Symplicity Spyral Renal Denervation Catheter Reduces Procedure Time/Blood Pressure
At EuroPCR 2013, being held from 21st to 24th May, in Paris, France, preliminary results from the feasibility study of Medtronic's Symplicity Spyral multi-electrode, 6 Fr renal denervation catheter, showed safe, significant blood pressure reduction at one month in patients with treatment-resistant hypertension. Additionally, patients who had the renal denervation procedure with the catheter (n=29) had a mean procedure time of 21 minutes, a decrease of 33 minutes from the mean procedure time for the Symplicity Flex single-electrode catheter shown in the Symplicity HTN-2 trial. Nearly all of the patients in the one-month analysis had a radiofrequency (RF) treatment time of one minute per artery; two of the 29 patients received more than one treatment in a single artery.
The Symplicity Spyral catheter feasibility study is prospective, single-arm, non-randomised and will enrol approximately 50 patients at sites in Australia and New Zealand. The study's primary endpoint is acute procedure safety associated with the delivery and/or use of the catheter. Its primary effectiveness endpoint is change in office blood pressure from baseline at six months.
At one month, patients in this study experienced an average blood pressure reduction of -16/-7 mm/Hg (p<0.001) from baseline. These results are consistent with the efficacy data seen in the Symplicity HTN-1 feasibility study for the Symplicity Flex single-electrode catheter, which showed an average blood pressure reduction of -19/-9 mm/Hg (p<0.01; n=143) after one month follow-up. Furthermore, average heart rate reduction for patients in the study was -4.3+/-11.0 beats per minute from baseline (p=0.047) to one month; pulse pressure also improved significantly following treatment with a reduction of -8.8+/14.9 mm/Hg (p<0.004).