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Source: Mass Device
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Total 467 results found since Jan 2013.
Medtronic launches post-market study of CoreValve Evolut Pro heart valve
Medtronic (NYSE:MDT) said today it launched a post-market clinical study of its CoreValve Evolut Pro valve, looking to evaluate performance out to 5 years for the self-expanding transcather aortic valve implantation system.
The multi-center, prospective single-arm study aims to enroll 600 patients across 35 European sites to evaluate the safety of the CoreValve Evolut Pro, including all-cause mortality and all stroke at 30 days and clinical performance including valve hemodynamics and paravalvular regurgitation.
“We look forward to replicating the excellent clinical outcomes demonstrated by the Evolut Pro valve in a...
Source: Mass Device - September 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Medtronic Source Type: news
Rapid Medical launches Tigertriever registry study
Neurovascular device maker Rapid Medical said it launched a registry study of its Tigertreiver controllable stent retriever.
The Israel-based company touts the Tigertriever as the only controllable, fully-visible stent retriever which can be adjusted by the physician to fit in the dimensions of the blocked blood vessel.
The newly launched European multi-center registry study looks to enroll patients in France and Switzerland, and will be the 1st to examine the use of the Tigertriever in a real-life setting. The company said it has enrolled its 1st patient in the trial at Switzerland’s Cantonal Hospital of Lucerne.
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Source: Mass Device - September 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Catheters Clinical Trials Stents rapidmedical Source Type: news
Claret Medical touts Sentinel data in TAVR study
Claret Medical today released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortality rates.
The study of the device was recently published in the Journal of the American College of Cardiology: Cardiovascular Interventions, the Santa Rosa, Calif.-based company said.
The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medical touts as the 1st and only FDA-cleared device to do so.
“In pat...
Source: Mass Device - September 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Neurological Claret Medical Inc. Source Type: news
MassDevice.com +5 | The top 5 medtech stories for September 15, 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. FDA cuts could threaten medtech innovation: Here’s why
The Trump administration’s proposed federal budget could hurt the speed and quality of FDA review times, says a top expert at Musculoskeletal Clinical Regulatory Advise...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news
HRS releases CIED lead extraction guidelines
The Heart Rhythm Society this week released its guidelines on device lead management and extraction for implantable cardiovascular electronic devices.
The new guidelines are the result of a collaboration amongst 10 international organizations, according to the HRS.
Included contributing organizations are the HRS, American College of Cardiology, American Heart Association, Asia Pacific Heart Rhythm Society, American Society of Anesthesiologists, European Heart Rhythm Association, Infectious Diseases Society of America, Latin American Hearth Rhythm Society, Pediatric and Congenital Electrophysiology Society and the Society o...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blog Heart Rhythm Society Source Type: news
Studies support anti-stroke PFO closure devices from Abbott, Gore
Sykes and Clark; licensee BioMed Central Ltd.
A trio of studies published this week in the New England Journal of Medicine showed that devices from Abbott (NYSE:ABT) and W.L. Gore & Assoc. designed to close a heart defect lowered the risk of a recurring episode in certain cryptogenic stroke patients.
Long-term results from the 980-patient Respect trial of the Amplatzer device Abbott acquired along with St. Jude Medical this year, along with data from the Reduce study of Gore’s Helex and Cardioform and the French Close study of PFO closure devices with CE Mark approval, showed that they reduced the risk of recurr...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Surgical Abbott Structural heart W.L. Gore & Associates Source Type: news
Cheetah Medical raises $12m
Cheetah Medical said today it raised $11.8 million in an expanded Series C funding round as it looks to grow its US footprint.
Financing was provided by existing investors including MVM Life Science Partners, Springfield Investment Management, Fletcher Spaght Ventures, HighCape Partners and Robert Basch Venture Capital, the Newton, Mass.-based company said.
Cheetah Medical provides noninvasive hemodynamic monitoring devices and systems, including its Cheetah Nicom and Starlin SV technologies, which operate around a proprietary algorithm designed to allow physicians to examine a patient’s full hemodynamic profile.
&#...
Source: Mass Device - September 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cheetah Medical 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
Johnson & Johnson hosts launch party for Cerenovus neurovascular biz
Johnson & Johnson (NYSE:JNJ) said today it launched its Cerenovus brand, which combined its Pulsar Vascular and Neuravi acquisitions and its remaining Codman Neuro neurological portfolio.
Cerenovus was launched at the European Society of Minimally Invasive Neurological Therapy’s 9th annual meeting, J&J said.
Johnson & Johnson said that the Cerenovus product portfolio aims to help improve stroke care, with the number of strokes annually projected to rise from 1.1 million in 2000 to 1.5 million by 2025.
“We believe stroke should not be a life sentence. Cerenovus is inspired by our long heritage ...
Source: Mass Device - September 7, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neurological cerenovus johnsonandjohnson Neuravi Limited Pulsar Vascular Source Type: news
ESC 2017 Roundup: Biotronik touts lowered mortality for AF patients treated with cath ablation
Biotronik today released results from the Castle-AF study exploring the use of catheter ablation to treat heart failure patients with atrial fibrillation, touting a 38% composite reduction in all-cause mortality and hospitalization for worsening heart failure.
The 398-patient, 33-site study compared the results of catheter ablation treatment for AF in heart failure patients using implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators to standard-of-care pharmacological therapy, the company said. Biotronik touted it as the largest study of its kind to date.
Results indicated a 47% reduc...
Source: Mass Device - August 28, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Biotronik Medtronic Source Type: news
Medtronic readies pivotal trial in renal denervation
Medtronic (NYSE:MDT) said today that it’s ready for a run at FDA approval for renal denervation in treating high blood pressure, more than three years after the failure of a high-profile clinical trial.
Back in January 2014, Fridley, Minn.-based Medtronic shocked medtech when it announced that the highly anticipated Symplicity HTN-3 trial, examining ablation of the around the renal arteries in treating hypertension, failed to meet its efficacy endpoint. The company suspended enrollment in its other Symplicity trials around the world and later took a $200 million write-down on its renal denervation assets. News of th...
Source: Mass Device - August 28, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Wall Street Beat Medtronic Renal Source Type: news
FDA clears Nordisk ’s Victoza as only Type II diabetes drug to cut cardio risks
The FDA approved a new indication for Novo Nordisk‘s (NYSE:NVO) Victoza liraglutide injection, clearing it as the only Type II diabetes medication indicated to reduce the risk of cardiovascular diseases, like heart attack and stroke.
The regulatory watchdog’s decision is based on results from Nordisk’s 9,300-patient Leader trial, which showed that Victoza significantly reduced the risk of cardiovascular death, non-fatal heart attack and non-fatal stroke.
Get the full story at our sister site, Drug Delivery Business News.
The post FDA clears Nordisk’s Victoza as only Type II diabetes drug to cut cardio risks appear...
Source: Mass Device - August 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Novo Nordisk Source Type: news
FDA approves Malin ’ s Hourglass peripheral embolization plug
Irish life sciences company Malin Corp said today it won FDA 510(k) clearance for its Hourglass peripheral embolization plug.
The company said the Hourglass plug is designed to be deployed over-the-wire for peripheral embolization procedures, and can provide immediate occlusion with a single integrated device.
“This is the 1st integrated, over-the-wire device designed for peripheral embolization procedures. The goal with over-the-wire design is to provide physicians with accurate, stent-like delivery of the device in the vessel,” Hourglass co-developer George Wallace, said in prepared remarks.
“The Hourgl...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Regulatory/Compliance Vascular malincorp Source Type: news
MassDevice.com +5 | The top 5 medtech stories for August 18, 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. Study: New infrared imaging technique could help detect heart attack, stroke risk
A new near-infrared diagnostic technique could help improve early detection for patients at risk of heart attacks or strokes, according to a new ...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Study: New infrared imaging technique could help detect heart attack, stroke risk
A new near-infrared diagnostic technique could help improve early detection for patients at risk of heart attacks or strokes, according to a new multi-center study.
Researchers at the University of Warwick’s WMG, the Baker Institute and Monash University reported that when they increased the wavelength of light currently used to visualize athereosclerotic plaques, they were able to selectively identify rupture-prone deposits, which can lead to blood clots, heart attacks and strokes.
Data from a study of the technique was published in the journal Nature Communications.
Current imaging techniques are able to identify c...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Research & Development Source Type: news
