Medtronic Presents Three-Year Data From SYMPLICITY HTN-2

(RTTNews) - Medtronic Inc. (MDT) presented three-year data from SYMPLICITY HTN-2, the first and longest-running randomized, controlled clinical trial of renal denervation, which continue to demonstrate results consistent with data reported previously at six, 12 and 24-months of follow-up.

The company said the data shows significant and sustained drops in blood pressure after Treatment with the Symplicity Renal Denervation System.

The company noted that the Symplicity renal denervation system is available for investigational use only in the United States.

In a separate press release, Medtronic said CoreValve U.S. pivotal trial affirms benefits of self-expanding Transcatheter Aortic valve replacement in patients treated via alternative access routes.

As part of the Extreme Risk Study, 146 patients were treated via alternative access approach after extensive screening showed they were considered too ill or frail to have their aortic valves replaced through traditional open-heart surgery, and were ineligible for the more common transfemoral transcatheter aortic valve replacement or TAVR. Through one year these patients demonstrated high rates of procedural success and valve performance that were consistent with transfemoral patients, the company said.

According to the company, the strong clinical results were achieved in spite of statistically significant differences between transfemoral and alternative access patients, which showed an increased presence of peripheral vascular disease (35.3 percent vs 61.6 percent, p.

The major stroke rate was 6.3 percent at one month, which trended higher than patients receiving the device via femoral artery (2.4 percent), but lower than previously reported rates; moreover, in the CoreValve Continued Access Study, alternate access patients had a rate of major stoke of 2.3 percent at one month.