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Specialty: Medical Devices
Condition: Thrombosis
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Total 69 results found since Jan 2013.
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
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
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 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
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
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
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
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
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
