in our IDE trial is a significant milestone and brings us one step closer to potential U.S. approval of the CGuard Prime EPS stent system.
  • Notably, the trial was fully enrolled in less than two years, including first-in-human cases treated with our next generation CGuard Prime CAS delivery platform.
  • Completing enrollment of the C-Guardians trial, advancing our PMA submission and obtaining FDA approval would allow us to launch CGuard Prime EPS commercially in the U.S. and catalyze market adoption.
  • The study, which commenced enrollment in July 2021, enrolled 315 patients across 25 trial sites in the U.S. and Europe.

Asia Pacific Vascular Patches Market Report 2022: Featuring Edwards Lifesciences, Baxter International, Lemaitre Vascular, Becton, Dickinson & More - ResearchAndMarkets.com

Retrieved on: 
Friday, January 27, 2023
Medical Supplies, Health, Congenital heart defect, Superior, Restenosis, Stroke, Country, Synthetic, Carotid artery stenosis, Splenic infarction, Patient, Incidence, Abdominal aortic aneurysm, Fatality, Application, Radiation exposure, Biologic, Atherosclerosis, Cardiovascular disease, Hospital, Peripheral artery disease, Medical device, Pharmaceutical industry

The development of vascular surgery techniques and the treatment of vascular diseases will be influenced by impending technological developments.

Key Points: 
  • The development of vascular surgery techniques and the treatment of vascular diseases will be influenced by impending technological developments.
  • Statin medications are just becoming widely available, yet their use has already decreased the number of strokes, heart attacks, and fatalities.
  • The China market dominated the Asia Pacific Vascular Patches Market by Country in 2021, and would continue to be a dominant market till 2028; thereby, achieving a market value of $41, 515.5 Thousands by 2028.
  • Based on countries, the market is segmented into China, Japan, India, South Korea, Singapore, Malaysia, and Rest of Asia Pacific.

Asia Pacific Vascular Patches Market Report 2022: Sector to Grow by 7.9% Annually Through 2028

Retrieved on: 
Monday, January 30, 2023
Incidence, Peripheral artery disease, Carotid artery stenosis, Superior, Cardiovascular disease, Fatality, Country, Atherosclerosis, Splenic infarction, Restenosis, Synthetic, Application, Congenital heart defect, Abdominal aortic aneurysm, Stroke, Biologic, Hospital, Patient, Radiation exposure, Medical device, Pharmaceutical industry

The development of vascular surgery techniques and the treatment of vascular diseases will be influenced by impending technological developments.

Key Points: 
  • The development of vascular surgery techniques and the treatment of vascular diseases will be influenced by impending technological developments.
  • Statin medications are just becoming widely available, yet their use has already decreased the number of strokes, heart attacks, and fatalities.
  • The China market dominated the Asia Pacific Vascular Patches Market by Country in 2021, and would continue to be a dominant market till 2028; thereby, achieving a market value of $41, 515.5 Thousands by 2028.
  • Based on countries, the market is segmented into China, Japan, India, South Korea, Singapore, Malaysia, and Rest of Asia Pacific.