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Specialty: Medical Devices
Condition: Thrombosis
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Total 69 results found since Jan 2013.
HRS 2018: Device-related blood clots with Boston Scientific ’ s Watchman implant
Data from a study of device-related blood clots and the Watchman cardiac implant made by Boston Scientific (NYSE:BSX), presented today at the annual meeting of the Heart Rhythm Society in Boston, indicate the need for aggressive management of patients at risk for device-related thrombosis.
There were 74 incidences of DRT in 65 of the 1,739 Watchman patients examined in the study, or 3.7%; eight of those patients had multiple DRTs and two experienced embolic events (0.45%). There was no significant difference in mortality between patients with DRT and those without, according to the study.
Lead author Dr. Vivek Reddy, of N...
Source: Mass Device - May 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Boston Scientific HRS 2018 Source Type: news
HRS 2018 Roundup: Device-related blood clots with Boston Scientific ’ s Watchman implant
Data from a study of device-related blood clots and the Watchman cardiac implant made by Boston Scientific (NYSE:BSX), presented today at the annual meeting of the Heart Rhythm Society in Boston, indicate the need for aggressive management of patients at risk for device-related thrombosis.
There were 74 incidences of DRT in 65 of the 1,739 Watchman patients examined in the study, or 3.7%; eight of those patients had multiple DRTs and two experienced embolic events (0.45%). There was no significant difference in mortality between patients with DRT and those without, according to the study.
Lead author Dr. Vivek Reddy, of N...
Source: Mass Device - May 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Apple Bardy Diagnostics Boston Scientific Fitbit HRS 2018 Impulse Dynamics Imricor Medical Systems Inc. medicalgorithmics Medtronic Preventice samsung 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
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
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
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
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
Left Ventricular Assist Device Inflow Cannula Insertion Depth Influences Thrombosis Risk
Left ventricular assist device (LVAD) use has continued to grow. Despite recent advances in technology, LVAD patients continue to suffer from devastating complications, including stroke and device thrombosis. Among several variables affecting thrombogenicity, we hypothesize that insertion depth of the inflow cannula into the left ventricle (LV) influences hemodynamics and thrombosis risk. Blood flow patterns were studied in a patient-derived computational model of the LV, mitral valve (MV), and LVAD inflow cannula using unsteady computational fluid dynamics (CFD). Hundreds of thousands of platelets were tracked individuall...
Source: ASAIO Journal - June 27, 2020 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
Increased Rate of Pump Thrombosis and Cardioembolic Events Following Ventricular Tachycardia Ablation in Patients Supported With Left Ventricular Assist Devices
Ventricular arrhythmias are common following left ventricular assist device implantation (LVAD), and the effects of ventricular tachycardia (VT) ablation on thrombosis and embolic events are unknown. We aimed to assess LVAD thrombosis, stroke, and embolic event rates after VT ablation. Left ventricular assist device implantation patients from two academic centers who underwent endocardial VT ablation between 2009 and 2016 were compared to a control group with VT who were not ablated and followed for one year. The primary composite outcome was confirmed or suspected LVAD thrombosis, stroke, or other embolic event. Survival ...
Source: ASAIO Journal - November 1, 2020 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
Board #247 - Program Innovation Engaging Learners in an Annual Nursing Staff Competency Blitz through Video Simulations (Submission #9201).
Conclusion: Over 1,500 staff nurses and 500 assistive personnel participated in the nursing competency blitz over a two-week time frame. Overall, the nursing staff was very positive about the format and use of simulation to ensure competency. Approximately 48% of staff rated the use of video simulations for Blitz as being extremely effective (e.g. 10 on a 1-10 scale), with over 86% rating the effectiveness at an 8 or higher. Time to complete the competencies was much less (715 total hours) than expected (1400 hours) based on previous years. Improvements in competency were noted for both staff nurses (improvement in scores ...
Source: Simulation in Healthcare: The Journal of the Society for Simulation in Healthcare - December 1, 2014 Category: Medical Equipment Tags: Abstracts: 2ND PLACE AWARD WINNER: PDF Only Source Type: research
Platelet-Derived Microparticles Generated by Neonatal Extracorporeal Membrane Oxygenation Systems
The objective of this study was to compare PMP generation in five different neonatal ECMO systems, using a simulated circuit with swine blood at 300 ml/min for 4 hours. Systems were composed of both newer components (centrifugal pump and hollow-fiber oxygenator) and traditional components (roller-head pump and silicone membrane oxygenator). Free plasma hemoglobin levels were measured as an indicator of hemolysis and flow cytometry-measured PMP. Hemolysis generated in all ECMO systems was similar to that observed in noncirculated static blood (p = 0.48). There was no difference in net PMP levels between different oxygenator...
Source: ASAIO Journal - December 31, 2014 Category: Medical Equipment Tags: Pediatric Circulatory Support Source Type: research
Readmissions After Continuous Flow Left Ventricular Assist Device Implantation: Differences Observed Between Two Contemporary Device Types
Readmissions after continuous flow left ventricular assist devices implantation are common. We compared the frequency and etiology of readmissions between two continuous flow left ventricular assist devices 6 months after implant. We retrospectively assessed readmissions in 81 patients who received a bridge to transplant HeartMate-II (HM-II) n = 35, 43% or HeartWare (HW) n = 46, 57%, from 2009 to 2014. Readmissions were divided into cardiac, infection, gastrointestinal bleeding, stroke, pump thrombosis, and miscellaneous profiles. Age, gender, creatinine, INTERMACS profiles were comparable between groups (p> 0.05). Sixty-o...
Source: ASAIO Journal - July 1, 2015 Category: Medical Equipment Tags: Adult Circulatory Support Source Type: research
FDA warns on potential LVAD issues
The FDA published a safety communication today warning about issues with implantable left ventricular assist devices.
The federal watchdog referenced specific issues with both approved implantable LVADs: Thoratec’s HeartMate II and HeartWare’s HVAD system.
Adverse events referenced included increased rate of pump thrombosis with the HeartMate II and a high rate of stroke with HeartWare’s HVAD, as well as bleeding complications associated with both devices.
The FDA said they have received reports and information from a “variety of sources indicating an increase in the rate of pump thrombosis events i...
Source: Mass Device - August 5, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) HeartWare International Inc. St. Jude Medical Thoratec Corp. Source Type: news
Programmed Speed Reduction Enables Aortic Valve Opening and Increased Pulsatility in the LVAD-Assisted Heart
Aortic valve opening (AVO) during left ventricular assist device (LVAD) support aids in preventing valve fusion, incompetence, and thrombosis. The programmed low speed algorithm (PLSA) allows AVO intermittently by reducing continuous motor speed during a dwell time. AVO and hemodynamics in the LVAD-assisted heart were measured using a HeartMate II (Thoratec Corporation, Pleasanton, CA) LVAD with a PLSA controller in a mock circulatory loop. Left ventricle and aortic pressures, LVAD, and total aortic flow were measured during pre-LVAD, non-PLSA and PLSA combinations of cardiac function, and LVAD speed. The low cardiac setti...
Source: ASAIO Journal - September 1, 2015 Category: Medical Equipment Tags: Biomedical Engineering Source Type: research
HeartWare plunges on uncertainty around its next-gen MVAD pump
Shares of HeartWare International (NSDQ:HTWR) are down some 28% today after the implantable heart pump maker said it can’t predict when it will be able to get its next-generation MVAD program back on line.
Framingham, Mass.-based HeartWare said it expects to post sales of roughly $68 million for the 3 months ended Dec. 31, in line with the consensus forecast on Wall Street for $67.2 million. But the company said its still evaluating date from a CE Mark trial of the MVAD left ventricular assist device that was halted last fall, which it now says show evidence of blood clots in the pump. The incidence of pump thrombo...
Source: Mass Device - January 12, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Clinical Trials Wall Street Beat HeartWare International Inc. Source Type: news
