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Specialty: Medical Devices
Condition: Thrombosis

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Total 69 results found since Jan 2013.

The WATCHMAN left atrial appendage closure device for patients with atrial fibrillation: current status and future perspectives.
Authors: Wintgens LIS, Maarse M, Swaans MJ, Rensing BJWM, van Dijk VF, Boersma LVA Abstract INTRODUCTION: Atrial fibrillation (AF) is associated with an increased risk of stroke. Stroke prevention with oral anticoagulation (OAC) is recommended in AF patients at increased risk of stroke. The left atrial appendage (LAA) is the main source of thrombus formation in AF patients. The WATCHMAN percutaneous LAA closure (LAAC) device may serve as an alternative to OAC overcoming disadvantages including the risk of (major) bleeding. AREAS COVERED: This review will focus on LAAC with the Watchman device for stroke prevent...
Source: Expert Review of Medical Devices - June 18, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

FDA panel to mull St. Jude Medical’s Amplatzer PFO occluder cardiac implant
An FDA advisory panel is slated to review the clinical data behind St. Jude Medical‘s (NYSE:STJ) bid for pre-market approval of its Amplatzer cardiac implant for treating patent foramen ovale. The FDA’s Circulatory System Devices Panel is due to convene May 24 for a hearing on the Amplatzer PFO device,  a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis and stroke. Back in October 2012, the Amplatzer PFO device failed to meet the primary endpoint in a 980-patient clinical trial comparing it with dr...
Source: Mass Device - April 13, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Clinical Trials Food & Drug Administration (FDA) St. Jude Medical Source Type: news

Permanent Atrial Fibrillation and 2 Year Clinical Outcomes in Patients with a Left Ventricular Assist Device Implant
Atrial fibrillation (AF) may increase the risk of thromboembolic (TE) complications in patients with left ventricular assist devices (LVADs). In a single-center study, we investigated 205 patients with sinus rhythm (SR group) and 117 patients with AF (AF group). Our main read outs were 2 year overall survival (primary end point), perioperative right heart failure (RHF), and 2 year freedom from stroke, pump thrombosis, and gastrointestinal bleeding (secondary end points). Oral anticoagulation was performed with phenprocoumon (international normalized ratio target range: 2.3–2.8) and aspirin (100 mg/day). Propensity scor...
Source: ASAIO Journal - June 29, 2017 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

FDA recalls Penumbra 3D Revascularization device over wire separation issues
The FDA today released a recall notice for Penumbra‘s (NYSE:PEN) 3D Revascularization Device, part of its Penumbra system designed to remove thrombus from brain blood vessels during strokes, over issues with wire breaks and separations. The FDA labeled the recall as Class I, its most serious designation, indicating that there is a reasonable probability that use of the product could cause serious adverse health consequences or death. The 3D Revascularization device is designed to restore blood flow or remove blood clots in blood vessels in the brain during acute ischemic stroke in patients who are ineligible or fail...
Source: Mass Device - July 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Neurological Recalls Vascular Penumbra Inc. Source Type: news

TCT 2017: Medtronic touts results from 6-month Evolut Pro study
Medtronic (NYSE:MDT) today released six-month data from a study of its Evolut Pro transcatheter aortic valve replacement platform, touting low rates of paravalvular leaks and low rates of all-cause mortality and disabling stroke. Data came from 60 patients in the trial who received the Evolut Pro valve, and follow previously released 30-day outcomes. Results at six-months indicated trace or no paravalvular leaks in 88% of patients, with low rates of all-cause mortality and disabling stroke. No instances of coronary obstruction or valve thrombosis were reported and the permanent pacemaker implantation rate was 11.7%, Medt...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news

Lessons Learned from Managing Antithrombotic Therapy in Children Supported with Pediatric Ventricular Assist Devices
Stroke, thromboembolism, and bleeding are the most recognized complications associated with pediatric ventricular assist devices (VADs) and the leading cause of death and disability on VAD support. Recently, newer antithrombotic strategies like bivalirudin have emerged that appear to be associated with a reduction in the neurologic event rates, especially for smaller pediatric-specific VADs like the Berlin Heart and PediMag/CentriMag systems where the risk of stroke is the highest. While contemporary antithrombotic therapies have likely contributed to lowering adverse event rates, we speculate that clotting and bleeding ad...
Source: ASAIO Journal - November 1, 2022 Category: Medical Devices Tags: Review Source Type: research

UPDATE: Baxter recalls Vascu-Guard patches in FDA Class I recall
  UPDATED June 5, 2015, with details from the FDA. Baxter (NYSE:BAX) said this week that it’s recalling its Vascu-Guard peripheral vascular patches packaged under 4 specific product codes. The company began notifying customers May 2. The FDA has labeled it as a Class I recall, the most serious type of recall issued by the federal watch dog, which indicates that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” Deerfield Park, Ill.-based Baxter said it received complaints over the patches from customers who were unable to disting...
Source: Mass Device - June 4, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Recalls Vascular Baxter International 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

Thoratec HeartMate 3 CE trial meets primary endpoint
Thoratec (NSDQ:THOR) said today the CE Mark trial of its HeartMate 3 left ventricular assist device has met its primary endpoint and reported a 92% rate of survival at 6 months. Data from the trial was presented at the Heart Failure Society of America’s annual meeting in Washington D.C. The HeartMate 3 is a centrifugal-flow chronic left ventricular assist system which uses magnetically levitated technology and a reduced size for easier placement, the Pleasanton, Calif.-company said. “The CE Mark trial data represents a very positive initial experience with HeartMate 3, including high survival rates, material i...
Source: Mass Device - September 28, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Thoratec Corp. 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

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

MassDevice.com +5 | The top 5 medtech stories for May 26, 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. Get this in your inbox everyday by subscribing to our newsletters.   5. Ortho Kinematics wins Health Canada nod for VMA system Ortho Kinematics said today it won Health Canada authorization for its Vertebral Motion Analysis spinal imaging system. The VMA system from Austin, Texas-based Ortho Kinema...
Source: Mass Device - May 26, 2016 Category: Medical Equipment Authors: MassDevice Tags: Blog Plus 5 Source Type: news

Deaths prompt FDA warning on Baxter ’ s Vascu-Guard patch
The FDA today released a notice warning of issues with Baxter‘s (NYSE:BAX) Vascu-Guard peripheral vascular patch after receiving multiple adverse event reports including 3 patient deaths potentially related to the issue. The Vascu-Guard patch is designed for use in vascular reconstruction surgeries including carotid, renal, iliac, femoral, profund and tibial blood vessels and arteriovenous access revisions, the FDA said. The federal watchdog said it has received reports of issues with intraoperative or postoperative bleeding and hematomas, some of which required clinical interventions and 3 patient deaths which occur...
Source: Mass Device - September 1, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Recalls Vascular Baxter International Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 17, 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. GlucoMe tackles connected diabetes management with acoustic data transmission The Centers for Disease Control & Prevention predict that by 2050, if current trends continue, 1 in 3 adults in the U.S. will have diabetes. The d...
Source: Mass Device - March 17, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: News Well Plus 5 Source Type: news

ACC ’ 18 Roundup: Abbott releases long-term HeartMate 3 data
Abbott (NYSE:ABT) touted two-year data yesterday from its trial designed to compare the company’s HeartMate 3 left ventricular assist device to its HeartMate 2 device in patients with advanced heart failure. Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology’s 67th Annual Scientific Session. More than 1,000 patients participated in the study. Researchers assessed the trial’s participants for a short-term endpoint of six months and long-term endpoint of two years. The two-year cohort met its primary endpoint, achieving 77.9% event...
Source: Mass Device - March 12, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Research & Development Wall Street Beat Abbott Aetna AliveCor iRhythm Technologies Inc. Jan Source Type: news