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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

Gore wins expanded indications for Cardioform septal occluder
W.L. Gore & Associates said today it won expanded FDA indications for its Cardioform septal occluder, now cleared for the closure of patent foramen ovale to reduce the risk of recurrent ischemic stroke in certain patients. The expanded application was supported by results from the Reduce study, which the Newark, Del.-based company said showed that closure of PFOs could significantly prevent recurrent ischemic stroke regardless of PFO anatomy. “With the FDA approval of the Gore Cardioform septal occluder for PFO closure, we can now provide physicians with one device that can be used for both ASDs and PFOs. The val...
Source: Mass Device - April 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance W.L. Gore & Associates Source Type: news

How Genomic Research is Changing Heart Care
Genomic testing is most frequently associated with cancer testing, but this area of research is beginning to make an impact on cardiovascular care. A recent scientific statement by the American Heart Association shined a spotlight on how the expressed genome can potentially be used to diagnose diseases and predict who will develop diseases such as coronary artery disease (CAD), stroke, heart failure, and arrhythmias. According to the statement, scientists now have the ability to address disease at many levels that were inaccessible during the past century. This includes the genome, transcriptome, epigenome, proteome, metab...
Source: MDDI - October 27, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: IVD Cardiovascular Source Type: news

Medtronic readies pivotal trial in renal denervation
Medtronic (NYSE:MDT) said today that it’s ready for a run at FDA approval for renal denervation in treating high blood pressure, more than three years after the failure of a high-profile clinical trial. Back in January 2014, Fridley, Minn.-based Medtronic shocked medtech when it announced that the highly anticipated Symplicity HTN-3 trial, examining ablation of the around the renal arteries in treating hypertension, failed to meet its efficacy endpoint. The company suspended enrollment in its other Symplicity trials around the world and later took a $200 million write-down on its renal denervation assets. News of th...
Source: Mass Device - August 28, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Wall Street Beat Medtronic Renal Source Type: news

ESOC 2017 Roundup: Gore touts lowered ischemic stroke, new brain infarcts in PFO Occluder test
W.L. Gore & Associates yesterday released results from the Reduce study of its Cardioform Septal Occluder devices used to close patent foramen ovale, touting a reduction in recurrent ischemic strokes and new brain infarcts. The Gore Cardioform Septal Occluder is designed to be inserted via catheter and is currently cleared by the FDA for closure of atrial septal defects. “It is of the utmost importance to us to be transparent and share clinical data as quickly as possible. We completed our two-year primary endpoint follow-up with patients in March and have worked diligently to release these important data to the ...
Source: Mass Device - May 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Stryker W.L. Gore & Associates Source Type: news

InVivo Therapeutics Q2 meets the street, shares stay steady
InVivo Therapeutics (NSDQ:NVIV) shares stayed steady after the company released 2nd quarter earnings that met the street on losses per share. The Cambridge, Mass.-based company reported losses of $5.2 million, or 16¢ per share, for the 3 months ended June 30, 2016. That amounts to a 50% reduction in losses for InVivo Therapeutics compared with same period in 2015. After adjusting to exclude 1-time items, losses per share were 18¢, a good tick below what analysts on Wall Street were looking for with expectations set fro losses of 22¢ per share. “The 2nd quarter was one marked by continued advancements and outreach...
Source: Mass Device - August 5, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Neurological Spinal InVivo Therapeutics Corp. Source Type: news