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Total 237 results found since Jan 2013.
Paralyzed California man re-learns to walk via computer
(Reuters) — For paraplegic Adam Fritz, the thrill of the computer-assisted first steps he took five years after being paralyzed in a motorcycle crash came only after he was unhooked from the system that enabled him to walk briefly in a bioengineering lab.
During the experiment itself, Fritz recounted, he had to keep his mind focused entirely on placing one foot in front of the other as his brain waves were translated by a computer algorithm into impulses that bypassed his severed spinal cord and activated his legs.
“If you break your concentration, it wouldn’t work anymore,” he told Reuters shortly aft...
Source: Mass Device - September 24, 2015 Category: Medical Equipment Authors: MassDevice Tags: Research & Development Source Type: news
Medtronic launches Arc stroke catheter in the U.S.
Medtronic (NYSE:MDT) said today that it expanded its thrombectomy offering in the U.S. with the Arc catheter, designed for use with its Solitaire stent retriever in treating acute ischemic stroke.
Fridley, Minn.-based Medtronic said the Arc catheter won 510(k) clearance from the FDA in July.
“The Arc support catheter will complement our Solitaire stent retriever and demonstrates our organization’s focus on the treatment of stroke,” neurovascular president Brett Wall said in prepared remarks. “The device also represents our organization’s ability to continue to deliver innovative technology.&...
Source: Mass Device - September 17, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Catheters Neurological Medtronic Stroke Source Type: news
HeartStitch touts new PFO closure method
Structural heart focused HeartStitch said today its NobleStitch EL device was used to repair 3 patients with patent forman ovale heart defects in Astana, Kazakhstan.
A patent foramen ovale is a congenital heart disease in which hole in the heart that normally seals at birth remains open, and can lead to severe migraines, visual auras and stroke, the company said.
The procedures were performed by Dr. Michael Mullen and guided by Anthony Nobles at the National Research Cardiac Surgery Center in Astana, according to the company.
“We are gratified that our colleagues from abroad have brought this technology to Kazakhstan...
Source: Mass Device - September 11, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular HeartStitch Source Type: news
Study: Edwards’ Sapien and Medtronic’s CoreValve outcomes are similar
A new study published in the Journal of the American College of Cardiology found that patients treated with Edwards Lifesciences‘s (NYSE:EW) and Medtronic‘s (NYSE:MDT) CoreValve showed similar results after 1 year.
The 241-patient trial examined high-risk patients with symptomatic severe aortic stenosis 1 year after being treated with either Edwards’s Sapien balloon expanding or Medtronic’ self-expanding transcatheter heart valve.
The rates of all-cause death and cardiovascular death were not statistically different between the groups, with a 3-5% difference between the 2 devices, according to the ...
Source: Mass Device - August 11, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Edwards Lifesciences medtronic Source Type: news
HeartWare completes enrollment in Endurance2 HVAD trial
HeartWare International (NSDQ:HTWR) said today it completed enrollment of its Endurance 2 destination therapy trial of its HeartWare ventricular assist system.
The trial seeks to examine the rate of stroke in patients treated with HeartWare’s HVAD device as well as optimal blood pressure management, the company said.
Data from the 465-patient supplemental cohort trial will be used to support pre-market approval for the HeartWare HVAD as a destination therapy system intended for long term use, according to the Framingham, Mass.-based company.
The device is currently FDA approved for bridge-to-transplant applications....
Source: Mass Device - August 10, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Regulatory/Compliance Surgical HeartWare International Inc. Source Type: news
FDA warns on potential LVAD issues
The FDA published a safety communication today warning about issues with implantable left ventricular assist devices.
The federal watchdog referenced specific issues with both approved implantable LVADs: Thoratec’s HeartMate II and HeartWare’s HVAD system.
Adverse events referenced included increased rate of pump thrombosis with the HeartMate II and a high rate of stroke with HeartWare’s HVAD, as well as bleeding complications associated with both devices.
The FDA said they have received reports and information from a “variety of sources indicating an increase in the rate of pump thrombosis events i...
Source: Mass Device - August 5, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) HeartWare International Inc. St. Jude Medical Thoratec Corp. Source Type: news
Penumbra touts thrombectomy study data
Penumbra said last week that a study of its Ace64 thrombectomy system shows the device to be effective in patients with acute ischemic stroke. The data from the study was presented at the Society of NeuroInterventional Surgery’s annual meeting in San Francisco.
The 117-patient, 6-country study reported a 96% revascularization rate in acute ischemic stroke patients with large vessel occlusions and a 62% revascularization rate in patients with thrombolysis in cerebral infarction, according to Penumbra.
“The multi-center European experience has demonstrated the effectiveness of Ace64. The innovative technology of ...
Source: Mass Device - August 3, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Penumbra Inc. Source Type: news
TAVI: Study finds low stroke rates with Medtronic’s CoreValve
A clinical study of nearly 1,000 patients implanted with Medtronic‘s (NYSE:MDT) CoreValve replacement heart valve found a low rate of stroke out to 2 years.
The study, published last month in the Journal of the American College of Cardiology, evaluated patients for neurological events over 3 periods after the procedure to implant the CoreValve transcatheter aortic valve implant: Periprocedural (0 to 1 days); early (2 to 30 days); and late (31 to 730 days).
Results from the 996-patient trial, “The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic ...
Source: Mass Device - August 3, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Regulatory/Compliance CoreValve Inc. medtronic Source Type: news
Study: Manual thrombectomy increases stroke risk
Routine percutaneous coronary interventions with manual thrombectomies increase the risk of stroke compared to PCI alone, according to a new substudy published last month.
The substudy, published online already and set to go to print in the European Heart Journal, examined a 10,058-patient cohort from the earlier Total study of PCI and manual thrombectomies to better understand the increase in stroke rate.
The new analysis reported that the stroke difference was evident in as little as 48 hours, with 15 thrombectomy patients reporting an event versus 5 treated with only PCI. The overall risk was still low however, with a 0...
Source: Mass Device - July 20, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials European Heart Journal Source Type: news
Study challenges CABG mortality benefits over stenting
A new registry analysis study is challenging the benefits of coronary artery bypass grafting over percutaneous coronary interventions using everolimus-eluting stents in patients with diabetes mellitus and multivessel disease.
Results from the 16,000+ patient analysis, published July 8 in Circulation: Cardiovascular Interventions, did not support previous results that suggested that CABG treatments resulted in lower mortality rates than PCI .
The analysis of New York State registry data aimed to examine the comparative effectiveness of the 2 treatments, and results opposed those of the 5-year 2012 Freedom trial. The 1,90...
Source: Mass Device - July 17, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Diabetes Drug-Eluting Stents Vascular Source Type: news
Diabetes: Study finds bariatric surgery beats diet, exercise
A study designed to compare bariatric surgery with lifestyle interventions found that Type II diabetics treated with gastric bypass or banding procedures fared better than patients who watched their diets and exercised.
Results from “Bariatric Surgery versus Intensive Medical Therapy for Diabetes – 3-Year Outcomes,” which was funded by Johnson & Johnson (NYSE:JNJ) subsidiaries Ethicon and LifeScan, the Cleveland Clinic and the National Institutes of Health, were published online yesterday in the Journal of the American Medical Assn.
The 3-year, 61-patient study randomized obese subjects 1 of 3 arms: Ro...
Source: Mass Device - July 2, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Weight loss Journal of the American Medical Assn. (JAMA) Source Type: news
MassDevice.com +3 | The top 3 medtech stories for June 30, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.
3. EnteroMedics registers for $15m follow-on
EnteroMedics registered for a follow-on offering that could bring in as much as $15 million for its Maestro obesity device.
St. Paul, Minn.-based EnteroMedics won FDA approval for the Maestro device in January 2015, following a mixed vote last year aft...
Source: Mass Device - June 30, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
UPDATE: Medical societies update stroke guidelines
A bevy of cardiac medical societies updated their guidelines for stroke treatment yesterday to take into account new devices and technology, including left atrial appendage occlusion devices, stent retrievers and thrombectomy devices.
The American College of Cardiology, Heart Rhythm Society and Society for Cardiovascular Angiography and Interventions have updated their guidelines to include the benefits of left atrial appendage occlusion for patients with atrial fibrillation.
The groups suggests that the use of LAA occlusion devices, such as Medtronic‘s (NYSE:MDT) Watchman device, may lower the risk of stroke in se...
Source: Mass Device - June 30, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials American College of Cardiology American Heart Assn. Heart Rhythm Society Society for Cardiovascular Angiography & Intervention Source Type: news
AHA/ASA updates stroke treatment guidelines
The American Heart Association/American Stroke Association said today that it updated its treatment guidelines for patients suffering from ischemic stroke to include endovascular treatments.
The decision supports the use of stent retrieval, and other thrombectomy devices, used to remove clots in patients who have obstructions in the large arteries supplying blood to the brain according to a new focused update published in the American Heart Association journal Stroke.
The AHA/ASA said that optimal treatment still lies with the intravenous use of tissue plasminogen activators, used to break down clots, but recommends the u...
Source: Mass Device - June 29, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials American Heart Assn. Penumbra Inc. Source Type: news
UPDATE: FDA OKs new Sapien 3 valve from Edwards
UPDATED June 18, 2015, with details from Edwards and Leerink Partners.
The FDA said today that it approved Edwards Lifesciences‘s (NYSE:EW) Sapien 3 transcatheter heart valve for inoperable or high-risk patients with a narrowing in the heart’s aortic valve.
The approval was based on a 583-patient clinical study of patients who were at high risk for open heart surgery or who could not undergo the surgery due to excess risk, the federal watchdog said.
“Clinical data showed that the Sapien 3 transcatheter heart valve is superior to the 1st generation Sapien transcatheter heart valve, with significantly l...
Source: Mass Device - June 17, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Edwards Lifesciences Source Type: news
