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.
|Medtronic Vice President Nina Goodheart|
Medtronic considers itself the standard-bearer for renal denervation, Vice President Nina Goodheart said, and the company's 530-patient pivotal trial has the chance to put the treatment on the map.
"What we're hearing from physicians is that they're really seeing that as a global trial, even though it's in the U.S.," Goodheart said. "People are really looking to that trial to prove renal denervation's value."
And the early results have been more than promising. In 24-month data released at the American College of Cardiology's annual summit last week, Medtronic's Symplicity sustained an average 31-mmHg drop in systolic blood pressure after follow-up. Those results all go into Medtronic's registry of the more than 5,000 patients who have been treated with Symplicity around the globe, a pool of positive data Medtronic is counting on to keep the device on top abroad.
"Symplicity has been on the market the longest and has the most robust data set," Goodheart said. "We haven't seen a huge amount of commercial activity around the other devices. What physicians are telling us is that Symplicity is still a leader in the market, and our intention is to keep it there."
|St. Jude Cardiovascular President Frank Callaghan|
But St. Jude is right on its heels, Cardiovascular President Frank Callaghan said. In the first trial of EnligHTN, the device demonstrated an immediate systolic pressure reduction of 28 mmHg and sustained a 26-mmHg decrease through 6 months. Now the company is looking to expand on those data with a second, larger study overseas that will loop in patients with less-severe hypertension, Callaghan said.
"Now we're starting to get into a much broader patient population," he said. "We'll start to see a lot of ordinary patients that doctors see on a daily basis," and posting excellent results in that group will likely help grow EnligHTN's market share and expand indications for the device.
St. Jude's latest gambit is the EnligHTNment trial, designed to look at how its device can benefit patients beyond just treating hypertension. Uncontrolled hypertension puts people at risk for heart attack and stroke, and, in the first study of its kind, St. Jude is out to prove that EnligHTN can make a meaningful difference in the rates of major cardiac events.
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And that's where the money is, Callaghan said. EnligHTNment has the chance to prove that renal denervation is more than just a treatment for high blood pressure, and positive data in preventing heart attack, stroke and death could help make it the standard of care, he said.
"As we look forward and we think about what is it going to take for renal denervation to become a real, mainstream therapy available to large numbers of patients around the world, we've ultimately got to get to demonstrations of impact on key metrics of cardiovascular morbidity and mortality," Callaghan said. "When you look at our clinical evidence program, it moves toward stuff that's really going to be impactful."
'Ease of use is a big deal'
Just whose device has the widest-ranging long-term benefit remains to be seen. In the present, however, Medtronic and St. Jude are working to woo physicians abroad to implement their devices, and St. Jude says it has a leg up in both convenience and procedure time.
Symplicity uses a single electrode to ablate nerves in the renal artery, moving up and down the vessel with a mean procedure time of 38 minutes. EnligHTN, on the other hand, is tipped with a basket of four evenly spaced electrodes, allowing it to ablate all the way around the artery without the risk of putting lesions in the same place. That design lets it do the same job as Symplicity in as little as 12 minutes, Callaghan said.
"Ease of use is a big deal," he said. "It's a multi-electrode system, which makes it easier to use and probably contributes to the really strong data that we're getting from our trial."
But Medtronic plans to slash procedure times with the second generation of Symplicity, which Goodheart said the company will start marketing this summer. The new device will use four electrodes arrayed in a spiral, a design Goodheart says will make for a speedier, more predictable renal denervation process.
St. Jude's not sitting pat either. Callaghan said a next-gen EnligHTN is in the works, too, and the new device will be able to fire all its electrodes at the same time, treating the whole artery in around 60 seconds.
|St. Jude Medical's EnligHTN|
'A real chance of becoming the standard of care'
The two device magnates agree on at least one thing, though: Renal denervation has a bright future. Every 20-mmHg decline in blood pressure cuts the risk of major cardiovascular events in half, Callaghan said, and continued positive results from devices like EnligHTN and Symplicity have the potential to change the way the healthcare industry thinks about hypertension.
And the market for the treatment is only going to grow. By 2025, there will be about 1.5 billion people with some form of hypertension, Goodheart said.
"This is clearly an unmet need that's looking for new treatment strategies, and we think renal denervation has a real chance of becoming the standard of care," she said.
Analysts figure the market for devices like Symplicity and EnligHTN will soar past $2.8 billion by 2020, and, by then, Medtronic and St. Jude will likely have to contend with Boston Scientific, Covidien and any other newcomer for the biggest share of that sum.
Goodheart says Medtronic has worked tirelessly to demonstrate Symplicity's value around the world, running studies in India and Japan designed to spread the device's reach. Adding that to a continuous stream of positive results from its pivotal trial and the likelihood that Symplicity will be the first renal denervation technology on the U.S. market, Medtronic likes its chances of holding on to the lead.
But St. Jude is hardly planning to settle for second place. The company has blazed a quick trail to overseas commercialization, Callaghan said, and, considering EnligHTN's core technology is well within the company's wheelhouse, St. Jude figures it will continue to advance ahead of schedule.
"This is not a foreign concept to us," Callaghan said. "We build electrode ablation catheters. We're intimately familiar with the ablation of tissues. This program really is the culmination of bringing together all the core competencies we have throughout the company."
Callaghan points out that EnligHTN is an in-house innovation for St. Jude, whereas Medtronic spent $800 million on Ardian to acquire Symplicity back in 2010.
But how each player got to the table is unlikely to matter much when the two devices go head to head in the U.S. Instead, all the angling over renal denervation will come down to who has the most effective technology at the best cost. We'll just have to wait and see.
-- Damian Garde (email | Twitter)