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Source: Mass Device
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Total 467 results found since Jan 2013.
Stroke treatment: There ’ s a simple way to improve it in the U.S.
Stacey Pugh, VP and general manager of Medtronic’s neurovascular unit
Technology is already available to greatly improve outcomes for people suffering from strokes, but the present healthcare system is standing in the way of people getting it, according to Stacey Pugh, VP and general manager of the neurovascular unit at Medtronic.
The most important thing that could boost stroke treatment is passing proper legislation about taking patients in emergency situations to comprehensive stroke centers for proper treatment, Pugh explained during her keynote discussion at DeviceTalks West last month
Technology has changed, but s...
Source: Mass Device - January 3, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Neurological DeviceTalks West MedTech Medtronic Source Type: news
Conformal Medical raises $9m Series B for anti-stroke cardiac implant
Conformal Medical said today that it raised $9 million in a Series B round for the anti-stroke cardiac implant it’s developing.
Nashua, N.H.-based Conformal is working on a left atrial appendage seal to prevent stroke in atrial fibrillation patients. It’s designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging and without general anesthesia.
The funding round was led by Catalyst Health Ventures and included “a supportive group of Series A investors,” Conformal said.
“This financing will allow us to validate our novel sealing technology ...
Source: Mass Device - December 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Featured Funding Roundup Wall Street Beat Conformal Medical Source Type: news
Survey: Stroke still a mystery to many
Despite stroke being the 2nd leading cause of death worldwide, many people still don't recognize risk factors and warning signs, according to a new poll sponsored by Covidien and the World Stroke Organization.
Covidien, World Stroke OrganizationNews Well, Strokeread more
Source: Mass Device - October 23, 2014 Category: Medical Equipment Authors: Alexander Soule Source Type: news
SanBio touts 1-year data on stem cell transplant for stroke
SanBio Inc. (TYO:4592) released 1-year interim data from the phase 1/2a, open-label, single-arm dose escalation study of its intracerebral stem cell implant designed for stroke patients.
The Mountain View, Calif.-based company touted the results, which indicated that itsSB623 stem cell treatment was generally safe, well-tolerated and associated with improved motor functions in patients suffering with chronic impairment following an ischemic stroke.
SanBio presented interim results from the study at the American Congress of Rehabilitation Medicine Conference last week, and claims that the study is the 1st of its kind...
Source: Mass Device - November 4, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Neurological Research & Development Stem Cells SanBio Inc Source Type: news
InspireMD touts results of next-gen stroke prevention stent study
InspireMD (NYSE:NSPR) has released the results of a meta-analysis of four clinical studies involving dual-layered (DLS) and mesh-covered stents, including the company’s MicroNet-covered stent, the CGuard embolic prevention system.
The analysis concluded that carotid artery disease patients treated with mesh-covered stents experienced a 30-day minor stroke rate of 1.25%, lower than the 30-day minor stroke rates reported in other widely cited studies, such as CREST and ACT 1, for patients treated with both carotid endarterectomy and with those treated with conventional carotid stents. CREST and ACT 1 also involved lower...
Source: Mass Device - December 24, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiovascular Research & Development Stents InspireMD Terumo Source Type: news
Long-term stroke risk cut by carotid surgery or stenting
Methods of treating carotid artery disease. (Image from Mayo Clinic.)
An international research team who compared the long-term effects of carotid artery surgery and stenting found the risk of stroke “remarkably low” even 10 years later, regardless of the type of procedure.
Short-term stroke prevention was found to be better among surgery patients, but stenting technology has improved since these patients were implanted, said the study’s lead author, who predicted that short-term outcomes of stenting could soon match those of surgery.
Get the full story on our sister site, Medical Design & Outsourcing.
The post...
Source: Mass Device - February 11, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiovascular Clinical Trials Implants Neurological News Well Research & Development Mayo Clinic universitycollegelondon Source Type: news
HRS2014: Devices combat drugs for treatment of AF stroke-risk patients
Researchers say that devices used to close off the heart's left atrial appendage appear as good as anti-coagulation drugs for treating certain patients with an increased risk of having a stroke.
New clinical data continues to suggest that left atrial appendage occlusion devices may pose an improvement over warfarin drug regimens for treating patients at increased risk of stroke, researchers reported today.
Boston Scientific, Coherex Medical, Heart Rhythm Society, St. Jude MedicalNews Well, Cardiac Assist Devices, Cardiac Rhythm Management, Conference coverage, HRS 2014, Strokeread more
Source: Mass Device - May 8, 2014 Category: Medical Equipment Authors: Arezu Sarvestani Source Type: news
FDA wants another advisory panel hearing for BSX Watchman anti-stroke device | Regulatory news for the week of June 23, 2014
Here's a look at some of the top regulatory stories for medical device companies this week: FDA wants another panel hearing on Boston Scientific's Watchman anti-stroke device; FDA talks Twitter and other online etiquette for medtech makers; Malaysian medical device market regulators clarify, expand policies; FDA issues draft guidances for industry on social media and internet communications about medical products: Designed with patients in mind; Scotland curbs use of transvaginal mesh amid global outcry.
FDA wants another panel hearing on Boston Scientific's Watchman anti-stroke device
June 17, 2014 by Bra...
Source: Mass Device - June 24, 2014 Category: Medical Equipment Authors: MassDevice Source Type: news
UPDATE: 3rd FDA panel vote barely favors Boston Scientific's Watchman anti-stroke device
An FDA advisory panel's unprecedented 3rd hearing over Boston Scientific's Watchman anti-stroke device barely favors the cardiac implant.
Boston Scientific, Food & Drug Administration (FDA)News Well, Cardiac Implants, Regulatory/Compliance, Stroke, Wall Street Beatread more
Source: Mass Device - October 9, 2014 Category: Medical Equipment Authors: Brad Perriello Source Type: news
Penumbra prices $99m offering
Penumbra (NYSE:PEN) said today that it priced a public offering worth nearly $99 million, not including an underwriter’s option worth nearly $15 million.
Alameda, Calif.-based Penumbra makes a line of instruments designed for neurovascular and peripheral vascular procedures, including stroke revascularization, embolization and thrombectomy.
The company said it plans to float 1.3 million shares at $76 apiece. The offering also includes a 30-day over-allotment option of some 195,000 shares that, if exercised in full, would bring the total raise to more than $113.6 million.
Penumbra said it plans to use the proceeds fo...
Source: Mass Device - March 17, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Catheters Funding Roundup Wall Street Beat Penumbra Inc. Peripheral Artery Disease Stroke Source Type: news
Slow enrollment delays Nexstim pivotal trial
Nexstim said today that slow enrollment in pivotal trial of its Navigated Brain Therapy transcranial magnetic stimulation device in treating patients rehabilitating from stroke.
The 60-patient E-Fit study, launched in March, is designed to supplement Nexstim’s already complete Niche study. The Finnish company originally expected to conclude the E-Fit supplemental during the 1st quarter next year, but said today that “start-up issues” at some of the 5 U.S. sites “created a slight delay in the enrollment rate.”
The E-Fit trial is now slated to be completed during the 2nd quarter of 2018, the ...
Source: Mass Device - May 19, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Neuromodulation/Neurostimulation Nexstim Stroke Source Type: news
Medtronic touts therapy delivered via SynchroMed pump in patients with post-stroke spasticity
Medtronic (NYSE:MDT) touted data today showing that intrathecal baclofen therapy delivered via the company’s SychroMed II infusion pump performed better than the conventional treatment for patients with severe post-stroke spasticity.
The medtech titan’s SynchroMed II pump is the only device approved in the U.S. for ITB therapy.
Get the full story at our sister site, Drug Delivery Business News.
The post Medtronic touts therapy delivered via SynchroMed pump in patients with post-stroke spasticity appeared first on MassDevice.
Source: Mass Device - January 11, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Neurological Pharmaceuticals Wall Street Beat Medtronic Source Type: news
Medline buys Canadian stroke rehab device maker NeuroGym
Medline has acquired physical therapy and rehabilitation equipment maker NeuroGym Technologies of Ottawa.
NeuroGym’s equipment is designed for people who have had a stroke or other traumatic brain injury, spinal cord injury, chronic neurological conditions such as multiple sclerosis, balance issues and/or the need for fall prevention therapy.
The equipment requires the patient to initiate movement, which the company says can help rewire the brain and speed recovery. It includes a sit-to-stand trainer, bungee mobility trainer to re-teach walking and improve balance, a pendulum stepper for lower extremity strength and r...
Source: Mass Device - July 11, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Source Type: news
SynCardia responds to FDA note warning of high rates of stroke, mortality risk with TAH-t C2 Driver
SynCardia Systems this week responded to an FDA notice warning about a higher mortality risk and stroke rate with the company’s Temporary Total Artificial Heart Companion 2 Driver System noted as part of a post-approval study of the device.
In its response, the Tucson, Ariz.-based company said that the FDA letter, which warned of risks associated with the next-gen C2 driver, was not a recall notice, and that hospitals should continue to use the C2 driver without restriction.
SynCardia also said that the C2 Driver had not been identified as the root cause of the issues, which included higher rates of mortality and cerebr...
Source: Mass Device - August 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) SynCardia Source Type: news
ACC 2019: Abbott touts reduced stroke, bleeding and pump-clotting in HeartMate 3 trial
Abbott (NYSE:ABT) yesterday presented data from a new trial of its HeartMate 3 left ventricular assist device, touting a reduced rate of strokes, pump-related blood clots and bleeding episodes at two years as compared with the previous generation HeartMate II.
Data in the trial was presented at the American College of Cardiology’s 68th Annual Scientific Session 2019 in New Orleans and published simultaneously in the New England Journal of Medicine, the Chicago-area medical device company said.
Abbott touted its HeartMate 3 as the first implantable mechanical pump using fully magnetic levitation technology, making it fri...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Abbott Source Type: news
