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Specialty: Medical Devices
Condition: Thrombosis

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Total 69 results found since Jan 2013.

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

Abbott ’s Amplatzer Stroke Reduction Data Is Strong at EuroPCR
Abbott Laboratories’ Amplatzer Amulet left atrial appendage (LAA) occlusion device has been shown at one year to reduce stroke by 57% as compared to the predicted stroke risk. The data also showed it was able to make this reduction without the need for lifetime blood thinners.  The Abbott Park IL-based company released the data at EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions in Paris, and simultaneously published in EuroIntervention. More than 1,078 patients suffering from atrial fibrillation (Afib) were in the study with one-year-follow up. “The Amulet is a devi...
Source: MDDI - May 24, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

FDA clears Medtronic ’ s Riptide clot aspiration device
Medtronic (NYSE:MDT) said today that it won 510(k) clearance from the FDA for its Riptide clot aspiration device for treating ischemic stroke. The Riptide device is designed to retrieve blood clots via the Arc catheter to restore blood flow to the brain. The clearance covers patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within eight hours of first symptoms, including patients who can’t take or failed off of anti-clotting drugs. Medtronic called the Riptide design “a foundational platform” for other aspiration catheters it’s developing. The Fridley, M...
Source: Mass Device - January 16, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Neurological Medtronic Stroke Source Type: news

FDA panel backs St. Jude’s Amplatzer stroke device in 15-1 vote
An FDA panel Tuesday voted 15-1 in support of St. Jude Medical‘s (NYSE:STJ) Amplatzer cardiac implant for treating patent foramen ovale, according to the Minneapolis Star Tribune. The Amplatzer PFO device is 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. The panel found in favor of the device, saying that a long-running study of it showed a “reasonable assurance” that it was safe for use, according to the paper. In a closer vote, the same panel ruled 11-5 that the device’s benefits o...
Source: Mass Device - May 26, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) St. Jude Medical Source Type: news

What Causes LVAD-Associated Ischemic Stroke? Surgery, Pump Thrombosis, Antithrombotics, and Infection
Acute ischemic stroke (AIS) is a major complication in left ventricular assist device (LVAD) population. A better understanding of clinical risk factors associated with AIS may help mitigate risk of stroke. We reviewed prospectively collected data of 477 LVAD patients from a tertiary center from October 1, 2004 to December 31, 2016. Supplemental data abstraction was performed on patients with AIS. Fifty-seven (12%) developed 61 AIS. Of 61, 17 (28%) AIS occurred perioperatively. The median time from implant to perioperative AIS was 5 days (interquartile range: 3–9). Pump thrombosis accounted for 19 (31%) of 61 AIS, and 7 ...
Source: ASAIO Journal - November 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Fibrinogen Albumin Ratio and Ischemic Stroke During Venoarterial Extracorporeal Membrane Oxygenation
Fibrinogen is a clotting factor and a major determinant of platelet aggregation. Albumin, on the other hand, inhibits platelet function and thrombus formation. Taken together, an elevated fibrinogen albumin ratio (FAR) has been described as a marker of disease severity during prothrombotic conditions. We evaluated the association of FAR and ischemic stroke during venoarterial extracorporeal membrane oxygenation (VA ECMO) support. A single center, retrospective study was performed including all adult patients placed on VA ECMO. FAR was calculated from fibrinogen and albumin measurements in the first 24 hours of VA-ECMO init...
Source: ASAIO Journal - February 28, 2020 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Ischemic Stroke and Intracranial Hemorrhages During Impella Cardiac Support
Impella is a percutaneously placed, ventricular assist device for short-term cardiac support. We aimed to study acute neurologic complications during short-term cardiac support with Impella. We reviewed prospectively collected data of 79 consecutive persons implanted with Impella at a single tertiary center. Acute neurologic events (ANE) were defined as ischemic strokes or intracranial hemorrhages. Among those with ANE, specific causes of ischemic and hemorrhagic events were collected and discussed. Of 79 persons with Impella with median 8 days of support (range 1–33 days), six (7.5%) developed ANE at a median of 5 days ...
Source: ASAIO Journal - July 30, 2020 Category: Medical Devices Tags: Case Report Source Type: research

Study of Boston Scientific ’s Lotus, Medtronic’s CoreValve shows similar outcomes at 2 years
Two-year results from a head-to-head study comparing transcatheter aortic heart valve replacement devices from both Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) indicated similar outcomes for the competing products. The study, published recently in the journal JAMA Cardiology, compared Marlborough, Mass.-based Boston Scientific’s Lotus valve to Fridley, Minn.-based Medtronic’s CoreValve system. Investigators in the study compared outcomes for 912 patients with high or extreme risk and severe, symptomatic aortic stenosis after treatment with one of the two devices. Patients, treated between September 22, 2014...
Source: Mass Device - February 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured Replacement Heart Valves Boston Scientific Medtronic Source Type: news

Penumbra launches Ace68 Reperfusion thrombectomy catheter
Penumbra today announced the U.S. launch of the Ace68 Reperfusion thrombectomy catheter designed for extracting thrombus in acute ischemic stroke patients. The company said the Ace68 catheter was engineered on an entirely new platform from hub to tip, which features coil winding geometry along 16 transitions to create a more optimal tracking profile. “With the Ace68 Reperfusion Catheter, I can easily deliver full aspiration power to the occlusion. The Ace68’s large lumen increases the likelihood of capturing the clot fully within the catheter or the canister, potentially reducing the number of passes to achieve ...
Source: Mass Device - July 25, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Business/Financial News Catheters Penumbra Inc. Source Type: news

Abbott Gains on Medtronic in LVAD Market
Abbott Laboratories said late-breaking clinical trial data from its MOMENTUM 3 clinical study shows its HeartMate 3 Left Ventricular Assist Device (LVAD) has improved survival and lowered rates of stroke and pump thrombosis. The Abbott Park, IL-based company released the data during the American College of Cardiology’s 67th Annual Scientific Sessions this past weekend. Data from MOMENTUM 3 was also published in the New England Journal of Medicine and showed patients with the HeartMate 3 LVAD had a survival rate of 82.8% at two years compared with 76.2% for those with the HeartMate II LVAD. Pump thrombosis rates remained ...
Source: MDDI - March 12, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

J & J ’s Cerenovus launches global thrombectomy registry
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said today that it launched a new registry aiming to collect and analyze stroke-inducing blood clots removed with the company’s Embotrap II revascularization device. The Irvine, Calif.-based company touted the Excellent registry as the single largest global registry of its kind to date, looking to enroll up to 1,000 ischemic stroke patients across 50 locations in the U.S. and Europe. Investigators in the trial will collect and analyze clots removed to explore how different characteristics, including size, composition and density may affect outcomes, the company said. I...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Featured Neurological cerenovus johnsonandjohnson Source Type: news

Individualized Antithrombotic Therapy in Heartware HVAD Recipients
There are no evidence-based guidelines for antithrombotic therapy in left ventricular assist device patients. We evaluated the efficacy of a multi-agent, test-guided protocol, which remained consistent throughout our use of the Heartware HVAD. Thrombelastography and platelet function analyzer (PFA)-100 guide antiplatelet titration. Goals are normal kaolin thrombelastography maximum amplitude and prolonged PFA-100. We analyzed incidence and rates of nonprocedural bleeding, stroke, and pump thrombosis for all 81 primary Heartware left ventricular assist devices implanted since 2011. For each event, we examined whether each t...
Source: ASAIO Journal - December 28, 2018 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Atrial Fibrillation Is Not Associated With Thromboembolism in Left Ventricular Assist Device Patients: A Systematic Review and Meta-Analysis
Atrial fibrillation (AF) is a well-established risk factor of thromboembolism (TE). Thromboembolism is one of the most common complications in patients supported by continuous-flow left ventricular assisted devices (CF-LVADs). However, the association between AF and TE complications in this population is controversial. We conducted a systematic review and meta-analysis to assess the association between AF and overall TE, stroke, and device thrombosis events in CF-LVAD patients. We performed a comprehensive literature search through September 2017 in the databases of MEDLINE and EMBASE. Included studies were prospective or ...
Source: ASAIO Journal - July 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

TCT 2015: Thrombectomy no benefit in Medtronic’s Export studies
Thrombus aspiration in heart attack patients showed no benefit and raised the risk of stroke, according to a pair of studies of percutaneous coronary interventions using Medtronic‘s (NYSE:MDT) Export aspiration catheter, presented today at the annual Transcatheter Cardiovascular Therapies conference in San Francisco. Early thrombectomy’s promise Totaled? The 10,064-patient Total study compared PCI alone and PCI with thrombectomy in ST-elevated myocardial infarctions within 12 hours of onset. The primary endpoint (a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or class...
Source: Mass Device - October 13, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Medtronic TCT 2015 Source Type: news

Conformal Medical launches LAA seal study
Conformal Medical said yesterday that it launched an investigational device exemption trial for a device designed to seal off the heart’s left atrial appendage to help prevent stroke in atrial fibrillation patients. Nashua, N.H.-based Conformal’s device is designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging and without general anesthesia. The 45-patient, single-arm study is designed to evaluate the device’s performance, with an estimated primary completion date of April 2020 and a final completion date of June 2025, according to ClinicalTrials.gov. Th...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Clinical Trials Featured Conformal Medical Source Type: news