Preliminary findings from a study of the Enlightn system found that patients with hypertension saw a 28 point reduction in blood pressure after 30 days.
"The risk of cardiovascular death doubles with every 20 point increase in systolic blood pressure, so an average blood pressure reduction of 28 points is quite significant and demonstrates just how effective the technology is," principal investigator Prof. Stephen Worthley said in prepared remarks. "From other clinical trials studying the impact of renal denervation we have learned that blood pressure continues to be reduced over time, so I would not be surprised to see this trend continue and see an even greater benefit for patients."
St. Jude’s study included 47 patients with high blood pressure that wasn’t managed with drug therapy.
Participants had an average of 176/96 mmHg baseline blood pressure, despite taking multiple medications, before the denervation procedure and an average of 148/87 mmHg after. More than 40% had systolic rates below 140 mmHg, according to a press release.
St. Jude won CE Mark approval in the European Union for the Enlightn system and announced commercial launch earlier this week.
The Enlightn system will compete against some big players, including Medtronic’s Symplicity which is on the road to FDA review with clinical trials approved in the U.S. last summer. The device has CE Mark approval and TGA listing in Australia, and last month won clearance from Health Canada.
Fellow med-tech giant Covidien (NYSE:COV) recently vaulted into the renal denervation space with a surprise introduction of its OneShot system, which also has CE Mark approval in the European Union. The OneShot system was gained through the acquisition of Maya Medical late last month in a deal worth up to $230 million.
St. Jude this week also announced that it will provide updates on the ongoing study of its Portico transcatheter aortic valve implantation technology, which is slated for a limited European launch in 2012, according to a press release.