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Specialty: Medical Devices
Condition: Heart Failure
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Total 93 results found since Jan 2013.
Medtronic touts stroke data for HeartWare LVAD
A retrospective analysis of two studies involved the HeartWare left-ventricular assist device Medtronic (NYSE:MDT) acquired in 2016 showed that managing blood pressure reduced the severity of strokes in patients implanted with the HVAD pump.
The analysis, of “destination therapy” patients who are not candidates for a heart transplant, took data from the Endurance and Endurance Supplemental studies. Results were presented this week at the annual meeting of the International Society for Heart & Lung Transplantation in London, Medtronic said.
The 465-patient Endurance Supplemental study compared 308 patients i...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Assist Devices Clinical Trials Featured Abbott HeartWare International Inc. Medtronic stjudemedical Thoratec Corp. Source Type: news
Study: Manual thrombectomy increases stroke risk
Routine percutaneous coronary interventions with manual thrombectomies increase the risk of stroke compared to PCI alone, according to a new substudy published last month.
The substudy, published online already and set to go to print in the European Heart Journal, examined a 10,058-patient cohort from the earlier Total study of PCI and manual thrombectomies to better understand the increase in stroke rate.
The new analysis reported that the stroke difference was evident in as little as 48 hours, with 15 thrombectomy patients reporting an event versus 5 treated with only PCI. The overall risk was still low however, with a 0...
Source: Mass Device - July 20, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials European Heart Journal Source Type: news
ISHLT 2017: Medtronic HVAD trial misses primary endpoint, reports lowered stroke rates
Medtronic (NYSE:MDT) said today that results from the Endurance supplemental trial of its HVAD heart pump system did not meet its primary endpoint, but did report lowered stroke rates compared to standard treatment.
The trial aimed to evaluate the use of the HVAD system, which it picked up along with HeartWare last year, as a destination therapy for patients who require a left ventricular assist device and received improved blood pressure management, the Fridley, Minn.-based company said.
Data from the study was presented at the 2017 International Society for Heart and Lung Transplantation Scientific Meeting in San Dieg...
Source: Mass Device - April 5, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials HeartWare International Inc. Medtronic Source Type: news
FDA warns of high stroke, mortality risk with SynCardia TAH-t C2 controller
The FDA on Friday released a letter warning of a higher mortality risk and stroke rate than expected for patients receiving treatment from SynCardia Systems’ Temporary Total Artificial Heart Companion 2 Driver System.
Data indicating the higher mortality and stroke rate came from a post-approval study conducted by the company itself, the FDA said. The study indicated that patients treated with the previous generation driver of the device, the Circulatory Support System Console, experienced a lower rate of stroke and mortality compared with the C2.
The TAH-t system is designed to function as a bridge to a heart transplant...
Source: Mass Device - August 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) SynCardia Source Type: news
Medtronic touts stroke data from HeartWare HVAD thoracotomy study
Medtronic (NYSE:MDT) today touted stroke data from the Lateral trial of its HeartWare HVAD left ventricular assist device involving implantation via thoracotomy instead of open surgery.
With a thoracotomy implantation, surgeons insert the pump via a small, lateral incision between the left ribs and make a second small incision to accommodate the pump’s outflow graft. Fridley, Minn.-based Medtronic said Lateral results presented at the annual meeting of the American Society for Artificial Internal Organs showed that 95% of thoractomy patients were free from disabling stroke at two years.
Adverse events were more like...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Featured Medtronic Source Type: news
Irregular heartbeat may be tied to more than just stroke risk
(Reuters) – Atrial fibrillation, a type of irregular heartbeat that’s already linked to an increased risk of stroke, may also be tied to higher risk of heart attack, heart failure, kidney disease and sudden death, according to a new research review.
“It was particularly noteworthy that the relative and absolute risk increase for heart failure was the highest among all outcomes examined, even higher than the risk of stroke, said lead author Ayodele Odutayo, a doctoral candidate at the University of Oxford in the U.K.
In atrial fibrillation, the upper chambers of the heart flutter or beat irregularly. Sometimes...
Source: Mass Device - September 8, 2016 Category: Medical Equipment Authors: MassDevice Tags: Cardiovascular American Heart Assn. Source Type: news
ACC 2019: Abbott touts reduced stroke, bleeding and pump-clotting in HeartMate 3 trial
Abbott (NYSE:ABT) yesterday presented data from a new trial of its HeartMate 3 left ventricular assist device, touting a reduced rate of strokes, pump-related blood clots and bleeding episodes at two years as compared with the previous generation HeartMate II.
Data in the trial was presented at the American College of Cardiology’s 68th Annual Scientific Session 2019 in New Orleans and published simultaneously in the New England Journal of Medicine, the Chicago-area medical device company said.
Abbott touted its HeartMate 3 as the first implantable mechanical pump using fully magnetic levitation technology, making it fri...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Abbott Source Type: news
ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology.
Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine.
Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at inte...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic 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
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
Effect of Preoperative Atrial Fibrillation on Patients with Chronic Heart Failure Who Undergo Long-Term Continuous-Flow LVAD Implantation
Although preoperative atrial fibrillation (AF) is common in patients undergoing continuous-flow left ventricular assist device (CF-LVAD) implantation, how AF affects outcomes remains unclear. We analyzed our single-center experience with CF-LVAD implantation to determine whether preoperative AF was associated with inferior outcomes. From November 2003 through March 2016, 526 patients with chronic heart failure underwent implantation with the HeartMate II (HMII; n = 403) or HeartWare VAD (HVAD; n = 123). We identified 229 patients (165 HMII, 65 HVAD) who had preoperative AF and compared them with non–preoperative AF patie...
Source: ASAIO Journal - August 28, 2018 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
Permanent Atrial Fibrillation and 2 Year Clinical Outcomes in Patients with a Left Ventricular Assist Device Implant
Atrial fibrillation (AF) may increase the risk of thromboembolic (TE) complications in patients with left ventricular assist devices (LVADs). In a single-center study, we investigated 205 patients with sinus rhythm (SR group) and 117 patients with AF (AF group). Our main read outs were 2 year overall survival (primary end point), perioperative right heart failure (RHF), and 2 year freedom from stroke, pump thrombosis, and gastrointestinal bleeding (secondary end points). Oral anticoagulation was performed with phenprocoumon (international normalized ratio target range: 2.3–2.8) and aspirin (100 mg/day). Propensity scor...
Source: ASAIO Journal - June 29, 2017 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
ESC 2017 Roundup: Biotronik touts lowered mortality for AF patients treated with cath ablation
Biotronik today released results from the Castle-AF study exploring the use of catheter ablation to treat heart failure patients with atrial fibrillation, touting a 38% composite reduction in all-cause mortality and hospitalization for worsening heart failure.
The 398-patient, 33-site study compared the results of catheter ablation treatment for AF in heart failure patients using implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators to standard-of-care pharmacological therapy, the company said. Biotronik touted it as the largest study of its kind to date.
Results indicated a 47% reduc...
Source: Mass Device - August 28, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Biotronik Medtronic Source Type: news
FDA clears AliveCor ’ s KardiaBand ECG for Apple Watch
AliveCor said today that the FDA cleared its KardioBand electrocardiogram device for the Apple Watch, designed to monitor for early signs of atrial fibrillation.
First introduced in March 2016, KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch, Mountain View, Calif.-based AliveCor said. It’s designed to display and record clinical-grade cardiac rhythm readings in real time in about 30 seconds, the company said.
AliveCor also said it launched the SmartRhythm artificial intelligence app for the Apple Watch, which is designed to continuously evaluate the ...
Source: Mass Device - November 30, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Patient Monitoring Wall Street Beat AliveCor Cardiac Rhythm Management Source Type: news
Salutary Effects of the PULVAD, a Novel Implantable Counterpulsation Assist Device, on Cardiac Mechanoenergetics
In conclusion, the PULVAD unloads the failing LV, optimizes LV mechanoenergetics, and augments coronary blood flow. These salutary effects of short-term PULVAD support provide the foundation for long-term testing.
Source: ASAIO Journal - July 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
