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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

Bloodstream Infections in Continuous Flow Left Ventricular Assist Device Recipients: Diagnostic and Clinical Implications
Bloodstream infection (BSI) is a common complication of left ventricular assist device (LVAD) support and particularly difficult to treat. The presentation is often variable because of altered physiology and augmentation of cardiac output by the device. We studied LVAD recipients at a single institution. Multivariate logistic and Cox (with time-varying parameters) regression were implemented. Of 212 patients, 58% experienced infections. Driveline infection (DLI) affected 31%, with 60% of them having deep-tissue involvement. Sixty-six patients (31%) suffered from 135 BSIs. Systemic inflammatory response syndrome (SIRS) was ...
Source: ASAIO Journal - November 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

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

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

Ventricular assist devices for the failing univentricular circulation.
Authors: Buratto E, Shi WY, Ye XT, Konstantinov IE Abstract INTRODUCTION: Improved survival following single ventricle palliation has led to a large population of patients with a Fontan circulation, many of whom will eventually develop Fontan failure. Many of these patients will require heart transplantation. However, more than half of these patients have Fontan failure despite preserved ventricular function. Increasing experience with ventricular assist devices (VAD) in children has paved the way for VAD support in those with failing univentricular circulation. Areas covered: The use of VADs to support the failing...
Source: Expert Review of Medical Devices - May 24, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

St. Jude Medical ’ s HeartMate 3 implantable pump beats HeartMate II in pivotal trial
The next-generation HeartMate 3 implantable pump St. Jude Medical (NYSE:STJ) acquired when it paid $3 billion for Thoratec last year proved superior to the older HeartMate II device at 6 months in pivotal clinical trial results released today. The Momentum 3 study enrolled more than 1,000 patients for a short-term outcome after 6 months and a longer-term, 2-year outcome; the initial 6-month data comes from 294 subjects. Unlike the HeartMate II device, which uses an axial-flow pump, the HeartMate 3 device uses a centrifugal-flow pump designed to reduce the risk of blood clots. The primary endpoint at 6 months was a compo...
Source: Mass Device - November 16, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Cardiovascular Clinical Trials American Heart Assn. New England Journal of Medicine St. Jude Medical Thoratec Corp. 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

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

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