Renal denervation: Medtronic, St. Jude vie for lion's share of billions
Renal denervation devices could be worth about $3 billion within the decade, a gleaming opportunity for companies slogging through slumping demand for banner businesses like heart and spine devices.
Boston Scientific ($BSX), Covidien ($COV) and ReCor Medical all have renal denervation technologies on the market overseas, but none has specified a timeline for FDA approval. So, for now, cross-town rivals Medtronic ($MDT) and St. Jude Medical ($STJ) are the furthest along in the race to cash in on the innovative treatment, amassing data to secure future FDA approvals. And while Medtronic has a definite head start, St. Jude believes it has the know-how to catch up in a hurry and contend for a share of the next big thing in medical devices.
Medtronic is running a total of 6 trials around the world on its Symplicity device, designed to lower blood pressure by deadening nerves in the renal artery, and this month the company asked for the FDA's blessing in launching a 7th that would study patients with less severe hypertension. Medtronic will roll all that data together when it heads to the FDA for approval, which it expects in 2015.
Meanwhile, St. Jude is charting a similar path with its EnligHTN device, working through three overseas studies to demonstrate the device's safety, chart its effectiveness in lowering blood pressure and gather data on whether the device can help patients in ways beyond hypertension. St. Jude has yet to kick off its FDA-targeted trial, but the company says it is in talks with the agency and plans to start enrollment later this year.
Which company reaps the most cash out of the innovative therapy is likely to be decided by physicians and payers, and the two have already hit the ground running, angling to establish their devices as the safest and most effective. We talked to executives from Medtronic and St. Jude to find out what sets the technologies apart.