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How Did Medtronic ’s HVAD Perform in LATERAL Trial?
Medtronic’s HeartWare HVAD pump system could get a significant boost after performing well in the LATERAL clinical trial. The Dublin-based company presented results from the study at the American Society for Artificial Internal Organs 65th Annual Conference, that showed patients who received the system had 95% freedom from disabling stroke at two years. The medtech giant now plans to launch a global registry to collect additional clinical evidence to further characterize survival, adverse events, and economic benefits of the HVAD System. The HVAD Pump is a left ventricle assist device (LVAD) approved in t...
Source: MDDI - July 8, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular 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

Medtronic ’s HVAD System Just Became Less Invasive
Medtronic has gained FDA approval for a less-invasive implant approach of its HVAD System, a left ventricular assist device (LVAD) for advanced heart failure patients. The Dublin-based company picked up the technology when it acquired HeartWare in 2016. The firm said the technology is the only LVAD approved in the U.S. for implant via thoracotomy, a small lateral, surgical incision between the patient's ribs on the left side of the chest. FDA approval for HVAD implantation via thoracotomy is based on data from the LATERAL prospective clinical trial, in which 144 patients, with end-stage heart failure who were eligible for ...
Source: MDDI - July 12, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Medtronic wins FDA nod for thoracotomy-based HVAD procedure
Medtronic (NYSE:MDT) said today it won FDA approval for thoracotomy-based implantation procedures with its HVAD left ventricular assist device, which it said is a less-invasive implantation approach. The Fridley, Minn.-based medtech giant touted the approval as the first for any commercially available LVAD in the US, and said that the clearance came based on data from the Lateral clinical trial of the device. The 44-patient trial met its primary endpoint of non-inferiority, with data indicating an 88.1% rate of survival at six months free from disabling stroke or device explant or exchange due to malfunction. Results also...
Source: Mass Device - July 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance 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