|St. Jude Medical says its EnligHTN renal denervation device is more effective than its competitors--courtesy of St. Jude Medical|
St. Jude Medical's ($STJ) renal denervation device, EnligHTN, reduced blood pressure in patients by 28 mmHg over 30 days and remained stable over three months, according study results released Tuesday.
That's double the pressure reduction offered by competing devices in the same time frame, St. Jude says, claiming EnligHTN is the best bet for drug-resistant hypertension.
In study results unveiled at the annual European Society of Cardiology, St. Jude treated 46 patients with EnligHTN, all of whom came in with an average blood pressure of 176/96 mmHg (normal is below 120/80 mmHg) despite being on three antihypertensive medications. After undergoing the renal denervation procedure with the device, patients experienced an average 22 mmHg drop in blood pressure upon leaving the hospital and another 6 mmHg drop at the study's 30-day milestone.
"The risk of cardiovascular death is cut in half with every 20 mmHg decrease in systolic blood pressure, so it is a tremendous benefit to patients that the EnligHTN renal denervation technology is able to reduce blood pressure very rapidly at one month and sustain that reduction," said Costas Tsioufis, a cardiology professor at University of Athens and the study's primary investigator.
The new data comes as St. Jude fights for renal denervation primacy in Europe. Also on the market overseas are Medtronic's ($MDT) Symplicity, Covidien's ($COV) OneShot and Vessix Vascular's Vessix V2, and each company is engaged in post-market studies to demonstrate its device's superiority. Late to the game is Boston Scientific ($BSX), which plans to get a CE mark for its device in 2013.
Considering the money at stake, it's no surprise everyone wants in on the market. Analysts have said annual sales for the techs could reach $2.8 billion by 2020. And experts say that if the positive results keep rolling in, the devices will likely get expanded indications for all varieties of hypertension, not just the drug-resistant sort.
For now, the devices are only available in Europe, but Medtronic is engaged in a large IDE study seeking FDA approval, which it expects in 2015. If Symplicity gets approved stateside, we can expect to see similar filings from the rest of the players.
- read St. Jude's release
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