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Source: Mass Device
Condition: Atrial Fibrillation
Management: Hospitals
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Total 18 results found since Jan 2013.
Boston Scientific touts 1-year stroke reduction results in Watchman non-valvular AF trial
Boston Scientific (NYSE:BSX) today released 1-year results from the Ewolution registry study of its Watchman left atrial appendage closure device, touting a high implant success rate and stroke reduction in patients with non-valvular atrial fibrillation patients.
Data was presented today at the Heart Rhythm Society’s 39th Annual Scientific Sessions in Chicago.
“We are pleased to see that these ‘real-world’ results reinforce the positive outcomes observed in our clinical trial program, despite the registry patients being older and sicker than those enrolled in our previous trials,” rhythm man...
Source: Mass Device - May 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Boston Scientific Source Type: news
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
Edwards Lifesciences touts intermediate-risk data for Sapien devices | ACC 2016
Data from a large trial of the Sapien line of replacement heart valves made by Edwards Lifesciences (NYSE:EW) are slated to be used to back bids for expanded indications in intermediate-risk patients.
Presented over the weekend at the American College of Cardiology’s annual meeting in Chicago, results from the Partner II trial involving the Sapien XT and Sapien 3 transcatheter aortic valve replacements compared the TAVR treatments with traditional open surgery in the intermediate-risk cohort (both of the Edwards valves are already approved in the U.S. for high-risk patients).
Sapien XT non-inferior to surgery at 2...
Source: Mass Device - April 4, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Replacement Heart Valves American College of Cardiology Conference (ACC) Edwards Lifesciences Source Type: news
Biotronik launches trial of CLS AF algorithm
Biotronik said today it enrolled the 1st patient in its B3 trial examining the company’s Closed Loop Stimulation physiologic rate response sensor and algorithm.
The study aims to whether pacemakers and implantable cardioverter-defibrillators equipped with the CLS sensor and algorithm are able to reduce the rate of stroke and improve outcomes in patients with atrial fibrillation compared to those without the system.
“AF is a huge clinical challenge, affecting over 20 million patients in Europe and the US alone. I am very excited to begin this groundbreaking trial. We hope to demonstrate that the physiological h...
Source: Mass Device - December 1, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Implants Software / IT Biotronik Source Type: news
Prominent cardiologist calls for a halt to Watchman implants
A prominent cardiologist is calling for a stop to left atrial appendage closure procedures using Boston Scientific‘s (NYSE:BSX) Watchman device, claiming the procedures, which seek to reduce stroke in patients with nonvalvular atrial fibrillation, result in the opposite.
Dr. John Mandrola argues that randomized, controlled trials of the Watchman, designed for LAA closure, showed the device failed to reduce ischemic stroke, despite being designed for just that purpose.
“Yet we look away; or we let advocates distract us with complicated statistics,” Dr. Mandrola wrote in an article on Medscape. “Iâ€...
Source: Mass Device - November 10, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Boston Scientific Source Type: news
J & J ’ s Biosense Webster launches WaveCrest study
Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said today that the first patient has been enrolled in an investigational device exemption trial for its WaveCrest system.
The 1,250-patient study is designed to assess the safety and efficacy of the WaveCrest left atrial appendage occlusion system as a way to reduce the risk of embolic stroke in atrial fibrillation patients.
“The WaveCrest System is designed to enable physicians to close the heart’s LAA, where most stroke-causing blood clots occur,” Dr. Larry Chinitz, who treated the first patient in the trial at New York University Hospital, s...
Source: Mass Device - January 16, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials BioSense Webster Inc. johnsonandjohnson Source Type: news
FDA clears AliveCor ’ s KardiaBand ECG for Apple Watch
AliveCor said today that the FDA cleared its KardioBand electrocardiogram device for the Apple Watch, designed to monitor for early signs of atrial fibrillation.
First introduced in March 2016, KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch, Mountain View, Calif.-based AliveCor said. It’s designed to display and record clinical-grade cardiac rhythm readings in real time in about 30 seconds, the company said.
AliveCor also said it launched the SmartRhythm artificial intelligence app for the Apple Watch, which is designed to continuously evaluate the ...
Source: Mass Device - November 30, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Patient Monitoring Wall Street Beat AliveCor Cardiac Rhythm Management Source Type: news
Boston Scientific wins CE Mark for next-gen Watchman FLX
Boston Scientific (NYSE:BSX) said today it won CE Mark approval in the European Union for its Watchman FLX left atrial appendage closure device, and announced the device has been successfully implanted in its 1st set of patients.
The 1st Watchamn FLX devices were implanted last week by Dr. Horst Sievert of Frankfurt, Germany’s Sankt Katharinen Hospital, Dr. Vivek Reddy of Mt. Sinai Hospital in Prague’s Na Homolce Hospital and by Dr. Saibal Kar of Cedars-Sinai Heart Institute at Izola, Slovenia’s MC Medicor, Marlborough, Mass.-based Boston Scientific said.
“The Watchman Device is the most studied l...
Source: Mass Device - November 19, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Boston Scientific Source Type: news
Biotronik launches CLS-equipped pacer trial for treating syncope
Biotronik said today it enrolled the 1st patients in its BioSync CLS trial looking to examine whether its closed loop stimulation-equipped pacemakers can prevent syncope.
Recurrent syncope, or fainting, is often proceeded by a drop in blood pressure or heart rate, so patients diagnosed with the disorder are often indicated for pacemakers, Biotronik said.
“While not fatal, recurrent syncope is quite dangerous and seriously compromises the patient’s quality of life. Previous studies have provided contradictory results regarding the benefit of cardiac pacing in syncope, and the current European Society of Cardiology...
Source: Mass Device - December 10, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Clinical Trials Biotronik Source Type: news
HRS 2016 roundup: Leadless pacers at the fore
Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ), aiming to distinguish their respective leadless pacemaker offerings, presented new data last week in San Francisco at the Heart Rhythm Society’s annual meeting.
St. Jude said a subset of data from the Leadless II trial showed that its Nanostim device was was successfully retrieved in 14 patients up to 3.2 years after implantation, with no serious adverse events.
“We’ve now shown that for patients requiring device upgrades or new leadless pacing options, late retrievability – even up to 3 years – is possible with the Nanostim leadless pacemak...
Source: Mass Device - May 9, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Boston Scientific Cardiac Rhythm Management HRS 2016 Medtronic St. Jude Medical Source Type: news
Biotronik launches Itrevia MRI-safe quad CRT-D in Japan
Biotronik said today that it launched its Itrevia MRI-safe quad cardiac resynchronization therapy defibrillator in Japan, part of a Japanese rollout of new devices for 2015.
The device is equipped with home monitoring connectivity, as well as compatibility with up to 1.5 tesla MRI machines, the German medical device giant said.
“As a producer of superior medical technologies, it is imperative for us to have a presence in the world’s leading technologies market. It also makes sense that the world’s biggest producer of ProMRI technology should have a strong presence in the country where MRI scanning is the...
Source: Mass Device - July 2, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Surgical Biotronik Source Type: news
MassDevice.com +5 | The top 5 medtech stories for April 21, 2016
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.
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5. US gov’t delays CMS hospital rating system
The Obama Administration is holding off from publishing new hospital-quality ratings over concerns raised by healthcare providers and Congress over the methodology of the ratings sys...
Source: Mass Device - April 21, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
FDA approves afib-detecting Visia ICD from Medtronic
Medtronic (NYSE:MDT) said it won FDA approval for its Visia AF line of implantable cardioverter defibrillators, which are designed to detect and monitor atrial fibrillation symptoms.
Fridley, Minn.-based Medtronic said it plans to have the Visia AF MRI SureScan and Visia AF single-chamber ICDs on the market in early summer. The devices won CE Mark approval in the European Union last October.
“Early detection of AF is vital to assist physicians in making treatment decisions that can reduce stroke and heart failure risk,” cardiac rhythm & heart failure president Dr. John Liddicoat said in prepared rema...
Source: Mass Device - May 2, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Cardiac Rhythm Management Medtronic Source Type: news
SentreHeart logs German reimbursement win for Lariat, Eclipse LAA closure devices
SentreHeart said today that the German Institute for the Hospital Remuneration System granted renewed Status 1 to its Lariat and Eclipse left atrial appendage closure devices.
The coverage will allow 50 hospitals under the NUB1 innovation program to negotiate for reimbursement to cover costs for treating patients with the Lariat for LAAC when such a procedure is a suitable alternative to anticoagulation. The decision is valid for 1 year and can be renewed by application, the Redwood City, Calif.-based company said.
“We are very pleased with the NUB renewal and the robust number of applications for 2017. This is vali...
Source: Mass Device - February 10, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiovascular SentreHeart Source Type: news
