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Specialty: Medical Devices
Condition: Thrombosis
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Total 69 results found since Jan 2013.
Sky Medical Technology Nabs FDA Clearance for VTE Device
Sky Medical Technology Ltd. won FDA clearance for a device that stimulates calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism.
The Daresbury, England-based company said the geko device is the first muscle pump activator of its kind to be cleared by FDA for VTE prevention across all patients.
Sky Medical Technology’s geko is a non-invasive battery-powered, wearable therapy device that is about the size of wristwatch. The technology is worn at the knee. Geko works by gently stimulating the common peroneal nerve, activating the calf and foot muscle pumps, re...
Source: MDDI - October 12, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Boston Scientific ’s Shining Moment at TCT
Perhaps one of Boston Scientific’s greatest moments at the 31st Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, came when the company announced primary endpoint results from the EVOLVE Short DAPT clinical trial.
The Marlborough, MA-based company said the trial evaluated its Synergy Bioabsorbable Polymer (BP) stent and that the EVOLVE is first prospective study initiated in the U.S. to examine the safety of a shortened duration of dual antiplatelet therapy (DAPT) in patients at high risk for bleeding.
Results and demonstrated that ...
Source: MDDI - September 30, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news
Management of Antiplatelet Therapy During Continuous-Flow Left Ventricular Assist Device Support After Thrombotic Hemorrhagic Events
Hemorrhagic or thrombotic events are common complications in heart failure patients with continuous-flow left ventricular assist device (CF-LVAD) support. Aim of this study is to investigate the effect of change in antiplatelet therapy after thrombotic or hemorrhagic events in patients with CF-LVAD support. A total of 231 CF-LVAD patients were included in this study. Patients with CF-LVAD were categorized into three groups: (1) high antiplatelet regimen as control group (aspirin [ASA] 325 mg; n = 115), (2) low antiplatelet regimen (ASA 81 mg; n = 82), started after hemorrhagic complications, and (3) double antiplatelet...
Source: ASAIO Journal - September 1, 2019 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
Shear-Mediated Platelet Activation Enhances Thrombotic Complications in Patients With LVADs and Is Reversed After Heart Transplantation
This study provides further insight into our understanding of the pathogenesis of LVAD thrombosis, addressing SMPA as a relevant key factor associated with thrombotic complications. With the PAS assay, we have identified a reliable biomarker to promote tailored pharmacological therapy for the prevention of thromboembolic events in patients with LVADs.
Source: ASAIO Journal - April 30, 2019 Category: Medical Devices Tags: Case Reports Source Type: research
Long-term safety and efficacy of combined percutaneous LAA and PFO/ASD closure: a single-center experience (LAAC combined PFO/ASD closure).
CONCLUSIONS: LAAC combined with PFO/ASD closure might be an ideal choice to prevent stroke and other thrombotic complications in patients with both NVAF and PFO/ASD.
PMID: 30999776 [PubMed - as supplied by publisher]
Source: Expert Review of Medical Devices - April 20, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research
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
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
Low-Dose Prothrombin Complex Concentrate in Patients with Left Ventricular Assist Devices
We describe two cases of warfarin reversal with low-dose 4-factor PCC (4F-PCC) in two different LVAD patient scenarios. Low-dose 4F-PCC was administered to one patient with a Heart Mate II (HM II) LVAD, international normalized ratio (INR) of 4.7 on admission and in need of an urgent procedure. He received approximately 16 units/kg of 4F-PCC with reversal of his INR to 2.3 within 45 minutes. The second patient also had a HM II LVAD and presented with a right occipital intraparenchymal hemorrhage and subdural hematoma with an INR of 3.7. He received approximately 11 units/kg of 4F-PCC with INR reversal to 1.6 within 1 hour....
Source: ASAIO Journal - January 30, 2019 Category: Medical Devices Tags: Case Reports Source Type: research
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
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
Abbott & #039;s HeartMate 3 Pump Can Now be Offered as a Destination Therapy
As if Abbott Laboratories hasn't had enough to celebrate this year, the company just scored FDA approval for the use of its Heartmate 3 pump as a destination therapy. The approval, which CEO Miles White hinted about earlier in the week, is a big win for Abbott – and an even bigger win for advanced heart failure patients.
The approval means that doctors can now offer the HeartMate 3 system to patients who are not eligible for a transplant. These patients will live with the device for the rest of their lives.
For advanced heart failure patients who can no longer rely on earlier stage treatment o...
Source: MDDI - October 19, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Business Source Type: news
FDA approves Abbott ’ s HeartMate 3 as a destination therapy
Abbott (NYSE:ABT) said today it won FDA approval for its HeartMate 3 left ventricular assist device, now approved as a destination therapy for patients with advanced heart failure.
With the approval, the Chicago-based company said that the device can now be used in patients not eligible for a transplant as a life-long implant.
“We partner with physicians to holistically develop therapies that benefit patients and achieve better outcomes. The unique design of the HeartMate 3 LVAD—with its Full MagLev technology—takes an established innovation and improves upon it in meaningful ways to help people with advanced he...
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news
Incidence and Outcomes of Postoperative Atrial Fibrillation After Left Ventricular Assist Device
This study sought to determine the incidence, predictors, and outcomes of postoperative atrial fibrillation (POAF) in patients undergoing implantation of left ventricular assist devices (LVADs). A retrospective analysis of all patients who underwent LVAD implantation from 2013 to 2014 was conducted. Postoperative AF, survival, and thrombotic complications were evaluated after surgery. A total of 47 patients (mean age, 56.4 ± 12.5 years; 33 male) were included and followed for a median of 331 days. Within 30 days of surgery, 13 (28%) patients developed POAF at mean 7.9 ± 8.5 days. Obstructive lung disease was a predictor ...
Source: ASAIO Journal - August 28, 2018 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
Accelerometer Detects Pump Thrombosis and Thromboembolic Events in an In vitro HVAD Circuit
Pump thrombosis and stroke are serious complications of left ventricular assist device (LVAD) support. The aim of this study was to test the ability of an accelerometer to detect pump thrombosis and thromboembolic events (TEs) using real-time analysis of pump vibrations. An accelerometer sensor was attached to a HeartWare HVAD and tested in three in vitro experiments using different pumps for each experiment. Each experiment included thrombi injections sized 0.2–1.0 mL and control interventions: pump speed change, afterload increase, preload decrease, and saline bolus injections. A spectrogram was calculated from the acc...
Source: ASAIO Journal - August 28, 2018 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
