|Medtronic is planning to study its Symplicity device on patients with less-severe hypertension.--Courtesy of Medtronic|
Renal denervation has wowed researchers and analysts with its effects on severely hypertensive patients, but the starry-eyed projections of the technology's eventual market size hinge on it benefiting the millions around the world with less severe high blood pressure. Now, Medtronic ($MDT) is on the verge of a U.S. study to see how its market-leading Symplicity device works on patients with moderate uncontrolled hypertension, the first randomized, controlled clinical trial to do so.
Medtronic won FDA approval to enroll up to 580 patients with treatment-resistant hypertension and systolic blood pressure between 140 mmHg and 160 mmHg, looking for whether the nerve-deadening Symplicity can reduce pressure while limiting rates of renal artery stenosis. To date, randomized renal denervation trials have focused only on patients north of 160 mmHg, and none of the systems on the market are approved for more moderate cases of hypertension.
"This highly-anticipated, robust study will serve a key role in evaluating renal denervation in these underserved patients with less severe hypertension so that we're able to understand what benefit this novel therapy may offer patients outside of the currently indicated patient population," co-principal investigator Michael Weber said in a statement. Medtronic estimates that roughly 27 million people around the globe have moderate drug-resistant high blood pressure.
The latest trial will run in tandem with Medtronic's pivotal U.S. study, now in the patient follow-up stage, making for 9 total Symplicity trials including one in India, one in Japan and one for the next-generation Symplicity Spyral.
Medtronic expects to have pivotal data in hand in the first half of 2014, and the company is still on track for an expected 2015 FDA approval, which would make it the first on the U.S. market among the world's renal denervation players. And, if all goes according to plan, Symplicity will hit the ground running with CMS coverage and an indication for more moderate patients.
Meanwhile, St. Jude Medical ($STJ), Boston Scientific ($BSX) and Covidien ($COV) are in various stages of developing their CE-marked technologies, angling for spots at cardiovascular conferences with promising data on blood pressure reduction. St. Jude would appear to be first behind Medtronic on the road to the U.S., launching an FDA-targeted trial in June.
Symplicity, which Medtronic picked up in its $800 million buyout of Ardian in 2010, has been CE marked since 2008.
- read the release
Special Report: Renal denervation: Medtronic, St. Jude vie for lion's share of billions