Medtronic (NYSE:MDT) today released six-month results from a trial of its Symplicity Spyral renal denervation system exploring its use treating hypertensive patients who are already taking anti-hypertension medications, touting significant reductions in blood pressure and no major adverse safety events.
Results were presented at the 2018 EuroPCR annual meeting in Paris and were published in The Lancet.
In the trial, patients were prescribed up to three anti-hypertensive medications, including diuretics, calcium channel blockers, ACE/ARB inhibitors or beta blockers, the Fridley, Minn.-based company said. Patients were then randomized, with one arm receiving treatment with the Symplicity Spyral renal denervation system and one arm receiving a sham treatment.
Data indicated that patients who received the renal denervation procedure had an average 9 mm Hg drop in 24-hour mean systolic ambulatory blood pressure at six months, which equals a 7.4 mmHg difference compared to patients in the sham control arm. Renal denervation patients also reported a 24-hour mean diastolic ABPM drop of 6 mm Hg, 4.1 mm Hg lower than those in the sham control arm, Medtronic said.
Average office systolic blood pressure in patients who received treatment with the Symplicity system dropped 9.4 mm Hg, 6.8 mm Hg lower than those in the sham control arm. Diastolic OBP also declined 5.2 mm Hg, 3.5 mm Hg different than the control arm.
“Data from the Spyral HTN-On Med study is important for the clinical community and for patients with hypertension as it represents a typical scenario of managing uncontrolled hypertension patients, prescribed up to three blood pressure medications. With these new results, mirroring those of the parallel Spyral HTN-Off Med trial, we have convincing evidence at six months showing the continued safety and efficacy of RDN in both the presence and absence of blood pressure medication,” co-principal investigator Dr. David Kandzari of Atlanta’s Piedmont Heart Institute said in a press release.
Data from an analysis of cyclical hourly changes in blood pressure showed that blood pressure lowering effects of the renal denervation procedure were distributed throughout the day, and more importantly at night, when Medtronic claims that blood pressure control is more critical due to higher risk of adverse events including heart attack and stroke.
“We are encouraged by these data showing the procedure may enable a blood pressure lowering effect 24 hours a day. RDN is essentially ‘always on’ even when the effect of medications may be subsiding between doses. These data also show that treatment with RDN in the main renal artery and branches with the Spyral System can help reduce blood pressure,” co-principal investigator Dr. Raymond Townsend of the Hospital of the University of Pennsylvania said in a prepared statement.
Drug testing of patients in the trial indicated that adherence to their prescribed anti-hypertensive medication was “inadequate,” Medtronic said, with only 60% of patients taking the medication as prescribed.
In response to the six-month results, the company’s Spyral HTN clinical program, including the On and Off Med trials, has moved into its final pivotal phase, Medtronic said.
“These positive outcomes, taken together with the already presented Off Med data, and the recent initiation of our Spyral HTN Pivotal Trial, are strong indicators that RDN may one day play a significant role in helping to address the hypertension epidemic that more than one billion patients face around the world,” coronary & renal denervation biz GM Dave Moeller said in a prepared release.
Earlier this month, Medtronic released data from a clinical study of an algorithm used with its Micra transcatheter pacing system, touting that it has the potential to restore atrioventricular synchrony and improve cardiac function in patients with sinus rhythm and AV block.
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