Medtronic looks to be back on track with its renal denervation plans, after announcing its Symplicity Spyral system got off to a good start with positive six-month results in the SPYRAL HTN-ON MED pilot study. The data, presented at EuroPCR 2018 in Paris, showed that Symplicity Spyral was able to reduce blood pressure significantly in hypertensive patients prescribed anti-hypertension medications, with no major adverse safety events out to six months.
Positive six-month results, the first-ever data from Medtronic PLC's SPYRAL HTN-ON MED pilot study of its Symplicity Spyral renal denervation (RDN) system, hold the promise of setting the medtech giant back on track and toward a market opportunity worth billions of dollars.
The study results, announced May 23 at EuroPCR in Paris, showed that Symplicity Spyral reduced blood pressure significantly in hypertensive patients who were prescribed anti-hypertension
King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.
The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.
SS Innovations announced plans to file a de novo application with the US FDA for its SSi Mantra 3 surgical robot, already approved for marketing in six countries. The Florida-based firm also plans to pursue the CE mark for European commercialization.
“It’s quite likely [consumer wearable manufacturers] are changing the sensitivity and specificity based on consumer feedback, but not for medical reasons,” said Dipak Kotecha, a University of Birmingham professor of cardiology. Often, self-reported performance evidence from manufacturers is “low quality and biased.”
The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.
Despite Danaher’s confident outlook, the company acknowledged near-term profitability fluctuations, particularly in the second quarter. Matt McGrew, Danaher’s CFO, clarified during the company’s first-quarter earnings call on 22 April, that expected operating margin softness in the second quarter – forecast at 25.5% – was not related to tariffs, but to seasonal dynamics in its respiratory diagnostics business.
After publishing encouraging results from first-in-human trials of its brain-computer interface, Axoft announced plans to sell its BCI-enabling material Fleuron to researchers and private organizations for R&D use. The company sees this as a revenue stream and feedback loop to refine its BCI platform designed for safer, longer-lasting brain implants.
