Medtronic’s SPYRAL HTN-ON MED study demonstrated that Symplicity Spyral renal denervation (RDN) system has reduced blood pressure in hypertensive patients taking anti-hypertension medications.
The company is assessing the efficacy and safety of the Symplicity Spyral system at the centers in the US and Japan.
The late-breaking trial data showed that the patients randomized to the renal denervation procedure experienced an average 9mm Hg drop in 24-hour mean systolic ambulatory blood pressure (ABPM) at six months, resulting in a 7.4 mm Hg difference compared to patients in the sham control arm.
Similarly, the average office systolic blood pressure (OBP) in patients in the RDN arm turned down to 9.4mm Hg, a 6.8mm Hg difference from the sham control arm.
The diastolic OBP decreased by 5.2mm Hg, a 3.5mm Hg difference from the sham control arm.
The subjects in the study have been prescribed a stable regimen of up to three anti-hypertensive medications, including diuretics, calcium channel blockers, ACE /ARB inhibitors or beta blockers.
Drug testing showed that adherence to prescribed anti-hypertensive medication was inadequate as only about 60% of patients were determined to be taking medications as prescribed, which is similar to recent studies of uncontrolled hypertension.
The clinical program is said to use the firm’s next-generation renal denervation technology, which includes 6 Fr guide catheter compatible Symplicity Spyral multi-electrode renal denervation catheter and Symplicity G3 renal denervation RF (radiofrequency) generator.
Medtronic cardiac and vascular group’s coronary and renal denervation business general manager and vice president Dave Moeller 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.”