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Source: Mass Device
Condition: Atrial Fibrillation
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Total 67 results found since Jan 2013.
Study: Medtronic touts increased AF detection with Reveal Linq system
Medtronic (NYSE:MDT) today released 1-year results from a study of patients who experienced a cryptogenic stroke, claiming that its Reveal Linq insertable cardiac monitor was able to detect atrial fibrillation at a greater rate than previously reported in a 2014 clinical trial.
Results from the real-world study were presented at the 68th American Academy of Neurology’s annual meeting in Vancouver, Canada.
The Reveal Linq device is designed to be implanted beneath the skin on the upper left side of the chest and is indicated for monitoring patients experiencing dizziness, palpitation, fainting or syncope, chest pain ...
Source: Mass Device - April 20, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Patient Monitoring Medtronic Source Type: news
Biotronik wins FDA nod for BioMonitor 2
Biotronik said today it won FDA premarket approval for its BioMonitor 2 magnetic resonance imaging-compatible insertable cardiac remote monitor.
The BioMonitor 2 device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said. The device uses Biotronik’s ProMRI technology and is approved for full-body MRI scans at 1.5 and 3 tesla strength.
“Accurate diagnosis is the first step towards saving and improving patient lives. Too many patients suffer from undiagnosed heart conditions that lead to traumatic events including stroke and heart attack. BioMo...
Source: Mass Device - April 12, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Biotronik 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
MassDevice.com +3 | The top 3 medtech stories for December 15, 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. Study: Boston Scientific’s Watchman cheaper than drugs in reducing afib stroke risk
A study comparing the stroke risk for atrial fibrillation patients treated with Boston Scientific‘s Watchman device with the anticoagulant drug warfarin and non-warfarin oral anticoagulants found Watchman t...
Source: Mass Device - December 15, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
Study: Boston Scientific’s Watchman cheaper than drugs in reducing afib stroke risk
A study comparing the stroke risk for atrial fibrillation patients treated with Boston Scientific‘s (NYSE:BSX) Watchman device with the anticoagulant drug warfarin and non-warfarin oral anticoagulants found Watchman to be more cost-effective than its counterparts.
Watchman is a catheter-delivered cardiac implant designed to close off the left atrial appendage, to prevent blood clots from forming there that could later cause a stroke.
The study, published online in the Journal of the American College of Cardiology, showed that the Watchman device was cost-effective at 7 years at a cost of $42,994 per quality-adjust...
Source: Mass Device - December 15, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Wall Street Beat Cardiovascular Cardiac Implants Clinical Trials Boston Scientific Reimbursement 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
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
J&J’s Biosense Webster buys Coherex Medical and its WaveCrest anti-stroke device
Johnson & Johnson (NYSE:JNJ) subsidiary Biosense Webster said today that it acquired Coherex Medical for an undisclosed amount.
Salt Lake City-based Coherex makes the Wavecrest anti-stroke device, which is designed to occlude the heart’s left atrial appendage to prevent blood clots from forming that could cause stroke.
“The addition of the Coherex WaveCrest system complements our comprehensive portfolio of therapeutic solutions for patients suffering from atrial fibrillation who not only suffer from reduced quality of life but also face a significantly greater risk of a stroke,” group chairman Shlomi...
Source: Mass Device - November 20, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Mergers & Acquisitions BioSense Webster Inc. Coherex Medical Johnson & Johnson 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
Boston Scientific dips on Medicare reimbursement hit for Watchman anti-stroke device
Boston Scientific (NYSE:BSX) shares took a hit yesterday after a Centers for Medicare & Medicaid Services proposal that would limit coverage for the Watchman anti-stroke device. Investors also likely reacted to a pair of Class II recalls from the FDA, sending BSX shares down -4.2% to $18.01 apiece yesterday.
Watchman, a transcatheter implant designed to seal off the left atrial appendage to prevent the formation of blood clots that could cause stroke, was approved by the FDA in March and asked for a CMS coverage decision in May. The federal health insurer proposed to limit coverage for Watchman to patients in approv...
Source: Mass Device - November 12, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Recalls Boston Scientific Cardiac Rhythm Management Stroke Source Type: news
Boston Scientific touts Watchman study data
Boston Scientific (NYSE:BSX) yesterday presented data on its Watchman left atrial appendage occlusion device. The data was presented at the annual American Heart Association’s Scientific Sessions in Orlando, Fla.
The data comes from the Ewolution registry, the 1st real-world study of the Marlborough, Mass.-based company’s Watchman device.
The patient population of the study was the ‘highest risk patient population ever studied in a Watchman trial,” Boston Scientific said. A total 61.8% of the patient population were deemed contraindicated for oral anticoagulants.
The study reported the lowest peri-...
Source: Mass Device - November 10, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Blog Boston Scientific Source Type: news
SentreHeart wins CE Mark for Lariat LAA closure device
SentreHeart said today it won CE Mark approval in the European Union for its Lariat surgical left atrial appendage suture delivery device used for soft tissue closure.
The device is commonly used for the ligation of the LAA as an adjunctive treatment to ablation in patients with persistent atrial fibrillation, the Redwood City, Calif.-based company said.
Closing off the LAA prevents blood clots from forming that could later cause stroke in AF patients.
“The Lariat surgical device solves many of the issues posed by current closure technologies in surgery. Improving the surgeon’s control, reducing operator variabilit...
Source: Mass Device - October 8, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Regulatory/Compliance Surgical SentreHeart 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
FDA warns on SentreHeart’s Lariat anti-stroke device
The FDA today warned healthcare providers about the possibility of potentially deadly adverse effects from the Lariat anti-stroke device made by SentreHeart, saying a review of its adverse events database turned up 45 incidents involving Lariat, including 6 deaths.
The Lariat device is designed to close off the heart’s left atrial appendage, to prevent blood clots from forming there that could later cause stroke in patients with atrial fibrillation. The FDA said the reports from its Manufacturer & User Facility Device Experience database included complications from the Lariat procedures that included lacerati...
Source: Mass Device - July 13, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance SentreHeart Stroke Source Type: news
