Ambient occlusion

Study Investigators Conclude RapidPulse™ Precise Cyclic Aspiration Is Highly Effective and Safe for Ischemic Stroke Large Vessel Occlusions

Retrieved on: 
Thursday, April 4, 2024
Brain, Ambient occlusion, AIS, Cerebral infarction, Patient, Stroke, Sale, Thrombolysis, Reperfusion, FDA, Interventional Neuroradiology, Medical device

RapidPulse is a spin-out of Syntheon 2.0, LLC, an innovative medical device incubator with a long track record of successful exits.

Key Points: 
  • RapidPulse is a spin-out of Syntheon 2.0, LLC, an innovative medical device incubator with a long track record of successful exits.
  • In this study, 40 patients were enrolled in the RapidPulse arm and treated using an 0.071-inch catheter.
  • The investigators used commercially available aspiration catheters ranging in size from 0.070 to 0.072 to treat the control arm patients with standard aspiration pumps.
  • Dr. Serdar Geyik from Istanbul's Aydin University commented, “This is an exciting improvement for the treatment of ischemic stroke due to large vessel occlusion.

Route 92 Medical Announces Completion of Enrollment in the SUMMIT MAX Clinical Trial

Retrieved on: 
Wednesday, February 21, 2024
SAN, Medicine, Ambient occlusion, Randomized controlled trial, Catheter, MD, Principal, FDA, Route, Reperfusion, Safety, Radiology, Patient, Anatomy, Neurosurgery, RCT, DRS, MAX, Brain, Pharmaceutical industry

SAN MATEO, Calif., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the completion of enrollment in its 250-patient SUMMIT MAX clinical trial ( NCT05018650 ) evaluating the safety and effectiveness of its HiPoint™ 88 and HiPoint 70 Reperfusion Catheters as part of the MonopointⓇ Reperfusion System.

Key Points: 
  • SAN MATEO, Calif., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the completion of enrollment in its 250-patient SUMMIT MAX clinical trial ( NCT05018650 ) evaluating the safety and effectiveness of its HiPoint™ 88 and HiPoint 70 Reperfusion Catheters as part of the MonopointⓇ Reperfusion System.
  • SUMMIT MAX is the first FDA-approved aspiration thrombectomy trial which is randomized.
  • Randomized controlled trials provide the best clinical science and the SUMMIT MAX Trial compares the Route 92 Medical Monopoint System to the largest commercially available conventional aspiration system.
  • “Route 92 Medical is leading the way in neurovascular innovation technology, bringing clinicians complete solutions designed to improve endovascular thrombectomy procedure times and outcomes.

Viz.ai Announces Six Clinical Studies that Further Validate Impact of Viz™ Neuro Suite on Patient Care

Retrieved on: 
Wednesday, February 7, 2024
Software, Research, General Health, Technology, Medical Devices, Infectious Diseases, Hospitals, Artificial Intelligence, Health Technology, Clinical Trials, Science, Neurology, Health, Shift, CNN, Conference, ISC, Atrial fibrillation, DTG, Neurosurgery, Workflow, FAHA, Diagnosis, ICM, Aneurysm, Intraparenchymal hemorrhage, AI, MLS, Automation, MD, Single Center, Abstract (summary), Stroke, Viz, ICH, Patient, Groin, Triage, Intervention, Artificial intelligence, CSC, UIA, Intracranial hemorrhage, Associate, University of Kentucky, University, McGovern Medical School, Ambient occlusion, Medical device

Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced new clinical data supporting advancements in neurovascular care.

Key Points: 
  • Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced new clinical data supporting advancements in neurovascular care.
  • “As a leader in AI-powered stroke detection and care coordination, Viz.ai does not rest on what we have done, but instead continues to invest in proving the accuracy and impact of our comprehensive Viz Neuro Suite,” said Molly Madziva Taitt, VP, Global Clinical Affairs.
  • This study is the first of its kind to assess the impact of AI in the acute stroke workflow based on user engagement.
  • For more information on the Viz Neuro Suite, visit https://www.viz.ai/neuro .

Leading Neurointerventionalists Say New Insights on TRIAGE-STROKE and RACECAT Affirm Benefits of Direct Transport to CSCs for ELVO Patients

Retrieved on: 
Tuesday, December 19, 2023
CSCS, TCC, Neuroradiology, State, PSC, Risk, Ambient occlusion, Research, EMS, National Association, Health, MD, Triage, ELVO, Stroke, Column, Standard of care, Society, Death, Transport, Patient, Journal, CSC, Life, Pharmaceutical industry

FAIRFAX, Va., Dec. 19, 2023 /PRNewswire/ -- In an Editor's Column published in the Journal of NeuroInterventional Surgery (JNIS), leaders of the Society of NeuroInterventional Surgery (SNIS) conclude that the entire body of research, including evidence from two new prospective trials, clearly confirm that most patients with emergent large vessel occlusions (ELVO) will benefit from triage directly to comprehensive stroke centers (CSCs).

Key Points: 
  • Since the release of this prospective data earlier this year, SNIS leaders say trade media and select hospital systems have issued messaging proclaiming, without qualification, that direct triage programs are ineffective.
  • This has caused concerns about risks to patient care and outcomes in the neurointerventional community.
  • Globally, mechanical thrombectomy is not only considered effective for eligible patients, but firmly established as the standard of care for ELVO patients.
  • These are life and death decisions, and it is our duty as care providers to prioritize patient outcomes over additional profits."

Surmodics Announces 24-Month Data from the SWING Trial Presented at VEITHsymposium

Retrieved on: 
Thursday, November 16, 2023
Health, Clinical Trials, Medical Devices, Safety, Peripheral artery disease, FRANZCR, DCB, Aortoiliac occlusive disease, Auckland City Hospital, Ambient occlusion, PP, CLTI, Freedom, HIV disease progression rates, Classification, ONZM, Pharmaceutical industry, Medical imaging

The SWING Trial is a 35-subject prospective, multi-center, single-arm, feasibility study to evaluate the safety and performance of the Sundance Sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries.

Key Points: 
  • The SWING Trial is a 35-subject prospective, multi-center, single-arm, feasibility study to evaluate the safety and performance of the Sundance Sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries.
  • Both primary endpoints of the SWING Trial were achieved.
  • Primary safety endpoint data showed no perioperative deaths or major amputations at 30 days, and just one major re-intervention was reported among the 35 trial subjects.
  • “These results are promising and will inform future trials, which we hope will continue to advance improved treatments for our patients.”

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.

Terumo Medical Corporation's New AZUR HydroPack™ Peripheral Coil System Provides a Soft-Packing, Long-Lasting Solution to Embolotherapy

Retrieved on: 
Monday, December 11, 2023
Food, FACC, Reperfusion, Patient, TIS, Food and Drug Administration, Ambient occlusion, Terumo, Physician, Electric motor, AZUR, MD

SOMERSET, N.J., Dec. 11, 2023 /PRNewswire/ -- Terumo Medical Corporation is pleased to announce the launch of its new AZUR HydroPack Peripheral Coil System in the United States. The AZUR HydroPack Coil System is a soft, universal-shaped platinum and hydrogel coil designed to find and fill empty space within the vessel. It is also the only packing coil to use proprietary designed hydrogel technology to create a gel core for mechanical occlusion, a unique feature of AZUR peripheral coils.[1] Terumo received Food and Drug Administration clearance for the AZUR HydroPack Coil System earlier this year; it is fully available starting today.

Key Points: 
  • The AZUR HydroPack Coil System is a soft, universal-shaped platinum and hydrogel coil designed to find and fill empty space within the vessel.
  • [1] Terumo received Food and Drug Administration clearance for the AZUR HydroPack Coil System earlier this year; it is fully available starting today.
  • "The AZUR HydroPack Peripheral Coil System provides optimized stability and precise delivery.
  • The AZUR HydroPack Peripheral Coil System – the latest addition to the TIS embolotherapy portfolio – is designed to fill volume behind the Terumo AZUR™ CX Peripheral Coil System for vessel occlusion and to fill volume inside of the AZUR™ Framing Coil System for aneurysm occlusion.

Heuron to Participate in RSNA 2023, Showcasing Neuro AI Solutions and Presenting Abstract on AI Solutions for Stroke

Retrieved on: 
Thursday, November 16, 2023
RSNA, Brain, Research, Parkinson's disease, Bleeding, DSM-IV codes, Patient, Multimedia, Intraparenchymal hemorrhage, European, FDA, Artificial intelligence, Stroke, Workflow, Ambient occlusion, Dementia, Radiology, Abstract, Diagnosis, Exhibition, Neurology, MRI, PET, AI, Physician, Certification, Medical imaging

During this conference, Heuron will be showcasing Heuron AgingCare Suite™, an MRI-based diagnostic support solution for degenerative brain diseases, and Heuron StroCare Suite™, a non-contrast CT-based comprehensive diagnostic support solution for stroke.

Key Points: 
  • During this conference, Heuron will be showcasing Heuron AgingCare Suite™, an MRI-based diagnostic support solution for degenerative brain diseases, and Heuron StroCare Suite™, a non-contrast CT-based comprehensive diagnostic support solution for stroke.
  • Moreover, during the research abstract presentation, Heuron will disclose the clinical evaluation results of Heuron ELVO, a component of Heuron StroCare Suite™, designed to identify patients with suspected emergent large vessel occlusions automatically.
  • The current stroke diagnosis and treatment procedure typically starts with a non-contrast CT scan to rule out cerebral hemorrhage.
  • We are committed to actively promoting the adoption of Heuron's AI solutions in the medical field across various countries."

Surmodics Announces SWING Trial 24-Month Data to be Presented at VEITH Symposium on November 15

Retrieved on: 
Tuesday, November 7, 2023
Biotechnology, Medical Devices, Health, Clinical Trials, Medical Supplies, Sale, Aortoiliac occlusive disease, DCB, Cell, Sundance, ISET, Master of Medicine, Freedom, Restenosis, Safety, PHD, Ambient occlusion, PP, MS, Pharmaceutical industry, MBBS, Anesthetic, FRACS

The session will be held on Wednesday, November 15th, at the 50th annual VEITH Symposium in New York, New York.

Key Points: 
  • The session will be held on Wednesday, November 15th, at the 50th annual VEITH Symposium in New York, New York.
  • Professor Varcoe previously presented SWING Trial 12-month data on January 18th at the 35th Annual International Symposium on Endovascular Therapy (ISET) conference.
  • Sirolimus, a potent anti-inflammatory and anti-proliferative compound, has been used successfully in coronary drug-eluting stents.
  • The Sundance Sirolimus Drug-Coated Balloon is not available for sale anywhere in the world, and currently is for investigational use only.

Medtronic receives FDA approval for extravascular defibrillator to treat abnormal heart rhythms, sudden cardiac arrest

Retrieved on: 
Monday, October 23, 2023
Conductance quantum, Ventricular tachycardia, Patient, FDA, SCA, EV, NYSE, Food, ICD, Heart, ATP, Trial of the century, Longevity, Vein, Video-assisted thoracoscopic surgery, Kaplan–Meier estimator, Ventricular fibrillation, Risk, The New England Journal of Medicine, Lead, Sternum, Arrhythmia, Safety, Ambient occlusion, Hospital, Food and Drug Administration, Medical imaging, Medical device, Electrophysiology, Medtronic

DUBLIN, Oct. 23, 2023 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, has received U.S. Food and Drug Administration (FDA) approval for the Aurora EV-ICD™ MRI SureScan™ (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV™ MRI SureScan™ defibrillation lead to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA). The Aurora EV-ICD system is the first-of-its-kind to provide the life-saving benefits of traditional, transvenous ICDs with a lead (thin wire) placed under the breastbone, outside of the heart and veins. The Aurora EV-ICD delivers lifesaving defibrillation, anti-tachycardia pacing (ATP), and back-up (pause-prevention) pacing therapies via a device similar in size, shape, and longevity to traditional, transvenous ICDs.

Key Points: 
  • In the coming weeks, the Aurora EV-ICD system will be commercially available on a limited basis in the United States.
  • [1] Additionally, 33 defibrillation shocks were avoided1 by having ATP – which paces the heart to interrupt and terminate a dangerous rhythm – programmed "on."
  • Traditional ICDs typically are implanted below the collarbone, with the lead(s) threaded through the veins and into the heart.
  • Boersma, M.D., Ph.D., cardiologist at St. Antonius Hospital, Nieuwegein, The Netherlands, and a limited launch is underway in select European countries.