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Embolic Device Articles & Analysis

22 news found

AngioDynamics Completes Patient Enrollment in APEX-AV Study Assessing AlphaVac F1885 System in Treatment of Pulmonary Embolism

AngioDynamics Completes Patient Enrollment in APEX-AV Study Assessing AlphaVac F1885 System in Treatment of Pulmonary Embolism

” APEX-AV is a single-arm Investigational Device Exemption study that enrolled 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the United States. ...

ByAngioDynamics, Inc.


Instylla announces positive results from preclinical studies of Embrace™ Hydrogel Embolic System in hemorrhage models

Instylla announces positive results from preclinical studies of Embrace™ Hydrogel Embolic System in hemorrhage models

There was no angiographic evidence of non-target embolization. “Embrace was effective in achieving hemostasis in an animal hemorrhage model without evidence of non-target embolization. ...

ByInstylla, Inc.


Synchron Appoints Kurt Haggstrom as Chief Commercial Officer

Synchron Appoints Kurt Haggstrom as Chief Commercial Officer

Haggstrom brings an extensive background in medical device commercialization and product launches, with a technical background in R&D engineering, holding over 20 U.S. patents. ...

BySynchron, Inc.


SafeHeal appoints medical device industry veteran Chris Richardson as Chief Executive Officer

SafeHeal appoints medical device industry veteran Chris Richardson as Chief Executive Officer

Most recently, he was President and CEO of Keystone Heart, a structural heart medical device company, and creator of the first Cerebral Embolic Protection device designed to provide complete coverage to all brain regions for patients undergoing cardiac procedures. ...

BySafeHeal


Cordis-X Makes Strategic Investment in Adient Medical, Developer of First Fully Absorbable Inferior Vena Cava (IVC) Filter

Cordis-X Makes Strategic Investment in Adient Medical, Developer of First Fully Absorbable Inferior Vena Cava (IVC) Filter

Cordis-X today announced an $11.5 million Series F investment in Adient Medical, maker of a next-generation absorbable inferior vena cava (IVC) filter that provides protection against pulmonary embolisms (PE). The device is designed to avoid well-documented risks of perforation, migration, fracture, and thrombosis currently associated with IVC filters. ...

ByAdient Medical, Inc.


Okami Medical Announces FDA 510(k) Clearance of the LOBO-7 and LOBO-9 Vascular Occluders To Address A Wide Range Of Peripheral Embolization Cases

Okami Medical Announces FDA 510(k) Clearance of the LOBO-7 and LOBO-9 Vascular Occluders To Address A Wide Range Of Peripheral Embolization Cases

The LOBO occluders integrate patented HDBRAID® technology and an innovative design to provide interventional physicians with a One-and-Done solution for embolization. The highly occlusive braided structure rapidly reduces flow and enables single-device occlusions of blood vessels throughout the body. ...

ByOkami Medical


Instylla First-In-Human Clinical Trial Published Results Demonstrate Technical Success and Persistent Embolization Across All Patients

Instylla First-In-Human Clinical Trial Published Results Demonstrate Technical Success and Persistent Embolization Across All Patients

Instylla, Inc., a privately held company developing next-generation liquid embolics for peripheral vascular embolotherapy, today announced the publication of results[i] from the first-in-human clinical trial of Embrace™ Hydrogel Embolic System (HES) for the treatment of hypervascular tumors, in the Journal of Vascular and Interventional Radiology (JVIR). ...

ByInstylla, Inc.


InspireMD Announces Publication of 12-Month Results of CGuard™ EPS SIBERIA Trial in Journals of the American College of Cardiology: Cardiovascular Interventions

InspireMD Announces Publication of 12-Month Results of CGuard™ EPS SIBERIA Trial in Journals of the American College of Cardiology: Cardiovascular Interventions

(Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of Carotid Artery Disease (CAD), today announced that results from the investigator-initiated SIBERIA randomized clinical trial of CGuard EPS, that evaluated the peri-procedural and 30-day silent brain infarcts associated with the use of its ...

ByInspireMD Inc.


InspireMD to Report Third Quarter 2021 Financial Results on November 9, 2021 and Provide Corporate Business Update -Earnings Conference Call to be held Tuesday, November 9, 2021, at 8:30 a.m. ET

InspireMD to Report Third Quarter 2021 Financial Results on November 9, 2021 and Provide Corporate Business Update -Earnings Conference Call to be held Tuesday, November 9, 2021, at 8:30 a.m. ET

(Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease (CAD) and stroke prevention, today announces it will report third quarter 2021 financial results on Tuesday, November 9, 2021, before the market opens. ...

ByInspireMD Inc.


InspireMD Receives Reimbursement Approval for CGuard™ Embolic Prevention System from the French National Authority for Health

InspireMD Receives Reimbursement Approval for CGuard™ Embolic Prevention System from the French National Authority for Health

(Nasdaq: NSPR), a global developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease (CAD) and stroke prevention, today announced that its CGuard EPS stent system has received a positive opinion from the National Commission for the Evaluation of Medical Devices and Health Technologies ...

ByInspireMD Inc.


InspireMD Announces Strong Second Quarter 2021 Financial Results

InspireMD Announces Strong Second Quarter 2021 Financial Results

(Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of Carotid Artery Disease (CAD), today announced financial and operating results as of and for the second quarter ended June 30, 2021. ...

ByInspireMD Inc.


InspireMD Enrolls and Treats First Patients at Ballad Health System in U.S. Registration C-Guardian Clinical Trial of CGuard EPS

InspireMD Enrolls and Treats First Patients at Ballad Health System in U.S. Registration C-Guardian Clinical Trial of CGuard EPS

(Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease (CAD) and stroke prevention, today announces the initiation of enrollment and successful completion of the first cases of the Company’s U.S. registration C-Guardian trial of CGuard EPS. The first patients, who were under ...

ByInspireMD Inc.


Performance Under Pressure: Studying Elite Free Divers with MediPines’ AGM100

Performance Under Pressure: Studying Elite Free Divers with MediPines’ AGM100

With experiments in extreme environments such as high altitude and free diving, these scientists are using our device to better understand compromised lung function due to disease processes. ...

ByMediPines


Study Finds MediPines’ Breakthrough Non-invasive Gas Exchange Method Highly Precise: Ideal for Covid Response

Study Finds MediPines’ Breakthrough Non-invasive Gas Exchange Method Highly Precise: Ideal for Covid Response

Using the MediPines AGM100®, a respiratory medical device,researchers were able to demonstrate that the new breath-based measurement of gas exchange efficiency has very low variability and is highly correlated with established blood-sampling methods. ...

ByMediPines


Covid-19 respiratory monitoring with MediPines AGM100

Covid-19 respiratory monitoring with MediPines AGM100

Ramirez, an emergency physician in Toronto, “By using the device (AGM100), we are sending fewer patients to the Intensive Care Unit, and we have higher confidence that those sent to the ICU really need to be there. ...

ByMediPines


Okami Medical Announces FDA 510(k) Clearance of the LOBO-5 Vascular Occluder

Okami Medical Announces FDA 510(k) Clearance of the LOBO-5 Vascular Occluder

“LOBO-3 and LOBO-5, to be followed by LOBO-7 and LOBO-9, are designed and built to enable fast, predictable and complete occlusion of a diverse set of vascular targets without the need for multiple embolic devices.” About Okami Medical Okami Medical, Inc. is a privately-held medical device company with a mission to address the ...

ByOkami Medical


Ground-breaking New Medical Device Saving Lives and Resources During Pandemic

Ground-breaking New Medical Device Saving Lives and Resources During Pandemic

Patients wear a small clip on their nose while breathing normally into a disposable mouthpiece that is connected to a monitor. The device can be delivered to Canada in a few days. “This portable device, while doing complex things, is simple to operate,” Dr. ...

ByMediPines


Okami Medical Announces Closing Of $7.2M Series D Financing

Okami Medical Announces Closing Of $7.2M Series D Financing

To date, Okami has developed the LOBO™ Vascular Occlusion System, which is uniquely designed to provide interventional physicians with a single-device, one-and-done solution for the occlusion of a wide range of arterial targets without the need for multiple embolic devices. ...

ByOkami Medical


Balt Receives IDE Approval From the FDA to Begin the STEM Trial

Balt Receives IDE Approval From the FDA to Begin the STEM Trial

Balt announced today it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin The Squid Trial for the Embolization of the Middle meningeal artery (STEM) for the treatment of chronic Sub-Dural Hematoma. ...

ByBalt USA LLC.


Okami Medical Announces First Patients Treated With The LOBO Vascular Occluder

Okami Medical Announces First Patients Treated With The LOBO Vascular Occluder

The LOBO (LOw-profile Braided Occluder) system is uniquely designed to provide interventional physicians with a single-device, one-and-done solution for the occlusion of various arterial targets without the need for multiple embolic devices. ...

ByOkami Medical

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