Thrombectomy

Stamford Health and Columbia University Irving Medical Center Deepen Relationship With Neurosciences Partnership

Retrieved on: 
Thursday, March 21, 2024
Stroke, American Heart Association, Brain, Neuroscience, Joint Commission, Partnership, Stamford Hospital, Headache, Patient, Research, Columbia, Columbia University, Surgeon, Spine, Joint, CUIMC, Pain management, Thrombectomy, FACS, Physician, Hospital

The neurosciences partnership builds on Stamford Health's existing relationship with CUIMC and earlier this year, Stamford Health welcomed Columbia University Irving Medical Center endovascular neurosurgeon, Max Shutran, MD , to its medical staff.

Key Points: 
  • The neurosciences partnership builds on Stamford Health's existing relationship with CUIMC and earlier this year, Stamford Health welcomed Columbia University Irving Medical Center endovascular neurosurgeon, Max Shutran, MD , to its medical staff.
  • Through its expanded partnership with Columbia University Irving Medical Center, one of the nation's premier medical centers, Stamford Health provides the most advanced and sophisticated cardiac and neurosurgical care to lower Fairfield County.
  • "We are so excited for Dr. Max Shutran to join our department in this exciting new role with Stamford Health," noted E. Sander Connolly, MD , Neurosurgeon-in-Chief at Columbia University Irving Medical Center.
  • "Our partnership with Columbia University Irving Medical Center is one that we are extremely proud of," added Rod Acosta, MD, Chief Physician Executive and President & CEO of Stamford Health Medical Group.

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.

MIVI Neuroscience™ Presents Primary Endpoint Results from the EvaQ Trial — at the 2024 International Stroke Conference

Retrieved on: 
Thursday, February 8, 2024
Technology, Radiology, Health Technology, Pharmaceutical, Neurology, Other Science, Research, Medical Devices, Infectious Diseases, Hospitals, Clinical Trials, Cardiology, Biotechnology, Health, Practice Management, General Health, Nanotechnology, Science, Medical Supplies, Software, FDA, Surgery, Other Health, Sich, CE marking, Cerebrovascular disease, LVO, NIHSS, Conference, Bangladesh Technical Education Board, Intracranial hemorrhage, Thrombectomy, Safety, Physician, ECASS, Reperfusion, IDE, Thrombus, Patient, Stroke, System, Death

MIVI Neuroscience, Inc. (Eden Prairie, MN) announces the primary endpoint results of its EvaQ Trial, a prospective, multi-center, global, single arm, FDA-regulated IDE trial study to evaluate the safety and effectiveness of the MIVI Q™ Revascularization System for treating acute ischemic stroke.

Key Points: 
  • MIVI Neuroscience, Inc. (Eden Prairie, MN) announces the primary endpoint results of its EvaQ Trial, a prospective, multi-center, global, single arm, FDA-regulated IDE trial study to evaluate the safety and effectiveness of the MIVI Q™ Revascularization System for treating acute ischemic stroke.
  • The data were presented yesterday at the 2024 International Stroke Conference (AZ), a premier event featuring global thought leaders and dedicated to the latest in the science and treatment of cerebrovascular disease and brain health.
  • Results of the EvaQ Trial show the Q Revascularization System to be safe and effective for thrombectomy of Large Vessel Occlusion (LVO) strokes.
  • The primary safety endpoint was symptomatic intracranial hemorrhage (sICH) which was observed at a rate of 6.5%.

NICE Endorses Brainomix AI-Enabled Software in Stroke

Retrieved on: 
Tuesday, February 6, 2024
Intelligence, Thrombectomy, HTA, Royal Berkshire Hospital, Patient, FDA, NHS, Disability, Stroke, Health technology assessment, Software, Hospital, Pharmaceutical industry

The NICE guidance elevates the Brainomix 360 stroke platform, the European market leading solution now entering the US market, to an evidence generation framework, which enables stroke units across the UK to utilize the technology while further evidence is collected.

Key Points: 
  • The NICE guidance elevates the Brainomix 360 stroke platform, the European market leading solution now entering the US market, to an evidence generation framework, which enables stroke units across the UK to utilize the technology while further evidence is collected.
  • Brainomix was the recipient of the prestigious NHS AI in Health & Care Award in 2020 enabling its Brainomix 360 stroke platform to be deployed across multiple UK stroke networks.
  • Dr Kiruba Nagaratnam, Consultant Stroke Physician and Clinical Lead for Stroke Medicine at the Royal Berkshire Hospital in Reading, commented: "We welcome this latest guidance from NICE, which reflects the clinical value that Brainomix 360 brings to stroke care – which we have been seeing since we first implemented the software in March 2020.
  • The Brainomix 360 stroke platform has been widely adopted across England and is now used in the majority of stroke centres.

Surmodics Announces Successful Early Clinical Use of Pounce™ LP (Low Profile) Thrombectomy System, Designed to Address a Critical, Unmet Need by Facilitating Removal of Thrombi and Emboli Below the Knee

Retrieved on: 
Monday, January 22, 2024
Medical Devices, Health, Surgery, Clinical Trials, General Health, Pharmaceutical, Thrombectomy, Knee, Thrombus, Food and Drug Administration, Foot, Thrombosis, University, LME, BTK, Food, Hospital, FDA, Dell Seton Medical Center, Embolism, Medical imaging

Surmodics’ Pounce Thrombectomy devices are intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.

Key Points: 
  • Surmodics’ Pounce Thrombectomy devices are intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.
  • The new Pounce LP Thrombectomy System is indicated for use in vessels ranging from 2 mm to 4 mm in diameter, sizes typical of vessels found below the knee.
  • The Pounce LP System complements the original Pounce Thrombectomy System, introduced in 2021, which is indicated for use in vessels 3.5 mm to 6 mm in diameter.
  • The Pounce LP System’s ability to capture and remove these unexpected emboli adds yet more value to this device for BTK revascularization.”

AngioDynamics Reports Fiscal Year 2024 Second Quarter Financial Results; Revises Fiscal Year 2024 Guidance

Retrieved on: 
Friday, January 5, 2024
Health, General Health, Nanoknife, Quality of life, SKU, Table, Public expenditure, Dialysis, Education, News, Cancer, Rationalization, MED, Unless, Thrombectomy, Growth, Patient, Medical laboratory scientist, GAAP, EPS, Pharmaceutical industry

Net sales for the second quarter of fiscal year 2024 were $79.1 million, an increase of 2.7% compared to the prior-year quarter.

Key Points: 
  • Net sales for the second quarter of fiscal year 2024 were $79.1 million, an increase of 2.7% compared to the prior-year quarter.
  • AngioVac sales were $5.4 million in the quarter, a decline of 10.8% from the second quarter of fiscal 2023.
  • U.S. net sales in the second quarter of fiscal 2024 were $64.0 million, an increase of 0.6% from sales of $63.6 million a year ago.
  • Gross margin for the second quarter of fiscal 2024 was 50.9%, a decrease of 80 basis points from gross margin of 51.7% in the second quarter of fiscal 2023.

InspireMD Announces Strategic Agreement with Jacobs Institute to Execute Early Feasibility Study of CGuard EPS for the Treatment of Acute Stroke Patients with Tandem Lesions

Retrieved on: 
Monday, November 27, 2023
NSPR, Buffalo, Stroke, FDA, TEL, EFS, Stenosis, Prolapse, Stent, Thrombectomy, Growth, Patient, Safety, Plaque, State university system, EPS, Pharmaceutical industry

As a result, there are currently no FDA approved stents for this specific indication.

Key Points: 
  • As a result, there are currently no FDA approved stents for this specific indication.
  • Retrospective analyses from large centers across the globe have suggested the safety and efficacy of stenting in conjunction with intracranial thrombectomy.
  • I am also excited that this brings the carotid disease as it pertains to neurointerventionalists to the forefront.
  • The EFS is expected to enroll 15 patients across three U.S. trial sites and explore the safety and feasibility of using the CGuard EPS carotid stent, with its unique MicroNet™ mesh covering, to treat acute ischemic stroke patients with tandem lesions.

Perfuze® Announces FDA Clearances for Novel Neurovascular Aspiration and Access Catheters for Stroke Treatment

Retrieved on: 
Wednesday, December 20, 2023
FDA, General Health, Health, Medical Devices, Architecture, Reperfusion, Multimedia, U.S. FDA, Physician, Stroke, Access, MARRS, Brain, Navigability, Death, Thrombectomy, Patient, Diagnosis, Medical device

View the full release here: https://www.businesswire.com/news/home/20231220858228/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231220858228/en/
    The Millipede 070 Aspiration Catheter is built upon a pioneering, distinctive technology that enables physicians to address critical unmet needs in ischemic stroke treatment.
  • Perfuze takes a physician-led approach to device innovation, working to advance all aspects of stroke treatment from vessel access through to thrombectomy.
  • Stroke is a critically time-sensitive disease and without appropriate diagnosis and treatment, a majority of patients suffer permanent disability or death.
  • Despite recent advances in life-saving endovascular treatment, just 10 percent of eligible stroke patients receive thrombectomy treatment today.

Route 92 Medical Announces Impressive Clinical Results for its Tenzing® Technology.

Retrieved on: 
Tuesday, November 14, 2023
Research, Safety, SAN, NIHSS, Route, Patient, Medicine, Thrombectomy, Cooper University Hospital, Embolus, Neuroradiology, Doctor of Philosophy, Medical device, Nursing, Stroke, MD

SAN MATEO, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Route 92 Medical, a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced compelling results from a multicenter clinical study 1 on the Tenzing® 7 Delivery Catheter published in Stroke: Vascular and Interventional Neurology.

Key Points: 
  • SAN MATEO, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Route 92 Medical, a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced compelling results from a multicenter clinical study 1 on the Tenzing® 7 Delivery Catheter published in Stroke: Vascular and Interventional Neurology.
  • "Early clinical and in vitro experiences have always shown the potential of the Tenzing 7 delivery catheter.
  • "These findings underline our unwavering commitment to elevating patient outcomes through the development of best-in-class neurovascular intervention tools,” said Joey D. English, MD, PhD, Chief Medical Officer at Route 92 Medical.
  • Tenzing is a major advance.”
    For more information about Route 92 Medical and the Tenzing 7 Delivery Catheter, visit www.route92medical.com .

Q'Apel Medical Inc. Launches "Hippo" The New Generation Aspiration System for Stroke Thrombectomy

Retrieved on: 
Tuesday, December 12, 2023
DNA, Prisma Health, Patient, Thrombectomy, FDA, Baylor College of Medicine, Neuron, Stroke, Ambient occlusion, Biomedical sciences, MBA, MD, Physician, Professor, Face, Medical device, Cheetah, Walrus, Medicine, Hippopotamus, Radiology, Neurosurgery

FREMONT, Calif., Dec. 12, 2023 /PRNewswire/ -- Q'Apel Medical Inc. launches a new generation aspiration technology - the 072 Hippo Aspiration System, developed for patients suffering from a stroke due to a large vessel occlusion.

Key Points: 
  • FREMONT, Calif., Dec. 12, 2023 /PRNewswire/ -- Q'Apel Medical Inc. launches a new generation aspiration technology - the 072 Hippo Aspiration System, developed for patients suffering from a stroke due to a large vessel occlusion.
  • The recent FDA cleared stroke system, comprised of the 072 Hippo Aspiration Catheter and its Cheetah companion, represents a paradigm shift in emergent neurovascular intervention.
  • "Our initial experience with the Hippo Aspiration System really demonstrated outstanding system performance.
  • The Hippo Aspiration System also grants us the ability to offer physicians a complete stroke procedure.