Medtronic has initial positive blood pressure reduction system results

Medtronic announced first-ever-data from the SPYRAL HTN-ON MED Study. Initial study results found statistically significant and clinically important blood pressure reductions in hypertensive patients prescribed anti-hypertension medications treated with the Symplicity Spyral renal denervation, or RDN, system with no major adverse safety events out to six months. The Late-Breaking Trial data, presented at the 2018 EuroPCR Annual Meeting in Paris, was published simultaneously in The Lancet. The Symplicity Spyral system is investigational in the United States and Japan. At six months, patients randomized to the renal denervation procedure experienced an average 9 mm Hg drop in 24-hour mean systolic ambulatory blood pressure, or ABPM, resulting in a 7.4 mm Hg difference compared to patients in the sham control arm. For RDN patients, 24-hour mean diastolic ABPM also declined 6 mm Hg, which is 4.1 mm Hg lower than the sham control arm. Likewise, average office systolic blood pressure, or OBP, in patients in the RDN arm declined 9.4 mm Hg – a 6.8 mm Hg difference from the sham control arm, and the diastolic OBP declined 5.2 mm Hg, a 3.5 mm Hg difference from the sham control arm

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