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ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology.
Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine.
Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at inte...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news
Medtronic touts study data for thoracic aortic stent
Medtronic (NYSE:MDT) said that its thoracic stent graft for the treatment of a potentially deadly blunt-force chest injury performed well five years after implantation, according to a new study.
The Rescue study of the long-term durability, safety, and efficacy of the Medtronic’s Valiant Captivia thoracic stent graft system for blunt thoracic aortic injury (BTAI) was presented at The Society of Thoracic Surgeons annual meeting in San Diego this week. It was the first five-year, industry-issued dataset ever reported for patients with aortic transections undergoing thoracic endovascular aortic repair (TEVAR).
BTAI is...
Source: Mass Device - January 30, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Clinical Trials News Well Research & Development Stent Grafts Medtronic Society of Thoracic Surgeons Source Type: news
InspireMD inks distro deal for CGuard in South Africa
InspireMD (NYSE:NSPR) said today that it inked a deal with Torque Medical to distribute its CGuard Embolic Prevention System in South Africa.
The Israel-based company reported that it will begin the commercial launch for CGuard in South Africa immediately.
“We are extremely pleased with the opportunity to offer CGuard EPS in the South African market. We were approached by some of our key customers in the Vascular Surgery, Interventional Neurology and Interventional Cardiology field who had learned about CGuard EPS through conferences and publications and wanted us to make it available in South Africa,” Craig G...
Source: Mass Device - January 14, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Distribution Featured Vascular Wall Street Beat InspireMD Source Type: news
Boston Scientific touts Acurate Neo2 CE Mark study
Boston Scientific (NYSE:BSX) yesterday touted results from a European study of the Acurate Neo2 replacement heart valve it acquired along with Symetis last year.
Thirty-day results from a 120-patient trial backing a bid for CE Mark approval for the transcatheter aortic valve replacement, acquired for $435 million in May 2017, were presented at the annual PCR London Valves conference, Marlborough, Mass.-based Boston Scientific said.
Patients treated in the single-arm study showed a 97% rate of mild or less-than-mild paravalvular leakage and a procedural success rate of 97.5%, the company said. All-cause mortality (the p...
Source: Mass Device - September 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Boston Scientific Source Type: news
Penumbra touts non-inferiority in Compass aspiration thrombectomy trial
Penumbra (NYSE:PEN) late last month released results from the Compass trial of its aspiration thrombectomy system designed to treat acute ischemic stroke, touting that the system was shown to be non-inferior to stent retrievers.
Results from the trial were presented at the International Stroke Conference, the Alameda, Calif.-based company said.
Investigators in the trial aimed to compare the use of Penumbra’s aspiration thrombectomy system, which uses a suction to remove clots, against traditional stent retrievers in treating patients with acute ischemic stroke.
Results from the study indicated 52% of patients treat...
Source: Mass Device - February 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Vascular Penumbra Inc. Source Type: news
J & J ’ s Cerenovus launches Galaxy G3 mini embolic coil, touts Arise II Embotrap study data
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus division this week announced the launch of its Galaxy G3 Mini embolic coil and released data from a study of its Embotrap device designed to remove clots from the brain following ischemic stroke.
The Galaxy G3 Mini coils are designed to be approximately 25% softer than the Galaxy G3 xsft coils, with an ultra-low coil profile and a primary wind diameter of 0.009 inches, which Cerenovus said is the lowest profile available in its Spectra line.
The newly launched coil is designed to have a random complex shape to make it comformable and enable the device to seek and fill open...
Source: Mass Device - January 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Catheters Clinical Trials Neurological Vascular cerenovus johnsonandjohnson Source Type: news
Stryker touts post-market Wingspan stent trial results
Stryker (NYSE:SYK) today released results from the post-market Weave trial of its Wingspan stent system designed for treating intracranial atherosclerotic disease.
Data from the study was presented at the International Stroke Conference, the Kalamazoo, Mich.-based company said.
The Weave trial is a multi-center, prospective, post-market surveillance study which aimed to evaluate rates of stroke or death within 72 hours in patients treated with the Wingspan stent system.
Results from the FDA-mandated trial indicated that patients receiving treatment with the Wingspan stent system had a 2.6% rate of stroke or death, lower ...
Source: Mass Device - January 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Stents Vascular Stryker Source Type: news
Penumbra touts real-world study results in Penumbra System acute ischemic stroke trial
Penumbra (NYSE:PEN) today released results from the Promise real-world safety and efficacy study of its Penumbra System with ACE 68 and 64 reperfusion catheters as a treatment for patients with acute ischemic stroke, touting high rates of revascularization and low rates of all-cause mortality.
Results were presented at the International Stroke Conference this week in Los Angeles.
“We thank the Promise investigators for this important contribution to the growing body of global evidence supporting Adapt as a frontline approach for patients with acute ischemic stroke. The Promise study affirms our belief that the Penu...
Source: Mass Device - January 25, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Penumbra Inc. Source Type: news
Former CDC chief Frieden to head $225m anti-heart disease initiative
Previous US Centers for Disease Control and Prevention director Dr. Tom Frieden said he will head Resolve, a new public health initiative focused on fighting heart disease and stroke which has already raised $225 million in backing from a handful of private philanthropies.
The Bill & Melinda Gates Foundation, Bloomberg Philanthropies and the Chan Zuckerberg Initiative have joined in to fund the initiative.
Resolve plans to invest in efforts to reduce trans-fats from restaurant menus, which follows up on Frieden’s 2006 efforts to ban trans-fats as the New York City health commissioner. The initiative will also look to...
Source: Mass Device - September 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Centers for Disease Control & Prevention (CDC) Source Type: news
MassDevice.com +5 | The top 5 medtech stories for June 12, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
Get this in your inbox everyday by subscribing to our newsletters.
5. MassDevice Q&A: Claret Medical’s Azin Parhizgar on trying to make TAVR safer
Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent...
Source: Mass Device - June 12, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Neural Analytics touts 95% accuracy for TCD platform in Expedite trial
Neural Analytics today released initial results from the Expedite study of its Transcranial Doppler Tech platform, touting 95% accuracy in the early detection of acute ischemic stroke due to large vessel occlusion.
Data from the study was presented at the 26th annual European Stroke Conference this week in Berlin.
The 45-subject trial examined the use of TCD scans in patients experiencing computer tomography angiography confirmed acute ischemic stroke due to large vessel occlusion of the internal carotid artery or middle cerebral artery.
Scans with the TCD platform were analyzed with 2 different stroke assessment algorith...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Diagnostics Neurological Ultrasound Neural Analytics Source Type: news
CytoSorbents touts Refresh trial study data
CytoSorbents (OTC:CTSO) today presented results from the Refresh trial of its CytoSorb blood purification technology, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery.
Data was presented at the American Association for Thoracic Surgery’s centennial conference in Boston this week.
The Monmouth Junction, N.J.-based company’s CytoSorb is an extracorporeal cytokine filter, made up of biocompatible, porous polymer beads that use pore capture and surface adsorption to remove toxic substances from the blood and other bodily fluids.
The pr...
Source: Mass Device - May 5, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Clinical Trials CytoSorbents Corp. Source Type: news
Keystone Heart, Venus Medtech ink Asian TAVR stroke partnership deal
Keystone Heart and Chinese heart valve maker Venus Medtech said today they inked a partnership deal covering China and other Asian markets.
Through the deal, the companies will provide Venus Medtech’s transcatheter aortic valve replacement system along with Keystone’s TriGuard cerebral embolic protection device.
TriGuard is a cerebral embolic protection device designed to reduce the amount of embolic material entering blood circulation to the brain during TAVR procedures, by allowing blood to pass through while catching potentially dangerous embolic debris.
“Providing brain protection for every TAVR pat...
Source: Mass Device - March 2, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiovascular Catheters Replacement Heart Valves Keystone Heart Venus Medtech 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
7 medtech stories we missed this week: Feb. 24, 2017
[Photo from unsplash.com]Several companies made distribution deals this week, while others received approval for their products. Here are 7 medtech stories we missed this week but were still worth mentioning.
1. Israel OKs E-Qure’s BST device for chronic wounds
E-Qure Corp. announced this week that it received marketing approval for its Bio-electrical Signal Therapy Device (BST Device) from the Israeli Ministry of Health, according to a Feb. 24 news release. BST is an electrotherapeutic method for treating chronic wounds. E-Qure will begin marketing its device in Israel by activating a signed distribution agreement with...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Electronic Medical Records Imaging Mergers & Acquisitions mHealth (Mobile Health) Regulatory/Clearance Align Technology Clarius Mobile Health Corin Group E-Qure Henry Schein Medical Nexstim Skyline Medical Source Type: news
