Blood vessel

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.

Integer to Showcase Recently Acquired Capabilities and New Technologies at MD&M West 2024

Retrieved on: 
Thursday, February 1, 2024
Neuromodulation, Electrophysiology, MD, Integer, Patient, Gen, Second generation, Anaheim Convention Center, Risk, Acquisition, Cardio, Arrhythmia, Blood vessel, Medical imaging

PLANO, Texas, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Integer Holdings Corporation (NYSE: ITGR), a leader in medical device outsource manufacturing, will join innovators and industry leaders around the world in exhibiting at MD&M West, Feb. 6-8, 2024, at the Anaheim Convention Center in Anaheim, California.

Key Points: 
  • Integer’s exhibit will spotlight the recent strategic acquisitions of InNeuroCo and Pulse Technologies, each of which have further enhanced Integer’s capability spectrum in the medical device sector.
  • The acquisition of InNeuroCo brings specific expertise in neurovascular solutions and advanced catheter technologies, while the combination with Pulse Technologies enhances capabilities in precision micro machining, backed by proprietary technologies and a focus on high-growth medical markets.
  • Cardio and Vascular Solutions: A full range of electrophysiology, structural heart, and neurovascular product solutions including high-performing guidewires, steerable introducers and sheaths, therapy delivery systems, and implant technologies.
  • In addition to Integer’s exhibit at booth #1439, MD&M West 2024 attendees can also visit Pulse Technologies at booth #2844 to learn more about complex micro machining for critical medical device components.

InspireMD Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 6, 2023
CAS, Blood vessel, National coverage determination, Stroke, Medical Affairs Bureau, Nine Months, Medicare, TEL, NCD, NSPR, Global marketing, IDE, Quality assurance, EPS, CEA, Clinical trial, Risk, Myocardial infarction, Medicaid, TCAR, Center for Medicare and Medicaid Innovation, Safety, Stenosis, Investment, Patient, Death, CMS, Birth control, Medical device, Clothing, Cryptocurrency, Pharmaceutical industry, Beauty salon, Video game, Film industry, MD

TEL AVIV, Israel and MIAMI, Nov. 06, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for treatment of carotid artery disease and prevention of stroke today announced financial results and business updates for the third quarter ended September 30, 2023.

Key Points: 
  • Generated CGuard revenue for the third quarter 2023 of $1,556,072, an 8.8 % increase over the same period in 2022.
  • Sold 2,734 CGuard EPS stent systems in the third quarter of 2023, as compared to 2,624 in the third quarter of 2022, an increase of 4.2 %.
  • Total financial income for the third quarter of 2023 was $461,000, an increase of $380,000 or 469% compared to $81,000 for the third quarter of 2022.
  • Management will host a conference call today, Monday, November 6th, at 8:30 AM ET, to review financial results and provide an update on corporate developments.

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.

Contego Medical Announces One-Year Outcomes From the Performance II Carotid Stent Trial

Retrieved on: 
Wednesday, November 1, 2023
Biotechnology, Medical Devices, Health, Clinical Trials, Cardiology, Blood vessel, Stroke, Standard of care, IEP, Medicare, Trial of the century, Physician, Moyamoya disease, Division, Risk, VIVA, Safety, Stenosis, Centers for Medicare & Medicaid Services, Patient, CMS, Medical imaging, Pharmaceutical industry

Contego Medical Inc., a company dedicated to improving patient outcomes and procedural efficiency in the treatment of carotid and peripheral vascular disease, today announced the presentation of late-breaking clinical results from the PERFORMANCE II carotid stent trial at the annual VIVA (Vascular InterVentional Advances) multidisciplinary vascular education conference.

Key Points: 
  • Contego Medical Inc., a company dedicated to improving patient outcomes and procedural efficiency in the treatment of carotid and peripheral vascular disease, today announced the presentation of late-breaking clinical results from the PERFORMANCE II carotid stent trial at the annual VIVA (Vascular InterVentional Advances) multidisciplinary vascular education conference.
  • PERFORMANCE II is a prospective, multicenter study evaluating the safety and effectiveness of the Neuroguard IEP® System in 305 patients at 40 clinical sites.
  • The Neuroguard closed cell stent utilizes FlexRingTM technology, providing optimized radial strength and flexibility while leveraging nitinol’s proven long-term material performance.
  • “The IEP platform, as demonstrated in the PALADIN, PERFORMANCE I and PERFORMANCE II studies, meaningfully advances stroke protection for patients.

Vibrato Medical Announces Positive Results for Early Feasibility Study of Wearable, Non-Invasive Therapeutic Ultrasound to Treat Chronic Limb-Threatening Ischemia (CLTI)

Retrieved on: 
Wednesday, November 1, 2023
Health, Medical Devices, Radiology, Clinical Trials, Research, Science, Cardiology, Blood vessel, TUS, Patient, Heart, Chronic limb threatening ischemia, Medicine, Vasodilation, CLTI, Perfusion, Vibrato, Ischemia, Claudication, Moyamoya disease, Disease, Orange County, VIVA, Amputation, PAD, Perception, Wynn Las Vegas, Prelude, Medical imaging, Pharmaceutical industry, MD

Vibrato Medical, an innovator in the treatment of peripheral arterial disease (PAD), announced today that data from an early feasibility study of Non-Invasive Therapeutic Ultrasound (TUS) to treat Chronic Limb-Threatening Ischemia (CLTI) has successfully met its endpoint.

Key Points: 
  • Vibrato Medical, an innovator in the treatment of peripheral arterial disease (PAD), announced today that data from an early feasibility study of Non-Invasive Therapeutic Ultrasound (TUS) to treat Chronic Limb-Threatening Ischemia (CLTI) has successfully met its endpoint.
  • The study evaluated patients with infrapopliteal PAD and measured changes in foot perfusion and oxygenation as well as therapy tolerance, compliance and perception.
  • Patients in the trial had Rutherford class 3, 4 or 5 PAD, meaning severe claudication, ischemic rest pain or tissue loss including nonhealing ulcers.
  • “These early findings are promising for the future of non-invasive therapeutic options to treat chronic limb-threatening ischemia,” said Juliana Elstad, CEO at Vibrato.

Final Round of Late-Breaking Clinical Trial Results Announced at VIVA23

Retrieved on: 
Wednesday, November 1, 2023
Female, Blood vessel, Maes, Kidney disease, Education, DCB, Freedom, MAE, TASC, Safety, Diabetes, Kaplan–Meier estimator, Research, Subgroup analysis, Meta-analysis, Pulmonary embolism, Death, BD, DVT, Detour, Clinical trial, Hypertension, Femoral vein, VIVA, TVR, Amputation, PTAB, Patient, Wynn Las Vegas, TLR, Medical imaging, Birth control, Pharmaceutical industry, Airline, SFA, Torus, EU

Below are highlights of this afternoon's 3 late-breaking clinical trial presentations.

Key Points: 
  • Below are highlights of this afternoon's 3 late-breaking clinical trial presentations.
  • A total of 1,005 patients at 74 investigational sites were treated with the Lutonix 035 DCB and were followed to 36 months.
  • Freedom from TLR at 12 months was 88.6%, and freedom from primary safety events at 30 days was 98.2%.
  • DETOUR clinical data demonstrate the clinical utility of this novel therapy in long femoropopliteal lesions.

Second Round of Late-Breaking Clinical Trial Results Announced at VIVA23

Retrieved on: 
Tuesday, October 31, 2023
Blood vessel, Patient, Angiography, Isabella Tree, Peripheral artery disease, PTA, De novo, Artery, Education, Incidence, DCB, Ioctl, BMI, AVF, CLTI, Kaplan–Meier estimator, Kidney disease, Research, HIV disease progression rates, RCT, Wound healing, BRS, Dialysis, Thrombosis, Clinical trial, Extremities, Risk, Dural arteriovenous fistula, Magnitude, Classification, VIVA, IVUS, Amputation, BTK, PAD, Wynn Las Vegas, Infection, Medical imaging, Pharmaceutical industry, Silviculture

Below are highlights of this afternoon's 3 late-breaking clinical trial presentations.

Key Points: 
  • Below are highlights of this afternoon's 3 late-breaking clinical trial presentations.
  • Results from Abbott's LIFE-BTK randomized clinical trial (RCT) demonstrate that Esprit BTK (Abbott) reduces disease progression and helps improve medical outcomes compared to balloon angioplasty, the current state of care.
  • In the LIFE-BTK trial, wound assessment was not a prespecified powered primary or secondary endpoint but rather a prespecified descriptive endpoint.
  • The trial offers the largest ischemic wound data set to date, collected systematically and adjudicated independently in a blinded fashion.

First Round of Late-Breaking Clinical Trial Results Announced at VIVA23

Retrieved on: 
Tuesday, October 31, 2023
Atheroma, Peripheral artery disease, Diabetes, Pivotal trial, Ulcer, Transducer, Male, Disease, PAP, Buerger's test, Classification, The Unreconstructed M, IVUS, Amputation, Stent, PAD, PP, Thorpe tube flowmeter, TUS, Calf, Chin Na, Vein, Telephone, TASC, Bare, Vibrato, Life, SP, W. L. Gore & Associates, VIVA, Safety, Patient, Dyslipidemia, Blood vessel, Plaque, History, CLTI, Coronary artery disease, Perfusion, Restenosis, Research, Foot, Spur, Atherectomy, Șaeș, Artery, Education, DCB, Doppler effect, Dialysis, Hypertension, FP, Freedom, Wynn Las Vegas, Wound healing, Medical imaging, Pharmaceutical industry, Birth control, Surveying, Medtronic

Below are highlights of this morning's 5 late-breaking clinical trial presentations.

Key Points: 
  • Below are highlights of this morning's 5 late-breaking clinical trial presentations.
  • At 20 centers without roll-ins across the United States, 105 no-option CLTI patients were enrolled in a nonrandomized manner.
  • The median age was 70 years, two-thirds of the patients were male, and one-quarter of patients were Hispanic or Latino.
  • 1-Year Results of the DEEPER OUS Trial: The Bare Temporary Spur Stent System in Combination With a Paclitaxel-Coated Balloon
    The DEEPER OUS trial is a prospective, nonrandomized, multicenter, single-arm trial taking place in New Zealand, Germany, and Switzerland.

InspireMD Supports CMS’ Final National Coverage Determination (NCD) Expanding Coverage of Carotid Stenting (CAS) to Include Both Asymptomatic and Standard Risk Patients

Retrieved on: 
Thursday, October 12, 2023
Center for Medicare and Medicaid Innovation, CAS, Stroke, TEL, EPS, Risk, Blood vessel, Safety, National coverage determination, NCD, Patient, CMS, FDA, Medicare, IDE, Centers for Medicare & Medicaid Services, Clinical trial, TCAR, NSPR, VIVA, PMA, Physician, Medical device, Pharmaceutical industry

TEL AVIV, Israel and MIAMI, Oct. 12, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced its support for the Centers for Medicare and Medicaid Services (CMS) final National Coverage Determination (NCD) which expands coverage of carotid artery stenting (CAS) and transcarotid artery revascularization (TCAR) to include both asymptomatic and standard risk patients.

Key Points: 
  • Provides additional treatment options for patients and treating physicians; likely expands CAS addressable market
    InspireMD advancing both CAS and TCAR stent delivery platforms along U.S. and E.U.
  • Marvin Slosman, Chief Executive Officer of InspireMD, stated, “We support CMS’s final decision on the expansion of coverage of CAS to include both symptomatic and asymptomatic carotid artery disease patients considered to be either standard or high risk for surgery.
  • The company anticipates filing for Premarket Approval (PMA) in the second half of 2024 when one-year follow up has been completed.
  • InspireMD will provide further updates on this and other recent developments during its regularly scheduled third quarter 2023 conference call in November.