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Report: Extra insights, but no clear-cut answers from TAVR embolic protection studies
Data from two new studies has provided extra insights, but no clear-cut solution for predicting stroke and which patients should receive embolic protection devices during transcatheter aortic valve replacement procedures, according to a new Medscape report. Results from a meta-analysis of 1,285 patients indicated that the use of embolic protection devices during TAVR procedures did not reduce mortality, but was associated with a lowered rate of stroke at 30 days, according to the report. The decline was mainly driven by registry data and was not confirmed by randomized controlled trials, Medscape specified. Stroke was repo...
Source: Mass Device - May 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Claret Medical Inc. Source Type: news

Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 70 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 28 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 569 Total Active: 422 Total On Hold: 147 Summary of All PMA Submissions Originals: 5 Supplements: 90 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 70 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 229.0 FDA Time: 130...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news

No-touch ’ heart bypass surgery reduces strokes
Four surgical methods of coronary artery bypass grafting with increasing degrees of aortic manipulation. Percentages pictured represent the relative decrease in risk of perioperative stroke using anOPCABG compared to the other techniques. [Image from the researchers]]A recent study from the University of Sydney and Sydney Heart and Lung Surgeons has shown that a new “no-touch” beating heart bypass surgery technique has reduced post-operative stroke by 78%. The procedure, known as an OPCABG, also reduced post-operative mortality by 50% compared to traditional coronary artery bypass grafting. It reduced renal failure by ...
Source: Mass Device - May 17, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular CABG MedTech Sydney Heart and Lung Surgeons University of Sydney Source Type: news

EuroPCR 2018 Roundup: Medtronic touts BP reductions, no major adverse events in renal denervation trial
Medtronic (NYSE:MDT) today released six-month results from a trial of its Symplicity Spyral renal denervation system exploring its use treating hypertensive patients who are already taking anti-hypertension medications, touting significant reductions in blood pressure and no major adverse safety events. Results were presented at the 2018 EuroPCR annual meeting in Paris and were published in The Lancet. In the trial, patients were prescribed up to three anti-hypertensive medications, including diuretics, calcium channel blockers, ACE/ARB inhibitors or beta blockers, the Fridley, Minn.-based company said. Patients were then...
Source: Mass Device - May 23, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Cardiac Implants Cardiovascular Clinical Trials Abbott Medtronic ReCor Medical Source Type: news