Medtronic (NYSE:MDT) has announced data from a study demonstrating a significant reduction in blood pressure with the Symplicity Renal Denervation System.
The SYMPLICITY HTN-3 clinical trial observed subjects who underwent radiofrequency renal denervation (RF RDN) with first-generation Symplicity. The results demonstrated a statistically significant reduction in office and outpatient blood pressure compared to a sham control group.
Medtronic’s minimally invasive RDN procedure delivers radiofrequency energy to specific nerves near the kidneys that can become overactive and cause high blood pressure.
Data, presented at 34e Transcatheter Cardiovascular Therapeutics (TCT) conference in Boston, was also published in The Lancet.
SYMPLICITY HTN-3 evaluated 535 patients with treatment-resistant hypertension, randomized 2:1. After six months, 101 patients in the sham arm underwent RDN treatment. At three years, the RDN group showed a 26.4 mm Hg reduction in office systolic blood pressure. This compared to a reduction of 5.7 mm Hg in the sham group.
Patients experienced a 15.6 mm Hg reduction in 24-hour ambulatory systolic blood pressure in the RDN group. The sham group produced a reduction of 0.3 mm Hg.
A total of 535 patients with treatment-resistant hypertension were randomized in a 2:1 ratio between RDN (n=364) and sham control (n=171). After six months, 101 patients from the sham control group were treated with RDN (crossover group). When performing a longer-term analysis with all available data and accounting for control crossover patients using their last observation carried forward (imputation), the three-year results are as follows:
On average, 17.5% of RDN patients spent time in the target range, compared to 8.2% in the sham group. Medtronic stated that Symplicity demonstrated long-term safety consistent with expected outcomes for the patient population.
“These results provide important insights into the evolution of patients’ blood pressure control, with and without renal denervation, in a scenario closer to the real world – under the daily management of a physician without the frequent follow-up visits and monitoring that occur in research settings,” said Dr. Deepak L. BhattExecutive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School and co-principal investigator of the trial.
Bhatt said the results show that for some patients with high blood pressure, it remains poorly controlled. This puts them at risk for cardiovascular complications such as strokes, he added.
Medtronic found “much to learn” in trial data
“Although we did not find a significant difference in blood pressure reduction over six months between RDN and sham in HTN-3, we felt there was much to learn by following HTN-3 patients for a longer period, especially in sham patients with sustained elevations in blood pressure that have ‘passed’ to RDN,” said Dr. Jeffrey Popma CMO for the Coronary & Renal Denervation business and the Structural Heart & Aortic business at Medtronic. “Using standard imputation methods for comparison of BP in crossover patients, we were delighted to see a sustained benefit in blood pressure reduction over three years in HTN-3 patients treated with RDN.
“This study adds important additional information to the totality of evidence now supporting the long-term effect of RDN in patients with hypertension. Documentation of medication compliance and improvements to the new Spyral catheter may have the potential to further influence clinical outcomes in patients enrolled in the SPYRAL study portfolio.
Medtronic is committed to advancing treatment
Jason Weidman, senior vice president of Medtronic and president of the Coronary & Renal Denervation business, added that the data provides “a better understanding” of long-term patient behavior and RDN impacts.
“We remain deeply committed to this complementary hypertension treatment option and look forward to data from additional studies, including the SPYRAL HTN-ON MED extension trial, which we plan to have at the Scientific Sessions. from the American Heart Association, subject to acceptance,” Weidman said. .
Medtronic’s Symplicity Spyral Renal Denervation is available in more than 60 countries. However, it remains experimental in the United States, as well as in Japan and Canada.
In May, the company presented data demonstrating the benefits of the Symplicity blood pressure procedure with Simplicity Spyral. Analysts remained optimistic about Medtronic’s RDN treatment, despite news last year that it was to continue its Spyral HTN-ON MED trial this year after failing to obtain the positive results needed to end the trial early. registration for the potential treatment of hypertension.
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