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COVID-19 Business Updates Provide Some Clarity
The unknowns still outnumber the knowns, but recent business updates provide some clarity around how the medical device industry is fairing during the COVID-19 pandemic. First and foremost, it is clear that companies are hurting in the areas of elective procedures, which are being deferred. But there may be some silver linings hidden amongst the bad news. Needham & Co. medtech analyst Mike Matson estimates that medical device sales across the industry will continue to drop by an average of 40% to 50% until the economy begins to reopen and hospitals start to resume elective procedures. Matson's e...
Source: MDDI - April 10, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Business Source Type: news

Device profile of the Wingspan Stent System for the treatment of intracranial atherosclerotic disease: overview of its safety and efficacy.
Authors: Barnard ZR, Alexander MJ Abstract Introduction: This Wingspan Stent is a self-expanding, laser-cut, nitinol stent designed for the treatment of severe symptomatic intracranial artery stenosis to be used in conjunction with the Gateway angioplasty balloon. This review will describe the technical features of the stent, its composition, design, and functional characteristics, as well as an overview of its safety and efficacy.Areas covered: The engineering and manufacturing specifications are described for the stent. A systematic review of the literature from 2005 to 2019 is performed to define the safety prof...
Source: Expert Review of Medical Devices - February 21, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Device profile of different paclitaxel-coated balloons: Neuro Elutax SV, Elutax "3" Neuro and SeQuent Please NEO for the treatment of symptomatic intracranial high-grade stenosis: overview of their feasibility and safety.
Authors: Gruber P, Remonda L Abstract Introduction: Intracranial atherosclerotic disease (ICAD) is highly prevalent and probably the most common cause of stroke worldwide. Despite best medical treatment (BMT), the rate of recurrent stroke in symptomatic ICAD patients is elevated, especially in those with high-grade stenosis. Thus, alternative treatment options are needed. So far, endovascular ICAD treatment has been considered a second-line therapy. However, recent progress in the endovascular acute stroke treatment challenges this issue. Drug-coated balloon (DCB) - percutaneous transluminal angioplasty (PTA) repre...
Source: Expert Review of Medical Devices - January 23, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

FDA clears Contego Medical ’ s Paladin carotid balloon
Contego Medical said today that it won 510(k) clearance from the FDA for its Paladin carotid balloon with embolic protection. Raleigh, N.C.-based Contego said the Paladin device consists of an angioplasty balloon and a 40-micron filter for carotid stenting procedures. It won CE Mark approval in 2015 in the European Union, where it launched the following January. A post-market surveillance study of 106 patients showed a 0.9% risk of death, stroke and myocardial infarction at 30 days and zero procedural strokes, the company said. “We are thrilled to have achieved this milestone for the first of several devices Conteg...
Source: Mass Device - September 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Food & Drug Administration (FDA) Contego Medical Source Type: news

Contego Medical launches Neuroguard IEP trial
Contego Medical said today it launched the Performance I trial of its Neuroguard IEP 3-in-1 carotid stent and post-dilation balloon system with integrated embolic protection designed to treat carotid artery stenosis. The first patient in the trial has already been enrolled and treated at Skopje, Macedonia’s University Clinic of Cardiology by Dr. Saško Kedev, the Raleigh, N.C.-based company said. “We are pleased to initiate this trial evaluating the Neuroguard IEP System, the first of its kind for carotid stenting. Protection from stroke is key during carotid artery interventions. This 3-in-1 system includes a ...
Source: Mass Device - March 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Contego Medical Source Type: news

Bringing Robotics into the Cath Lab to Protect Physicians
Percutaneous Coronary Intervention (PCI, or angioplasty with stent) is a common procedure used to treat patients with obstructive coronary artery disease, with an estimated 600,000 procedures performed annually in the United States. PCI has a low risk of complications for patients, but that's not the case for clinicians. Patients receive a dose of radiation during a PCI procedure, which takes anywhere from 30 minutes to a few hours. Interventional cardiologists and cardiac catheterization laboratory personnel are exposed to ionizing radiation all day, every day. Protective measures, such as radiation safety caps, goggles...
Source: MDDI - December 15, 2017 Category: Medical Devices Authors: Heather R. Johnson Tags: Medical Device Business Source Type: news

4 Key Insights When Raising Money for Your Medtech Startup: Interview with Bruce Shook, CEO of Intact Vascular
Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them! Bruce Shook joined Intact Vascular in 2014 as President and CEO. A highly-experienced, medical device executive with more than 30 years of industry experience, Bruce was previously Co-founder, Director, President, and CEO of Neuronetics, which is a privately held medical device company that markets a non-invasive brain stimulation technology for the treatment of depression. Previously, Shook was Co-founder, Director, President, an...
Source: Mass Device - February 27, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Blog medsider Source Type: news

Distinct Effects of Left or Right Atrial Cannulation on Left Ventricular Hemodynamics in a Swine Model of Acute Myocardial Injury
We examined the effects of right atrial to femoral artery (RA–FA; VA-ECMO) bypass versus left atrial to femoral artery (LA–FA; TandemHeart) bypass using a centrifugal pump (Cardiac Assist Inc, Pittsburgh, PA) on LV hemodynamics in a swine model of acute LV injury. In eight male swine, the RA–FA bypass group employed a 21 Fr inflow cannula in the right atrial (RA) and a 17 Fr FA outflow cannula. The LA–FA bypass group employed a 21 Fr inflow cannula in the LA and a 17 Fr FA outflow cannula. Both pump configurations were activated at 3,500 rotations per minute (RPMs) followed by balloon angioplasty-mediated occlusion...
Source: ASAIO Journal - November 1, 2016 Category: Medical Equipment Tags: Adult Circulatory Support Source Type: research

VasSol touts data on MRI-based blood flow measurement
VasSol said last week that results from a trial of its Nova non-invasive optimal vessel analysis showed that the device was able to identify critical trial patients at higher risk of recurrent stroke. The results from the study were published in the JAMA Neurology journal. Results from the 6-year, multi-center Veritas trial indicated that patients who experience a stroke in the back of their brain, and continue to have reduced blood flow to the area, have a higher risk of having another stroke within 2 years. “Nova is the only technology that can visualize and quantify the volume, speed and direction of blood flow...
Source: Mass Device - January 20, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Clinical Trials Diagnostics Software / IT VasSol Source Type: news